Mindfulness-Based Blood Pressure Reduction (MB-BP) Stage 1 Single Arm Trial: Acceptability and Feasibility Study; Additionally Exploring the Preliminary Effects on Self-Regulation Targets, Including Self Awareness, Emotion Regulation and Attention Control
Phase: NA
Conditions: Prehypertension, Hypertension
Sponsor: Brown University

 
 
 
 
FULL PROTOCOL TITLE 
Mindfulness-Based Blood Pressure Reduction (MB-BP) Study 
 
Study Chairman or Principal Investigator: 
Eric B. Loucks, PhD 
Assistant Professor, Department of Epidemiology 
Brown University School of Public Health 
 
Supported by:  
The National Center for Complementary and Integrative Health 
1UH2AT009145-01 
 
 
 
 
 

A NOTE TO READERS: 
v.2019.01.11 
 
This document is to serve as a supporting information file to the PLOS ONE manuscript titled, 
Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 Single-Arm Clinical Trial. The 
study protocol that is found with the following pages contains the complete and detailed plan (in 
its original language as it was submitted) for the conduct and analysis of the trial that the ethics 
committee (i.e., Brown University Institutional Review Board (IRB)) approved before the trial 
began. 
 
The original protocol that was submitted to the Brown IRB on December 5, 2014 was a pilot 
study and precursor to the MB-BP Stage 1 Single Arm Clinical Trial funded by the NCCIH. In 
September 2015, the study PI (Loucks) was awarded a five year NIH UH2/UH3 grant (1 UH2 
AT009145-01 entitled “Mindfulness Influences on Self-Regulation: Mental and Physical Health 
Implications”). With this funding, the pilot study approved by the Brown IRB was amended to 
match the proposed single arm trial approved by NCCIH. Data from the NIH-funded study are 
presented in this paper. Data from the pilot study are not, as primary outcomes were different 
between studies.  
 
The Brown IRB reviews and approves modifications to study protocols through the use of stand-
alone modification submission forms. That being said, the IRB approved study protocol for 
Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 Single-Arm Clinical Trial is the 
conglomeration of the original submission along with all approved modification submissions 
included in this report.  
 
To assist in navigating, please use the hyperlinked table found on the proceeding pages. 
 
Additional questions can be directed to the study investigator: Eric_Loucks@brown.edu. 
 
 
 
 
 

Mindfulness-Based Blood Pressure Reduction (MB-BP) Study: Brown University 
IRB Submission History and Summary of Protocol Amendments 
For additional detail on protocol revisions and/or for a copy of the full IRB amendment submissions, 
with Study PI Signature, contact the Senior Project Coordinator, Frances_Saadeh@brown.edu or study 
PI, Eric_Loucks@brown.edu.  
 
IRB 
Submission # 
Submitted 
Approved 
Stage 
Summary of Submission / Protocol Revisions 
Original 
Submission 
12/5/14 
3/12/15 
Pilot 
The project was submitted to the Brown IRB in 
December 2014. The IRB requested three iterations of 
revisions to the submission prior to granting approval. 
These revisions were submitted: 1/5/15, 2/10/15, and 
2/19/15. 
Amendment #1 
4/8/15 
7/1/15 
Pilot 
This amendment dated 6/17/15, (originally submitted 
4/8/15) includes changing the survey software to 
Qualtrics, updating the phone screening questionnaire, 
clarifying the study safety  plan, modifying the consent 
form, adding questionnaires to the baseline survey, and 
modifying  recruitment procedures. 
Amendment #2 
7/15/15 
8/6/15 
Pilot 
This amendment dated 7/15/15 (revised and re-
submitted on 8/5/15) included: The addition of a  new 
participant population (NEFS sub-set) and new 
recruitment procedures for that population,  revisions to 
the In-person Screening Assessments 1 and 2, revisions 
to wording of the phone  screening questionnaire, 
addition of a place for staff to note contact information on 
the safety plan  document, adding a version footer to the 
consent document. 
Amendment #3 
9/1/15 
9/3/15 
Stage 1 
This amendment dated 9/1/15 included the addition of a 
funding source (grant #1 UH2  AT009145-01, grant title: 
Mindfulness Influences on Self-Regulation: Mental and 
Physical Health  Implications), a change in scope of work 
and related study activities secondary data analyses  
involving concurrent studies, additional measures and 
study procedures, and revised informed  consent 
document. 
Amendment #4 
11/11/15 
1/7/16 
Stage 1 
This amendment (dated: 11/11/2015) requests approval 
to (a) add compensation, (b) add a NIH  safety 
monitoring plan, (c) update the names and content of the 
phone screen and assessments,(d) add a 1-year follow-
up visit, and (e) update the consent document to 
incorporate these changes. 
Amendment #5 
2/26/16 
2/26/16 
Stage 1 
This amendment (dated: 2/26/16) requests approval to 
allow participants, who are not able to  come to the study 
site in person, the option to participate by online video 
conferencing. 
Amendment #6 
4/11/16 
5/9/16 
Stage 1 
This amendment (dated: 4/11/2016) requests approval to 
(a) change the study title; (b) revise the NCCIH Safety 
Monitoring Protocol; (c) separate the Baseline and 
Follow-up Assessments  into two visits; (d) change the 
data collection mode to Qualtrics for Daily Practice 
Forms and  Class questionnaires; (e) revise study 
recruitment material and use online advertising; (f) revise  
the in-class worksheets and assessments; and (g) revise 
the MB-BP Questionnaire, In-Person  Assessment, 
Home Assessment, and Measurement of Mindfulness 
Practices. 

IRB 
Submission # 
Submitted 
Approved 
Stage 
Summary of Submission / Protocol Revisions 
Amendment #7 
8/9/16 
9/13/16 
Stage 1 
Approval of the amendment (memo dated August 9, 
2016) includes the addition of 2 new  questions to the 
Home Baseline Assessment. 
Amendment #8 
5/15/17 
6/12/17 
Stage 2a 
This amendment (dated 5/15/2017) requests approval to 
(a) begin Stage 2a (previously called Stage 1b) to 
conduct the Randomized Controlled Trial with enhanced 
usual care. Stage 2a  comes with changes to the study 
flow, incentives, screening and eligibility, consent 
document,  phone screener, in-person screener, 
baseline in-person assessment, baseline-online home 
assessment, safety protocol, and study recruitment 
material. 
Amendment #9 
8/26/17 
10/13/17 
Stage 2a 
This amendment (dated: 8/28/2017) requests approval to 
(a) add an Infographic Card, (b)  add a Recruitment 
Card, (c) conduct a direct mailing at a partnering provider 
office, (d) add NIH Administrative Supplement funding to 
award #004754-001 "Mindfulness Influences on Self-
Regulation: Mental and Physical Health Implications," IP 
#17101586, and (e) update the  consent document with 
Certificate of Confidentiality language. 
Amendment 
#10 
11/6/17 
1/25/18 
Stage 2a 
and 
additional 
follow up 
for Stage 
1 
This amendment (dated: 11/6/2017) requests approval to 
(a) modify the approved focus group  discussion 
questions into a one-on-one qualitative phone interview, 
(b) re-contact Stage 1  participants for a 2-year in-person 
assessment, (c) rearrange compensation amounts, (d) 
add  recruitment for and data sharing from the UMass 
Medical School fMRI study, (e) add the "UMass  Medical 
School fMRI Study Recruitment Talking Points," (f) add a 
consent addendum for enrolled  participants to complete 
the phone interview, and (g) revise the approved consent 
to reflect the  appropriate changes. 
Amendment 
#11 
5/8/18 
6/13/18 
Stage 2a 
This amendment (dated: 5/8/2018) requests approval to 
(a) drop the 12 month and two year  follow-ups for Stage 
2a participants only; (b) reduce the number of home 
blood pressure readings  and drop the mandatory 
introduction session that is part of the course; (c) assist 
collaborators at  UMass Medical School with the initial 
screening and scheduling processes for their fMRI study; 
(d) conduct the 9-week mindfulness intervention off site 
in safe, community-based locations; (e) recruit from the 
partnership at Lifespan Emergency Department; (f) 
conduct qualitative interviews with low SES population to 
explore perceptions of and openness to mindfulness-
based interventions; and (g) update consent forms with 
new format. Also includes approval of revised phone 
screener (SCR-P, v.3.0 – 5/10/2018) 
Amendment 
#12 
8/7/18 
10/15/18 
Stage 2a 
Requested the following: 1) permission to conduct 
abbreviated 1 year follow-up assessment with the 
intervention arm of the study; 2) request to use a general 
release form to video-record mindfulness classes; 3) 
video-recording; 4) removal of the actigraph device; 5) 
additional questions for the 6 month follow-up 
assessment for control participants; 6) updated consent 
document (v.3.1 – 10/11/18); and 7) consent addendum 
for already enrolled participants. 
 
Amendment #8
(b) re-contact Stage 1  participants for a 2-year in-person
assessment,
(f) add a 
consent addendum for enrolled  participants to complete 
the phone interview,

 
 
 
 
 
 
 
 
 
                              
B R O W N U NI V E R SI T Y  
I N S TI T U TI O N A L R E VI E W B O A R D 
H U M A N R E S E A R C H P R O T O C O L  
 
 
Pr ot oc ol Titl e:        
 
Pri nci p al I n v e sti g at or:        
 
F u n di n g S o urc e  (if n o e xt er n al f u n di n g f or t h e pr oj e ct, e nt er "U ni v ersit y") :        
 
( 1) 
Att a c h t o t his f or m t h e i nf or m ati o n r e q uir e d f or a c o m pl et e pr ot oc ol, as o utli n e d o n t h e I R B F or m # 1 
I nstr u cti o n s a n d I nf or m ati o n p a g e s.  I n a d diti o n, pl e as e r e vi e w t h e d oc u m e nt “ W h at M a k es a C o m pl et e 
Pr ot oc ol ” ( a n a p p e n di x t o t h e ‘ Br o w n U ni v ersit y P olici es a n d Pr o c e d ur es f or t h e Pr ot e cti o n of H u m a n 
P arti ci p a nts i n R e s e ar c h’) at htt p: / /r e s e ar c h. br o w n. e d u /  a b o ut -br o w n -r es e ar c h / p oli ci e s /ir b-p oli ci e s -
pr o c e d ur es -p r ot e cti o n-h u m a n -p arti ci p a nts -r e s e ar c h.  
 
( 2) 
S el e ct t h e a p pr o pri a t e t y p e ( a n d c at e g or y n u m b er) of r e vi e w.  (S e e t h e f oll o wi n g p a g e s f or a d e s cri pti o n of t h e 
e x e m pt a n d e x p e dit e d c at e g ori e s.  If n o e x e m pt or e x p e dit e d c at e g ori e s c o m pl et el y d e scri b e t h e pr o p os e d 
r es e ar c h, s el e ct ‘ F ull B o ar d’. ) 
 
  E x e m pt #       
 E x p e dit e d #        
 F ull B o ar d 
  
( 3) 
Pri nci p al I n v e sti g at or C o nfli ct of I nt er e st St at e m e nt:    
 
( 1) H a v e y o u fil e d t h e a n n u al Ass ur a n c e of C o m pli a n c e f or m a n d, if n e c e ss ar y, a dis cl os ur e a s r e q uir e d b y t h e 
U ni v ersit y’s C o nflict of I nt er e st P oli c y f or Offi c ers of I n str u cti o n a n d R e s e ar c h ( htt p: / /r e s e arc h. br o w n. e d u /  
a b o ut -br o w n -r es e arc h / p olici e s / c o nflict-of -i nt er est-st at e m e nt) ? 
Y E S       
N O    
 
( 2) D o y o u h a v e a si g nifi c a nt fi n a n ci al i nt er est t h at is r el at e d t o t his r es e ar c h pr ot o c ol?              
                 
 
 
 
Y E S       
N O  
 
Pri nci p al I n v e sti g at or c ertifi e s t o t h e  f oll o wi n g:  ( 1) T h e ri g hts a n d w elf ar e of t h e p artici p a nts ar e a d e q u at el y 
pr ot e ct e d.  ( 2)  T h e ris k s t o a n i n di vi d u al ar e o ut w ei g h e d b y t h e p ot e nti al b e n efits t o hi m / h er or b y t h e i m p ort a nc e of 
t h e k n o wl e d g e t o b e g ai n e d.  ( 3)  T his pr ot o c ol is a cc ur at e an d c o m pl et e; a n d if t h e pr oj e ct sc o p e or d esi g n is l at er 
c h a n g e d, t h e PI will r e s u b mit f or r e vi e w.  ( 4)  All r e s e ar c h p ers o n n el, i ncl u di n g t h e PI, h a s b e e n, or will b e, a d e q u at el y 
e d u c at e d i n h u m a n r e s e arc h pr ot e cti o n s pri or t o b e gi n ni n g w or k o n t h e pr oj e c t.  ( 5)  W h er e a fi n a n ci al c o nflict e xists, 
t h e PI h a s dis cl os e d all r el e v a nt i nf or m ati o n r e g ar di n g C o nflict of I nt er e st a c c or di n g t o U ni v ersit y p olic y. 
  
Pri nci p al I n v e sti g at or si g n at ur e:  _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
D at e:  _ _ _ _ _ _ _ _ _ _ _ _ _  
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =  
( A d vis or’s si g n at ur e is r e q uir e d f or all gr a d u at e / m e dic al st u d e nt pr oj e cts.) 
A d vi s or c ertifi e s t o t h e f oll o wi n g:   A d vis or h a s r e a d t h e pr ot o c ol a n d a p pr o v es of t h e pr oj e ct. 
A d vi s or' s s i g n at ur e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
D at e:  _ _ _ _ _ _ _ _ _ _ _ _ _ 
Pri nt n a m e:         
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =  
U n d er gr a d u at e st u d e nt i n v e sti g at or s i g n at ur e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _         D at e:   _ _ _ _ _ _ _ _ _ _ _ 
Pri nt n a m e:                                                                             ( o pti o n al si g n at ur e) 
 
F or I R B Us e O nl y  
F U L L B O A R D P R O T O C O L S  - I nstit uti o n al R e vi e w B o ar d M e m b ers:  If a p pr o vi n g t h e pr o p os e d pr oj e ct, pl e a s e c ertif y 
t o t h e b e st of y o ur k n o wl e d g e t o t h e f oll o wi n g:  ( 1)  I R B M e m b er is f a mili ar wit h t h e a b o v e d e s cri b e d pr o p os e d 
r es e ar c h.  ( 2)  T h e ri g hts a n d w elf ar e of t h e r e s e ar c h p arti ci p a nts will b e a d e q u at el y s af e g u ar d e d b y t h e pr oc e d ur e s 
d es cri b e d.   ( 3)  T h e p ot e nti al b e n efits j ustif y t h e ris k s i n v ol v e d.  ( 4)  I R B M e m b er h as n o v est e d i nt er e st i n t h e pr oj e ct.  
I R B M e m b er Si g n at ur e:  _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
D at e:  _ _ _ _ _ _ _ _ _ _ _   
 
Si g n at ur e of t h e A ut h ori z e d Offi ci al of t h e I R B:  _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D at e:  _ _ _ _ _ _ _ _ 
I R B F or m # 1 ( R e v. 1 0 / 1 0) 
 
 X
 X
 X
1 2 / 5 / 2 0 1 4
 X
 X
X
12/5/2014

 
 
Protocol Checklist and Submission Procedures 
 
Protocol Checklist 
 
All protocols for IRB review (full board, expedited, or exempt) must be submitted in the following format.  
Protocols that do not follow this required format will be returned to the investigator without IRB review. 
 
#1 ___X__ 
IRB Form # 1 (fully signed) 
 
#2 ___X__ 
Required protocol components (pages must be numbered) (see “What Makes a Complete 
Protocol” for a more detailed description) 
 
#3 ___X__ 
Consent forms, including assent forms (if applicable) (pages must be numbered) 
 
#4 ___X_ 
Interview instruments/questionnaires (if applicable) (pages must be numbered) 
 
#5 ___X_ 
Recruitment documents (such as advertisements, flyers, cards) (if applicable) 
 
#6 _N/A_ 
Letters of commitment/approval from collaborating organizations (see “What Makes a Complete 
Protocol” for a more detailed description) (if applicable) 
 
#7 _N/A__ 
Copies of other IRB approvals (if applicable) 
 
#8 _N/A_ 
Checklist Form for Research Involving the Use of Prisoners as Study Participants (if applicable) 
 
#9 _N/A__ 
Complete application for outside funding/support (pages must be numbered) 
 
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 
 
Protocol Submission Procedures 
 
Full Board Protocols:  Submit the original and 11 copies of the complete protocol (as identified above) to the 
Research Protections Office, Box 1986 in sufficient time to meet the agenda deadline (see 
http://research.brown.edu/rschadmin/hrpo_meetingdates.php for upcoming IRB meeting dates and protocol 
deadlines). 
 
Exempt or Expedited Protocols: There is no specified deadline for submissions of Exempt or Expedited 
Protocols. Review time varies depending upon the project. The average review time is approximately 4 weeks. 
Please submit the complete (as identified above) original protocol to the Research Protections Office (RPO), 
Box 1986, with sufficient time to allow for review and revisions, if necessary. 
 
{Note that the IRB (not the investigator) makes the final determination of whether a protocol is full board, 
expedited, or exempt. Thus, full board review may be necessary even if you suggest expedited or exempt review 
in your protocol.} 
 
 
 
 

 
1 
 
 
 
 
 
 
 
 
 
MINDFULNESS-BASED  
HYPERTENSION THERAPY PILOT STUDY 
 
IRB APPLICATION 
 
 
December 5th, 2014 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eric B. Loucks, PhD 
Assistant Professor 
Department of Epidemiology  
Brown University School of Public Health 
121 South Main St., Box G-S121 
Providence, RI, 02912 
Phone: 401-863-6283 
Email: eric.loucks@brown.edu 
 

 
2 
 
 
 
 
 
 
 
 
 
 
 
Section A: 
Lay-Person Summary of Proposed Project 
 
 

 
3 
1 Specific Aims 
 
1. To formally develop a Mindfulness-Based Hypertension Therapy (MBHT) intervention tailored to the 
needs for hypertensive patients, utilizing a multi-disciplinary team of experts and patients, and 
incorporating a Delphi-like technique to adapt protocols of a standardized mindfulness-based 
intervention developed at UMass Medical School for patients with prehypertension or hypertension. 
2. To determine the optimal dose of the intervention developed in aim 1. We will estimate the feasibility, 
acceptability and safety of two different doses of the MBHT intervention in 60 patients (30 per dose 
arm) randomly assigned to a “low” or “high” dose of MBHT.  
3. To finalize the protocol of the MBHT intervention and design of the future RCT. We will use the results 
of our developmental work (aim 1) and of the dosing study (aim 2) to make the final adjustments to the 
protocol of the intervention that will be tested for efficacy in our future RCT, incorporating the expertise 
of our interdisciplinary panel to optimize the design of the future RCT.  
2 Significance and Innovation 
The World Health Organization reported that suboptimal BP is responsible for over half of cardiovascular 
disease mortality world-wide.1,2 Furthermore, of those with hypertension, more than half have uncontrolled 
BP.3,4 This is despite widespread knowledge of hypertension risk factors and treatments including diet, obesity, 
physical activity, medication adherence and excessive alcohol consumption.5,6 Mindfulness interventions 
appear to improve self-regulation, self-care, and the ability to not respond to cravings for hypertension risk 
factors such as high caloric palatable foods and sedentary activities (and resulting obesity).7-11 In fact, a 2009 
Institute of Medicine report recommended prioritizing research to “Compare the effectiveness of mindfulness-
based interventions (e.g. yoga, meditation, deep breathing training) and usual care in treating… cardiovascular 
risk factors.”12 Evidence-based mindfulness interventions including Mindfulness-Based Stress Reduction 
(MBSR) may have some effects, where a recent meta-analysis and systematic review of 4 randomized 
controlled trials (RCTs) demonstrated significant effects, but evidence of heterogeneity in effect sizes.13 The 
methodologically highest quality studies had the smallest effect sizes. MBSR has been customized to a 
number of disease processes, such as recurrent depression, smoking and substance use addiction with 
resulting increases in effect sizes compared to general mindfulness-based interventions that do not take the 
disease process of interest into consideration.10,14,15 The same may be true for hypertension, however this has 
not yet been studied. 
Until methodologically rigorous studies to evaluate customized mindfulness-based interventions for 
hypertension are performed, we will not know if the observed preliminary effects of mindfulness-based 
interventions on BP could have much greater effect with a tailored approach. Consequently, we propose to 
conduct a stage I behavioral therapy intervention study to provide the most rigorous evaluation to date on 
whether MBSR customized to prehypertensive and hypertensive patients provides clinically relevant reductions 
in BP.  
3 Approach 
3.1 Initial Development of High and Low-Dose MBHT (Aim 1) 
We will assemble a team of experts in cardiology (e.g. Dudley, Wu, Shimbo), family medicine (e.g. Eaton), 
physical activity (e.g. Williams, Davidson), diet (e.g. McCaffery), medication adherence (e.g. Kronish), 
mindfulness interventions (e.g. Britton, Salmoirago-Blotcher, Brewer), and patients with prehypertension or 
hypertension. With this team, we use an iterative, Delphi-like technique to adapt protocols of a standardized 
mindfulness-based intervention developed at UMass Medical School, called MBSR, for patients with 
prehypertension or hypertension, to the unique safety and treatment needs of this population. Adaptions may 
include, for example, types of specific mindfulness exercises, sequence in which they are introduced, and 
relative emphasis on hypertension education vs. mindfulness practice components. 
3.2 Study Population (Aim 2) 
Participants will be recruited through cardiology and family practices via established relationships with 
physicians at Rhode Island Hospital (e.g. Sam Dudley, MD), Memorial Hospital of Rhode Island (e.g. Charles 

 
4 
Eaton, MD), Providence VA Medical Center (e.g. Hank Wu, MD), amongst others. Furthermore, 
advertisements will be posted throughout Rhode Island inviting participants with pre-hypertension or 
hypertension to enroll. For Aim 2, we anticipate n=60 participants with equal proportions of males and females, 
and stratified across prehypertension/hypertension categories, including (1) pre-hypertension, (2) controlled 
hypertension, and (3) uncontrolled hypertension. This will allow for early indications of potential differential 
effects of MBHT by gender and prehypertension/hypertension status. 
Inclusion Criterion: Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or 
taking antihypertensive medication).  
Exclusion Criteria: Exclusion criteria follow standard guidelines:16 current regular meditation practice 
(>once/week); current substance abuse, suicidal ideation or eating disorder; history of bipolar or psychotic 
disorders or self-injurious behaviors.  
3.3 MBHT Intervention Groups 
High Dose: MBHT is based on the standardized MBSR intervention described elsewhere,17-20 and will likely 
consist of nine 2.5-hour weekly group sessions and an 8-hour one-day session, led by Dr. Loucks. Dr. Loucks 
is an expert in cardiovascular physiology, cardiovascular epidemiology, and social epidemiology. He completed 
MBSR instructor training at UMass Medical School, and has 16 years of mindfulness meditation experience, 
including teaching and mentoring community members, as well as a recent publication record investigating 
associations of mindfulness with cardiovascular health.11,21,22 The unique areas of MBHT are expected to be 
education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused 
on awareness of diet, physical activity, medication adherence, alcohol consumption, stress, and social support 
for behavior change. A preliminary manual has been created based on the standardized MBSR manual 
developed at UMass Medical School, and will be further developed through the Delphi-like approach described 
above, and sequentially revised based on participant feedback and preliminary findings.19,20 MBHT sessions 
contain instruction and practice in mindfulness meditation, and conversations about stress and coping. 
Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Homework 
consists of practicing skills for ≥45 min/day, 6 days/week. Booster sessions will be offered (likely 2.5-hour 
sessions every 2 months).  
Low Dose: Low Dose MBHT will be based on the High Dose intervention above, but instead prioritizing 
practices to fit within nine 1-hour weekly groups sessions. Through the aforementioned Delphi-like approach, 
the most salient parts of the high dose intervention described above will be offered in low dose MBHT.  
3.4 Measures of Compliance 
Participant Adherence: Data on treatment protocol adherence will be collected weekly by research staff.  
MBHT Instructor Competency and Treatment Fidelity: Treatment fidelity strategies will be performed in 
accordance with recommendations of the NIH Behavior Change consortium.23 
3.5 Blinding 
All study staff, including those performing health assessments and contacting participants to schedule 
follow-up assessments, will be blinded to treatment allocation with the exception of the MBHT instructor 
(Loucks) and data manager (who performs randomization).  
3.6 Equipoise 
This study will be designed to disrupt clinical equipoise, defined as “no consensus within the expert clinical 
community about the comparative merits of the alternative [trial arms] to be tested.”24 
3.7 Assessments 
We will follow study procedures similar to those performed during previous epidemiologic studies by our 
group. In-person screenings will take place at the Brown University Center for Population Health and Clinical 
Epidemiology, described in Sections 2.7.1 and 2.7.2 at baseline, completion of the 9-week MBHT course and 
at 3- and 6-months post-intervention. Major assessment variables are shown in Table 1. Qualitative interviews 
(likely focus groups) will evaluate participants’ experiences such as usefulness of specific modules, duration of 
sessions, time burden, and overall intervention effectiveness.  
 
 

 
5 
3.7.1 Primary Outcomes 
Clinic BP Assessment: Clinic-assessed systolic and 
diastolic BP remains the standard of care for monitoring 
hypertension treatment.3,5,6,25,26 Baseline clinic BP will be 
determined at two in-person screening visits ≥1 week 
apart, completed according to American Heart 
Association guidelines,25  followed by in-person 
assessments at all follow-up periods. BP will be 
assessed using a calibrated Omron HEM907XL 
Intellisense automated BP monitor with established 
validity.27  
3.7.2 Potential Mediators 
Examples of mediators to be assessed include: (1) 
Body Mass Index: height and weight directly assessed 
using standard epidemiologic methods. (2) Physical 
activity: MET minutes per week, assessed using 
actigraphy, which enables the  quantification of physical 
activity.28-32 (3) Diet: diet assessed utilizing Dietary 
Approaches to Stop Hypertension (DASH) eating pattern 
score,33 measured via diet history food frequency 
questionnaire.34 (4) Perceived stress: measured using 
Perceived Stress Scale.35 (5) Antihypertensive 
Medication Adherence: measured continuously using 
electronic medication bottle caps (GlowCaps).  
3.7.3 Potential Effect Modifiers 
We propose to evaluate 2 potentially important effect modifiers: (1) gender, (2) 
prehypertension/hypertension category. 
3.8 Intervention Allocation 
Stratified randomization will be used.36,37 Variables used to create strata include gender (male vs. female), 
race/ethnicity (white vs. non-white), and prehypertension/ hypertension status (pre-hypertension, controlled 
hypertension, uncontrolled hypertension). Simple random sampling will occur within each strata.  
3.9 Data Analysis 
Qualitative analyses will evaluate participant experiences such as usefulness of specific modules, duration 
of sessions, time burden, and overall intervention effectiveness. Quantitative analyses will incorporate 
generalized linear models (GLM) with properly chosen link functions, performed using generalized estimating 
equations (GEE) with robust standard error estimators.38,39 We will test effects of high vs. low dose MBHT on 
clinic-assessed systolic and diastolic BP. Following “intention-to-treat” principles, analyses will be conducted 
on all participants randomized to high vs. low dose, regardless of intervention completion. To test whether 
effects of MBHT on BP may be effect modified by variables described in Section 2.7.3 we will add product 
terms between MBHT and each potential effect modifier to models described above. Formal statistical 
significance tests of product terms will be performed. Analyses are considered statistically underpowered, but 
will provide effect size estimates and statistical variances for NIH grant applications to support studies with 
larger sample sizes.  
 
 
Baseline 8 w 3 m
6 m
Race/ethnicity
✓
Gender
✓
Adverse childhood experiences
✓
Socioeconomic status
✓
✓
✓
✓
Depressive symptomatology
✓
✓
✓
✓
Anxiety
✓
✓
✓
✓
Perceived stress
✓
✓
✓
✓
Self efficacy
✓
✓
✓
✓
Mindfulness
✓
✓
✓
✓
Blood pressure
✓
✓
✓
Smoking
✓
✓
✓
✓
Diet
✓
✓
✓
✓
Physical activity
✓
✓
✓
✓
Alcohol consumption
✓
✓
✓
✓
Body mass index
✓
✓
✓
Sleep quantity and quality
✓
✓
✓
✓
Social support
✓
✓
✓
✓
Loneliness
✓
✓
✓
✓
Medication use and adherence
✓
✓
✓
✓
Obtained During Study
Variables
m, months; w,weeks
Table 1. Examples of variables proposed to be assessed 
during MBHT study 

 
6 
References 
1. 
Mendis S, Puska P, Norrving B. Global atlas on cardiovascular disease prevention and control. 
Geneva: World Health Organization;2011. 
2. 
Hoyert DL, Xu J. Deaths: Preliminary Data for 2011. National Vital Statistics Reports. 2012;61(6):1-65. 
3. 
Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on 
Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. Dec 
2003;42(6):1206-1252. 
4. 
United States Centers for Disease Control and Prevention. Getting blood pressure under control. CDC 
Vitalsigns. 2012;September. 
5. 
James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood 
pressure in adults: report from the panel members appointed to the Eighth Joint National Committee 
(JNC 8). JAMA. Feb 5 2014;311(5):507-520. 
6. 
Weber MA, Schiffrin EL, White W, et al. Clinical practice guidelines for the management of 
hypertension in the community: A statement by the American Society of Hypertension and the 
International Society of Hypertension. J Hypertens. 2014;32(1):3-15. 
7. 
Epstein RM. Mindful practice. JAMA. Sep 1 1999;282(9):833-839. 
8. 
Sedlmeier P, Eberth J, Schwarz M, et al. The psychological effects of meditation: a meta-analysis. 
Psychol Bull. Nov 2012;138(6):1139-1171. 
9. 
Lutz A, Slagter HA, Dunne JD, Davidson RJ. Cognitive-emotional interactions - Attention regulation and 
monitoring in meditation. Trends Cogn Sci. Apr 2008;12(4):163-169. 
10. 
Brewer JA, Mallik S, Babuscio TA, et al. Mindfulness training for smoking cessation: results from a 
randomized controlled trial. Drug Alc Depend. 2011;119(1-2):72-80. 
11. 
Loucks EB, Britton WB, Howe CJ, Eaton CB, Buka SL. Positive associations of dispositional 
mindfulness with cardiovascular health: The New England Family Study. Int J Behav Med. 2014: DOI 
10.1007/s12529-12014-19448-12529. 
12. 
Institute of Medicine. Initial National Priorities for Comparative Effectiveness Research. Washington, 
D.C. 2009. 
13. 
Abbott RA, Whear R, Rodgers LR, et al. Effectiveness of mindfulness-based stress reduction and 
mindfulness based cognitive therapy in vascular disease: A systematic review and meta-analysis of 
randomised controlled trials. J Psychosom Res. May 2014;76(5):341-351. 
14. 
Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological stress and well-being: A 
systematic review and meta-analysis. JAMA Intern Med. Mar 1 2014;174(3):357-368. 
15. 
Bowen S, Witkiewitz K, Clifasefi SL, et al. Relative Efficacy of Mindfulness-Based Relapse Prevention, 
Standard Relapse Prevention, and Treatment as Usual for Substance Use Disorders: A Randomized 
Clinical Trial. JAMA Psychiatr. Mar 19 2014. 
16. 
Santorelli SF, Kabat-Zinn J. MBSR Curriculum Guide and Supporting Materials. Mindfulness Based 
Stress Reduction Professional Training. Worcester, MA: University of Massachusetts Center for 
Mindfulness; 2003. 
17. 
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the 
practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp 
Psychiatry. Apr 1982;4(1):33-47. 
18. 
Kabat-Zinn J, Massion AO, Kristeller J, et al. Effectiveness of a meditation-based stress reduction 
program in the treatment of anxiety disorders. Am J Psychiatry. Jul 1992;149(7):936-943. 
19. 
Santorelli S, Bonus K, McCallum C, et al. Mindfulness-Based Stress Reduction:  Guidelines and 
Standards of Practice. Integrative Medicine Mindfulness Program at University of Wisconsin- Madison 
and the Center for Mindfulness, University of Massachusetts. 2004. 
20. 
MacCoon DG, Imel ZE, Rosenkranz MA, et al. The validation of an active control intervention for 
Mindfulness Based Stress Reduction (MBSR). Behav Res Ther. Jan 2012;50(1):3-12. 
21. 
Loucks EB. Meditation intervention reviews: selecting ideal control groups for meditation interventions. 
JAMA Intern Med. Jul 2014;174(7):1194-1195. 
22. 
Loucks EB, Britton WB, Howe CJ, et al. Associations of dispositional mindfulness with obesity and 
central adiposity: The New England Family Study. Under Review. 
23. 
Bellg AJ, Borrelli B, Resnick B, et al. Enhancing treatment fidelity in health behavior change studies: 
best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. Sep 
2004;23(5):443-451. 

 
7 
24. 
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. Jul 16 1987;317(3):141-145. 
25. 
Pickering TG, Hall JE, Appel LJ, et al. Recommendations for blood pressure measurement in humans 
and experimental animals: part 1: blood pressure measurement in humans: a statement for 
professionals from the Subcommittee of Professional and Public Education of the American Heart 
Association Council on High Blood Pressure Research. Circulation. Feb 8 2005;111(5):697-716. 
26. 
Williams B, Lindholm LH, Sever P. Systolic pressure is all that matters. Lancet. Jun 28 
2008;371(9631):2219-2221. 
27. 
El Assaad MA, Topouchian JA, Darne BM, Asmar RG. Validation of the Omron HEM-907 device for 
blood pressure measurement. Blood Press Monit. Aug 2002;7(4):237-241. 
28. 
Chen KY, Acra SA, Majchrzak K, et al. Predicting energy expenditure of physical activity using hip- and 
wrist-worn accelerometers. Diabet Technol Therapeut. 2003;5(6):1023-1033. 
29. 
Crouter SE, Clowers KG, Bassett DR, Jr. A novel method for using accelerometer data to predict 
energy expenditure. J Appl Physiol (1985). Apr 2006;100(4):1324-1331. 
30. 
Troiano RP. Translating accelerometer counts into energy expenditure: advancing the quest. J Appl 
Physiol (1985). Apr 2006;100(4):1107-1108. 
31. 
Esliger DW, Tremblay MS. Technical reliability assessment of three accelerometer models in a 
mechanical setup. Med Sci Sports Exerc. Dec 2006;38(12):2173-2181. 
32. 
Heil DP. Predicting activity energy expenditure using the Actical activity monitor. Res Quart Exercise 
Sport. Mar 2006;77(1):64-80. 
33. 
Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2012 update: a report 
from the American Heart Association. Circulation. Jan 3 2012;125(1):e2-e220. 
34. 
Subar AF, Thompson FE, Kipnis V, et al. Comparative validation of the Block, Willett, and National 
Cancer Institute food frequency questionnaires: The Eating at America's Table Study. Am J Epidemiol. 
Dec 15 2001;154(12):1089-1099. 
35. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. Dec 
1983;24(4):385-396. 
36. 
Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J 
Clin Epidemiol. 1999;52(1):19-26. 
37. 
Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. New York, NY: Springer; 2010. 
38. 
Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 
1986;73(1):13-22. 
39. 
Zeger SL, Liang K-Y. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 
1986;42:121-130. 
 

 
8 
 
 
 
 
 
 
 
 
 
Section B: 
 
Application for Funding 
 
 
An Application for the Brown internal Richard B. Salomon Faculty Research 
Award has been made.  
 
An NIH R34 is planned to be submitted in March, 2015.  
 
 

 
9 
 
 
 
 
 
 
 
 
 
 
 
Section C: 
Specific Aims and Methodology 
 
 

 
10 
1 Significance and Innovation 
The World Health Organization reported that suboptimal BP is responsible for over half of 
cardiovascular disease mortality world-wide.1,2 Furthermore, of those with hypertension, more than half 
have uncontrolled BP.3,4 This is despite widespread knowledge of hypertension risk factors and 
treatments including diet, obesity, physical activity, medication adherence and excessive alcohol 
consumption.5,6 Mindfulness interventions appear to improve self-regulation, self-care, and the ability to 
not respond to cravings for hypertension risk factors such as high caloric palatable foods and sedentary 
activities (and resulting obesity).7-11 In fact, a 2009 Institute of Medicine report recommended prioritizing 
research to “Compare the effectiveness of mindfulness-based interventions (e.g. yoga, meditation, deep 
breathing training) and usual care in treating… cardiovascular risk factors.”12 Evidence-based 
mindfulness interventions including Mindfulness-Based Stress Reduction (MBSR) may have some 
effects, where a recent meta-analysis and systematic review of 4 randomized controlled trials (RCTs) 
demonstrated significant effects, but evidence of heterogeneity in effect sizes.13 The methodologically 
highest quality studies had the smallest effect sizes. MBSR has been customized to a number of disease 
processes, such as recurrent depression, smoking and substance use addiction with resulting increases 
in effect sizes compared to general mindfulness-based interventions that do not take the disease process 
of interest into consideration.10,14,15 The same may be true for hypertension, however this has not yet 
been studied. 
Until methodologically rigorous studies to evaluate customized mindfulness-based interventions for 
hypertension are performed, we will not know if the observed preliminary effects of mindfulness-based 
interventions on BP could have much greater effect with a tailored approach. Consequently, we propose 
to conduct a stage I behavioral therapy intervention study to provide the most rigorous evaluation to date 
on whether MBSR customized to prehypertensive and hypertensive patients provides clinically relevant 
reductions in BP. These preliminary findings will set the stage for NIH applications, including R34 and 
R01 applications.  
2 Specific Aims 
1 
To formally develop a Mindfulness-Based Hypertension Therapy (MBHT) intervention tailored to the 
needs for hypertensive patients, utilizing a multi-disciplinary team of experts and patients, and 
incorporating a Delphi-like technique to adapt protocols of a standardized mindfulness-based 
intervention developed at UMass Medical School for patients with prehypertension or hypertension. 
2 
To determine the optimal dose of the intervention developed in aim 1. We will estimate the feasibility, 
acceptability and safety of two different doses of the MBHT intervention in 60 patients (30 per dose 
arm) randomly assigned to a “low” or “high” dose of MBHT.  
3 
To finalize the protocol of the MBHT intervention and design of the future RCT. We will use the 
results of our developmental work (aim 1) and of the dosing study (aim 2) to make the final 
adjustments to the protocol of the intervention that will be tested for efficacy in our future RCT, 
incorporating the expertise of our interdisciplinary panel to optimize the design of the future RCT.  
4 Approach 
4.1 Initial Development of High and Low-Dose MBHT (Aim 1) 
We will assemble a team of experts in cardiology (e.g. Dudley, Wu, Shimbo), family medicine (e.g. 
Eaton), physical activity (e.g. Williams, Davidson), diet (e.g. McCaffery), medication adherence (e.g. 
Kronish), mindfulness interventions (e.g. Britton, Salmoirago-Blotcher, Brewer), and patients with 
prehypertension or hypertension. With this team, we use an iterative, Delphi-like technique to adapt 
protocols of a standardized mindfulness-based intervention developed at UMass Medical School, called 
MBSR, for patients with prehypertension or hypertension, to the unique safety and treatment needs of 
this population. Adaptions may include, for example, types of specific mindfulness exercises, sequence 
in which they are introduced, and relative emphasis on hypertension education vs. mindfulness practice 
components. 

 
11 
4.2 Study Population (Aim 2) 
Participants will be recruited through cardiology and family practices via established relationships 
with physicians at Rhode Island Hospital (e.g. Sam Dudley, MD), Memorial Hospital of Rhode Island (e.g. 
Charles Eaton, MD), Providence VA Medical Center (e.g. Hank Wu, MD), amongst others. Furthermore, 
advertisements will be posted throughout Rhode Island inviting participants with pre-hypertension or 
hypertension to enroll. For Aim 2, we anticipate n=60 participants with equal proportions of males and 
females, and stratified across prehypertension/hypertension categories, including (1) pre-hypertension, 
(2) controlled hypertension, and (3) uncontrolled hypertension. This will allow for early indications of 
potential differential effects of MBHT by gender and prehypertension/hypertension status. 
Inclusion Criterion: Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic 
pressure or taking antihypertensive medication). All genders and racial/ethnic groups are eligible to be 
included.  
Exclusion Criteria: Exclusion criteria follow standard guidelines and recommendations:1 (a) current 
regular meditation practice (>once/week); (b) serious medical illness precluding regular class 
attendance; (c) current substance abuse, suicidal ideation or eating disorder, (d) history of bipolar or 
psychotic disorders or self-injurious behaviors. These participants are excluded because they may 
disrupt group participation, require additional or specialized treatment, or are already participating in 
practices similar to the intervention. 
 
4.3 Confidentiality of Data 
The clinical data will be de-identified but linked. Private information such as name, date of birth, and 
address for recontacting will be kept in a password protected, encrypted database on a different disk that 
the clinical data. Only the principal investigator for the purposes of patient safety or monitoring by the 
NIH, data safety monitoring boards or HIPPA compliance officer approved agents will be given access to 
identifiable personal information. 
Data which contains person-identifiers is considered highly sensitive.  Such data is, by policy, only 
stored within the VMScluster at the Brown University Center for Population Health and Clinical 
Epidemiology.  Access is controlled by the VMS ACL mechanism, allowing read-only access to a small 
group of specific users and read-write access to an even smaller group.  Internet access (e.g., via a Web 
server) is disallowed for such storage areas.  Windows security controls are superceded by VMS 
controls, although Windows access is permitted since some data is acquired on Windows-specific media 
(e.g., CD-ROM).  All uses of privileged necessary to grant/revoke access to any data, as well as any 
other security-relevant event data, is continuously logged and analyzed in the context of both the 
VMScluster and the Windows Domain.  Network access is tightly controlled to allow anonymous access 
only to a small amount of read-only data; all “risky protocols” are disallowed from Internet access.  For 
any given study with person-identifying information, such data is stripped before the data is made 
accessible to staff not authorized to access such identifiers.  In those cases where the data is 
longitudinal, a non-reversible encryption of the person ID is made in order to provide a unique person ID 
not traceable to the underlying person.  The specific algorithm used for any given set of data is stored in 
the same fashion and given the same security as the data itself.  To make data use simpler, hierarchical 
“trees” of directories are given consistent access controls tied to a unique identifier, which is then granted 
to staff authorized to use such data.  Programming staff authorized to make individual-level data 
available to staff not authorized to access the person-identifying components routinely copy the 
“encrypted” versions from the more-secured tree to a less-secured tree.  Security controls are thus 
relatively automatic, based on the propagation of rights based on the location of a file within the file 
system and the identity of the user attempting to access it. 
 
4.4 MBHT Intervention Groups 
High Dose: MBHT is based on the standardized MBSR intervention described elsewhere,17-20 and will 
likely consist of nine 2.5-hour weekly group sessions and an 8-hour one-day session, led by Dr. Loucks. 
Dr. Loucks is an expert in cardiovascular physiology, cardiovascular epidemiology, and social 
epidemiology. He completed MBSR instructor training at UMass Medical School, and has 16 years of 

 
12 
mindfulness meditation experience, including teaching and mentoring community members, as well as a 
recent publication record investigating associations of mindfulness with cardiovascular health.11,21,22 The 
unique areas of MBHT are expected to be education on hypertension risk factors, hypertension health 
effects, and specific mindfulness modules focused on awareness of diet, physical activity, medication 
adherence, alcohol consumption, stress, and social support for behavior change. A preliminary manual 
has been created based on the standardized MBSR manual developed at UMass Medical School, and 
will be further developed through the Delphi-like approach described above, and sequentially revised 
based on participant feedback and preliminary findings.19,20 MBHT sessions contain instruction and 
practice in mindfulness meditation, and conversations about stress and coping. Students learn a range of 
mindfulness skills including body scan exercises, meditation and yoga. Homework consists of practicing 
skills for ≥45 min/day, 6 days/week. Booster sessions will be offered (likely 2.5-hour sessions every 2 
months).  
Low Dose: Low Dose MBHT will be based on the High Dose intervention above, but instead 
prioritizing practices to fit within nine 1-hour weekly groups sessions. Through the aforementioned 
Delphi-like approach, the most salient parts of the high dose intervention described above will be offered 
in low dose MBHT.  
4.5 Measures of Compliance 
Participant Adherence: Data on treatment protocol adherence will be collected weekly by research 
staff.  
MBHT Instructor Competency and Treatment Fidelity: Treatment fidelity strategies will be performed 
in accordance with recommendations of the NIH Behavior Change consortium.23 
4.6 Blinding 
All study staff, including those performing health assessments and contacting participants to 
schedule follow-up assessments, will be blinded to treatment allocation with the exception of the MBHT 
instructor (Loucks) and data manager (who performs randomization).  
4.7 Equipoise 
This study will be designed to disrupt clinical equipoise, defined as “no consensus within the expert 
clinical community about the comparative merits 
of the alternative [trial arms] to be tested.”24 
4.8 Assessments 
We will follow study procedures similar to 
those performed during previous epidemiologic 
studies by our group. In-person screenings will 
take place at the Brown University Center for 
Population Health and Clinical Epidemiology, 
described in Sections 2.7.1 and 2.7.2 at baseline, 
completion of the 9-week MBHT course and at 3- 
and 6-months post-intervention. Major 
assessment variables are shown in Table 1. 
Qualitative interviews (likely focus groups) will 
evaluate participants’ experiences such as 
usefulness of specific modules, duration of 
sessions, time burden, and overall intervention 
effectiveness.  
4.8.1 Primary Outcomes 
Clinic BP Assessment: Clinic-assessed 
systolic and diastolic BP remains the standard of 
care for monitoring hypertension 
treatment.3,5,6,25,26  Baseline clinic BP will be 
Baseline 8 w 3 m
6 m
Race/ethnicity
✓
Gender
✓
Adverse childhood experiences
✓
Socioeconomic status
✓
✓
✓
✓
Depressive symptomatology
✓
✓
✓
✓
Anxiety
✓
✓
✓
✓
Perceived stress
✓
✓
✓
✓
Self efficacy
✓
✓
✓
✓
Mindfulness
✓
✓
✓
✓
Blood pressure
✓
✓
✓
Smoking
✓
✓
✓
✓
Diet
✓
✓
✓
✓
Physical activity
✓
✓
✓
✓
Alcohol consumption
✓
✓
✓
✓
Body mass index
✓
✓
✓
Sleep quantity and quality
✓
✓
✓
✓
Social support
✓
✓
✓
✓
Loneliness
✓
✓
✓
✓
Medication use and adherence
✓
✓
✓
✓
Obtained During Study
Variables
m, months; w,weeks
Table 1. Examples of variables proposed to be assessed 
during MBHT study 

 
13 
determined at two in-person screening visits ≥1 week apart, completed according to American Heart 
Association guidelines,25  followed by in-person assessments at all follow-up periods. BP will be 
assessed using a calibrated Omron HEM907XL Intellisense automated BP monitor with established 
validity.27  
4.8.2 Potential Mediators 
Examples of mediators to be assessed include: (1) Body Mass Index: height and weight directly 
assessed using standard epidemiologic methods. (2) Physical activity: MET minutes per week, assessed 
using actigraphy, which enables the  quantification of physical activity.28-32  (3) Diet: diet assessed 
utilizing Dietary Approaches to Stop Hypertension (DASH) eating pattern score,33 measured via diet 
history food frequency questionnaire.34 (4) Perceived stress: measured using Perceived Stress Scale.35 
(5) Antihypertensive Medication Adherence: measured continuously using electronic medication bottle 
caps (GlowCaps).  
4.8.3 Potential Effect Modifiers 
We propose to evaluate 2 potentially important effect modifiers: (1) gender, (2) 
prehypertension/hypertension category. 
4.9 Intervention Allocation 
Stratified randomization will be used.36,37 Variables used to create strata include gender (male vs. 
female), race/ethnicity (white vs. non-white), and prehypertension/ hypertension status (pre-
hypertension, controlled hypertension, uncontrolled hypertension). Simple random sampling will occur 
within each strata.  
4.10 Data Analysis 
Qualitative analyses will evaluate participant experiences such as usefulness of specific modules, 
duration of sessions, time burden, and overall intervention effectiveness. Quantitative analyses will 
incorporate generalized linear models (GLM) with properly chosen link functions, performed using 
generalized estimating equations (GEE) with robust standard error estimators.38,39 We will test effects of 
high vs. low dose MBHT on clinic-assessed systolic and diastolic BP. Following “intention-to-treat” 
principles, analyses will be conducted on all participants randomized to high vs. low dose, regardless of 
intervention completion. To test whether effects of MBHT on BP may be effect modified by variables 
described in Section 2.7.3 we will add product terms between MBHT and each potential effect modifier to 
models described above. Formal statistical significance tests of product terms will be performed. 
Analyses are considered statistically underpowered, but will provide effect size estimates and statistical 
variances for NIH grant applications to support studies with larger sample sizes.  
 

 
14 
References 
1. 
Mendis S, Puska P, Norrving B. Global atlas on cardiovascular disease prevention and control. 
Geneva: World Health Organization;2011. 
2. 
Hoyert DL, Xu J. Deaths: Preliminary Data for 2011. National Vital Statistics Reports. 
2012;61(6):1-65. 
3. 
Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on 
Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. Dec 
2003;42(6):1206-1252. 
4. 
United States Centers for Disease Control and Prevention. Getting blood pressure under control. 
CDC Vitalsigns. 2012;September. 
5. 
James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high 
blood pressure in adults: report from the panel members appointed to the Eighth Joint National 
Committee (JNC 8). JAMA. Feb 5 2014;311(5):507-520. 
6. 
Weber MA, Schiffrin EL, White W, et al. Clinical practice guidelines for the management of 
hypertension in the community: A statement by the American Society of Hypertension and the 
International Society of Hypertension. J Hypertens. 2014;32(1):3-15. 
7. 
Epstein RM. Mindful practice. JAMA. Sep 1 1999;282(9):833-839. 
8. 
Sedlmeier P, Eberth J, Schwarz M, et al. The psychological effects of meditation: a meta-
analysis. Psychol Bull. Nov 2012;138(6):1139-1171. 
9. 
Lutz A, Slagter HA, Dunne JD, Davidson RJ. Cognitive-emotional interactions - Attention 
regulation and monitoring in meditation. Trends Cogn Sci. Apr 2008;12(4):163-169. 
10. 
Brewer JA, Mallik S, Babuscio TA, et al. Mindfulness training for smoking cessation: results from 
a randomized controlled trial. Drug Alc Depend. 2011;119(1-2):72-80. 
11. 
Loucks EB, Britton WB, Howe CJ, Eaton CB, Buka SL. Positive associations of dispositional 
mindfulness with cardiovascular health: The New England Family Study. Int J Behav Med. 2014: 
DOI 10.1007/s12529-12014-19448-12529. 
12. 
Institute of Medicine. Initial National Priorities for Comparative Effectiveness Research. 
Washington, D.C. 2009. 
13. 
Abbott RA, Whear R, Rodgers LR, et al. Effectiveness of mindfulness-based stress reduction and 
mindfulness based cognitive therapy in vascular disease: A systematic review and meta-analysis 
of randomised controlled trials. J Psychosom Res. May 2014;76(5):341-351. 
14. 
Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological stress and well-
being: A systematic review and meta-analysis. JAMA Intern Med. Mar 1 2014;174(3):357-368. 
15. 
Bowen S, Witkiewitz K, Clifasefi SL, et al. Relative Efficacy of Mindfulness-Based Relapse 
Prevention, Standard Relapse Prevention, and Treatment as Usual for Substance Use Disorders: 
A Randomized Clinical Trial. JAMA Psychiatr. Mar 19 2014. 
16. 
Santorelli SF, Kabat-Zinn J. MBSR Curriculum Guide and Supporting Materials. Mindfulness 
Based Stress Reduction Professional Training. Worcester, MA: University of Massachusetts 
Center for Mindfulness; 2003. 
17. 
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on 
the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen 
Hosp Psychiatry. Apr 1982;4(1):33-47. 
18. 
Kabat-Zinn J, Massion AO, Kristeller J, et al. Effectiveness of a meditation-based stress reduction 
program in the treatment of anxiety disorders. Am J Psychiatry. Jul 1992;149(7):936-943. 
19. 
Santorelli S, Bonus K, McCallum C, et al. Mindfulness-Based Stress Reduction:  Guidelines and 
Standards of Practice. Integrative Medicine Mindfulness Program at University of Wisconsin- 
Madison and the Center for Mindfulness, University of Massachusetts. 2004. 
20. 
MacCoon DG, Imel ZE, Rosenkranz MA, et al. The validation of an active control intervention for 
Mindfulness Based Stress Reduction (MBSR). Behav Res Ther. Jan 2012;50(1):3-12. 
21. 
Loucks EB. Meditation intervention reviews: selecting ideal control groups for meditation 
interventions. JAMA Intern Med. Jul 2014;174(7):1194-1195. 
22. 
Loucks EB, Britton WB, Howe CJ, et al. Associations of dispositional mindfulness with obesity 
and central adiposity: The New England Family Study. Under Review. 

 
15 
23. 
Bellg AJ, Borrelli B, Resnick B, et al. Enhancing treatment fidelity in health behavior change 
studies: best practices and recommendations from the NIH Behavior Change Consortium. Health 
Psychol. Sep 2004;23(5):443-451. 
24. 
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. Jul 16 
1987;317(3):141-145. 
25. 
Pickering TG, Hall JE, Appel LJ, et al. Recommendations for blood pressure measurement in 
humans and experimental animals: part 1: blood pressure measurement in humans: a statement 
for professionals from the Subcommittee of Professional and Public Education of the American 
Heart Association Council on High Blood Pressure Research. Circulation. Feb 8 2005;111(5):697-
716. 
26. 
Williams B, Lindholm LH, Sever P. Systolic pressure is all that matters. Lancet. Jun 28 
2008;371(9631):2219-2221. 
27. 
El Assaad MA, Topouchian JA, Darne BM, Asmar RG. Validation of the Omron HEM-907 device 
for blood pressure measurement. Blood Press Monit. Aug 2002;7(4):237-241. 
28. 
Chen KY, Acra SA, Majchrzak K, et al. Predicting energy expenditure of physical activity using 
hip- and wrist-worn accelerometers. Diabet Technol Therapeut. 2003;5(6):1023-1033. 
29. 
Crouter SE, Clowers KG, Bassett DR, Jr. A novel method for using accelerometer data to predict 
energy expenditure. J Appl Physiol (1985). Apr 2006;100(4):1324-1331. 
30. 
Troiano RP. Translating accelerometer counts into energy expenditure: advancing the quest. J 
Appl Physiol (1985). Apr 2006;100(4):1107-1108. 
31. 
Esliger DW, Tremblay MS. Technical reliability assessment of three accelerometer models in a 
mechanical setup. Med Sci Sports Exerc. Dec 2006;38(12):2173-2181. 
32. 
Heil DP. Predicting activity energy expenditure using the Actical activity monitor. Res Quart 
Exercise Sport. Mar 2006;77(1):64-80. 
33. 
Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2012 update: a 
report from the American Heart Association. Circulation. Jan 3 2012;125(1):e2-e220. 
34. 
Subar AF, Thompson FE, Kipnis V, et al. Comparative validation of the Block, Willett, and 
National Cancer Institute food frequency questionnaires: The Eating at America's Table Study. 
Am J Epidemiol. Dec 15 2001;154(12):1089-1099. 
35. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 
Dec 1983;24(4):385-396. 
36. 
Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical 
trials. J Clin Epidemiol. 1999;52(1):19-26. 
37. 
Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. New York, NY: Springer; 
2010. 
38. 
Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 
1986;73(1):13-22. 
39. 
Zeger SL, Liang K-Y. Longitudinal data analysis for discrete and continuous outcomes. 
Biometrics. 1986;42:121-130. 
 
 

 
16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section D:  
Possible Risks to Participants 
 
 
 
 
 

 
17 
The following is a statement from NCCAM about the potential risks of meditation practice: “Meditation 
is considered to be safe for healthy people. There have been rare reports that meditation could cause or 
worsen symptoms in people who have certain psychiatric problems, but this question has not been fully 
researched. People with physical limitations may not be able to participate in certain meditative practices 
involving physical movement. Individuals with existing mental or physical health conditions should speak 
with their health care providers prior to starting a meditative practice and make their meditation instructor 
aware of their condition.”285 
Discomfort during meditation: Meditation-based interventions may results in discomfort with attention 
to unpleasant thoughts, feelings or body sensations. Some individuals may experience an initial increase 
in undesirable emotions with increased attention to them. In order to minimize risk, instructors encourage 
participants to be aware of their discomfort and to set their own limitations. Participants are encouraged 
to alter their postures, including standing, sitting in chairs, lying down, as needed in order to be 
comfortable. In addition, the curriculum of the training program is specifically geared towards addressing 
such discomfort.  
Psychological distress: Research subjects participating in this study may have feelings of loss of 
privacy from being contacted about participating in the study, and possible psychological distress caused 
by questions on the diagnostic interview that bring up painful memories or feelings. However, the 
resulting potential for injury to research subjects is judged to be minimal.  We have already contacted 
and clinically evaluated thousands of participants from the New England Family using similar 
assessment procedures to this study, with good responses from the participants. With regard to 
psychological distress from taking part in the MBHT intervention, given that screening questions will 
exclude participants with substantial mental illness, and given the NCAAM statement above that 
“Meditation is considered to be safe for healthy people.”,285 we expect that risk of psychological distress 
will be low. The risk of increased psychological distress from meditation will be clearly outlined in the 
consent form and participants will be encouraged to consult with both the course instructor and study 
staff in the case of any increased distress. One of the co-investigators (Dr. Britton) is a clinical 
psychologist. She will be available to advise on any psychological events that occur, and provide 
referrals for treatment if needed.  
Loss of confidentiality: Likelihood: rare. Minimization: Confidentiality will be maintained by numerically 
coding all data, by disguising identifying information, and by keeping all data in locked file drawers.  All 
information obtained from participants will be accessible only to research staff.  
Potential Benefits of the Proposed Research to Human Subjects and Others: There may be no direct 
benefits from participating in this study. The potential benefits of participating in the proposed study 
include improved knowledge on stress reduction techniques and risk for hypertension.  Each participant 
will also be contributing to an important study which will answer questions on whether mindfulness-based 
stress reduction may influence health.   
 
 

 
18 
 
 
 
 
 
 
 
 
 
 
 
 
Section E: 
Informed Consent 
 
 
 

 
19 
Each potential participant will be fully informed about the nature of the study, its risks and benefits, 
and about his/her rights as a research subject. The person performing the consent will be either Dr. 
Loucks or a trained undergraduate trained research assistant. The participant will sign and receive a 
copy of the document stating that he/she has given his/her informed consent to participate before 
interviewing is begun. In every instance, project personnel will verbally review the content of the consent 
form before participants sign.   
 
 
 
 

 
20 
Agreement to Participate in a Research Study 
 
Investigation of the effects of mindfulness meditation on blood pressure and well-being 
 
 
You are being asked to take part in a Brown University research study about the effects of mindfulness 
and hypertension education on blood pressure and risk factors for hypertension. This form will explain 
the purpose of the study, how the study will be carried out and what you will be expected to do.  It will 
also explain the possible risks and possible benefits of being in the study.  If any part of the following 
description is not clear to you, you are encouraged to contact the researcher to answer any questions 
before you decide whether to take part in the study. If you decide to participate, please fill out and sign 
the last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health education on 
blood pressure. You have been selected for this study because you expressed interest and met entrance 
criteria for having prehypertension or hypertension, or another cardiovascular risk factor that could be 
influenced by this program. In order to assess the effects of these practices, you will be asked to 
complete some questionnaires, and a laboratory assessment before and after learning the mindfulness 
practices. 
 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
 
1) Participate in an interview in which you will be asked questions about past and present mental health, 
including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, smoking, 
medication use, personality, emotions, attention and past experiences, including stressful or 
traumatic experiences. These questions will probe sensitive psychological areas, including physical, 
emotion and sexual abuse. These questionnaires may take up to 2 hours to complete. By completing 
the interviews and questionnaires, you are giving the researchers permission to use the information 
you have provided. You have the right not to answer any of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference and hip circumference.  
 
4) You will be asked to perform some cognitive tasks. One of these tasks may involve computer-based 
tests of attention or decision-making. Together these tests may take as long as 45 minutes. 
 
5) You will be randomly assigned (like the flip of a coin) to enter one of two 9 week meditation 
programs. 
 
6) You will participate in the 9-week meditation program, which consists of 9 weekly sessions of 1-2.5 
hours each and may include one 6 hour weekend retreat. Daily homework assignments may take as 
long as one hour and consist of  practicing mindfulness exercises with the aid of a guided audio CD 
and completing worksheets related to stress, thoughts, and common reactions to various types of 
events. 
 

 
21 
7) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. The 
recordings will be transcribed so that we may analyze the text. The recordings will be identified by 
study number, will only be heard by study staff and will be destroyed after transcription.  
 
8) You will be asked to complete a few short questionnaires each week during the 9 week condition and 
to notify the lab if you change your medication in any way. 
 
9) After 9 weeks, you will be asked to complete a second packet of questionnaires and return to the 
laboratory to repeat the same procedures for a second day of testing. 
 
10) Three months and six months after the end of the 9 week condition, you will be asked to return to the 
laboratory to repeat the same testing procedures. 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred since the 
first assessment. Specifically, you will receive an individualized handout listing % change (increase or 
decrease) on scales of attention, stress, mood, health behaviors and blood pressure across the study. 
 
2.  Discomforts and Risks 
The questionnaires are routine, standardized forms for epidemiologic research.  Certain questions may 
be upsetting as they may probe sensitive psychological areas and inquire about upsetting or traumatic 
events, including physical, sexual or emotional abuse and/or current psychiatric symptoms.  Since your 
participation is voluntary, you have the right to skip any questions that make you uncomfortable.  
 
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, feelings 
or body sensations. Some individuals may experience an initial increase in undesirable feelings with 
increased attention to them. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this study.  
However, participation in the study creates the potential benefit of a) identifying effective treatments for 
elevated blood pressure, b) gaining knowledge of the effects of mindfulness practices, c) gaining first-
hand knowledge about the most current scientific methods in scientific research d) receiving information 
about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical activity, 
and reducing excessive alcohol consumption may also be beneficial for reducing blood pressure. 
Education about these therapies are integrated into this course, but other forms of these alternative 
therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to a study 
ID# instead of your name.  All questionnaires in this study will be filled out through an online survey 
website (SurveyMonkey).  All of these questionnaires will be linked solely to your study ID#, so that your 
identity is protected and your answers are confidential.  Although these measures have been taken to 
protect your personal information, complete confidentiality cannot be guaranteed when transmitting 
information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to confidentiality. If 
your questionnaire responses indicate that you pose a serious danger to yourself or to another person, 
then the PI, or a co-investigator (Willoughby Britton) who is a clinical psychologist, may contact the you 

 
22 
to discuss your responses and possible referral to another treatment provider. Questionnaire items that 
may warrant follow-up include endorsements of statements about hurting yourself or others, any high 
scores in depression, anxiety, aggressive behaviors, or other clinically significant problems. You should 
also know that there are times when the law might require the release of your responses without your 
permission.  For example, State law requires researchers to report abuse or neglect of children to the 
Department of Children, Youth and Families (DCYF).   State law also requires researchers to report 
abuse or neglect of people age 60 and older to the Department of Elderly Affairs. 
 
The findings of the study may be used for medical publication. Your name will not be used in any 
published reports about this study. Results will be reported in a summarized manner in such a way that 
you cannot be identified. All personally identifiable information will be "de-identified" and only a unique 
code number will be used. Study records will be identified with a unique code number and initials. All 
study records and specimens will be stored in a secure storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, including not 
answering certain questions. If you decide now to participate, you can change your mind later and quit 
the study.  The decision to not participate or to withdraw from the study will not adversely affect current 
or future interactions with Brown University. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for alternative 
treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. Eric B. 
Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like more information 
about the rules for research studies, or the rights of people who take part in those studies, you may 
contact the Brown University Research Protections Office, telephone number 1-866-309-2095 or 401-
863-3050. 
 

 
23 
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY QUESTIONS HAVE BEEN 
SATISFACTORILY ANSWERED, AND, I AGREE TO PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
____________________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):____________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):____________________________________________________________________ 
 
Telephone:__________________________(cell)______________________________(other) 
 
 
 
 
 
 
 
 

 
24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section F: 
Recruiting Materials 
 
 

 
25 
 
 
Front of Advertisement Card: 
 
 
 
 
Brown University  
School of Public Health 
Department of Epidemiology 
 
 
 
 
RESEARCH STUDY: 
Mindfulness-Based Intervention for 
Blood Pressure Reduction 
 
 
 
 
 
 
 
Free to qualified participants 
 
 
 
Back of Advertisement Card: 
 
 
 
This is a 9-week program that includes mindfulness 
meditation, mindful movements, and education about 
risk factors for blood pressure. The study is testing 
whether combining these interventions lowers blood 
pressure. The program consists of nine weekly sessions 
that are 1 or 2.5 hours (depending on study arm), and 
an all-day weekend retreat.  
 
Research participation includes interviews, 
questionnaires and measurements of blood pressure, 
height, weight, and waist circumference, before and 
after the meditation program.  
 
Contact: For more information, or to see if you qualify, 
call the Brown Sociobiology Laboratory at 401-863-
6283, or email SBL@gmail.com. See website at [URL 
needs to be created]. 
 
 
 
 
 
 

 
26 
Sample Text of Recruitment Letter (placed on Dr. Loucks’ letterhead): 
 
[Date] 
 
Dear _____,  
 
Your physician [name of physician] identified you as someone with prehypertension or hypertension who 
may be interested in participating in a new study at Brown University that is designed to evaluate effects 
of an intervention called Mindfulness-Based Hypertension Therapy (MBHT). MBHT combines 
mindfulness practices such as meditation and mindful movements with education about hypertension 
management and prevention. The aim of MBHT is to create a skill set and supportive environment to 
help to reduce blood pressure, and improve overall well-being. Your involvement in this study could help 
us better understand if MBHT is effective, and how it could be improved. The MBHT intervention will take 
place over 9 weeks, and would involve you attending a class once per week that would be between 1 
and 2.5 hours, depending on which group you are assigned to. You may also be assigned to participate 
in a full day mindfulness retreat that would be about 7.5 hours duration. Also, health assessments would 
be performed before you start the intervention, and again immediately at the end of the 9-week 
intervention, as well as at 3 months and 6 months follow-up. The assessments would include measures 
such as blood pressure, height, weight, diet, physical activity, smoking, depression, stress, and 
medication use. These assessments will take 1-2 hours to complete. 
 
At the end of the study, you will receive individual feedback about the changes that occurred since the 
first assessment. Specifically, you will receive an individualized handout listing your changes on scales of 
attention, stress, mood, health behaviors and blood pressure across the study. 
 
We cannot and do not guarantee or promise that you will receive any direct benefits from this study.  
However, participation in the study creates the potential benefit of a) identifying effective treatments for 
elevated blood pressure, b) gaining knowledge of the effects of mindfulness practices, c) gaining first-
hand knowledge about the most current scientific methods in scientific research d) receiving information 
about your psychological and physical functioning. 
 
If you are interested in participating in this study, please call 401-863-6283, or email 
eric.loucks@brown.edu. 
 
Sincerely yours, 
 
 
Eric B. Loucks, Ph.D. 
Assistant Professor 
 
 

 
27 
 
 
 
 
 
 
 
 
 
 
 
Section G: 
Questionnaires and Focus Group Topics 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 1 of 84 
	  
	  
	  
	  
	  
SCREENING QUESTIONNAIRE  
(PHONE-DELIVERED) 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 2 of 84
MBHT PHONE SCREEN 
 
Date of Screen: ___________________ 
 
Interviewer: _______________________ 
 
Screening #: _________________________________ (month.date.year.hour.minute) 
 
Name:  _________________________________________________  
 
Address: ____________________________________________________ 
 
Phone number(s): ____________________________________________________ 
 
Email address (or mailing if no email):__________________________________________ 
 
Notes from Interviewer: 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________ 
 
My name is ____________. I am calling from the Epidemiology Department at the Brown 
University School of Public Health, because you expressed interest in participating in our 
mindfulness study. I want to do 10-15 minutes phone interview with you to determine if you are a 
good match for this particular study. Is now a good time to speak? [If yes, proceed. If no, ask for 
other times and note in Potential Subject Log].  
 
 
There are a few things that I’d like to make clear before we start the interview. First of all, some 
of the questions will be very personal and sensitive. Are you in a private place to talk? Because 
this interview is of a personal nature, it is important that you understand that everything you say 
will be kept strictly confidential.  No one outside of our project will ever be able to see your 
answers, and we will not keep your name in the same place as any of your answers. If you are not 
eligible after the phone screen, we will destroy your information.  If you like, though, we can 
keep your information on file for future studies. 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 3 of 84
INCLUSION CRITERIA: Need YES to all 
 
 
 
Comments 
AGE 
 Age_______  Between 18 and 65?  
 
 
 
 
 
YES 
NO 
 
 
FXN 
Highest level of education? 
 
 
 
FXN 
Current occupation? 
 
 
 
ENG 
Can you read and write in English? 
YES 
NO 
 
 
INTEREST 
What interested you about this study? 
What kind of symptoms are you hoping to 
treat? 
YES 
NO 
 
EXCLUSION CRITERIA: LIFETIME: must be NO 
 
 
 
Comments 
Bipolar 
depression 
MANIA 
Has anyone ever told you that you have 
bipolar disorder or manic depression?  
YES 
NO   
BPD 
Has anyone ever used the word 
“Borderline” to describe you? 
YES 
NO   
Psychosis 
Have you ever had a hallucination or seen 
things that other people can’t see, or hear 
things other people can’t hear? Have you 
ever been diagnosed with schizophrenia 
or psychosis? 
YES 
NO 
 
MANIA/ 
Antipsychotic 
MEDS 
Have you ever taken any of the following 
medications?  
Lithium?                               
Seroquel (quetiapine) 
Abilify (aripiprazole)          
Zyprexa (olanzapine) 
Clozaril (clozapine)          
Haldol/Haloperidol 
Geodon (ziprasidone)         
Risperdal (risperidone) 
YES 
NO 
 
Self-harm 
Have you ever deliberately cut or injured 
yourself? Have you ever had a suicide 
attempt? (Details/age)  
YES 
NO 
 
 
 
Antisocial 
Have you ever been arrested? Any Legal 
problems? Have you ever been in a fight? 
YES 
NO 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 4 of 84
EXCLUSION: CURRENT (check timeframe) 
 
 
 
Comments 
PTSD 
Would you say you have a trauma 
history? Physical sexual abuse, assault 
rape? Where are you with that now? 
Any problems with dissociation (memory 
loss)? Flashbacks?  
YES 
NO Last month? 
OCD 
Any problems with obsessions or 
compulsions? Washing hands or 
checking the oven over and over? If yes, 
Has anyone diagnosed you with 
obsessive compulsive disorder? 
YES      NO 
Last month? 
PANIC 
Have you ever had a panic attack? 
(Sweating, heart palpitations, nausea, 
trouble breathing, fear of 
dying/choking/going crazy…  
Out of blue or triggered? 
Have you had one in the last month?   
YES 
NO Last  month? 
ALCOHOL 
How much alcohol do you currently 
drink?  
Any drug use? 
Ever abuse drug/alcohol? 
Time in recovery – min 1 year 
YES 
NO Last year? 
EATING DIS 
How is your relationship with food? Ever 
have an eating disorder? Starving, Binge 
eating, or vomiting? Where are you with 
that now? 
YES 
NO Last year? 
MEDITATION What is your experience with 
meditation? 
Rule out current regular practice (>1 
week) 
Lifetime daily mindfulness meditation 
(see “what is meditation?) 
YES 
NO  
MISC 
Any other psychological problem I 
haven’t mentioned?  
Social Anxiety? Ok in groups? 
Phobias? 
YES 
NO  
Time 
commitment 
(After study explanation)This study is a 
significant time commitment, is this a 
good time for you? 
 
 
DECISION 
 PASS           NO PASS             QUERY 
 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 5 of 84
 
PASS FORM: Initial appropriate boxes with dates 
Date/initials 
NO PASS 
According to this test, it doesn’t look like 
you are going to be a good fit for the study.  
There may be other studies you quality for. 
Would you like me to keep your information 
to pass on to these studies? Otherwise, our 
copy of this information can be destroyed. 
 
QUERY 
There are several items I will need to check 
with my supervisor about. We will get back 
in touch. 
 
PASS: 
Study description and 
requirements 
Time commitment 
You qualify for the study. If you want to 
continue, 
the next phase would require an interview, a 
packet of questionnaires and evening visit to 
the laboratory before the 9 week meditation 
program. After the program, you would fill 
out the same questionnaires and do the lab 
visit again.  
The meditation program is either 1 or 2.5 
hours once a week, usually in the evening, 
and requires up to an hour of practice every 
day. There also may be an all-day retreat on a 
Saturday part way through the course.  
Is this something that you would be able to 
make time for in your schedule? 
 
 
YES       NO 
SCHEDULE 
Available for current 
program? 
It’s important to attend all 9 sessions. 
The next program is: 
Availability: 
Mon 9:00-11:30, 4-6:30 pm 
Tues 9:00-11:30, 4-6:30 pm 
Wed 9:00-11:30, 4-6:30 pm 
Thurs 9:00-11:30, 4-6:30 pm 
 
Other: 
 
YES   NO 
 
 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 6 of 84
 
 
 
 
 
QUESTIONNAIRES ANSWERED BY PARTICIPANTS 
AT BASELINE 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 7 of 84
Questionnaire Table of Contents 
 
Introductory Questions .................................................................................................................... 8	  
Background Questions ................................................................................................................... 10	  
Physical Activity ............................................................................................................................ 14	  
Food and Drinks (FD) .................................................................................................................... 16	  
Eating Practices (EP) ..................................................................................................................... 21	  
Alcohol Consumption (AC) ........................................................................................................... 23	  
Smoking (SM) ............................................................................................................................... 24	  
Medications (ME) .......................................................................................................................... 25	  
Self-Control ................................................................................................................................... 47	  
Sense of Control ............................................................................................................................ 48	  
CES-D Depression Inventory ........................................................................................................ 50	  
Perceived Stress Scale ................................................................................................................... 52	  
Mindfulness ................................................................................................................................... 53	  
Emotion Regulation ....................................................................................................................... 64	  
Beck Anxiety Inventory ................................................................................................................. 66	  
Parent’s Education ......................................................................................................................... 67	  
Your Childhood Experiences ......................................................................................................... 69	  
Loneliness ...................................................................................................................................... 74	  
Your Sleep ..................................................................................................................................... 75	  
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 8 of 84
Introductory Questions 
 
IQ1. What is your main reason for participating in this study? 
 
 
 
 
 
IQ2. What do you care about most? 
 
 
 
 
 
IQ3. What gives you most pleasure in your life? 
 
 
 
 
 
IQ4. What are your greatest worries? 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 9 of 84
Please list three personal goals you have for taking this mindfulness program: 
 
1.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 10 of 84
Background Questions 
 
B1. What is your age?   
_____ years old        □ I do not know   □ I prefer not to answer  
 
 
 
 
B2. Are you Latino or Hispanic?  
 
 
 
□ No à skip to B3 
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
  
B2a.    Which of the following represents your family's country of origin? (check  
 
  
 
    all that apply) 
 
 
 
 
 
 
□ Cuba 
 
 
 
 
□ Mexico 
 
 
 
 
□ Puerto Rico 
 
 
 
 
□ Spain 
                         □ South America 
 
 
 
 
□ Columbia 
 
□ Dominican Republic 
 
□ Other Central American 
 
□ Other: _______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 
B3. If you were asked to put yourself into only one of these groups, in which one would you 
 
place yourself? (select one only): 
 
 
 
□ Asian 
 
 
□ Pacific Islander 
 
 
□ African American/Black 
 
 
□ Caucasian/White 
 
□ Native American 
□ Other : ________________________ 
□ I do not know 
□ I prefer not to answer
B4. Which of the following best describes your current work situation? (select one only) 
 
 
 
□ Working full-time 
 
 
□ Working part-time  
 
 
□ Retired 
 
 
□ Unemployed:  
 
 
Looking for work 
□ Unemployed: Not currently    
      
looking for work 
 
 
□ Unemployed due to disability 
□ Keeping house or raising children  
    
full-time 
 
□ Military 
 
□ Full-time student 
 
□ Other:_______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 11 of 84
B9.    What is the highest grade or level of regular school you have completed? 
 
 
 
□ Elementary School 
 
 
□ Junior High  
 
 
□ High School 
 
 
□ College 
 
 
□ Graduate School  
 
 
□ I do not know 
 
 
□ I prefer not to answer 
     
B11.    What is the highest degree you earned? (select one only) 
 
 
 
□ GED 
 
 
□ High school diploma or   
 
    
 
     equivalency 
 
 
□ Associate degree (Junior  
 
 
    College) 
 
 
□ Bachelor’s degree 
 
 
□ Master’s degree 
 
 
□ Doctorate (Phd, EdD, etc) 
□ Professional (MD, JD, DDS, DVM, etc.) 
□ Other: _____________________________ 
□ None of the above (less than GED or less             
than high school graduation) 
□ I do not know 
□ I prefer not to answer 
 
 
B12.    Did you ever attend any other school like a technical, vocational, or trade school? 
 
 
 
□ No 
 
 
 
□ Yes 
 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
B13.    In total, about how many full-time years of education have you had, including 1st grade 
and all years of school after 1st grade? 
 
 
 
________ years 
 
 □ I do not know 
 
 
□ I prefer not to answer 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 12 of 84
B14.    Do you currently live alone? 
 
 
 
□ No 
 
 
 
□ Yes à skip to B15 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
 
 
B14a. 
How many people are currently living in your household, including  
 
 
 
             yourself? 
 
 
 
 
 
_________ people 
□ I do not know      □ I prefer not to answer 
      
 
 
 
 
 
 
 
 
 
 
 
B14b.    Of these people, how many are under 18? 
 
 
 
 
 
 
 _________ people 
□ I do not know      □ I prefer not to answer 
          
 
(if none, write 0) 
 
 
 
 
 
B14c. 
  Of the adults in your household (including yourself), how many bring   
 
 
      
 income into the household?   
 
 
 
 
 
 
_________ people 
□ I do not know       □ I prefer not to answer 
          
 
(if none, write 0) 
 
 
B16.    How much did YOU earn, before taxes and other deductions, during the past 12 months? 
 
 (Please include all income from your job(s), money from government programs, child   
support, interest and dividends, money from rental property, etc.) 
 
 
 
□ Less than $5,000 
 
 
□ $5,000 through $11,999 
 
 
□ $12,000 through $15,999 
 
 
□ $16,000 through $24,999 
 
 
□ $25,000 through $34,999 
 
 
□ $35,000 through $49,999 
 
□ $50,000 through $74,999 
 
□ $75,000 through $99,999 
 
□ $100,000 and greater  
 
□ I do not know 
 
□ I prefer not to answer 
     
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
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B17.    How much did your HOUSEHOLD earn, before taxes and other deductions, during the 
 
   past 12 months? (Please include all income from your job(s), your family member’s     
 
   job(s), money from government programs, child support, interest and dividends, money 
 
  from rental property, etc.) 
 
 
 
□ Less than $5,000 
 
 
□ $5,000 through $11,999  
 
 
□ $12,000 through $15,999  
 
 
□ $16,000 through $24,999  
 
 
□ $25,000 through $34,999  
 
 
□ $35,000 through $49,999  
 
□ $50,000 through $74,999  
 
□ $75,000 through $99,999  
 
□ $100,000 and greater  
 
□ I do not know 
 
□ I prefer not to answer
 
 
 
 
 
 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 14 of 84
Physical Activity 
 
Physical activities are activities where you move and increase your heart rate above its resting rate, 
whether you do them for pleasure, work, or transportation. The following questions ask about the 
amount and intensity of physical activity you usually do. The intensity of the activity is related to the 
amount of energy you use doing these activities. 
 
Examples of physical activity intensity levels: 
 
Light activities 
 
Your heart beats slightly faster than normal 
You can talk and sing 
 
 
 
 
 
 
 
 
 
Moderate activities 
 
Your heart beats faster than normal 
You can talk but not sing 
 
 
 
 
 
 
 
 
 
 
Vigorous activities 
 
Your heart rate increases a lot 
You can’t talk, or your talking is broken 
up by large breaths 
 
 
 
 
 
 
 
 
Light exercise   
 
Light stretching  
 
Light vacuuming  
or yard work 
Brisk walking     Aerobics class      Strength training    Swim gently 
Aerobics classes 
 Jogging, Running,   
Singles tennis, 
or Power Walking  
 
Racquetball, Pickle ball 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 15 of 84
How physically active are you? 
 
 
 
YES 
NO 
PA1. I rarely or never do any physical activities. 
 
 
 
PA2. I do some light and/or moderate physical activities, but not 
every week. 
 
 
 
PA3. I do some light physical activity every week. 
 
 
 
PA4. I do moderate physical activity every week but less than 5 days 
per week or less than 30 minutes on those days. 
 
 
 
PA5. I do vigorous physical activities every week, but less than 3 
days per week or less than 20 minutes on those days. 
 
 
 
PA6. I do 30 minutes or more per day of moderate physical activities 
5 or more days per week. 
 
 
 
PA7. I do 20 minutes or more per day of vigorous physical activities 
3 or more days per week. 
 
 
 
PA8. I do activities to increase muscle strength, such as lifting 
weights or calisthenics, once a week or more. 
 
 
 
PA9. I do activities to improve flexibility, such as stretching or yoga, 
once a week or more. 
 
 
 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 16 of 84
Food and Drinks (FD) 
 
The first set of questions ask about foods you usually eat or drink.  For each food, please place an X in 
the box (e.g. ý) for the answer that best matches how often you eat or drink it. Remember to count 
fruit or vegetables that were part of another dish, like a banana on cereal or vegetables in a stew. Also, 
please pay attention to the serving sizes. For example, one serving size of bread is one slice, so a 
sandwich would contain 2 servings of bread. Please include all foods you eat, both at home and away 
from home.   Enclosed are pictures of common serving sizes to assist you in filling out your 
questionnaire. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4-6 ounces
1 teaspoon 
3 ounces 
1 tablespoon 
1 cup  
1 cup  
8 ounces
4 ounces 
Small glass 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 17 of 84
 
How Often You Eat or Drink This Item 
 
Never 
or less 
than 1 
per 
month 
1-3 per 
month 
1 per 
week 
2-4 per 
week 
5-6 per 
week 
1 per 
day 
2-3    
per 
day 
4-5    
per 
day 
More 
than 5 
per 
day 
I don’t 
know 
I prefer 
not to 
answer 
FD1. 
Skim/low fat 
milk  (8 oz. 
glass) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD2. Whole 
milk  (8 oz. 
glass) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD3. Ice 
cream (1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD4. Yogurt 
(1 cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD5. 
Cottage or 
ricotta 
cheese    
(1/2 cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD6. Butter, 
added to 
food or 
bread (1 
pat), exclude 
use in 
cooking 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD7. Fruit 
(not 
including 
fruit juice. A 
serving = 1 
piece, or 1/2 
grapefruit, 
or 1/2 cup 
berries) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD8. 100% 
fruit juice, 
not 
including 
fruit drinks 
(small glass) 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 18 of 84
How Often You Eat or Drink This Item 
 
Never 
or less 
than 1 
per 
month 
1-3 per 
month 
1 per 
week 
2-4 per 
week 
5-6 per 
week 
1 per 
day 
2-3    
per 
day 
4-5    
per 
day 
More 
than 5 
per 
day 
I don’t 
know 
I prefer 
not to 
answer 
FD9. 
Vegetables - 
raw and 
cooked (1/2 
cup), 
including 
mixed dishes 
such as 
soups, 
casseroles 
and lasagna. 
Do not 
include 
potatoes. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD10. Eggs 
(do not 
include egg 
beaters) (1) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD11. 
Chicken or 
turkey (4-6 
oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD12. 
Processed 
meat (1 
piece 
sausage, 1 
slice salami, 
2 pieces 
bacon) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD13. Hot 
dog/ 
hamburger 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 19 of 84
 
                   
 How Often You Eat or Drink This Item 
 
Never or 
less than 
1 per 
month 
1-3 
per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3    
per 
day 
4-5   
per 
day 
More 
than 
5 per 
day 
I don’t 
know 
I prefer 
not to 
answer 
FD14. Beef, pork, or 
lamb as a sandwich 
or mixed dish, e.g. 
stew, casserole, 
lasagna, etc. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD15. Beef, pork, or 
lamb as a main dish, 
e.g. steak, roast, 
ham, etc.   (4-6 oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD16. Fish 
(including canned 
tuna) (3-5 oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD17. Shellfish such 
as shrimp, lobster, 
scallops and clams as 
a main dish 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD18. White bread 
(including pita 
bread) (slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD19. Dark bread 
(incl. whole wheat 
and rye) (slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD20. Bakery items 
(cookies, brownies, 
doughnuts, cake) (1 
piece or slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD21. Nuts (small 
packet, 1 oz., 1 Tbs 
peanut butter) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD22. Pasta (e.g. 
spaghetti, and 
macaroni and cheese; 
1 cup cooked) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD23. Potatoes, 
baked, boiled or 
mashed (do not 
include French fries/ 
chips) (1 potato or 1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
  
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 20 of 84
                                  How Often You Eat or Drink This Item 
 
Never or 
less than 
1 per 
month 
1-3 
per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3    
per 
day 
4-5   
per 
day 
More 
than 
5 per 
day 
I don’t 
know 
I prefer 
not to 
answer 
FD24. Regular soft 
drinks (including 
caffeine free, but 
NOT including diet 
colas) (consider the 
serving size as 1 
glass, bottle or can) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FD25. Coffee 
(regular or decaf) (1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 21 of 84
Eating Practices (EP) 
 
 
Definitely 
True 
Mostly 
True 
Mostly 
False 
Definitely 
False 
1. I deliberately take small helpings to control 
my weight. 
□ 
□ 
□ 
□ 
2. I start to eat when I feel anxious. 
□ 
□ 
□ 
□ 
3. Sometimes when I start eating, I just can’t 
seem to stop. 
□ 
□ 
□ 
□ 
4. When I feel sad, I often eat too much. 
□ 
□ 
□ 
□ 
5. I don’t eat some foods because they make me 
fat. 
□ 
□ 
□ 
□ 
6. Being with someone who is eating, often 
makes me want to also eat. 
□ 
□ 
□ 
□ 
7. When I feel tense or ‘‘wound up’’, I often 
feel I need to eat. 
□ 
□ 
□ 
□ 
8. I often get so hungry that my stomach feels 
like a bottomless pit. 
□ 
□ 
□ 
□ 
9. I’m always so hungry that it’s hard for me to 
stop eating before finishing all of the food on 
my plate. 
□ 
□ 
□ 
□ 
10. When I feel lonely, I console myself by 
eating. 
□ 
□ 
□ 
□ 
11. I consciously hold back on how much I eat 
at meals to keep from gaining weight. 
□ 
□ 
□ 
□ 
12. When I smell a sizzling steak or see a juicy 
piece of meat, I find it very difficult to keep 
from eating even if I’ve just finished a meal. 
□ 
□ 
□ 
□ 
13. I’m always hungry enough to eat at any 
time. 
□ 
□ 
□ 
□ 
14. If I feel nervous, I try to calm down by 
eating. 
□ 
□ 
□ 
□ 
15. When I see something that looks very 
delicious, I often get so hungry that I have to eat 
right away. 
□ 
□ 
□ 
□ 
16. When I feel depressed, I want to eat. 
□ 
□ 
□ 
□ 
 
 
 
Almost 
Never 
Seldom 
Usually 
Almost 
Always 
17. How often do you avoid ‘stocking up’’ on tempting 
foods? 
□ 
□ 
□ 
□ 
 
 
Unlikely 
A little 
likely 
Somewhat 
likely 
Very 
likely 
18. How likely are you to make an effort to eat less 
than you want? 
□ 
□ 
□ 
□ 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 22 of 84
 
 
Never 
Rarely Sometimes 
At least 
once a week 
19. Do you go on eating binges even though you’re 
not hungry? 
□ 
□ 
□ 
□ 
 
 
Only at 
mealtimes 
Sometimes 
between 
meals 
Often 
between 
meals 
Almost 
always 
20. How often do you feel hungry? 
□ 
□ 
□ 
□ 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
21. On a scale from 1 to 8, where 1 means no restraint in eating and 
8 means total restraint, what number would you give yourself? Mark 
the number that best applies to you: 
□ □ □ □ □ □ □ □ 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 23 of 84
Alcohol Consumption (AC) 
 
A drink of alcohol is defined as 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine cooler, 1 
cocktail, or 1 shot of liquor. 
 
AC1. During the past 30 days, how many days per week or per month did you have at least 1 drink of 
any alcoholic beverage? [if none, STOP] 
 
_______________ 
 
 
AC2. On the days when you drank, about how many drinks did you drink on average?  
 
______________ 
 
 
AC3. Men: Considering all types of alcoholic beverages, how many times during the past 30 days did 
you have 5 or more drinks on an occasion? 
Women: Considering all types of alcoholic beverages, how many times during the past 30 days 
did you have 4 or more drinks on an occasion? 
 
_________________ 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
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Smoking (SM) 
 
SM1. 
Have you smoked at least 100 cigarettes in your entire life? 
 
¨ Yes 
¨ No 
¨ Don’t know 
¨ Prefer not to answer 
 
 
SM2.  
Did you ever become a daily smoker (that is, smoke every day or nearly every day for two 
months or longer)? 
 
¨ Yes 
¨ No à skip to SM6 
¨ Don’t know 
¨ Prefer not to answer 
 
SM3.  
How old were you when you last smoked daily? 
 
  
Age ______ (in years) 
 
 
¨ Don’t know 
¨ Prefer not to answer  
¨ Still smoking daily 
 
 
 
SM4. 
Do you smoke cigarettes now? 
 
¨ Yes 
¨ No à skip to next section 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 SM4a.    How many cigarettes per day do you smoke? (One pack equals 20   
 
    
 
cigarettes) 
 
  
 
 
Number of cigarettes ________  
 
 
 
 
 
 
 
 
¨ Don’t know 
 
 
 
 
¨ Prefer not to answer 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 25 of 84
Medications (ME) 
 
 
ME1. 
Do you take any prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
 
What is the name of the first prescription medication or over-the-counter drug that you take? 
 
ME2a. 
¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
ME2b. 
What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME2c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME2d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME2d1. 
Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 26 of 84
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME2e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME2f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME2g. 
Interviewer comments: 
________________________________________________________________________ 
 
 
ME2h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME83a. ¨ Label product name: 
 
______________________________________________________________________ 
 
¨ Label generic name:  ______________________________________________________________________ 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
ME3b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 27 of 84
 
ME3c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME3d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.) 
 
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME3d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME3e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME3f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME3g. 
Interviewer comments:  
 
 
________________________________________________________________________ 
 
 
ME3h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
ME4a. 
¨ Label product name: ______________________________________________________________________ 
 
¨ Label generic name: ______________________________________________________________________ 
 
¨ Don’t know 
 
¨ Prefer not to answer 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 28 of 84
ME4b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME4c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME4d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME4d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME4e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME4f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 29 of 84
ME4g. 
Interviewer comments: 
 
________________________________________________________________________ 
 
ME4h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to next section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME5a. 
¨ Label product name: 
 
______________________________________________________________________ 
 
 
 
¨ Label generic name:  ______________________________________________________________________ 
 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
ME5b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME5c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
 
ME5d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 

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ME5d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
ME5e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
ME5f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME5g. 
Interviewer comments: 
________________________________________________________________________ 
 
 
ME5h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME6a. 
¨ Label product name: 
 
______________________________________________________________________ 
 
¨ Label generic name:  ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
 
 
 
 
 
 
ME6b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 

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¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME6c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME6d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME6d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
ME6e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
ME6f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME6g. 
Interviewer comments: 
________________________________________________________________________ 
 
 

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ME6h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to next section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME7a. 
¨ Label product name: 
 
______________________________________________________________________ 
 
 
¨ Label generic name:  ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
ME7b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME7c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
ME7d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME7d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 

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¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME7e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME7f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME7g. 
Interviewer comments: 
________________________________________________________________________ 
 
 
 
 
ME7h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME8a. 
¨ Label product name: 
 
______________________________________________________________________ 
 
 
¨ Label generic name:  ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
 
 
 
 
 
 
ME8b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 

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Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME8c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME8d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME8d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME8e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
 
 
ME8f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME8g. 
Interviewer comments: 
________________________________________________________________________ 
 
 
ME8h. Do you take any other prescription medications or over-the-counter drugs? 

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¨ No à skip to next section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME9a. 
¨ Label product name: 
 
______________________________________________________________________ 
 
 
¨ Label generic name:   
 
______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
ME9b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME9c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
ME9d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME9d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 

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¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME9e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME9f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME9g. 
Interviewer comments: 
________________________________________________________________________ 
 
ME9h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to next section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer 
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME10a. ¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
 
 
 
 
 
 
 
 
ME10b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 

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Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME10c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME10d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
ME10d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME10e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
 
 
ME10f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME10g. 
Interviewer comments: 
________________________________________________________________________ 
 
ME10h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 

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What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME11a. ¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
ME11b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME11c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
 
 
ME11d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME11d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 

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ME11e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME11f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME11g. 
Interviewer comments: 
________________________________________________________________________ 
 
 
 
 
 
ME11h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME12a. ¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
 
ME12b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME12c. 
How frequently do you take it? 

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¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME12d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME12d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME12e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
ME12f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME12g. 
Interviewer comments: 
________________________________________________________________________ 
 
ME12h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME13a. ¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 

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ME13b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME13c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
ME13d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME13d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME13e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME13f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 

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¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME13g. 
Interviewer comments: 
________________________________________________________________________ 
 
ME13h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to next section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME14a. ¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
 
 
 
 
ME14b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME14c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME14d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 

MBHT Questionnaire, Version 1.1, November 28, 2014 
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¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME14d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME14e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME14f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME14g. 
Interviewer comments: 
________________________________________________________________________ 
 
 
 
ME14h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of survey 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME15a. ¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
ME15b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 44 of 84
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME15c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
 
 
 
ME15d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME15d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME15e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME15f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME15g. 
Interviewer comments: 
________________________________________________________________________ 
 
ME15h. Do you take any other prescription medications or over-the-counter drugs? 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 45 of 84
¨ No à skip to next section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
What is the name of the next prescription medication or over-the-counter drug that you take? 
 
ME16a. ¨ Label product name: ______________________________________________________________________ 
 
 
¨ Label generic name: ______________________________________________________________________ 
 
 
¨ Don’t know 
 
¨ Prefer not to answer 
 
 
 
 
ME16b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
 
 
 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME16c. 
How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
ME16d. 
What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME16d1.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 

MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 46 of 84
¨ _________ I.U. 
¨ _________ Other unit: _____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME16e. 
Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME16f. 
For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME16g. 
Interviewer comments:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 47 of 84
Self-Control 
 
Using the scale provided, please indicate how much each of the following statements reflects 
how you typically are.  
 
 
Not at 
all 
A little 
Somewhat 
Fair 
Amount 
Very 
much 
1. I am good at resisting temptation. 
□ 
□ 
□ 
□ 
□ 
2. I have a hard time breaking bad 
habits. 
□ 
□ 
□ 
□ 
□ 
3. I am lazy.  
□ 
□ 
□ 
□ 
□ 
4. I say inappropriate things. 
□ 
□ 
□ 
□ 
□ 
5. I do certain things that are bad for 
me, if they are fun.  
 
□ 
□ 
□ 
□ 
□ 
6. I refuse things that are bad for me. 
□ 
□ 
□ 
□ 
□ 
7. I wish I had more self-discipline. 
□ 
□ 
□ 
□ 
□ 
8. People would say that I have iron 
self-discipline. 
□ 
□ 
□ 
□ 
□ 
9. Pleasure and fun sometimes keep 
me from getting work done. 
□ 
□ 
□ 
□ 
□ 
10. I have trouble concentrating. 
□ 
□ 
□ 
□ 
□ 
11. I am able to work effectively 
toward long-term goals. 
□ 
□ 
□ 
□ 
□ 
12. Sometimes I can’t stop myself 
from doing something, even if I know 
it is wrong. 
□ 
□ 
□ 
□ 
□ 
13. I often act without thinking 
through all the alternatives. 
 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 48 of 84
 
 
Sense of Control 
 
The next few statements are about certain ways you may feel about your life. Please indicate how 
strongly you agree or disagree with each of the following statements: Strongly agree; Agree; 
Neutral, Disagree, or Strongly disagree 
 
 
 
 
  
Strongly 
agree 
Agree 
Neutral 
Disagree 
Strongly 
disagree 
Don’t 
know 
Prefer 
not to 
answer 
SE1. I have little control 
over the things that 
happen to me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE2. There is really no 
way I can solve some of 
the problems I have. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE3. There is little I can 
do to change many of the 
important things in my 
life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE4. I often feel helpless 
in dealing with the 
problems of life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE5. Sometimes I feel that 
I am being pushed around 
in life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE6. What happens to me 
in the future mostly 
depends on me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE7. I can do just about 
anything I really set my 
mind to do. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 49 of 84
Self-Compassion 
 
Please read each statement carefully before answering. To the left of each item, indicate how 
often you behave in the stated manner, using the following scale: 
 
0 
1 
2 
3 
4 
Almost never 
 
 
 
Almost always 
 
_____1. When I fail at something important to me I become consumed by feelings of inadequacy. 
 
_____2. I try to be understanding and patient towards those aspects of my personality I don’t like. 
 
_____3. When something painful happens I try to take a balanced view of the situation. 
 
_____4. When I’m feeling down, I tend to feel like most other people are probably happier than I 
am. 
 
_____5. I try to see my failings as part of the human condition. 
 
_____6. When I’m going through a very hard time, I give myself the caring and tenderness I 
need. 
 
_____7. When something upsets me I try to keep my emotions in balance. 
 
_____8. When I fail at something that’s important to me, I tend to feel alone in my failure 
 
_____9. When I’m feeling down I tend to obsess and fixate on everything that’s wrong. 
 
_____10. When I feel inadequate in some way, I try to remind myself that feelings of inadequacy 
are shared by most people. 
 
_____11. I’m disapproving and judgmental about my own flaws and inadequacies. 
 
_____12. I’m intolerant and impatient towards those aspects of my personality I don’t like. 
 
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 50 of 84
CES-D Depression Inventory 
 
For each statement, please place a mark in the column that best describes how you have been 
feeling in the past week. 
 
 
Rarely or none 
of the time 
(less than 1 
day) 
Some or a little 
of the time 
(1 – 2 days) 
Occasionally 
or a moderate 
amount of the 
time 
(3 – 4 days) 
Most or all of 
the time 
(5 – 7 days) 
C1. I was bothered by things that 
usually don’t bother me. 
 
□ 
□ 
□ 
□ 
C2. I did not feel like eating; my 
appetite was poor. 
 
□ 
□ 
□ 
□ 
C3. I felt that I could not shake off 
the blues, even with the help 
from family or friends. 
 
□ 
□ 
□ 
□ 
C4. I felt that I was just as good as 
other people. 
 
□ 
□ 
□ 
□ 
C5. I had trouble keeping my mind 
on what I was doing. 
 
□ 
□ 
□ 
□ 
C6. I felt depressed. 
 
□ 
□ 
□ 
□ 
C7. I felt that everything I did was 
an effort. 
 
□ 
□ 
□ 
□ 
C8. I felt hopeful about the future. 
 
□ 
□ 
□ 
□ 
C9. I thought my life had been a 
failure. 
 
□ 
□ 
□ 
□ 
C10. I felt fearful. 
 
□ 
□ 
□ 
□ 
C11. My sleep was restless. 
 
□ 
□ 
□ 
□ 
C12. I was happy. 
 
□ 
□ 
□ 
□ 
C13. I talked less than usual. 
 
□ 
□ 
□ 
□ 
C14. I felt lonely. 
 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 51 of 84
 
Rarely or none 
of the time 
(less than 1 
day) 
Some or a little 
of the time 
(1 – 2 days) 
Occasionally 
or a moderate 
amount of the 
time 
(3 – 4 days) 
Most or all of 
the time 
(5 – 7 days) 
C15. People were unfriendly. 
 
□ 
□ 
□ 
□ 
C16. I enjoyed life. 
 
□ 
□ 
□ 
□ 
C17. I had crying spells. 
 
□ 
□ 
□ 
□ 
C18. I felt sad. 
 
□ 
□ 
□ 
□ 
C19. I felt that people dislike me. 
 
□ 
□ 
□ 
□ 
C20. I could not get “going”. 
 
□ 
□ 
□ 
□ 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 52 of 84
Perceived Stress Scale  
The questions in this scale ask you about your feelings and thoughts during the last month. In 
each case, you will be asked to indicate by circling how often you felt or thought a certain way.  
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
P1. 
In the last month, how often have you 
been upset because of something that happened 
unexpectedly?  
□ 
□ 
□ 
□ 
□ 
P2. In the last month, how often have you 
felt that you were unable to control the 
important things in your life?  
□ 
□ 
□ 
□ 
□ 
P3. 
In the last month, how often have you 
felt nervous and “stressed”? 
□ 
□ 
□ 
□ 
□ 
P4. 
In the last month, how often have you 
felt confident about your ability to handle your 
personal problems?  
□ 
□ 
□ 
□ 
□ 
P5. 
In the last month, how often have you 
felt that things were going your way? 
□ 
□ 
□ 
□ 
□ 
P6. 
In the last month, how often have you 
found that you could not cope with all the 
things that you had to do?  
□ 
□ 
□ 
□ 
□ 
P7. 
In the last month, how often have you 
been able to control irritations in your life? 
□ 
□ 
□ 
□ 
□ 
P8. 
In the last month, how often have you 
felt that you were on top of things? 
□ 
□ 
□ 
□ 
□ 
P9. 
In the last month, how often have you 
been angered because of things that were 
outside of your control? 
□ 
□ 
□ 
□ 
□ 
P10. In the last month, how often have you 
felt difficulties were piling up so high that you 
could not overcome them?  
□ 
□ 
□ 
□ 
□ 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 53 of 84
Mindfulness 
 
Instructions: Below is a collection of statements about your everyday experience. Using the scale 
below, please indicate how frequently or infrequently you currently have each experience. Please 
answer according to what really reflects your experience rather than what you think your 
experience should be. Please treat each item separately from every other item.  
 
Please indicate the degree to which you agree with each of the following items using the scale 
below. Simply check your response to each item 
  
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
Y5. 
I could be 
experiencing 
some emotion 
and not be 
conscious of 
it until some 
time later.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y6. 
I break or spill 
things 
because of 
carelessness, 
not paying 
attention, or 
thinking of 
something 
else.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y7. 
I find it 
difficult to 
stay focused 
on what’s 
happening in 
the present. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y8. 
I tend to walk 
quickly to get 
where I’m 
going without 
paying 
attention to 
what I 
experience 
along the 
way.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y9. 
I tend not to 
notice 
feelings of 
physical 
tension or 
discomfort 
until they 
really grab 
my attention.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 54 of 84
 
 
  
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
Y10. It seems I am 
“running on 
automatic” 
without much 
awareness of 
what I’m 
doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y11. I rush through 
activities 
without being 
really 
attentive to 
them.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y12. I get so 
focused on 
the goal I 
want to 
achieve that I 
lose touch 
with what I 
am doing 
right now to 
get there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y13. I do jobs or 
tasks 
automatically, 
without being 
aware of what 
I’m doing.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y14. I find myself 
listening to 
someone with 
one ear, doing 
something 
else at the 
same time.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y15. I drive places 
on “automatic 
pilot” and 
then wonder 
why I went 
there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y16. I find myself 
preoccupied 
with the 
future or the 
past.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Y17. I find myself 
doing things 
without 
paying 
attention. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 55 of 84
 
 
 
 
 
 
 
 
 
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
Y18. I snack 
without being 
aware that 
I’m eating.    
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 56 of 84
Please rate each of the following statements using the scale provided. Write the number in the 
blank that best describes your own opinion of what is generally true for you.  
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
F1. When I’m walking, I deliberately notice the 
sensations of my body moving.  
□ 
□ 
□ 
□ 
□ 
F2. I’m good at finding words to describe my 
feelings.  
□ 
□ 
□ 
□ 
□ 
F3. I criticize myself for having irrational or 
inappropriate emotions.  
□ 
□ 
□ 
□ 
□ 
F4. I perceive my feelings and emotions without 
having to react to them.  
□ 
□ 
□ 
□ 
□ 
F5. When I do things, my mind wanders off and 
I’m easily distracted.  
□ 
□ 
□ 
□ 
□ 
F6. When I take a shower or bath, I stay alert to 
the sensations of water on my body.  
□ 
□ 
□ 
□ 
□ 
F7. I can easily put my beliefs, opinions, and 
expectations into words.  
□ 
□ 
□ 
□ 
□ 
F8. I don’t pay attention to what I’m doing 
because I’m daydreaming, worrying, or 
otherwise distracted.  
□ 
□ 
□ 
□ 
□ 
F9. I watch my feelings without getting lost in 
them.  
□ 
□ 
□ 
□ 
□ 
F10. 
I tell myself I shouldn’t be feeling the 
way I’m feeling.  
□ 
□ 
□ 
□ 
□ 
F11. 
I notice how foods and drinks affect my 
thoughts, bodily sensations, and emotions.  
□ 
□ 
□ 
□ 
□ 
F12. 
It’s hard for me to find the words to 
describe what I’m thinking.  
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 57 of 84
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
F13. 
I am easily distracted. 
□ 
□ 
□ 
□ 
□ 
F14. 
I believe some of my thoughts are 
abnormal or bad and I shouldn’t think that 
way.  
□ 
□ 
□ 
□ 
□ 
F15. 
I pay attention to sensations, such as the 
wind in my hair or sun on my face.  
□ 
□ 
□ 
□ 
□ 
F16. 
I have trouble thinking of the right 
words to express how I feel about things.  
□ 
□ 
□ 
□ 
□ 
F17. 
I make judgments about whether my 
thoughts are good or bad.  
□ 
□ 
□ 
□ 
□ 
F18. 
I find it difficult to stay focused on 
what’s happening in the present.  
□ 
□ 
□ 
□ 
□ 
F19. 
When I have distressing thoughts or 
images, I “step back” and am aware of the 
thought or image without getting taken over 
by it.  
□ 
□ 
□ 
□ 
□ 
F20. 
I pay attention to sounds, such as clocks 
ticking, birds chirping, or cars passing.  
□ 
□ 
□ 
□ 
□ 
F21. 
In difficult situations, I can pause 
without immediately reacting.  
□ 
□ 
□ 
□ 
□ 
F22. 
When I have a sensation in my body, 
it’s difficult for me to describe it because I 
can’t find the right words.  
□ 
□ 
□ 
□ 
□ 
F23. 
It seems I am “running on automatic” 
without much aware- ness of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
F24. 
When I have distressing thoughts or 
images, I feel calm soon after.  
□ 
□ 
□ 
□ 
□ 
F25. 
I tell myself that I shouldn’t be thinking 
the way I’m thinking.  
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 58 of 84
 
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
F26. 
I notice the smells and aromas of things.  
□ 
□ 
□ 
□ 
□ 
F27. 
Even when I’m feeling terribly upset, I 
can find a way to put it into words.  
□ 
□ 
□ 
□ 
□ 
F28. 
I rush through activities without being 
really attentive to them.  
□ 
□ 
□ 
□ 
□ 
F29. 
When I have distressing thoughts or 
images, I am able just to notice them without 
reacting.  
□ 
□ 
□ 
□ 
□ 
F30. 
I think some of my emotions are bad or 
inappropriate and I shouldn’t feel them.  
□ 
□ 
□ 
□ 
□ 
F31. 
I notice visual elements in art or nature, 
such as colors, shapes, textures, or patterns of 
light and shadow.  
□ 
□ 
□ 
□ 
□ 
F32. 
My natural tendency is to put my 
experiences into words.  
□ 
□ 
□ 
□ 
□ 
F33. 
When I have distressing thoughts or 
images, I just notice them and let them go.  
□ 
□ 
□ 
□ 
□ 
F34. 
I do jobs or tasks automatically without 
being aware of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
F35. 
When I have distressing thoughts or 
images, I judge myself as good or bad 
depending what the thought or image is 
about.  
□ 
□ 
□ 
□ 
□ 
F36. 
I pay attention to how my emotions 
affect my thoughts and behavior.  
□ 
□ 
□ 
□ 
□ 
F37. 
I can usually describe how I feel at the 
moment in consider- able detail.  
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 59 of 84
 
 
 
 
 
 
 
 
Never 
Almost 
Never 
Someti
mes 
Fairly 
Often 
Often 
F38. 
I find myself doing things without 
paying attention. 
□ 
□ 
□ 
□ 
□ 
F39. 
I disapprove of myself when I have 
irrational ideas. 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 60 of 84
This Week's Experiences 
 
Instructions: Below is a collection of statements about how you find yourself reacting to 
unpleasant thoughts and feelings.  Using the scale below, please indicate how frequently or 
infrequently you experienced each of the following reactions this week.  Please answer 
according to what really reflects your experience this week rather than what you think your 
experience should be.  
 
This week, when I encountered an unpleasant thought or feeling,  
    
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
1. I tried to think pleasant 
thoughts instead 
□ 
□ 
□ 
□ 
□ 
□ 
2. I allowed myself to 
experience it 
□ 
□ 
□ 
□ 
□ 
□ 
3. I got angry or upset at 
myself for having the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
4. I felt the desire to 
make it better or make it 
go away 
□ 
□ 
□ 
□ 
□ 
□ 
5. I wished I didn’t feel 
or think that way 
□ 
□ 
□ 
□ 
□ 
□ 
6. I tried to let my 
thoughts just come and 
go without getting too 
entangled with them 
□ 
□ 
□ 
□ 
□ 
□ 
7. I thought the mood 
would never change 
□ 
□ 
□ 
□ 
□ 
□ 
8. I explored the body 
sensations that 
accompanied the 
emotion. 
□ 
□ 
□ 
□ 
□ 
□ 
9. I named the emotion 
over and over as long as 
it lasted 
□ 
□ 
□ 
□ 
□ 
□ 
10. I turned to work or 
other activities to take my 
mind off things. 
□ 
□ 
□ 
□ 
□ 
□ 
11. I named the emotion 
and then redirected my 
attention to the present 
moment  
□ 
□ 
□ 
□ 
□ 
□ 
12. I thought "This mood, 
too, shall pass" 
□ 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 61 of 84
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
13. I focused on my 
breathing 
□ 
□ 
□ 
□ 
□ 
□ 
14. I took an active 
interest in how the 
experience changed over 
time 
□ 
□ 
□ 
□ 
□ 
□ 
15. I explored my 
reactions to the thought 
or emotion 
□ 
□ 
□ 
□ 
□ 
□ 
16. I thought "my 
thinking is being 
distorted by my mood" 
□ 
□ 
□ 
□ 
□ 
□ 
17. Think "Why do I 
have problems that other 
people don't have?" 
□ 
□ 
□ 
□ 
□ 
□ 
18. I forgave myself for 
having the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
19. I challenged the 
thought’s validity 
□ 
□ 
□ 
□ 
□ 
□ 
20. I asked myself 
questions about the 
experience in order to 
explore it better 
□ 
□ 
□ 
□ 
□ 
□ 
21. I tried not to change it 
because I believe it is 
important to experience 
□ 
□ 
□ 
□ 
□ 
□ 
22. I labelled my 
thoughts "images" or 
verbal "talk" 
□ 
□ 
□ 
□ 
□ 
□ 
23. I thought "Why do I 
always react this way?" 
□ 
□ 
□ 
□ 
□ 
□ 
24. I adopted a 
welcoming stance toward 
the emotion/thought 
□ 
□ 
□ 
□ 
□ 
□ 
25. I went somewhere 
alone to think about my 
feelings 
□ 
□ 
□ 
□ 
□ 
□ 
26. I sent out compassion 
to all people who struggle 
with this emotion  
□ 
□ 
□ 
□ 
□ 
□ 
27. I restrained myself 
from doing anything too 
quickly 
□ 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 62 of 84
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
28. I became genuinely 
curious about the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
29. I laughed or kidded 
myself about the situation 
□ 
□ 
□ 
□ 
□ 
□ 
30. I treated the repetitive 
thought like a “top ten 
radio tune” that's playing 
in the background 
□ 
□ 
□ 
□ 
□ 
□ 
31. I talked to others 
about how I was feeling 
□ 
□ 
□ 
□ 
□ 
□ 
32. I tried to forget about 
it 
□ 
□ 
□ 
□ 
□ 
□ 
33.  I thought "Why can't 
I handle things better" 
□ 
□ 
□ 
□ 
□ 
□ 
34. I tried to come up 
with a way to make it go 
away 
□ 
□ 
□ 
□ 
□ 
□ 
35. I said to myself 
"thinking" or "this is just 
a thought" 
□ 
□ 
□ 
□ 
□ 
□ 
36. I thought about how 
much I disliked feeling 
that way 
□ 
□ 
□ 
□ 
□ 
□ 
37. I reminded myself 
thoughts are not accurate 
reflections of reality 
□ 
□ 
□ 
□ 
□ 
□ 
38. I thought that that I 
must be headed into a 
downward spiral  
□ 
□ 
□ 
□ 
□ 
□ 
39. I thought "What I am 
doing to deserve this? 
□ 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 63 of 84
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 64 of 84
Emotion Regulation 
Please indicate how often the following statements apply to you by checking the box that 
best describes your experience.  
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
1.  I am clear about my feelings. 
□ 
□ 
□ 
□ 
□ 
2.  I pay attention to how I feel. 
□ 
□ 
□ 
□ 
□ 
3.  I experience my emotions as 
overwhelming and out of control. 
□ 
□ 
□ 
□ 
□ 
4.  I have no idea how I am feeling. 
□ 
□ 
□ 
□ 
□ 
5.  I have difficulty making sense out 
of my feelings. 
□ 
□ 
□ 
□ 
□ 
6.  I am attentive to my feelings. 
□ 
□ 
□ 
□ 
□ 
7.  I know exactly how I am feeling. 
□ 
□ 
□ 
□ 
□ 
8.  I care about what I am feeling. 
□ 
□ 
□ 
□ 
□ 
9.  I am confused about how I feel. 
□ 
□ 
□ 
□ 
□ 
10.  When I’m upset, I acknowledge 
my emotions. 
□ 
□ 
□ 
□ 
□ 
11.  When I’m upset, I become angry 
with myself for feeling that way. 
□ 
□ 
□ 
□ 
□ 
12.  When I’m upset, I become 
embarrassed for feeling that way. 
□ 
□ 
□ 
□ 
□ 
13.  When I’m upset, I have difficulty 
getting work done. 
□ 
□ 
□ 
□ 
□ 
14. When I’m upset, I become out of 
control. 
□ 
□ 
□ 
□ 
□ 
15.  When I’m upset, I believe that I 
will remain that way for a long time. 
□ 
□ 
□ 
□ 
□ 
16.  When I’m upset, I believe that I 
will end up feeling very depressed. 
□ 
□ 
□ 
□ 
□ 
17.  When I’m upset, I believe that 
my feelings are valid and important. 
□ 
□ 
□ 
□ 
□ 
18.  When I’m upset, I have difficulty 
focusing on other things. 
□ 
□ 
□ 
□ 
□ 
19.  When I’m upset, I feel out of 
control. 
□ 
□ 
□ 
□ 
□ 
20.  When I’m upset, I can still get 
things done. 
□ 
□ 
□ 
□ 
□ 
21.  When I’m upset, I feel ashamed 
at myself for feeling that way. 
□ 
□ 
□ 
□ 
□ 
22.  When I’m upset, I know that I 
can find a way to eventually feel 
better. 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 65 of 84
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
23.  When I’m upset, I feel like I am 
weak. 
□ 
□ 
□ 
□ 
□ 
24.  When I’m upset, I feel like I can 
remain in control of my behaviours. 
□ 
□ 
□ 
□ 
□ 
25. When I’m upset, I feel guilty for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
26. When I’m upset, I have difficulty 
concentrating. 
□ 
□ 
□ 
□ 
□ 
27.  When I’m upset, I have 
difficulty controlling my behaviours. 
□ 
□ 
□ 
□ 
□ 
28.  When I’m upset, I believe there 
is nothing I can do to make myself 
feel better. 
□ 
□ 
□ 
□ 
□ 
29.  When I’m upset, I become 
irritated at myself for feeling that 
way. 
□ 
□ 
□ 
□ 
□ 
30.  When I’m upset, I start to feel 
very bad about myself. 
□ 
□ 
□ 
□ 
□ 
31.  When I’m upset, I believe that 
wallowing in it is all I can do. 
□ 
□ 
□ 
□ 
□ 
32.  When I’m upset, I lose control 
over my behaviour. 
□ 
□ 
□ 
□ 
□ 
33.  When I’m upset, I have 
difficulty thinking about anything 
else. 
□ 
□ 
□ 
□ 
□ 
34.  When I’m upset I take time to 
figure out what I’m really feeling. 
□ 
□ 
□ 
□ 
□ 
35.  When I’m upset, it takes me a 
long time to feel better. 
□ 
□ 
□ 
□ 
□ 
36.  When I’m upset, my emotions 
feel overwhelming. 
□ 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 66 of 84
Beck Anxiety Inventory 
Below is a list of common symptoms of anxiety. Please carefully read each item in the list. 
Indicate how much you have been bothered by that symptom during the past month, including 
today, by circling the number in the corresponding space in the column next to each symptom.  
 
 
 
 
Not At All 
Mildly – it 
didn’t bother 
me much 
Moderately – it 
wasn’t pleasant 
at all times 
Severely – 
it bothered 
me a lot 
Numbness or tingling 
□ 
□ 
□ 
□ 
Feeling hot 
□ 
□ 
□ 
□ 
Wobbliness in legs 
□ 
□ 
□ 
□ 
Unable to relax 
□ 
□ 
□ 
□ 
Fear of worst happening 
□ 
□ 
□ 
□ 
Dizzy or lightheaded 
□ 
□ 
□ 
□ 
Heart pounding/racing 
□ 
□ 
□ 
□ 
Unsteady 
□ 
□ 
□ 
□ 
Terrified or afraid 
□ 
□ 
□ 
□ 
Nervous 
□ 
□ 
□ 
□ 
Feeling of choking 
□ 
□ 
□ 
□ 
Hands trembling 
□ 
□ 
□ 
□ 
Shaky/unsteady 
□ 
□ 
□ 
□ 
Fear of losing control 
□ 
□ 
□ 
□ 
Difficulty in breathing 
□ 
□ 
□ 
□ 
Fear of dying 
□ 
□ 
□ 
□ 
Scared 
□ 
□ 
□ 
□ 
Indigestion 
□ 
□ 
□ 
□ 
Faint/lightheaded  
□ 
□ 
□ 
□ 
Face flushed 
□ 
□ 
□ 
□ 
Hot/cold sweats 
□ 
□ 
□ 
□ 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 67 of 84
Parent’s Education 
 
1. 
Please check the box beside the highest grade or degree that your BIOLOGICAL 
MOTHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I don’t know 
□ 
I prefer not to answer 
□ 
 
 
2. 
Please check the box beside the highest grade or degree that your BIOLOGICAL 
FATHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I don’t know 
□ 
I prefer not to answer 
□ 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 68 of 84
Now please think of the two most important adults in your home between the time you were born 
and age 18 years. Please check the category below that best described their lecel of education 
during this time period. 
 
3. First adult’s highest level of education: 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I don’t know 
□ 
I prefer not to answer 
□ 
 
4. Second adult’s highest level of education 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I don’t know 
□ 
I prefer not to answer 
□ 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 69 of 84
Your Childhood Experiences 
The following questions ask about some difficult experiences that you might have had as a child. 
These questions may be emotionally difficult to answer. Just as a reminder, you do not need 
answer any questions that you would prefer not to. Your answers to these questions, as with all 
questions, will remain confidential.  
 
C1.  Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Swear at you, insult you, put you down, or humiliate you? 
 
 
 
or 
Act in a way that made you afraid that you might be physically hurt? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
C2. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Push, grab, slap, or throw something at you? 
 
 
 
or 
Ever hit you so hard that you had marks or were injured?  
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
C3.  Before you were 18 years old, did an adult or person at least 5 years older than you ever… 
 
 
Touch or fondle you or have you touch their body in a sexual way? 
 
 
 
or 
Attempt or actually have oral, anal, or vaginal intercourse with you? 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 70 of 84
C4. Before you were 18 years old, did you often or very often feel that … 
 
 
No one in your family loved you or thought you were important or special? 
 
 
 
or 
Your family didn’t look out for each other, feel close to each other, or support each other? 
 
  
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
C5. Before you were 18 years old, did you often or very often feel that … 
 
 
You didn’t have enough to eat, had to wear dirty clothes, and had no one to protect you? 
 
 
 
or 
Your parents were too drunk or high to take care of you or take you to the doctor if you 
needed it? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
  
 
 
C6. Before you were 18 years old, was a biological parent ever lost to you through divorce, 
abandonment, or other reason?   
 
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
C7. Before you were 18 years old, was your mother or stepmother:   
 
 
Often or very often pushed, grabbed, slapped, or had something thrown at her? 
 
 
 
or 
Sometimes, often, or very often kicked, bitten, hit with a fist, or hit with something hard? 
 
 
 
or 
Ever repeatedly hit over at least a few minutes or threatened with a gun or knife? 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 71 of 84
 
C8. Before you were 18 years old, did you live with anyone who was a problem drinker or 
alcoholic, or who used street drugs? 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
     
 
C9. Before you were 18 years old, was a household member depressed or mentally ill, or did a 
household member attempt  
suicide? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
C10. 
Before you were 18 years old, did a household member go to prison? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 72 of 84
About You 
 
Y1. How many close friends do you have? By close friends, we mean people that you feel at 
 
ease with, and that you can talk to about private matters. 
 
 
 
□ None à skip to Y2  
 
 
 
____ Number of close friends   
 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
 
Y1a.    How many of these close friends do you see at least once a month?     
 
 
 
 
 
____ Number of close friends (if none, write zero) 
 
 
 
 
 
□ I do not know  
 
 
 
 
□ I prefer not to answer  
 
 
Y2. Thinking about your relatives, how many relatives do you feel at ease with, and feel that 
 
you can talk to about private matters?  
 
 
 
□ None à skip to Y3 
 
 
 
____ Number of relatives  
 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
 
Y2a.    How many of these relatives do you see at least once a month?  
 
 
 
 
 
____ Number of relatives (if none, write zero) 
 
 
 
 
 
 
 
□ I do not know  
 
 
 
 
□ I prefer not to answer  
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 73 of 84
Y3. About how often do you participate in groups or clubs, such as religious connected groups, 
 
self-help groups, charities, or a public service or community group. 
 
 
 
□ Never or almost never 
 
 
□ A few times a year 
 
 
□ Once or twice a month 
 
 
□ Once a week 
 
 
□ More than once a week 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
Y4. About how often do you go to religious meetings or services?  
 
 
 
□ Never or almost never 
 
 
□ A few times a year 
 
 
□ Once or twice a month 
 
 
□ Once a week 
 
 
□ More than once a week 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
 
 
 
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 74 of 84
Loneliness 
 
INSTRUCTIONS: Indicate how often each of the statements below is descriptive of you. 
 
Statement 
Never 
Rarely 
Sometimes 
Often 
1. I feel in tune with the people around me 
□ 
□ 
□ 
□ 
2. I lack companionship 
□ 
□ 
□ 
□ 
3. There is no one I can turn to 
□ 
□ 
□ 
□ 
4. I do not feel alone 
□ 
□ 
□ 
□ 
5. I feel part of a group of friends 
□ 
□ 
□ 
□ 
6. I have a lot in common with the people around 
me 
□ 
□ 
□ 
□ 
7. I am no longer close to anyone 
□ 
□ 
□ 
□ 
8. My interests and ideas are not shared by those 
around me 
□ 
□ 
□ 
□ 
9. I am an outgoing person 
□ 
□ 
□ 
□ 
10. There are people I feel close to 
□ 
□ 
□ 
□ 
11. I feel left out 
□ 
□ 
□ 
□ 
12. My social relationships are superficial 
□ 
□ 
□ 
□ 
13. No one really knows me well 
□ 
□ 
□ 
□ 
14. I feel isolated from others 
□ 
□ 
□ 
□ 
15. I can find companionship when I want it 
□ 
□ 
□ 
□ 
16. There are people who really understand me 
□ 
□ 
□ 
□ 
17. I am unhappy being so withdrawn 
□ 
□ 
□ 
□ 
18. People are around me but not with me 
□ 
□ 
□ 
□ 
19. There are people I can talk to 
□ 
□ 
□ 
□ 
20. There are people I can turn to 
□ 
□ 
□ 
□ 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 75 of 84
Your Sleep 
 
The following questions relate to your usual sleep habits during the past month only. Your 
answers should indicate the most accurate reply for the majority of days and nights in the past 
month. Please answer all questions. 
 
S1. During the past month, what time have you usually gone to bed at night? 
 
 
 
BED TIME ___________ AM / PM 
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
S2. During the past month, how long (in minutes) has it usually taken you to fall asleep each 
 
night? 
 
 
 
NUMBER OF MINUTES ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
S3. During the past month, at what time have you usually gotten up in the morning? 
 
 
 
GETTING UP TIME ___________ AM / PM 
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
S4. During the past month, how many hours of actual sleep did you get on average at night? 
 
(This may be different than the number of hours you spent in bed.) 
 
 
 
AVERAGE HOURS OF SLEEP PER NIGHT ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 76 of 84
 
For each of the remaining questions, check the one best response. Please answer all questions. 
 
During the past month, how often have you had trouble sleeping because you………….. 
 
 
S5.  …..Could not get to sleep within 30 minutes? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer 
 
 
S6. …..Woke up in the middle of the night or early morning? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
S7. …..Had to get up to use the bathroom? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
 
 
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 77 of 84
S8. …..Could not breathe comfortably? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
S9. …..Coughed or snored loudly? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
S10. 
  …..Felt too cold? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
S11. 
  …..Felt too hot? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 78 of 84
S12. 
  …..Had bad dreams? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
S13. 
  …..Had pain? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
S14. 
   Other reason(s), please describe: __________________________________________ 
 
S14a. How often during the past month have you had trouble sleeping because of   
 
 
this? 
  
 
□ Not during the past month 
  
 
□ Less than once a week  
  
 
□ Once or twice a week 
  
 
□ Three or more times a week  
  
 
□ I do not know 
  
 
□ I prefer not to answer  
 
 
S15. 
 During the past month, how would you rate your sleep quality overall? 
 
 
 
□ Very good 
 
 
□ Fairly good  
 
 
□ Fairly bad 
 
 
□ Very bad 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 79 of 84
S17. 
During the past month, how often have you taken medicine to help you sleep 
(prescribed  or "over the counter")? 
 
 
 
□ Not during the past month 
 
 
□ Less than once a week  
 
 
□ Once or twice a week 
 
 
□ Three or more times a week  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
S18. 
 During the past month, how often have you had trouble staying awake while driving, 
 
     eating meals, or engaging in social activity? 
 
 
 
□ Not during the past month 
 
 
□ Less than once a week  
 
 
□ Once or twice a week 
 
 
□ Three or more times a week  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
S19. 
 During the past month, how much of a problem has it been for you to keep up enough 
 
 enthusiasm to get things done? 
 
 
 
□ No problem at all 
 
 
□ Somewhat of a problem 
 
 
□ A very big problem 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
S20. 
 Do you have a bed partner or a room-mate in the same room ? 
 
 
 
□ No bed partner or roommate in the same room à skip to next survey section:  
 
 
□ Partner in same bed  
 
 
 
 
 
 
 
 
 
□ Room-mate in the same room  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 80 of 84
If you have a roommate or bed partner, ask him/her how often in the past month you 
have had . . . . . . . . . . . . . . . 
  
 S21.    …..Loud snoring 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 S22. 
    ……Long pauses between breaths while asleep 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
  
 S23.   …..Legs twitching or jerking while you sleep 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 
 
 
 
 
 
  

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 81 of 84
S24.    …..Episodes of disorientation or confusion during sleep 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 
 
S25.   ……Other restlessness while you sleep; please describe: 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
____________________________________________________ 
  
 
 S25a. 
  
□ Not during the past month 
  
 
□ Less than once a week  
  
 
□ Once or twice a week 
  
 
□ Three or more times a week  
  
 
□ Unable to ask him/her 
  
 
□ he/she does not know 
  
 
□ he/she prefers not to answer  
 
 
 
 
 
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 82 of 84
 
 
 
 
 
 
 
FOCUS GROUP TOPICS 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 83 of 84
Focus Group Topics 
 
• How is your experience of the class length? Does it seem about right, or would you prefer 
it longer or shorter? – e.g. length of each class (2.5 hours vs. 1 hour), 9 week duration 
• Which modules did you find worked the best for you? 
• Are there topics or modules you think would help improve the course? 
• Are there areas we should expand? 
• Are there areas we should reduce? 
• Describe different modules, and ask how well they worked, specifically what they liked, 
didn’t like, and recommendations for what to change and what to keep the same.  
o Hypertension education in the orientation session 
o Class 2: Highly palatable snack practice  
o Class 2: Home practice related to pleasant events calendar on eating and alcohol 
consumption 
o Class 3: Exploration of physical activity including discussion in class, and home 
practice of performing physical activity.  
o Class 4: 15 min physical activity module followed by discussion . 
o Class 4: Motivational interviewing module related to diet, alcohol consumption 
and physical activity 
o Class 4-7: Home practice related to goal for diet, alcohol consumption, physical 
activity or diet.  
o Class 5: Exploring relationship with medication adherence 
o Class 6: Social support module 
o All-Day: Silent exercise module 
o Booster sessions 
 
 
 
 
 

 
 
MBHT Questionnaire, Version 1.1, November 28, 2014 
Page 84 of 84
QUESTIONNAIRES ANSWERED BY PARTICIPANTS 
AT 9 WEEKS, 3 MONTHS AND 6 MONTHS 
FOLLOW-UP 
 
 
 
 
Questionnaires administered at 9 weeks, 3 months and 6 months follow-up are identical to those 
administered at baseline, with the exception that questionnaires for which the answers should not 
change or be informative (i.e. introductory questions, age, race/ethnicity, education, childhood 
experiences) are not given at follow-ups.   
 
 

 
1
 
 
 
 
 
 
 
 
MINDFULNESS-BASED  
HYPERTENSION THERAPY PILOT STUDY 
 
IRB APPLICATION 
 
 
January 5th, 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eric B. Loucks, PhD 
Assistant Professor 
Department of Epidemiology  
Brown University School of Public Health 
121 South Main St., Box G-S121 
Providence, RI, 02912 
Phone: 401-863-6283 
Email: eric.loucks@brown.edu 
 

 
2
COVER LETTER 
 
Thank you for the helpful feedback. Below is an itemized response to the Board’s recommendations.  
 
The Board requested the following: 
1. Please ensure the study documents are consistent throughout the entire protocol submission. 
The Board noted that the protocol, recruitment material, consent document, surveys, and focus 
group documents contained conflicting information, did not match each other, and referenced 
sections and procedures that were not included in other documents in the submission. 
RESPONSE: Thank you, we apologize for the inconsistencies. Documents should now be consistent 
throughout.  
2. Please provide further description of the recruitment and consenting processes. The Board 
noted that the protocol contained too few details about these parts of the study. 
RESPONSE: Please see increased information below.  
APPLICATION CHANGE (pg. 15):  
Participants will be recruited through cardiology and family practices via established relationships 
with physicians at Rhode Island Hospital (e.g. Sam Dudley, MD), Memorial Hospital of Rhode Island 
(e.g. Charles Eaton, MD), Providence VA Medical Center (e.g. Hank Wu, MD), amongst others. IRB 
approval will be obtained by hospitals requiring it, such as Rhode Island Hospital and the Providence 
VA Medical Center. Typically, invitation letters (example text shown in Section F) will be sent to 96 
eligible patients in each collaborative hospital. Patient eligibility will be based on medical records of 
blood pressure and gender. Participants will be recruited in equal numbers based on hypertension 
status (i.e. pre-hypertensive, controlled hypertensive, and uncontrolled hypertensive), with equal 
proportions being male and female when possible. This approach will provide important recruitment 
and participation rate data for future studies. Furthermore, advertisements will be posted throughout 
Rhode Island inviting participants with pre-hypertension or hypertension to enroll (example 
advertisement shown in Section F).  
3. Please clarify how many participants you intend to enroll in the study. The Board was unsure if 
you would enroll the first 60 participants, or if you intend to screen a much higher number of 
potential participants to enroll a total of 60 people. The Board also questioned how the 60 
participants would be stratified across the three prehypertension/hypertension categories 
described in the protocol. 
RESPONSE: This has now been clarified. Please see change below. 
APPLICATION CHANGE (pg. 15):  
For Aims 1-3, we anticipate n=60 participants with equal proportions of males and females, and 
stratified across prehypertension/hypertension categories, including (1) pre-hypertension, (2) 
controlled hypertension, and (3) uncontrolled hypertension. This will allow for early indications of 
potential differential effects of MBHT by gender and prehypertension/hypertension status. Likely 
substantially greater than 60 participants will need to be recruited for screening, of which a proportion 
will be eligible based on criteria below and strata requirements above. We expect approximately 120 

 
3
participants required to be screened for 60 participants to be included in the study. This study will 
provide more accurate information on recruitment rates, which will inform future randomized 
controlled trials if the study shows initial evidence of effectiveness. For Aim 4, pilot data from Aim 2 
will provide needed effect sizes and statistical variance for power calculations. However, current 
power calculations were based on SBP and DBP changes in the Mindfulness-Based Stress Reduction 
RCT performed by Hughes et al.1 Specifically, Hughes et al. showed, with mean baseline SBP of 
129.5 (6.3 SD) mmHg and DBP of 77.8 (5.5 SD) mmHg, at 8 weeks follow-up a net reduction of 4.2 
mmHg SBP and 3.1 mmHg DBP for MBSR vs. active control group.1 For a sample size of 35 
participants per group, power analyses show 80% and 90% power to detect differences of 4.3 and 4.9 
mmHg SBP, respectively. This suggests adequate power for main effects analyses. At this time, Aim 4 
anticipates 70 participants in the study (35 per treatment arm), of which we expect approximately 140 
participants will need to be screened.  
4. Please further clarify when, where, and how participants will be asked to complete the screening 
and baseline surveys. 
RESPONSE: This information has now been clarified in Part 3.7.5 of Section C, as well as changes 
throughout Section G.  
APPLICATION CHANGES:  
 
Pg. 17: 
Interviewer training includes high standards for selection of interviewers who are at ease with 
strangers, are culturally-sensitive and able to readily establish professional rapport. Interviewers will 
be thoroughly trained in the administration of the structured interview, anthropometry, and blood 
pressure assessments. Routine quality control procedures will be in place regarding calibration of 
scales and blood pressure instruments. Clinical exams will be supervised by Dr. Loucks to at least 
monthly to evaluate accuracy of technique, particularly for anthropometry and blood pressure 
assessment. Re-training will be implemented if needed. Data will be entered and cleaned in an 
ongoing matter to facilitate quality control and preliminary analyses.  
 
Pp. 18-19: 
3.7.5  Timing and Locations of Assessments 
Phone-Based Screening: For people who indicate interest in the study, this screening will take 
place by phone using trained research assistants to assess the following exclusion criteria (see Section 
G for questions): (a) current regular meditation practice (>once/week); (b) serious medical illness 
precluding regular class attendance; (c) current substance abuse, suicidal ideation or eating disorder, 
(d) history of bipolar or psychotic disorders or self-injurious behaviors. These participants are 
excluded because they may disrupt group participation, require additional or specialized treatment, or 
are already participating in practices similar to the intervention. 
In-Person Screening:  If participants remain eligible after the phone-based screening, they will 
attend an in-person screening for blood pressure and medication assessment. If mean blood pressure 
shows hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking 
antihypertensive medication), participants will be invited to return for a second blood pressure 
reading. At that time, if the mean blood pressure across both assessment times is ≥120 mmHg systolic, 
≥80 mmHg diastolic pressure, or the participants is taking antihypertensive medication, they will be 
invited to participant in the study.  
Baseline Assessments Completed at Home: Questions about demographics, health behaviors, self 
control, depressive symptomatology, anxiety symptoms, mindfulness, sleep, childhood experiences, 

 
4
amongst others will be assessed via internet-based Survey Monkey or via paper-based forms. Please 
see Section G for the questionnaires.  
Follow-Up Assessments at 8 Weeks and 3 Months Follow-Up: Identical assessments will take 
place at 8 weeks and 3 months follow-up, as done with the screening and baseline assessments 
described above. 
Focus Groups: Focus group assessments of participants will take place following the final week of 
class. Descriptions of focus group topics are in Section G.   
5. Please clarify whether the data collected from the screening survey will be destroyed after 
eligibility is determined, since participants will not go through a consent process before 
completing this survey. 
RESPONSE: Data for these participants will be destroyed.  
 
APPLICATION CHANGES (pg. 18): 
Phone-Based Screening: For people who indicate interest in the study, this screening will take 
place by phone using trained research assistants to assess the following exclusion criteria (see Section 
G for questions): (a) current regular meditation practice (>once/week); (b) serious medical illness 
precluding regular class attendance; (c) current substance abuse, suicidal ideation or eating disorder, 
(d) history of bipolar or psychotic disorders or self-injurious behaviors. These participants are 
excluded because they may disrupt group participation, require additional or specialized treatment, or 
are already participating in practices similar to the intervention. For participants excluded from the 
study at this stage, data will be destroyed, as participants will not have gone through a consent process 
prior to completing this survey.  
In-Person Screening:  If participants remain eligible after the phone-based screening, they will 
attend an in-person screening for blood pressure and medication assessment. If mean blood pressure 
shows hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking 
antihypertensive medication), participants will be invited to return for a second blood pressure 
reading. At that time, if the mean blood pressure across both assessment times is ≥120 mmHg systolic, 
≥80 mmHg diastolic pressure, or the participants is taking antihypertensive medication, they will be 
invited to participant in the study. For participants excluded from the study at this stage, data will be 
destroyed, as participants will not have gone through a consent process prior to completing this 
survey. 
6. Please ensure the "Confidentiality of Data" section of the protocol is consistent, and specify how 
the digital data will be protected. 
RESPONSE: The sections should now be consistent. Please see pg. 16 for the protection of digital 
data.  
7. Please describe your and your undergraduate students' training and qualifications related to 
conducting the psychological assessments of the phone screen survey. 
RESPONSE: 
 
I am a social epidemiologist studying psychosocial determinants of health. I received training at the 
University of Massachusetts Medical School on baseline assessment of participants prior to 
undergoing Mindfulness-Based Stress Reduction. Similar questions are asked and discussed with 

 
5
participants at the University of Massachusetts Mindfulness-Based Stress Reduction intervention as is 
proposed in the study at Brown University. Furthermore, I will work closely with co-investigator and 
psychologist Dr. Willoughby Britton, who has screening questions identical or similar to these 
assessed in her Brown University Mindfulness-Based Cognitive Therapy study entitled: "Dismantling 
Mindfulness: Contributions of attention vs. acceptance" (#1105000399).” She will be available for 
questions that arise in the context of this survey. Student interviewer training includes high standards 
for selection of interviewers who are at ease with strangers, are culturally-sensitive and able to readily 
establish professional rapport. Interviewers will be thoroughly trained in the administration of the 
structured interview, including the screening questionnaire. A Safety Plan has been developed, which 
will provide structure in cases of participants indicating mental distress, particularly related to suicidal 
ideation.  
 
APPLICATION CHANGE (pp. 31-33): 
 
Please see Safety Plan.  
8. Please confirm that the "MBHT Phone Screen" face page will not be attached or connected to 
the phone script or screening data collected. 
RESPONSE: This face page will not be attached or connected to the phone script or screening data 
collected. 
9. Please identify how data collected from Survey Monkey during the baseline survey will be 
linked to participants, and how participant e-mail addresses will not be linked with their data. 
RESPONSE: For online questionnaires, participants will be provided with a weblink to the survey. 
Upon going to the weblink, they will enter the survey. First, participants will be asked to enter their 
study ID #. There will be no opportunities for participants to enter their names, personal addresses or 
email addresses into the SurveyMonkey data collection forms. Data will then be downloaded and 
stored within the secure VMScluster at the Brown University Center for Population Health and 
Clinical Epidemiology. If participants prefer, they will be provided with a paper copy of the 
questionnaire that can be filled out. Study staff will then manually enter the responses, and the data 
will be stored on the VMScluster.  
10. The Board was unsure if the computer is the most effective data collection method for the types 
of questions in the baseline survey (for example, the lengthy "Medications" section). Please 
provide a rationale for why this survey should be completed by computer. 
RESPONSE: Thank you for pointing this out. The medications will be assessed in-person during the 
first screening assessment, as blood pressure medication use is one of the screening criteria. 
Medications will also be assessed during the in-person assessments at 9 weeks and 3 months follow-
up. Please see Part 3.7.5 in Section C, as well as Section G, for more details.  
11. To the baseline survey, please add a disclaimer informing participants that their answers will 
not be seen immediately, and include psychological and health resources for participant use. 
RESPONSE: Thank you, please see the changes below.  
 
APPLICATION CHANGES (pg. 77 of questionnaire document in Section H): 

 
6
Thank you for completing this survey!  
 
Please note that these responses will not be seen immediately. Resources are shown below if you feel 
that you would like to talk with someone immediately for assistance.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
National Sexual Assault Hotline: 1-800-656-4673 
 
Other options are to: 
• Call your doctor’s office 
• Call 911 for emergency services 
• Go to the nearest hospital emergency room.  
12. Please include a more complete safety plan and describe the role of the licensed clinician on the 
study, as the protocol does not provide sufficient detail of what will be required of them and 
exactly when they will be contacted during study procedures. Please note that the clinician must 
be licensed in Rhode Island and have the expertise in behavioral health necessary to address any 
potential risks that could arise during the course of the study. 
RESPONSE: Thank you, a safety plan has been added. We are currently in discussions with 
clinicians licensed in Rhode Island. Dr. Ellen Flynn, MD, is a Brown professor and RI licensed 
psychiatrist who has expressed interest in being the licensed clinician for this study. She is currently 
performing a similar role for collaborator Dr. Willoughby Britton’s Brown IRB approved protocol 
entitled “entitled: "Dismantling Mindfulness: Contributions of attention vs. acceptance" 
(#1105000399).” We will be meeting in early January 2015 to discuss further. This study will not be 
initiated until an IRB-approved clinician has been confirmed.  
APPLICATION CHANGE (pp. 31-33): 
 
Please see Safety Plan.  
13. The Board noted that participants may give answers to particular questions in the screening 
and baseline surveys that, when looked at individually or in combination with other answers, 
could indicate potential risk. The Board requested that you review each measure used to 
determine psychological state and identify the specific questions and responses that may trigger 
a call to the licensed clinician. 
RESPONSE: Thank you. This has now been added to the Safety Plan.  
 
APPLICATION CHANGE (pp. 31-33): 
 
Please see Safety Plan.  
14. To the "Advertisement Card" and "Recruitment Letter," please add the restriction that 
participants cannot be regular meditators. 
RESPONSE: This has been done.  
 
APPLICATION CHANGE (pg. 29):  

 
7
This is a 9-week program that includes mindfulness meditation, mindful movements, and education 
about risk factors for blood pressure. The study is testing whether combining these interventions 
lowers blood pressure. The program consists of nine weekly sessions that are 2.5 hours (depending 
on study arm), and an all-day weekend retreat. People who have a current regular meditation practice 
(i.e. meditate more than once per week) are not eligible.  
 
 
The Board requested the following revisions to the consent process: 
1. Please add a procedure table for both the "high dose" and "low dose" groups, detailing the 
different procedures for each group, the amount of time per procedure, and the total time of 
involvement for each group. 
RESPONSE: The high vs. low dose aspect of the protocol has been removed for scientific reasons. A 
stronger study design is now being employed. 
2. In the "Explanation of Procedures" section (#8), please clarify the request for participants to 
notify you if they change their medication. 
RESPONSE: We have removed reference to assessing medication use in this section, as medication 
use will be assessed in person at 8 weeks and 3 months follow-up.  
3. In the "Explanation of Procedures" section (#9), please clarify the "second packet of 
questionnaires" participants will be asked to complete, what these questionnaires will ask, and 
where participants will be asked to complete them. 
RESPONSE: We have changed the wording as shown below. 
 
APPLICATION CHANGES: 
Pp. 18-19:  
 
3.7.5. Timing and Locations of Assessments 
Phone-Based Screening: For people who indicate interest in the study, this screening will take 
place by phone using trained research assistants to assess the following exclusion criteria (see Section 
G for questions): (a) current regular meditation practice (>once/week); (b) serious medical illness 
precluding regular class attendance; (c) current substance abuse, suicidal ideation or eating disorder, 
(d) history of bipolar or psychotic disorders or self-injurious behaviors. These participants are 
excluded because they may disrupt group participation, require additional or specialized treatment, or 
are already participating in practices similar to the intervention. For participants excluded from the 
study at this stage, data will be destroyed, as participants will not have gone through a consent process 
prior to completing this survey.  
In-Person Screening:  If participants remain eligible after the phone-based screening, they will 
attend an in-person screening for blood pressure and medication assessment. If mean blood pressure 
shows hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking 
antihypertensive medication), participants will be invited to return for a second blood pressure 
reading. At that time, if the mean blood pressure across both assessment times is ≥120 mmHg systolic, 
≥80 mmHg diastolic pressure, or the participants is taking antihypertensive medication, they will be 
invited to participant in the study. For participants excluded from the study at this stage, data will be 

 
8
destroyed, as participants will not have gone through a consent process prior to completing this 
survey. 
Baseline Assessments Completed at Home: Questions about demographics, health behaviors, self 
control, depressive symptomatology, anxiety symptoms, mindfulness, sleep, childhood experiences, 
amongst others will be assessed via internet-based Survey Monkey or via paper-based forms. Please 
see Section G for the questionnaires.  
Follow-Up Assessments at 8 Weeks and 3 Months Follow-Up: Identical assessments will take 
place at 8 weeks and 3 months follow-up, as done with the screening and baseline assessments 
described above, with the exception that questionnaires for which the answers should not change or be 
informative (i.e. introductory questions, age, race/ethnicity, education, childhood experiences) are not 
given at follow-ups.   
Focus Groups: Focus group assessments of participants will take place following the final week of 
class. Descriptions of focus group topics are in Section G.   
4. Please revise the "Benefits" section by removing "c," as participants will not gain knowledge 
about scientific methods in research. 
RESPONSE: This has been done. 
5. In the "Refusal/Withdrawal" section, please add that participants' refusal to enroll or decision 
to withdraw from the study will also not affect their relationship with their physician. 
RESPONSE: This has been completed.  
 
APPLICATION CHANGE (pg. 26): 
Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, including 
not answering certain questions. If you decide now to participate, you can change your mind later and 
quit the study.  The decision to not participate or to withdraw from the study will not adversely affect 
current or future interactions with Brown University. The decision to not participate or to withdraw 
from the study will also not adversely affect your relationship with your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for 
alternative treatments, if desired. 
 
 
 
 
 
 

 
9
 
 
 
 
 
 
 
 
 
 
 
Section A: 
Lay-Person Summary of Proposed Project 
 
 

 
10
The World Health Organization reported that suboptimal blood pressure (BP) is responsible for more 
than half of cardiovascular disease mortality world-wide. Furthermore, greater than half of those with 
hypertension have uncontrolled BP. A 2009 Institute of Medicine report recommended prioritizing 
research to “Compare the effectiveness of mindfulness-based interventions (e.g. yoga, meditation, deep 
breathing training) and usual care in treating… cardiovascular risk factors.”  Evidence-based 
mindfulness interventions, including Mindfulness-Based Stress Reduction, may have some effects on 
blood pressure, where a recent meta-analysis and systematic review of 4 randomized controlled trials 
demonstrated significant effects, but evidence of heterogeneity in effect sizes. The methodologically 
highest quality studies had the smallest effect sizes (range 0-5 mmHg). Mindfulness-Based Stress 
Reduction (MBSR) has been customized to a number of disease processes, such as Mindfulness-Based 
Cognitive Therapy for patients with recurrent depression, and Mindfulness-Based Relapse Prevention for 
patients with substance use addictions. Effect sizes have been increased by customizing mindfulness 
interventions to diseases of interest. The same may be true for hypertension, however mindfulness 
interventions customized for prehypertensive/hypertensive patients have never been investigated. Until 
methodologically rigorous studies to evaluate customized interventions for hypertension are performed, 
we will not know if the observed preliminary effects of general mindfulness interventions on blood 
pressure reduction could be much more effective with a tailored approach. Consequently, we propose to 
conduct a stage I behavioral therapy intervention study to evaluate whether MBSR customized to 
prehypertensive and hypertensive patients has the potential to provide clinically relevant reductions in BP. 
Consequently the specific aims are: 
 
Stage 1a: Therapy Development/Manual Writing 
1 
To outline and evaluate key novel elements of mindfulness-based hypertension therapy (MBHT), 
customized from the evidence-based MBSR. We hypothesize that the most important novel element 
will be generation of mindfulness skills specifically applied to hypertension risk factors such as diet, 
physical activity, obesity, alcohol consumption and antihypertensive medication adherence. This aim 
will be achieved using (1) focus groups of participants undergoing the MBHT behavioral intervention, 
(2) discussion with experts (including cardiologists, epidemiologists, mindfulness experts, 
mindfulness intervention instructors) prior to, and following pilot testing of MBHT in participants, 
and (3) clinical judgment of the investigators performing the intervention.  
2 
To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, retention rates, 
recruitment rates, and adverse effects) and secondary outcomes (hypertension risk factors such as diet, 
physical activity, obesity, and antihypertensive medication adherence) in hypertension subgroups, 
specifically participants with (1) prehypertension, (2) controlled hypertension, and (3) uncontrolled 
hypertension. Initial decisions about the targeted sample based on hypertension status will be made. 
3 
To develop an MBHT therapist manual and training program, including procedures for training, 
supervising, and evaluating therapists. Furthermore, acceptable therapist characteristics will be 
developed. The manual and training program will include themes such as specification of unique and 
common elements of MBHT vs. other interventions, description of interventions excluded from 
MBHT, and specification of key treatment parameters such as frequency and duration of treatment, 
session length, topics addressed, sequence of sessions, as well as therapist adherence and competency 
measures. The MBHT training will consist of a therapist manual, a formal didactic training seminar, 
and at least one closely supervised training session. 
 
Stage Ib: Pilot Trial 
4 
To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, customized 
from the evidence-based MBSR, has promise to be an effective behavioral therapy for participants 
with hypertension and/or prehypertension. We will perform a randomized controlled pilot trial for 
MBHT vs. enhanced usual care control. We hypothesize that MBHT will have adequate recruitment 
rates (≥10% of prehypertensive/hypertensive participants invited from physicians’ offices), fairly low 

 
11
drop out rates (<15%), and medium effect sizes (e.g. 5-10 mmHg systolic BP) for reduction in blood 
pressure.  
These findings will provide publishable pilot data that will inform future randomized clinical trials 
that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and active control 
groups. If proven effective, MBHT could be offered as a complementary program in the 
prehypertensive/hypertensive patient population that contributes to over half of the cardiovascular 
disease mortality world-wide.  

 
12
 
 
 
 
 
 
 
 
 
Section B: 
 
Application for Funding 
 
 
An Application for the Brown internal Richard B. Salomon Faculty Research Award 
has been made.  
 
These data will provide preliminary findings for an NIH R34 application that is 
planned to be submitted.  
 
 

 
13
 
 
 
 
 
 
 
 
 
 
 
Section C: 
Specific Aims and Methodology 
 
 

 
14
1 Significance and Innovation 
The World Health Organization reported that suboptimal BP is responsible for over half of 
cardiovascular disease mortality world-wide.2,3 Furthermore, of those with hypertension, more than half 
have uncontrolled BP.4,5 This is despite widespread knowledge of hypertension risk factors and treatments 
including diet, obesity, physical activity, medication adherence and excessive alcohol consumption.6,7 
Mindfulness interventions appear to improve self-regulation, self-care, and the ability to not respond to 
cravings for hypertension risk factors such as high caloric palatable foods and sedentary activities (and 
resulting obesity).8-12 In fact, a 2009 Institute of Medicine report recommended prioritizing research to 
“Compare the effectiveness of mindfulness-based interventions (e.g. yoga, meditation, deep breathing 
training) and usual care in treating… cardiovascular risk factors.”13 Evidence-based mindfulness 
interventions including Mindfulness-Based Stress Reduction (MBSR) may have some effects, where a 
recent meta-analysis and systematic review of 4 randomized controlled trials (RCTs) demonstrated 
significant effects, but evidence of heterogeneity in effect sizes.14 The methodologically highest quality 
studies had the smallest effect sizes. MBSR has been customized to a number of disease processes, such 
as recurrent depression, smoking and substance use addiction with resulting increases in effect sizes 
compared to general mindfulness-based interventions that do not take the disease process of interest into 
consideration.11,15,16 The same may be true for hypertension, however this has not yet been studied. 
Until methodologically rigorous studies to evaluate customized mindfulness-based interventions for 
hypertension are performed, we will not know if the observed preliminary effects of mindfulness-based 
interventions on BP could have much greater effect with a tailored approach. Consequently, we propose 
to conduct a stage I behavioral therapy intervention study to provide the most rigorous evaluation to date 
on whether MBSR customized to prehypertensive and hypertensive patients provides clinically relevant 
reductions in BP. These findings will provide publishable pilot data that will inform future randomized 
clinical trials that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and 
active control groups. If proven effective, MBHT could be offered as a complementary program in the 
prehypertensive/hypertensive patient population that contributes to over half of the cardiovascular 
disease mortality world-wide.  
2 Specific Aims 
Stage 1a: Therapy Development/Manual Writing 
1 
To outline and evaluate key novel elements of mindfulness-based hypertension therapy (MBHT), 
customized from the evidence-based MBSR. We hypothesize that the most important novel element 
will be generation of mindfulness skills specifically applied to hypertension risk factors such as diet, 
physical activity, obesity, alcohol consumption and antihypertensive medication adherence. This aim 
will be achieved using (1) focus groups of participants undergoing the MBHT behavioral intervention, 
(2) discussion with experts (including cardiologists, epidemiologists, mindfulness experts, 
mindfulness intervention instructors) prior to, and following pilot testing of MBHT in participants, 
and (3) clinical judgment of the investigators performing the intervention.  
2 
To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, retention rates, 
recruitment rates, and adverse effects) and secondary outcomes (hypertension risk factors such as diet, 
physical activity, obesity, and antihypertensive medication adherence) in hypertension subgroups, 
specifically participants with (1) prehypertension, (2) controlled hypertension, and (3) uncontrolled 
hypertension. Initial decisions about the targeted sample based on hypertension status will be made. 
3 
To develop an MBHT therapist manual and training program, including procedures for training, 
supervising, and evaluating therapists. Furthermore, acceptable therapist characteristics will be 
developed. The manual and training program will include themes such as specification of unique and 
common elements of MBHT vs. other interventions, description of interventions excluded from 
MBHT, and specification of key treatment parameters such as frequency and duration of treatment, 
session length, topics addressed, sequence of sessions, as well as therapist adherence and competency 

 
15
measures. The MBHT training will consist of a therapist manual, a formal didactic training seminar, 
and at least one closely supervised training session. 
 
Stage Ib: Pilot Trial 
4 
To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, customized 
from the evidence-based MBSR, has promise to be an effective behavioral therapy for participants 
with hypertension and/or prehypertension. We will perform a randomized controlled pilot trial for 
MBHT vs. MBSR active control. We hypothesize that MBHT will have adequate recruitment rates 
(≥10% of prehypertensive/hypertensive participants invited from physicians’ offices), fairly low drop 
out rates (<15%), and medium effect sizes (e.g. 5 mmHg systolic BP) for reduction in blood pressure 
compared to MBSR.  
3 Approach 
3.1 Study Population (Aim 2) 
Participants will be recruited through cardiology and family practices via established relationships 
with physicians at Rhode Island Hospital (e.g. Sam Dudley, MD), Memorial Hospital of Rhode Island 
(e.g. Charles Eaton, MD), Providence VA Medical Center (e.g. Hank Wu, MD), amongst others. IRB 
approval will be obtained by hospitals requiring it, such as Rhode Island Hospital and the Providence VA 
Medical Center. Typically, invitation letters (example text shown in Section F) will be sent to 96 eligible 
patients in each collaborative hospital. Patient eligibility will be based on medical records of blood 
pressure and gender. Participants will be recruited in equal numbers based on hypertension status (i.e. pre-
hypertensive, controlled hypertensive, and uncontrolled hypertensive), with equal proportions being male 
and female when possible. This approach will provide important recruitment and participation rate data 
for future studies. Furthermore, advertisements will be posted throughout Rhode Island inviting 
participants with pre-hypertension or hypertension to enroll (example advertisement shown in Section F).  
For Aims 1-3, we anticipate n=60 participants with equal proportions of males and females, and 
stratified across prehypertension/hypertension categories, including (1) pre-hypertension, (2) controlled 
hypertension, and (3) uncontrolled hypertension. This will allow for early indications of potential 
differential effects of MBHT by gender and prehypertension/hypertension status. Likely substantially 
greater than 60 participants will need to be recruited for screening, of which a proportion will be eligible 
based on criteria below and strata requirements above. We expect approximately 120 participants required 
to be screened for 60 participants to be included in the study. This study will provide more accurate 
information on recruitment rates, which will inform future randomized controlled trials if the study shows 
initial evidence of effectiveness. For Aim 4, pilot data from Aim 2 will provide needed effect sizes and 
statistical variance for power calculations. However, current power calculations were based on SBP and 
DBP changes in the Mindfulness-Based Stress Reduction RCT performed by Hughes et al.1 Specifically, 
Hughes et al. showed, with mean baseline SBP of 129.5 (6.3 SD) mmHg and DBP of 77.8 (5.5 SD) 
mmHg, at 8 weeks follow-up a net reduction of 4.2 mmHg SBP and 3.1 mmHg DBP for MBSR vs. active 
control group.1 For a sample size of 35 participants per group, power analyses show 80% and 90% power 
to detect differences of 4.3 and 4.9 mmHg SBP, respectively. This suggests adequate power for main 
effects analyses. At this time, Aim 4 anticipates 70 participants in the study (35 per treatment arm), of 
which we expect approximately 140 participants will need to be screened.  
Inclusion Criterion: Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic 
pressure or taking antihypertensive medication). All genders and racial/ethnic groups are eligible to be 
included.  
Exclusion Criteria: Exclusion criteria follow standard guidelines and recommendations:17 (a) current 
regular meditation practice (>once/week); (b) serious medical illness precluding regular class attendance; 
(c) current substance abuse, suicidal ideation or eating disorder, (d) history of bipolar or psychotic 

 
16
disorders or self-injurious behaviors. These participants are excluded because they may disrupt group 
participation, require additional or specialized treatment, or are already participating in practices similar 
to the intervention. 
3.2 Confidentiality of Data 
The clinical data will be de-identified but linked. Private information such as name, date of birth, and 
address for recontacting will be kept in a password protected, encrypted database on a different disk that 
the clinical data. Only the principal investigator for the purposes of patient safety or monitoring by the 
NIH, data safety monitoring boards or HIPPA compliance officer approved agents will be given access to 
identifiable personal information. 
Data which contains person-identifiers is considered highly sensitive. Such data is, by policy, only 
stored within the VMScluster at the Brown University Center for Population Health and Clinical 
Epidemiology. Access is controlled by the VMS ACL mechanism, allowing read-only access to a small 
group of specific users and read-write access to an even smaller group.  Internet access (e.g., via a Web 
server) is disallowed for such storage areas.  Windows security controls are superceded by VMS controls, 
although Windows access is permitted since some data is acquired on Windows-specific media (e.g., CD-
ROM). All uses of privileged necessary to grant/revoke access to any data, as well as any other security-
relevant event data, is continuously logged and analyzed in the context of both the VMScluster and the 
Windows Domain.  Network access is tightly controlled to allow anonymous access only to a small 
amount of read-only data; all “risky protocols” are disallowed from Internet access.  For any given study 
with person-identifying information, such data is stripped before the data is made accessible to staff not 
authorized to access such identifiers. In those cases where the data is longitudinal, a non-reversible 
encryption of the person ID is made in order to provide a unique person ID not traceable to the underlying 
person. The specific algorithm used for any given set of data is stored in the same fashion and given the 
same security as the data itself. To make data use simpler, hierarchical “trees” of directories are given 
consistent access controls tied to a unique identifier, which is then granted to staff authorized to use such 
data. Programming staff authorized to make individual-level data available to staff not authorized to 
access the person-identifying components routinely copy the “encrypted” versions from the more-secured 
tree to a less-secured tree. Security controls are thus relatively automatic, based on the propagation of 
rights based on the location of a file within the file system and the identity of the user attempting to access 
it. 
For online questionnaires, participants will be provided with a weblink to the survey. Upon going to 
the weblink, they will enter the survey. First, participants will be asked to enter their study ID #. There 
will be no opportunities for participants to enter their names, personal addresses or email addresses into 
the SurveyMonkey data collection forms. Data will then be downloaded and stored within the secure 
VMScluster at the Brown University Center for Population Health and Clinical Epidemiology. If 
participants prefer, they will be provided with a paper copy of the questionnaire that can be filled out. 
Study staff will then manually enter the responses, and the data will be stored on the VMScluster.  
 
3.3 MBHT Intervention Groups 
MBHT Intervention: MBHT is based on the standardized MBSR intervention described elsewhere,18-21 
and will likely consist of nine 2.5-hour weekly group sessions and an 8-hour one-day session, led by Dr. 
Loucks. Dr. Loucks is an expert in cardiovascular physiology, cardiovascular epidemiology, and social 
epidemiology. He completed MBSR instructor training at UMass Medical School, and has 16 years of 
mindfulness meditation experience, including teaching and mentoring community members, as well as a 
recent publication record investigating associations of mindfulness with cardiovascular health.12,22,23 The 
unique areas of MBHT are expected to be education on hypertension risk factors, hypertension health 
effects, and specific mindfulness modules focused on awareness of diet, physical activity, medication 
adherence, alcohol consumption, stress, and social support for behavior change. A preliminary manual has 

 
17
been created based on the standardized MBSR manual developed at UMass Medical School, and will be 
further developed through the Delphi-like approach described above, and sequentially revised based on 
participant feedback and preliminary findings.20,21 MBHT sessions contain instruction and practice in 
mindfulness meditation, and conversations about stress and coping. Students learn a range of mindfulness 
skills including body scan exercises, meditation and yoga. Homework consists of practicing skills for ≥45 
min/day, 6 days/week. Booster sessions will be offered (likely 2.5-hour sessions every 2 months).  
MBSR Active Control Group: MBSR will consist of nine 2.5-hour weekly group sessions and an 8-
hour one-day session, led by Dr. Eric Loucks, who is has completed MBSR instructor training at UMass 
Medical School.18,19 MBSR sessions contain instruction and practice in mindfulness meditation, and 
conversations about stress and coping. Students learn a range of mindfulness skills including body scan 
exercises, meditation and yoga. Homework consists of practicing skills for ≥45 min/day, 6 days/week. 
Booster sessions will be offered (likely 2.5-hour sessions every 2 months).  
3.4 Measures of Compliance 
Participant Adherence: Data on treatment protocol adherence will be collected weekly by research 
staff.  
MBHT Instructor Competency and Treatment Fidelity: Treatment fidelity strategies will be performed 
in accordance with recommendations of the NIH Behavior Change consortium.24 
3.5 Blinding 
All study staff, including those performing health assessments and contacting participants to schedule 
follow-up assessments, will be blinded to treatment allocation with the exception of the MBHT/MBSR 
instructor (Loucks) and data manager (who performs randomization).  
3.6 Equipoise 
This study will be designed to disrupt clinical equipoise, defined as “no consensus within the expert 
clinical community about the comparative merits of the alternative [trial arms] to be tested.”25 
3.7 Assessments 
We will follow study procedures similar to 
those performed during previous epidemiologic 
studies by our group. In-person screenings will 
take place at the Brown University Center for 
Population Health and Clinical Epidemiology, 
described in Sections 2.7.1 and 2.7.2 at baseline, 
completion of the 8-week MBHT course and at 3-
months post-intervention. Major assessment 
variables are shown in Table 1. Qualitative 
interviews (focus groups) will evaluate 
participants’ experiences such as usefulness of 
specific modules, duration of sessions, time 
burden, and overall intervention effectiveness. 
Interviewer training includes high standards for 
selection of interviewers who are at ease with 
strangers, are culturally-sensitive and able to 
readily establish professional rapport. 
Interviewers will be thoroughly trained in the 
administration of the structured interview, 
anthropometry, and blood pressure assessments. 
Routine quality control procedures will be in 

 
18
place regarding calibration of scales and blood pressure instruments. Clinical exams will be supervised by 
Dr. Loucks to at least monthly to evaluate accuracy of technique, particularly for anthropometry and 
blood pressure assessment. Re-training will be implemented if needed. Data will be entered and cleaned 
in an ongoing matter to facilitate quality control and preliminary analyses.  
3.7.1 Primary Outcomes 
Clinic BP Assessment: Clinic-assessed systolic and diastolic BP remains the standard of care for 
monitoring hypertension treatment.4,6,7,26,27  Baseline clinic BP will be determined at two in-person 
screening visits ≥1 week apart, completed according to American Heart Association guidelines,26  
followed by in-person assessments at all follow-up periods. BP will be assessed using a calibrated Omron 
HEM907XL Intellisense automated BP monitor with established validity.28  
3.7.2 Potential Mediators 
Examples of mediators to be assessed include: (1) Body Mass Index: height and weight directly 
assessed using standard epidemiologic methods. (2) Physical activity: MET minutes per week, assessed 
using actigraphy, which enables the  quantification of physical activity.29-33  (3) Diet: diet assessed 
utilizing Dietary Approaches to Stop Hypertension (DASH) eating pattern score,34 measured via diet 
history food frequency questionnaire.35 (4) Perceived stress: measured using Perceived Stress Scale.36 (5) 
Antihypertensive Medication Use: recorded by trained technicians from medications brought in by 
participants at baseline assessment.  
3.7.3 Potential Effect Modifiers 
We propose to evaluate 2 potentially important effect modifiers: (1) gender, (2) 
prehypertension/hypertension category. 
3.7.4 Qualitative Assessments 
Following completion of the MBHT intervention, participants will be asked to participate in a focus 
group discussion outlined in Box 1, shown below. The goal of the focus groups will be to adapt MBHT to 
the unique needs of this population. Adaptions may include, for example, types of specific mindfulness 
exercises, sequence in which they are introduced, and relative emphasis on hypertension education vs. 
mindfulness practice components. 
3.7.5 Timing and Locations of Assessments 
Phone-Based Screening: For people who indicate interest in the study, this screening will take place 
by phone using trained research assistants to assess the following exclusion criteria (see Section G for 
questions): (a) current regular meditation practice (>once/week); (b) serious medical illness precluding 
regular class attendance; (c) current substance abuse, suicidal ideation or eating disorder, (d) history of 
bipolar or psychotic disorders or self-injurious behaviors. These participants are excluded because they 
may disrupt group participation, require additional or specialized treatment, or are already participating in 
practices similar to the intervention. For participants excluded from the study at this stage, data will be 
destroyed, as participants will not have gone through a consent process prior to completing this survey.  
In-Person Screening:  If participants remain eligible after the phone-based screening, they will attend 
an in-person screening for blood pressure and medication assessment. If mean blood pressure shows 
hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking 
antihypertensive medication), participants will be invited to return for a second blood pressure reading. At 
that time, if the mean blood pressure across both assessment times is ≥120 mmHg systolic, ≥80 mmHg 
diastolic pressure, or the participants is taking antihypertensive medication, they will be invited to 
participant in the study. For participants excluded from the study at this stage, data will be destroyed, as 
participants will not have gone through a consent process prior to completing this survey. 
Baseline Assessments Completed at Home: Questions about demographics, health behaviors, self 
control, depressive symptomatology, anxiety symptoms, mindfulness, sleep, childhood experiences, 

 
19
amongst others will be assessed via internet-based Survey Monkey or via paper-based forms. Please see 
Section G for the questionnaires.  
Follow-Up Assessments at 8 Weeks and 3 Months Follow-Up: Identical assessments will take place at 
8 weeks and 3 months follow-up, as done with the screening and baseline assessments described above, 
with the exception that questionnaires for which the answers should not change or be informative (i.e. 
introductory questions, age, race/ethnicity, education, childhood experiences) are not given at follow-ups.   
Focus Groups: Focus group assessments of participants will take place following the final week of 
class. Descriptions of focus group topics are in Section G.   
 
3.8 Intervention Allocation 
Stratified randomization will be 
used.37,38 Variables used to create 
strata include gender (male vs. 
female), race/ethnicity (white vs. 
non-white), and prehypertension/ 
hypertension status (pre-
hypertension, controlled 
hypertension, uncontrolled 
hypertension). Simple random 
sampling will occur within each 
strata.  
3.9 Data Analysis 
Qualitative analyses will 
evaluate participant experiences 
such as usefulness of specific 
modules, duration of sessions, time 
burden, and overall intervention 
effectiveness. Quantitative 
analyses will incorporate 
generalized linear models (GLM) 
with properly chosen link 
functions, performed using 
generalized estimating equations 
(GEE) with robust standard error 
estimators.39,40 We will test effects 
of high vs. low dose MBHT on 
clinic-assessed systolic and 
diastolic BP. Following “intention-
to-treat” principles, analyses will 
be conducted on all participants 
randomized to high vs. low dose, 
regardless of intervention completion. To test whether effects of MBHT on BP may be effect modified by 
variables described in Section 2.7.3 we will add product terms between MBHT and each potential effect 
modifier to models described above. Formal statistical significance tests of product terms will be 
performed. Analyses are considered statistically underpowered, but will provide effect size estimates and 
statistical variances for NIH grant applications to support studies with larger sample sizes.  
Box 1. Focus Group Topics 
 
• How is your experience of the class length? Does it seem 
about right, or would you prefer it longer or shorter? – e.g. 
length of each class, 8 week duration 
• Which modules did you find worked the best for you? 
• Are there topics or modules you think would help improve the 
course? 
• Are there areas we should expand? 
• Are there areas we should reduce? 
• Describe different modules, and ask how well they worked, 
specifically what they liked, didn’t like, and 
recommendations for what to change and what to keep the 
same.  
o 
Hypertension education in the orientation session 
o 
Class 2: Highly palatable snack practice  
o 
Class 2: Home practice related to pleasant events 
calendar on eating and alcohol consumption 
o 
Class 3: Exploration of physical activity including 
discussion in class, and home practice of performing 
physical activity.  
o 
Class 4: 15 min physical activity module followed by 
discussion . 
o 
Class 4: Motivational interviewing module related to 
diet, alcohol consumption and physical activity 
o 
Class 4-7: Home practice related to goal for diet, 
alcohol consumption, physical activity or diet.  
o 
Class 5: Exploring relationship with medication 
adherence 
o 
Class 6: Social support module 
o 
All-Day: Silent exercise module 
o 
Booster sessions 
 

 
20
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section D:  
Possible Risks to Participants 
 
 
 
 
 

 
21
The following is a statement from NCCAM about the potential risks of meditation practice: 
“Meditation is considered to be safe for healthy people. There have been rare reports that meditation 
could cause or worsen symptoms in people who have certain psychiatric problems, but this question has 
not been fully researched. People with physical limitations may not be able to participate in certain 
meditative practices involving physical movement. Individuals with existing mental or physical health 
conditions should speak with their health care providers prior to starting a meditative practice and make 
their meditation instructor aware of their condition.”41 
Discomfort during meditation: Meditation-based interventions may results in discomfort with 
attention to unpleasant thoughts, feelings or body sensations. Some individuals may experience an initial 
increase in undesirable emotions with increased attention to them. In order to minimize risk, instructors 
encourage participants to be aware of their discomfort and to set their own limitations. Participants are 
encouraged to alter their postures, including standing, sitting in chairs, lying down, as needed in order to 
be comfortable. In addition, the curriculum of the training program is specifically geared towards 
addressing such discomfort.  
Psychological distress: Research subjects participating in this study may have feelings of loss of 
privacy from being contacted about participating in the study, and possible psychological distress caused 
by questions on the diagnostic interview that bring up painful memories or feelings. However, the 
resulting potential for injury to research subjects is judged to be minimal.  We have already contacted and 
clinically evaluated thousands of participants from the New England Family using similar assessment 
procedures to this study, with good responses from the participants. With regard to psychological distress 
from taking part in the MBHT intervention, given that screening questions will exclude participants with 
substantial mental illness, and given the NCAAM statement above that “Meditation is considered to be 
safe for healthy people.”,41 we expect that risk of psychological distress will be low. The risk of increased 
psychological distress from meditation will be clearly outlined in the consent form and participants will 
be encouraged to consult with both the course instructor and study staff in the case of any increased 
distress. One of the co-investigators (Dr. Britton) is a clinical psychologist. She will be available to advise 
on any psychological events that occur, and provide referrals for treatment if needed.  
Loss of confidentiality: Likelihood: rare. Minimization: Confidentiality will be maintained by 
numerically coding all data, by disguising identifying information, and by keeping all hard copies data in 
locked file drawers.  All information obtained from participants will be accessible only to research staff. 
The clinical data will be de-identified but linked. For electronic data, private information such as name, 
date of birth, and address for recontacting will be kept in a password protected, encrypted database on a 
different disk than the clinical data. Only the principal investigator for the purposes of patient safety or 
monitoring by the NIH, data safety monitoring boards or HIPPA compliance officer approved agents will 
be given access to identifiable personal information. 
Potential Benefits of the Proposed Research to Human Subjects and Others: There may be no direct 
benefits from participating in this study. The potential benefits of participating in the proposed study 
include improved knowledge on stress reduction techniques and risk for hypertension.  Each participant 
will also be contributing to an important study which will answer questions on whether mindfulness-
based stress reduction may influence health.   
 
 

 
22
 
 
 
 
 
 
 
 
 
 
 
 
Section E: 
Informed Consent 
 
 
 

 
23
Each potential participant will be fully informed about the nature of the study, its risks and benefits, 
and about his/her rights as a research subject. The person performing the consent will be either Dr. 
Loucks or a trained undergraduate trained research assistant. The participant will sign and receive a copy 
of the document stating that he/she has given his/her informed consent to participate before interviewing 
is begun. In every instance, project personnel will verbally review the content of the consent form before 
participants sign.   
 
 
 
 

 
24
Agreement to Participate in a Research Study 
 
Investigation of the effects of mindfulness meditation on blood pressure and well-being 
 
 
You are being asked to take part in a Brown University research study about the effects of mindfulness 
and hypertension education on blood pressure and risk factors for hypertension. This form will explain the 
purpose of the study, how the study will be carried out and what you will be expected to do.  It will also 
explain the possible risks and possible benefits of being in the study.  If any part of the following 
description is not clear to you, you are encouraged to contact the researcher to answer any questions 
before you decide whether to take part in the study. If you decide to participate, please fill out and sign the 
last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health education on 
blood pressure. You have been selected for this study because you expressed interest and met entrance 
criteria for having prehypertension or hypertension, or another cardiovascular risk factor that could be 
influenced by this program. In order to assess the effects of these practices, you will be asked to complete 
some questionnaires, and a laboratory assessment before and after learning the mindfulness practices. 
 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
 
1) Participate in an interview in which you will be asked questions about past and present mental health, 
including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, smoking, 
medication use, personality, emotions, attention and past experiences, including stressful or traumatic 
experiences. These questions will probe sensitive psychological areas, including physical, emotion 
and sexual abuse. These questionnaires may take up to 2 hours to complete. By completing the 
interviews and questionnaires, you are giving the researchers permission to use the information you 
have provided. You have the right not to answer any of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference and hip circumference.  
 
4) You will be asked to perform some cognitive tasks. One of these tasks may involve computer-based 
tests of attention or decision-making. Together these tests may take as long as 45 minutes. 
 
5) You will be randomly assigned (like the flip of a coin) to enter one of two 8-week meditation 
programs. 
 
6) You will participate in the 8-week meditation program, which consists of 9 sessions of 2.5 hours each 
and will include one 8 hour weekend retreat. Daily homework assignments may take as long as one 
hour and consist of practicing mindfulness exercises with the aid of a guided audio CD and 
completing worksheets related to stress, thoughts, and common reactions to various types of events. 
 

 
25
7) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. The 
recordings will be transcribed so that we may analyze the text. The recordings will be identified by 
study number, will only be heard by study staff and will be destroyed after transcription.  
 
8) You will be asked to complete a few short questionnaires each week during the 8 week condition. 
 
9) After 8 weeks, you will be asked to complete questionnaires and return to the laboratory to repeat the 
same procedures for a second day of testing. 
 
10) Three months after the end of the 8 week condition, you will be asked to return to the laboratory to 
repeat the same testing procedures. 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred since the 
first assessment. Specifically, you will receive an individualized handout listing % change (increase or 
decrease) on scales of attention, stress, mood, health behaviors and blood pressure across the study. 
 
2.  Discomforts and Risks 
The questionnaires are routine, standardized forms for epidemiologic research.  Certain questions may be 
upsetting as they may probe sensitive psychological areas and inquire about upsetting or traumatic events, 
including physical, sexual or emotional abuse and/or current psychiatric symptoms.  Since your 
participation is voluntary, you have the right to skip any questions that make you uncomfortable.  
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, feelings 
or body sensations. Some individuals may experience an initial increase in undesirable feelings with 
increased attention to them. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this study.  
However, participation in the study creates the potential benefit of a) identifying effective treatments for 
elevated blood pressure, b) gaining knowledge of the effects of mindfulness practices, c) receiving 
information about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical activity, 
and reducing excessive alcohol consumption may also be beneficial for reducing blood pressure. 
Education about these therapies are integrated into this course, but other forms of these alternative 
therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to a study 
ID# instead of your name.  All questionnaires in this study will be filled out through an online survey 
website (SurveyMonkey) or a paper version of the survey if you prefer.  All of these questionnaires will 
be linked solely to your study ID#, so that your identity is protected and your answers are confidential.  
Although these measures have been taken to protect your personal information, complete confidentiality 
cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to confidentiality. If 
your questionnaire responses indicate that you pose a serious danger to yourself or to another person, then 

 
26
a collaborator [provide name] who is a licensed psychiatrist, may contact you to discuss your responses 
and possible referral to a treatment provider. Questionnaire items that may warrant follow-up include 
endorsements of statements about hurting yourself, any high scores in depression, anxiety, or other 
clinically significant problems. You should also know that there are times when the law might require the 
release of your responses without your permission.  For example, State law requires researchers to report 
abuse or neglect of children to the Department of Children, Youth and Families (DCYF).   State law also 
requires researchers to report abuse or neglect of people age 60 and older to the Department of Elderly 
Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in any 
published reports about this study. Results will be reported in a summarized manner in such a way that 
you cannot be identified. All personally identifiable information will be "de-identified" and only a unique 
code number will be used. Study records will be identified with a unique code number and initials. All 
study records and specimens will be stored in a secure storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, including not 
answering certain questions. If you decide now to participate, you can change your mind later and quit the 
study.  The decision to not participate or to withdraw from the study will not adversely affect current or 
future interactions with Brown University. The decision to not participate or to withdraw from the study 
will also not adversely affect your relationship with your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for alternative 
treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. Eric B. 
Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like more information 
about the rules for research studies, or the rights of people who take part in those studies, you may contact 
the Brown University Research Protections Office, telephone number 1-866-309-2095 or 401-863-3050. 

 
27
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY QUESTIONS 
HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO PARTICIPATE IN THIS 
RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
____________________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):____________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):____________________________________________________________________ 
 
Telephone:__________________________(cell)______________________________(other) 
 
 
 
 
 
 
 
 

 
28
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section F: 
Recruiting Materials 
 
 

 
29
 
 
Front of Advertisement Card: 
 
 
 
 
Brown University  
School of Public Health 
Department of Epidemiology 
 
 
 
 
RESEARCH STUDY: 
Mindfulness-Based Intervention for 
Blood Pressure Reduction 
 
 
 
 
 
 
 
Free to qualified participants 
 
 
 
Back of Advertisement Card: 
 
 
 
This is a 8-week program that includes mindfulness 
meditation, mindful movements, and education about 
risk factors for blood pressure. The study is testing 
whether combining these interventions lowers blood 
pressure. The program consists of nine weekly sessions 
that are 2.5 hours (depending on study arm), and an all-
day weekend retreat. People who have a current regular 
meditation practice (i.e. meditate more than once per 
week) are not eligible.  
 
Research participation includes interviews, 
questionnaires and measurements of blood pressure, 
height, weight, and waist circumference, before and after 
the meditation program.  
 
Contact: For more information, or to see if you qualify, 
call the Brown Sociobiology Laboratory at 401-863-
6283, or email SBL@gmail.com. See website at [URL 
needs to be created]. 
 
 
 

 
30
 
Sample Text of Recruitment Letter (placed on Dr. Loucks’ letterhead): 
 
[Date] 
 
Dear _____,  
 
Your physician [name of physician] identified you as someone with prehypertension or hypertension who 
may be interested in participating in a new study at Brown University that is designed to evaluate effects 
of an intervention called Mindfulness-Based Hypertension Therapy (MBHT). MBHT combines 
mindfulness practices such as meditation and mindful movements with education about hypertension 
management and prevention. The aim of MBHT is to create a skill set and supportive environment to help 
to reduce blood pressure, and improve overall well-being. Your involvement in this study could help us 
better understand if MBHT is effective, and how it could be improved. The MBHT intervention will take 
place over 8 weeks, and would involve you attending a class once per week that would be between 1 and 
2.5 hours, depending on which group you are assigned to. You may also be assigned to participate in a 
full day mindfulness retreat that would be about 7.5 hours duration. Also, health assessments would be 
performed before you start the intervention, and again immediately at the end of the 8-week intervention, 
as well as at 3 months and 6 months follow-up. The assessments would include measures such as blood 
pressure, height, weight, diet, physical activity, smoking, depression, stress, and medication use. These 
assessments will take 1-2 hours to complete. 
 
At the end of the study, you will receive individual feedback about the changes that occurred since the 
first assessment. Specifically, you will receive an individualized handout listing your changes on scales of 
attention, stress, mood, health behaviors and blood pressure across the study. 
 
We cannot and do not guarantee or promise that you will receive any direct benefits from this study.  
However, participation in the study creates the potential benefit of a) identifying effective treatments for 
elevated blood pressure, b) gaining knowledge of the effects of mindfulness practices, c) gaining first-
hand knowledge about the most current scientific methods in scientific research d) receiving information 
about your psychological and physical functioning. 
 
If you are interested in participating in this study, please call 401-863-6283, or email 
eric.loucks@brown.edu. 
 
Sincerely yours, 
 
 
Eric B. Loucks, Ph.D. 
Assistant Professor 
 
 

 
31
 
 
 
 
 
 
 
 
 
 
 
Section G:  
Safety Plan 
 
 

SAFETY PLAN 
 
If a participant’s interview or questionnaire responses indicate that he/she poses a serious 
danger to him/herself or to another person, then the safety plan described below will be 
triggered into effect. 
1 HOW QUESTIONNAIRES WILL BE USED TO DETERMINE RISK 
1.1 Beck Anxiety Inventory (BAI)  
 
The BAI was designed to measure clinical anxiety in a way that minimizes the overlap between 
depression and anxiety.1 A BAI score of 26-63 represents severe anxiety.1 Questionnaires will 
be reviewed within one week of completion. If participants score ≥26 on the BAI, study staff will 
notify the PI within 24 hours of seeing this information, who will in turn notify the collaborating 
clinical psychologist within 24 hours to determine need for a psychological consultation.  
1.2 Centers for Epidemiologic Studies Depression Revised (CESD-R) Scale 
 
The 20 items in CESD-R scale measure symptoms of depression in nine different groups as 
defined by the American Psychiatric Association Diagnostic and Statistical Manual, fourth 
edition.2 These symptom groups are shown below, with their associated scale question 
numbers. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Questionnaires will be reviewed within one week of completion.  
 
Participants are considered to meet criteria for major depressive episode if they have anhedonia 
or dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM 
symptom groups noted as occurring nearly every day for the past two weeks.2 If participants 
meet criteria for major depressive episode, study staff will notify the PI within 24 hours of seeing 
this information, who will in turn notify the collaborating clinical psychologist within 24 hours to 
determine need for a psychological consultation.  
 
If participants respond having any suicidal ideation (CESD-R questions 14 or 15), this will trigger 
the safety plan where our collaborating clinical psychologist will be notified directly by study staff 
to contact this participant immediately for suicidality evaluation and counseling. The PI will be 
informed that this has taken place.  
 

1.3 Other Triggers for the Safety Plan 
 
Although current suicidality is not assessed during verbal interviews, history of suicide attempts 
is asked verbally. If participants indicate current suicidal ideation at any time during the 
screening or other verbal interviews, study staff will be instructed to immediately end the 
interview in a sensitive way, and let participants know that a trained clinical psychologist will 
contact them to offer help. The staff member will provide the following information to study 
participants.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
2 References 
 
1. 
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: 
psychometric properties. Journal of consulting and clinical psychology. Dec 
1988;56(6):893-897. 
2. 
Van Dam NT, Earleywine M. Validation of the Center for Epidemiologic Studies 
Depression Scale--Revised (CESD-R): pragmatic depression assessment in the general 
population. Psychiatry research. Mar 30 2011;186(1):128-132. 
 

 
34
 
 
 
 
 
 
References 
 
 

 
35
 
 
1. 
Hughes JW, Fresco DM, Myerscough R, van Dulmen M, Carlson LE, Josephson R. Randomized 
controlled trial of Mindfulness-Based Stress Reduction for prehypertension. Psychosom Med. 
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2. 
Mendis S, Puska P, Norrving B. Global atlas on cardiovascular disease prevention and control. 
Geneva: World Health Organization;2011. 
3. 
Hoyert DL, Xu J. Deaths: Preliminary Data for 2011. National Vital Statistics Reports. 
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4. 
Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on 
Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. Dec 
2003;42(6):1206-1252. 
5. 
United States Centers for Disease Control and Prevention. Getting blood pressure under control. 
CDC Vitalsigns. 2012;September. 
6. 
James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high 
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7. 
Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of 
hypertension in the community a statement by the American Society of Hypertension and the 
International Society of Hypertension. J Hypertens. Jan 2014;32(1):3-15. 
8. 
Epstein RM. Mindful practice. JAMA. Sep 1 1999;282(9):833-839. 
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Sedlmeier P, Eberth J, Schwarz M, et al. The psychological effects of meditation: a meta-analysis. 
Psychol Bull. Nov 2012;138(6):1139-1171. 
10. 
Lutz A, Slagter HA, Dunne JD, Davidson RJ. Cognitive-emotional interactions - Attention 
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11. 
Brewer JA, Mallik S, Babuscio TA, et al. Mindfulness training for smoking cessation: results from 
a randomized controlled trial. Drug and alcohol dependence. Dec 1 2011;119(1-2):72-80. 
12. 
Loucks EB, Britton WB, Howe CJ, Eaton CB, Buka SL. Positive associations of dispositional 
mindfulness with cardiovascular health: The New England Family Study. Int J Behav Med. 
2014:DOI 10.1007/s12529-12014-19448-12529. 
13. 
Institute of Medicine. Initial National Priorities for Comparative Effectiveness Research. 
Washington, D.C.2009. 
14. 
Abbott RA, Whear R, Rodgers LR, et al. Effectiveness of mindfulness-based stress reduction and 
mindfulness based cognitive therapy in vascular disease: A systematic review and meta-analysis of 
randomised controlled trials. J Psychosom Res. May 2014;76(5):341-351. 
15. 
Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological stress and well-
being: A systematic review and meta-analysis. JAMA internal medicine. Mar 1 2014;174(3):357-
368. 
16. 
Bowen S, Witkiewitz K, Clifasefi SL, et al. Relative Efficacy of Mindfulness-Based Relapse 
Prevention, Standard Relapse Prevention, and Treatment as Usual for Substance Use Disorders: A 
Randomized Clinical Trial. JAMA psychiatry. Mar 19 2014. 
17. 
Santorelli SF, Kabat-Zinn J. MBSR Curriculum Guide and Supporting Materials. Mindfulness 
Based Stress Reduction Professional Training. . Worcester, MA: University of Massachusetts 
Center for Mindfulness; 2003. 
18. 
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the 
practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp 
Psychiatry. Apr 1982;4(1):33-47. 
19. 
Kabat-Zinn J, Massion AO, Kristeller J, et al. Effectiveness of a meditation-based stress reduction 
program in the treatment of anxiety disorders. Am J Psychiatry. Jul 1992;149(7):936-943. 

 
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20. 
Santorelli S, Bonus K, McCallum C, et al. Mindfulness-Based Stress Reduction:  Guidelines and 
Standards of Practice. Integrative Medicine Mindfulness Program at University of Wisconsin- 
Madison and the Center for Mindfulness, University of Massachusetts. 2004. 
21. 
MacCoon DG, Imel ZE, Rosenkranz MA, et al. The validation of an active control intervention for 
Mindfulness Based Stress Reduction (MBSR). Behaviour research and therapy. Jan 2012;50(1):3-
12. 
22. 
Loucks EB. Meditation intervention reviews: selecting ideal control groups for meditation 
interventions. JAMA internal medicine. Jul 2014;174(7):1194-1195. 
23. 
Loucks EB, Britton WB, Howe CJ, et al. Associations of dispositional mindfulness with obesity 
and central adiposity: The New England Family Study. Under Review. 
24. 
Bellg AJ, Borrelli B, Resnick B, et al. Enhancing treatment fidelity in health behavior change 
studies: best practices and recommendations from the NIH Behavior Change Consortium. Health 
Psychol. Sep 2004;23(5):443-451. 
25. 
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. Jul 16 1987;317(3):141-
145. 
26. 
Pickering TG, Hall JE, Appel LJ, et al. Recommendations for blood pressure measurement in 
humans and experimental animals: part 1: blood pressure measurement in humans: a statement for 
professionals from the Subcommittee of Professional and Public Education of the American Heart 
Association Council on High Blood Pressure Research. Circulation. Feb 8 2005;111(5):697-716. 
27. 
Williams B, Lindholm LH, Sever P. Systolic pressure is all that matters. Lancet. Jun 28 
2008;371(9631):2219-2221. 
28. 
El Assaad MA, Topouchian JA, Darne BM, Asmar RG. Validation of the Omron HEM-907 
device for blood pressure measurement. Blood Press Monit. Aug 2002;7(4):237-241. 
29. 
Chen KY, Acra SA, Majchrzak K, et al. Predicting energy expenditure of physical activity using 
hip- and wrist-worn accelerometers. Diabetes technology & therapeutics. 2003;5(6):1023-1033. 
30. 
Crouter SE, Clowers KG, Bassett DR, Jr. A novel method for using accelerometer data to predict 
energy expenditure. J Appl Physiol (1985). Apr 2006;100(4):1324-1331. 
31. 
Troiano RP. Translating accelerometer counts into energy expenditure: advancing the quest. J 
Appl Physiol (1985). Apr 2006;100(4):1107-1108. 
32. 
Esliger DW, Tremblay MS. Technical reliability assessment of three accelerometer models in a 
mechanical setup. Med Sci Sports Exerc. Dec 2006;38(12):2173-2181. 
33. 
Heil DP. Predicting activity energy expenditure using the Actical activity monitor. Research 
quarterly for exercise and sport. Mar 2006;77(1):64-80. 
34. 
Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2012 update: a 
report from the American Heart Association. Circulation. Jan 3 2012;125(1):e2-e220. 
35. 
Subar AF, Thompson FE, Kipnis V, et al. Comparative validation of the Block, Willett, and 
National Cancer Institute food frequency questionnaires : the Eating at America's Table Study. 
American journal of epidemiology. Dec 15 2001;154(12):1089-1099. 
36. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 
Dec 1983;24(4):385-396. 
37. 
Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for 
clinical trials. J Clin Epidemiol. 1999;52(1):19-26. 
38. 
Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. New York, NY: 
Springer; 2010. 
39. 
Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 
1986;73(1):13-22. 
40. 
Zeger SL, Liang K-Y. Longitudinal data analysis for discrete and continuous outcomes. 
Biometrics. 1986;42:121-130. 
41. 
(NCCAM) NCfCaAM. Meditation: An Introduction. 
http://nccam.nih.gov/health/meditation/overview.htm - sideeffects 2013. Accessed April 26, 2013. 

 
37
42. 
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: 
psychometric properties. Journal of consulting and clinical psychology. Dec 1988;56(6):893-897. 
43. 
Van Dam NT, Earleywine M. Validation of the Center for Epidemiologic Studies Depression 
Scale--Revised (CESD-R): pragmatic depression assessment in the general population. Psychiatry 
research. Mar 30 2011;186(1):128-132. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1
 
 
 
 
 
 
 
 
 
 
MINDFULNESS-BASED  
HYPERTENSION THERAPY PILOT STUDY 
 
REVISED IRB APPLICATION 
 
 
February 11th, 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eric B. Loucks, PhD 
Assistant Professor 
Department of Epidemiology  
Brown University School of Public Health 
121 South Main St., Box G-S121 
Providence, RI, 02912 
Phone: 401-863-6283 
Email: eric.loucks@brown.edu 

 
2
 
COVER LETTER 
 
Thank you for the helpful feedback. Below is an itemized response to the Board’s recommendations.  
 
The Board requested the following: 
1. The Board noted that Dr. Ellen Flynn will act as the new clinical psychologist on the study and 
asked that you confer with her regarding the safety plan. The Board specifically requested that 
participant responses on the "Center for Epidemiologic Studies Depression Revised Scale" 
(CESD-R) be reviewed immediately, since the proposed plan details a potential nine-day delay 
from a participant's completion of the CESD-R to when they may be contacted by Dr. Flynn for 
evaluation. 
RESPONSE: Thank you for this request. Dr. Flynn has reviewed the safety plan and provided 
comments for improvement. Those improvements are shown below in the safety plan and the initial 
phone-based screening questionnaire. Participants’ scores on the CESD-R are now planned to be 
reviewed much more quickly, as described in the updated safety plan below.  
CHANGE: Please see underlined sections of Safety Plan (pp. 12-13) and Phone-Based Screening 
Questionnaire (pp. 16-18).  
 
2. To the consent document's procedure section, please add a table detailing the different 
procedures, the amount of time per procedure, and the total time of involvement for 
participants. 
RESPONSE: The table shown below has been added to the consent document.  
 
CHANGE (pg. 7): 
 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as 
questionnaires, height, weight and waist 
circumference.  
2 hours 
Mindfulness course. 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 8 hours 
Total course time: 30.5 hours 
Home mindfulness practices assigned during 
course.  
1 hour per day, 6 days per week, for 8 weeks.  
Total time: 48 hours. 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, 
that take place immediately after course 
completion. 
2 hours 
Health assessments, such as questionnaires, blood 
2 hours 

 
3
pressure, height, weight and waist circumference, 
that take place that take place 3 months after 
course completion. 
TOTAL TIME COMMITMENT FOR STUDY 85 hours 
 
3. To the consent documents' "Confidentiality" section (pg. 26, 2nd paragraph), please correct the 
title "Department of Elderly Affairs" to "Division of Elderly Affairs." 
RESPONSE: This has been changed as requested, shown below. 
 
CHANGE (pg. 8 para. 5):  
State law also requires researchers to report abuse or neglect of people age 60 and older to the 
Division of Elderly Affairs. 
 
 
 
 
 

 
4
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
 
 

 
5
Each potential participant will be fully informed about the nature of the study, its risks and benefits, 
and about his/her rights as a research subject. The person performing the consent will be either Dr. 
Loucks or a trained undergraduate trained research assistant. The participant will sign and receive a copy 
of the document stating that he/she has given his/her informed consent to participate before interviewing 
is begun. In every instance, project personnel will verbally review the content of the consent form before 
participants sign.   
 
 
 
 

 
6
Agreement to Participate in a Research Study 
 
Investigation of the effects of mindfulness meditation on blood pressure and well-being 
 
 
You are being asked to take part in a Brown University research study about the effects of mindfulness 
and hypertension education on blood pressure and risk factors for hypertension. This form will explain the 
purpose of the study, how the study will be carried out and what you will be expected to do.  It will also 
explain the possible risks and possible benefits of being in the study.  If any part of the following 
description is not clear to you, you are encouraged to contact the researcher to answer any questions 
before you decide whether to take part in the study. If you decide to participate, please fill out and sign the 
last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health education on 
blood pressure. You have been selected for this study because you expressed interest and met entrance 
criteria for having prehypertension or hypertension, or another cardiovascular risk factor that could be 
influenced by this program. In order to assess the effects of these practices, you will be asked to complete 
some questionnaires, and a laboratory assessment before and after learning the mindfulness practices. 
 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
 
1) Participate in an interview in which you will be asked questions about past and present mental health, 
including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, smoking, 
medication use, personality, emotions, attention and past experiences, including stressful or traumatic 
experiences. These questions will probe sensitive psychological areas, including physical, emotion 
and sexual abuse. These questionnaires may take up to 1.5 hours to complete. By completing the 
interviews and questionnaires, you are giving the researchers permission to use the information you 
have provided. You have the right not to answer any of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference and hip circumference.  
 
4) You will be asked to perform some cognitive tasks. One of these tasks may involve computer-based 
tests of attention or decision-making. Together these tests may take as long as 30 minutes. 
 
5) You may be randomly assigned (like the flip of a coin) to enter one of two different 8-week 
meditation programs. 
 
6) You will participate in an 8-week meditation program, which consists of 9 sessions of 2.5 hours each 
and will include one 8-hour weekend retreat. Daily homework assignments may take as long as one 
hour and consist of practicing mindfulness exercises with the aid of a guided audio CD and 
completing worksheets related to stress, thoughts, and common reactions to various types of events. 
 

 
7
7) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. The 
recordings may be transcribed so that we can analyze the text. The recordings will be identified by 
study number, will only be heard by study staff and will be destroyed after transcription.  
 
8) You will be asked to complete a few short questionnaires each week during the 8 week condition. 
 
9) After 8 weeks, you will be asked to complete questionnaires and return to the laboratory to repeat the 
same procedures for a second day of testing. 
 
10) Three months after the end of the 8 week condition, you will be asked to return to the laboratory to 
repeat the same testing procedures. 
 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as 
questionnaires, height, weight and waist 
circumference.  
2 hours 
Mindfulness course 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 8 hours 
Total course time: 30.5 hours 
Home mindfulness practices assigned during 
course.  
1 hour per day, 6 days per week, for 8 weeks.  
Total time: 48 hours. 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, 
that take place immediately after course 
completion. 
2 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, 
that take place that take place 3 months after 
course completion. 
2 hours 
TOTAL TIME COMMITMENT FOR STUDY 
85 hours 
 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred since the 
first assessment. Specifically, you will receive an individualized handout listing % change (increase or 
decrease) on scales of attention, stress, mood, health behaviors, weight, and blood pressure across the 
study. 
 
2.  Discomforts and Risks 
The questionnaires are routine, standardized forms for epidemiologic research.  Certain questions may be 
upsetting as they may probe sensitive psychological areas and inquire about upsetting or traumatic events, 
including physical, sexual or emotional abuse and/or current psychiatric symptoms.  Since your 
participation is voluntary, you have the right to skip any questions that make you uncomfortable.  

 
8
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, feelings 
or body sensations. Some individuals may experience an initial increase in undesirable feelings with 
increased attention to them. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this study.  
However, participation in the study creates the potential benefit of a) identifying effective treatments for 
elevated blood pressure, b) gaining knowledge of the effects of mindfulness practices, c) receiving 
information about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical activity, 
and reducing excessive alcohol consumption may also be beneficial for reducing blood pressure. 
Education about these therapies are integrated into this course, but other forms of these alternative 
therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to a study 
ID# instead of your name.  All questionnaires in this study will be filled out through an online survey 
website (SurveyMonkey) or a paper version of the survey if you prefer.  All of these questionnaires will 
be linked solely to your study ID#, so that your identity is protected and your answers are confidential.  
Although these measures have been taken to protect your personal information, complete confidentiality 
cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to confidentiality. If 
your questionnaire responses indicate that you pose a serious danger to yourself or to another person, then 
a collaborator [provide name] who is a licensed psychiatrist, may contact you to discuss your responses 
and possible referral to a treatment provider. Questionnaire items that may warrant follow-up include 
endorsements of statements about hurting yourself, any high scores in depression, anxiety, or other 
clinically significant problems. You should also know that there are times when the law might require the 
release of your responses without your permission.  For example, State law requires researchers to report 
abuse or neglect of children to the Department of Children, Youth and Families (DCYF).   State law also 
requires researchers to report abuse or neglect of people age 60 and older to the Division of Elderly 
Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in any 
published reports about this study. Results will be reported in a summarized manner in such a way that 
you cannot be identified. All personally identifiable information will be "de-identified" and only a unique 
code number will be used. Study records will be identified with a unique code number and initials. All 
study records and specimens will be stored in a secure storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, including not 
answering certain questions. If you decide now to participate, you can change your mind later and quit the 
study.  The decision to not participate or to withdraw from the study will not adversely affect current or 
future interactions with Brown University. The decision to not participate or to withdraw from the study 
will also not adversely affect your relationship with your physician. 
 

 
9
If you decide not to participate, or if you quit the study, we will provide you with referrals for alternative 
treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. Eric B. 
Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like more information 
about the rules for research studies, or the rights of people who take part in those studies, you may contact 
the Brown University Research Protections Office, telephone number 1-866-309-2095 or 401-863-3050. 

 
10
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY QUESTIONS 
HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO PARTICIPATE IN THIS 
RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
____________________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):____________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):____________________________________________________________________ 
 
Telephone:__________________________(cell)______________________________(other) 
 
 
 
 
 
 
 
 

 
11
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Safety Plan 
 
 

 
12
 
SAFETY PLAN 
If a participant’s interview or questionnaire responses indicate that he/she poses a serious danger to 
him/herself or to another person, then the safety plan described below will be triggered into effect. 
1 HOW QUESTIONNAIRES WILL BE USED TO DETERMINE RISK 
1.1 Beck Anxiety Inventory (BAI)  
 
The BAI was designed to measure clinical anxiety in a way that minimizes the overlap between 
depression and anxiety.1 A BAI score of 26-63 represents severe anxiety.1 Questionnaires will be 
reviewed within 48 hours of completion. If participants score ≥26 on the BAI, study staff will immediately 
notify the PI, Dr. Eric Loucks, and the collaborating psychiatrist, Dr. Ellen Flynn, to determine need for a 
psychiatric consultation.  
1.2 Centers for Epidemiologic Studies Depression Revised (CESD-R) Scale 
 
The 20 items in CESD-R scale measure symptoms of depression in nine different groups as defined by 
the American Psychiatric Association Diagnostic and Statistical Manual, fourth edition.2 These symptom 
groups are shown below, with their associated scale question numbers. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Questionnaires will be reviewed within 48 hours of completion.  
 
Participants are considered to meet criteria for major depressive episode if they have anhedonia or 
dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM symptom 
groups noted as occurring nearly every day for the past two weeks.2 If participants meet criteria for major 
depressive episode, study staff will immediately notify the PI, Dr. Eric Loucks, and the collaborating 
psychiatrist, Dr. Ellen Flynn, to determine need for a psychiatric consultation. 
 
If participants respond having any suicidal ideation (CESD-R questions 14 or 15), this will trigger the 
safety plan where Dr. Flynn will be immediately notified directly by study staff to contact this participant 
immediately for suicidality evaluation and counseling. The PI will be informed that this has taken place.  
 
1.3 Other Triggers for the Safety Plan 
 
During the phone-based screening, if participants respond yes to “Are you currently suicidal?”, the 
interviewer will immediately have 911 and Dr. Ellen Flynn called by a colleague who has been informed 
beforehand that this is a possibility. Specifically, while keeping the participant on the phone, the text 
shown below in bold italics will be visually shown to the colleague.  

 
13
 
I have a study participant on the phone who is currently suicidal. Please call 911 
immediately, and tell them: 
 
“I am calling on behalf of [my name] who is performing a research study at Brown 
University, and has a participant on the phone who says they are currently suicidal.” 
Please provide the participants’ contact information to the 911 operator (i.e. name, 
address, phone #, email address) as requested. This information is on page 1 of the 
screening questionnaire right here [interviewer has this information]. 
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
While keeping the participant on the phone, questions to be asked, in this order, include: 
1. “Do you have a plan?” 
2. If yes… “What are you planning?” 
3. “Do you have the means to commit suicide?” 
4. “Do you have access to a gun?” 
5. “We are really concerned about you, and are calling 911.”  
 
Other questions that could be asked in order to keep them on the phone: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
 
The following information can be provided to study participants if they state they have had considered 
killing themselves in the past month. If they are currently suicidal, the main priority is to keep them on the 
phone while 911 and Dr. Flynn are being contacted.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
 
 
 
 

 
14
 
 
 
 
 
 
 
SCREENING QUESTIONNAIRE  
(PHONE-DELIVERED) 
 
 
 

 
15
MBHT PHONE SCREEN 
 
Date of Screen: ___________________ 
 
Interviewer: _______________________ 
 
Screening #: _________________________________ (month.date.year.hour.minute) 
 
Name:  _________________________________________________  
 
Address: ____________________________________________________ 
 
Phone number(s): ____________________________________________________ 
 
Email address (or mailing if no email):__________________________________________ 
 
Notes from Interviewer: 
_____________________________________________________________________________________
_____________________________________________________________________________________
________________________________________ 
 
My name is ____________. I am calling from the Brown University School of Public Health, because 
you expressed interest in participating in our mindfulness study. I want to do 10-15 minutes phone 
interview with you to determine if you are a good match for this particular study. Is now a good time to 
speak? [If yes, proceed. If no, ask for other times and note in Potential Subject Log].  
 
 
There are a few things that I’d like to make clear before we start the interview. First of all, some of the 
questions will be very personal and sensitive. Are you in a private place to talk? Because this interview is 
of a personal nature, it is important that you understand that everything you say will be kept strictly 
confidential.  No one outside of our project will ever be able to see your answers, and we will not keep 
your name in the same place as any of your answers. If you are not eligible after the phone screen, we will 
destroy your information.  If you like, though, we can keep your information on file for future studies. 
 
 

 
16
INCLUSION CRITERIA: All answers in 3rd column must be YES 
 
 
 
Comments 
AGE 
 Age_______  Between 18 and 65? 
 
 
 
 
 
 
YES 
NO 
 
 
ENG 
Can you read and write in English? 
YES 
NO 
 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO 
 
 
 
Comments 
Bipolar 
depression 
MANIA 
Has anyone ever told you that you have 
bipolar disorder or manic depression?  
YES 
NO  
 
BPD 
Has anyone ever used the word 
“Borderline” to describe you? 
YES 
NO  
 
Psychosis 
Have you ever had a hallucination or seen 
things that other people can’t see, or hear 
things other people can’t hear?  
 
Have you ever been diagnosed with 
schizophrenia or psychosis? 
YES 
NO 
 
 
 
YES 
NO 
 
MANIA/ 
Antipsychotic 
MEDS 
Have you ever taken any of the following 
medications?  
Lithium                              
Seroquel (quetiapine) 
Abilify (aripiprazole)          
Zyprexa (olanzapine) 
Clozaril (clozapine)          
Haldol/Haloperidol 
Geodon (ziprasidone)         
Risperdal (risperidone) 
 
 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
 
Self-harm 
Have you ever had a suicide attempt?  
 
[If yes, ask…] Have you considered 
killing yourself during the past month?  
 
[If yes, ask…] Are you currently suicidal? 
 
[If yes, keep participant on the phone, and 
follow suicide safety plan below] 
 
[If no, ask…] Are you getting any help 
for that? If not, then provide list of 
resources from Safety Plan including 
Gateway, Anchor and The Providence 
Center] Not urgent, but inform Dr. Flynn 
about what was discussed.  
 
 
YES 
NO 
 
 
YES 
NO 
 
 
 
 
YES 
NO 
 
 
 
 
 

 
17
EXCLUSION: CURRENT (check timeframe) 
PTSD 
Would you say you have a trauma 
history?  
[If yes…]  
In the past month, have you had any 
problems with dissociation (memory 
loss)?  
In the past month, have you had any 
flashbacks (i.e. sudden and disturbing 
vivid memory) about the trauma?  
 
 
 
YES 
NO 
 
YES 
NO 
 
 
 
OCD 
In the past month, have you had any 
problems with obsessions or 
compulsions, such as washing your hands 
or checking the oven over and over 
again?  
[If yes…] Has anyone diagnosed you 
with obsessive compulsive disorder? 
YES      NO 
 
 
 
 
YES 
NO 
 
 
PANIC 
In the past month, have you had a panic 
attack (i.e. sweating, heart palpitations, 
nausea, trouble breathing, fear of 
dying/choking/going crazy)?  
YES 
NO 
 
ALCOHOL 
Have you had any problems with 
alcoholism or drug use in the past year? 
YES 
NO 
 
EATING DIS 
In the past year, have you had an eating 
disorder, such as starving, binge eating, 
or vomiting?  
YES 
NO 
 
MEDITATION Do you currently practice meditation 
more than once per week? (yoga does not 
count as meditation in this context) 
YES 
NO 
 
MED ILL  
This class will take place at Brown 
University in-person. Do you have any 
medical or mobility issues that would 
affect you being able to attend class? 
YES 
NO 
 
DECISION 
 PASS           NO PASS             QUERY 
 
 
 
 
 

 
18
 
PASS FORM: Initial appropriate boxes with dates 
Date/initials 
NO PASS 
Thank you for taking the time to answer these 
questions. According to this test, it doesn’t look 
like you are going to be a good fit for the study.  
There may be other studies you quality for. Would 
you like me to keep your information to pass on to 
these studies? Otherwise, our copy of this 
information can be destroyed. 
 
QUERY 
Thank you for taking the time to answer these 
questions. There are a few items I need to check 
with my supervisor about. I will contact him right 
now, and we will get back in touch with you 
shortly about your participation in this study.  
 
PASS: 
Study description and 
requirements 
Time commitment 
Thank you for taking the time to answer these 
questions. You qualify for the next stage of 
screening, which is to take your blood pressure at 
two different times at least a week apart from each 
other. Before we go on to book this, I would like 
to tell you a little more about the study. If you 
want to continue, the next phase would require an 
interview, a packet of questionnaires and visit to 
the laboratory before the 8-week meditation 
program. After the program, you would fill out the 
same questionnaires and do the lab visit again 
twice – once right after the course, and again 3 
months later. This study involves an 8-week 
program that will provide training in mindfulness 
meditation, yoga and health behaviours related to 
blood pressure control. The mindfulness program 
takes place in a group setting meeting for 2 ½ 
hours once a week, 9 times over an 8 week period. 
For example if it were on a Monday, we would 
meet on 9 Mondays in a row. The program 
requires up to an hour of mindfulness practice 
every day. There will also be an all-day retreat on 
a Saturday part way through the course, that will 
be about 8 hours long. Is this something that you 
would be able to make time for in your schedule? 
YES       NO 
SCHEDULE 
Available for current program? 
It’s important to attend all 9 sessions. 
The next program is: 
Availability: 
Mon 9:00-11:30, 4:00-6:30 pm 
Tues 9:00-11:30, 4:00-6:30 pm 
Wed 9:00-11:30, 4:00-6:30 pm 
Thurs 9:00-11:30, 4:00-6:30 pm 
 
Other: 
 
YES   NO 

 
19
 
 
 
 
References 
 
 

 
20
 
 
1. 
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: 
psychometric properties. Journal of consulting and clinical psychology. Dec 1988;56(6):893-897. 
2. 
Van Dam NT, Earleywine M. Validation of the Center for Epidemiologic Studies Depression 
Scale--Revised (CESD-R): pragmatic depression assessment in the general population. 
Psychiatry research. Mar 30 2011;186(1):128-132. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1 
 
 
 
 
 
 
 
 
 
 
MINDFULNESS-BASED  
HYPERTENSION THERAPY PILOT STUDY 
 
REVISED IRB APPLICATION 
 
 
February 15th, 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eric B. Loucks, PhD 
Assistant Professor 
Department of Epidemiology  
Brown University School of Public Health 
121 South Main St., Box G-S121 
Providence, RI, 02912 
Phone: 401-863-6283 
Email: eric.loucks@brown.edu 

 
2 
 
COVER LETTER 
 
Thank you for the helpful feedback. Below is an itemized response to the Board’s recommendations.  
 
The Board requested the following: 
 
1. The plan says that Dr. Flynn will be notified immediately if participants meet the criteria for a 
major depressive episode or suicidality, but right above that, Section 1.2 says that the 
questionnaires will be reviewed within 48 hours of completion. Will these questionnaire not be 
immediately reviewed? Since these measures will not be completed in-person, if they may not be 
reviewed for 48 hours, Dr. Flynn may not interact with a participant in trouble for 2 days. The 
IRB feels that this is too long a delay to review these measures. 
 
RESPONSE: The anxiety and depressive symptomatology questionnaires have now been moved to 
be completed in-person instead of at home. Responses will be reviewed immediately upon completion 
of the in-person assessments. Values of concern will be reported immediately to Dr. Flynn.  
 
CHANGE: Please see underlined changes to the safety plan on pg. 11.  
 
 
2. The IRB also feels that the RA should not ask the types of clinical questions, as described in 
Section 1.3's script for talking to suicidal participants. The exact language the RA will use when 
speaking with participants does not need to be reviewed by the IRB, but once a participant 
expresses suicidal ideation, (step 1) Dr. Flynn should be contacted and (step 2) the RA should 
speak calmly with the participants about what the RA is doing (calling Dr. Flynn) and why. The 
RA can speak with participants to keep them on the phone, but the discussion should not be 
clinical in nature.  
 
 
RESPONSE: The clinical questions have been removed. Recommended steps 1 and 2 have been 
implemented.  
 
CHANGE: Please see underlined changes to the Safety Plan on pg. 12.  
 
 
3. The revised consent document's new activities/time table (pg. 7) says the total time commitment 
is 85 hours, but when I add up the time, it comes to 85.5 hours. Would you correct the consent 
document? 
 
RESPONSE: This has been changed to 85.5 hours as suggested.  
 
CHANGE: Please see underlined change to the consent document on pg. 6.  
 
 
 
 

 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
 
 

 
4 
Each potential participant will be fully informed about the nature of the study, its risks and benefits, 
and about his/her rights as a research subject. The person performing the consent will be either Dr. 
Loucks or a trained undergraduate trained research assistant. The participant will sign and receive a copy 
of the document stating that he/she has given his/her informed consent to participate before interviewing 
is begun. In every instance, project personnel will verbally review the content of the consent form before 
participants sign.   
 
 
 
 

 
5 
Agreement to Participate in a Research Study 
 
Investigation of the effects of mindfulness meditation on blood pressure and well-being 
 
 
You are being asked to take part in a Brown University research study about the effects of mindfulness 
and hypertension education on blood pressure and risk factors for hypertension. This form will explain the 
purpose of the study, how the study will be carried out and what you will be expected to do.  It will also 
explain the possible risks and possible benefits of being in the study.  If any part of the following 
description is not clear to you, you are encouraged to contact the researcher to answer any questions 
before you decide whether to take part in the study. If you decide to participate, please fill out and sign the 
last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health education on 
blood pressure. You have been selected for this study because you expressed interest and met entrance 
criteria for having prehypertension or hypertension, or another cardiovascular risk factor that could be 
influenced by this program. In order to assess the effects of these practices, you will be asked to complete 
some questionnaires, and a laboratory assessment before and after learning the mindfulness practices. 
 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
 
1) Participate in an interview in which you will be asked questions about past and present mental health, 
including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, smoking, 
medication use, personality, emotions, attention and past experiences, including stressful or traumatic 
experiences. These questions will probe sensitive psychological areas, including physical, emotion 
and sexual abuse. These questionnaires may take up to 1.5 hours to complete. By completing the 
interviews and questionnaires, you are giving the researchers permission to use the information you 
have provided. You have the right not to answer any of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference and hip circumference.  
 
4) You will be asked to perform some cognitive tasks. One of these tasks may involve computer-based 
tests of attention or decision-making. Together these tests may take as long as 30 minutes. 
 
5) You may be randomly assigned (like the flip of a coin) to enter one of two different 8-week 
meditation programs. 
 
6) You will participate in an 8-week meditation program, which consists of 9 sessions of 2.5 hours each 
and will include one 8-hour weekend retreat. Daily homework assignments may take as long as one 
hour and consist of practicing mindfulness exercises with the aid of a guided audio CD and 
completing worksheets related to stress, thoughts, and common reactions to various types of events. 
 

 
6 
7) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. The 
recordings may be transcribed so that we can analyze the text. The recordings will be identified by 
study number, will only be heard by study staff and will be destroyed after transcription.  
 
8) You will be asked to complete a few short questionnaires each week during the 8 week condition. 
 
9) After 8 weeks, you will be asked to complete questionnaires and return to the laboratory to repeat the 
same procedures for a second day of testing. 
 
10) Three months after the end of the 8 week condition, you will be asked to return to the laboratory to 
repeat the same testing procedures. 
 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as 
questionnaires, height, weight and waist 
circumference.  
2 hours 
Mindfulness course 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 8 hours 
Total course time: 30.5 hours 
Home mindfulness practices assigned during 
course.  
1 hour per day, 6 days per week, for 8 weeks.  
Total time: 48 hours. 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, 
that take place immediately after course 
completion. 
2 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, 
that take place that take place 3 months after 
course completion. 
2 hours 
TOTAL TIME COMMITMENT FOR STUDY 
85.5 hours 
 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred since the 
first assessment. Specifically, you will receive an individualized handout listing % change (increase or 
decrease) on scales of attention, stress, mood, health behaviors, weight, and blood pressure across the 
study. 
 
2.  Discomforts and Risks 
The questionnaires are routine, standardized forms for epidemiologic research.  Certain questions may be 
upsetting as they may probe sensitive psychological areas and inquire about upsetting or traumatic events, 
including physical, sexual or emotional abuse and/or current psychiatric symptoms.  Since your 
participation is voluntary, you have the right to skip any questions that make you uncomfortable.  

 
7 
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, feelings 
or body sensations. Some individuals may experience an initial increase in undesirable feelings with 
increased attention to them. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this study.  
However, participation in the study creates the potential benefit of a) identifying effective treatments for 
elevated blood pressure, b) gaining knowledge of the effects of mindfulness practices, c) receiving 
information about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical activity, 
and reducing excessive alcohol consumption may also be beneficial for reducing blood pressure. 
Education about these therapies are integrated into this course, but other forms of these alternative 
therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to a study 
ID# instead of your name.  All questionnaires in this study will be filled out through an online survey 
website (SurveyMonkey) or a paper version of the survey if you prefer.  All of these questionnaires will 
be linked solely to your study ID#, so that your identity is protected and your answers are confidential.  
Although these measures have been taken to protect your personal information, complete confidentiality 
cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to confidentiality. If 
your questionnaire responses indicate that you pose a serious danger to yourself or to another person, then 
a collaborator [provide name] who is a licensed psychiatrist, may contact you to discuss your responses 
and possible referral to a treatment provider. Questionnaire items that may warrant follow-up include 
endorsements of statements about hurting yourself, any high scores in depression, anxiety, or other 
clinically significant problems. You should also know that there are times when the law might require the 
release of your responses without your permission.  For example, State law requires researchers to report 
abuse or neglect of children to the Department of Children, Youth and Families (DCYF).   State law also 
requires researchers to report abuse or neglect of people age 60 and older to the Division of Elderly 
Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in any 
published reports about this study. Results will be reported in a summarized manner in such a way that 
you cannot be identified. All personally identifiable information will be "de-identified" and only a unique 
code number will be used. Study records will be identified with a unique code number and initials. All 
study records and specimens will be stored in a secure storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, including not 
answering certain questions. If you decide now to participate, you can change your mind later and quit the 
study.  The decision to not participate or to withdraw from the study will not adversely affect current or 
future interactions with Brown University. The decision to not participate or to withdraw from the study 
will also not adversely affect your relationship with your physician. 
 

 
8 
If you decide not to participate, or if you quit the study, we will provide you with referrals for alternative 
treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. Eric B. 
Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like more information 
about the rules for research studies, or the rights of people who take part in those studies, you may contact 
the Brown University Research Protections Office, telephone number 1-866-309-2095 or 401-863-3050. 

 
9 
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY QUESTIONS 
HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO PARTICIPATE IN THIS 
RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
____________________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):____________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):____________________________________________________________________ 
 
Telephone:__________________________(cell)______________________________(other) 
 
 
 
 
 
 
 
 

 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Safety Plan 
 
 

 
11 
 
SAFETY PLAN 
If a participant’s interview or questionnaire responses indicate that he/she poses a serious danger to 
him/herself or to another person, then the safety plan described below will be triggered into effect. 
1 HOW QUESTIONNAIRES WILL BE USED TO DETERMINE RISK 
1.1 Beck Anxiety Inventory (BAI)  
 
The BAI was designed to measure clinical anxiety in a way that minimizes the overlap between 
depression and anxiety.1 A BAI score of 26-63 represents severe anxiety.1 The BAI will be administered 
during the in-person assessment visits, and scores will be reviewed immediately upon completion of the 
in-person assessments. If participants score ≥26 on the BAI, study staff will immediately notify the PI, Dr. 
Eric Loucks, and the collaborating psychiatrist, Dr. Ellen Flynn, to determine need for a psychiatric 
consultation.  
1.2 Centers for Epidemiologic Studies Depression Revised (CESD-R) Scale 
 
The 20 items in CESD-R scale measure symptoms of depression in nine different groups as defined by 
the American Psychiatric Association Diagnostic and Statistical Manual, fourth edition.2 These symptom 
groups are shown below, with their associated scale question numbers. The CESD-R will be 
administered during the in-person assessment visits, and scores will be reviewed immediately upon 
completion of the in-person assessments. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Participants are considered to meet criteria for major depressive episode if they have anhedonia or 
dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM symptom 
groups noted as occurring nearly every day for the past two weeks.2 If participants meet criteria for major 
depressive episode, study staff will immediately notify the PI, Dr. Eric Loucks, and the collaborating 
psychiatrist, Dr. Ellen Flynn, to determine need for a psychiatric consultation. 
 
If participants respond having any suicidal ideation (CESD-R questions 14 or 15), this will trigger the 
safety plan where Dr. Flynn will be immediately notified directly by study staff to contact this participant 
immediately for suicidality evaluation and counselling. The PI will be informed that this has taken place.  
 
1.3 Other Triggers for the Safety Plan 
 
During the phone-based screening, if participants respond yes to “Are you currently suicidal?”, the 
interviewer should perform the following 2 steps: 
 

 
12 
1. Immediately have 911 and Dr. Ellen Flynn called by a colleague who has been informed beforehand 
that this is a possibility.  
 
Specifically, while keeping the participant on the phone, the text shown below in bold italics will be 
visually shown to the colleague.  
 
I have a study participant on the phone who is currently suicidal. Please call 911 
immediately, and tell them: 
 
“I am calling on behalf of [my name] who is performing a research study at Brown 
University. She has a participant on the phone who says they are currently suicidal.” 
Please provide the participants’ contact information to the 911 operator (i.e. name, 
address, phone #, email address) as requested. This information is on page 1 of the 
screening questionnaire right here [interviewer has this information]. 
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
 
2. While speaking calmly with the participant, let them know what you are doing. Specifically, let them 
know we are calling our study’s psychiatrist Dr. Flynn and 911, and why you are doing that (i.e. 
because we are concerned about you). You can speak with participant to keep him/her on the phone, 
but the discussion should not be clinical in nature.   
 
Examples of questions that could be asked in order to keep them on the phone: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
• 
Tell me more about why you are interesting in being part of this study.  
• 
What are you hoping to get out of this study? 
 
 
The following information can be provided to study participants if they state they have had considered 
killing themselves in the past month. If they are currently suicidal, the main priority is to keep them on the 
phone while 911 and Dr. Flynn are being contacted.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
 

 
13 
 
 
 
 
References 
 
 

 
14 
 
 
1. 
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: 
psychometric properties. Journal of consulting and clinical psychology. Dec 1988;56(6):893-897. 
2. 
Van Dam NT, Earleywine M. Validation of the Center for Epidemiologic Studies Depression 
Scale--Revised (CESD-R): pragmatic depression assessment in the general population. 
Psychiatry research. Mar 30 2011;186(1):128-132. 
 
 
 
 
 
 
 
 
 
 
 
 
 

Brown Universify
Research Protections Office
Institutional Review Board
Amendment Request
Date of Request: 6 / L7 / 15 Investigator's Name and Title: Eric Loucks , Assistant Prof essor
StudyTitle:Mindfulness-Based Hypertension Therapy Pilot Study (#141-2001171)
Original Type of Review: ! Exempt 
! Expedited 
E Full Board
l) Provide a brief lay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form) Please see attached.
2) Provide a detailed description of the changes being requested (Use additional pages, if necessary):
P1ease see attached.
3.) State the reason (iustification) for the requested amendment. (Use additional pages, if
necessary):
Please see attached.
4.) What is your assessment of how the changes will affect the overall risk/benefit ratio of the study
and the willingness of individuals to participate?
Please see attached.
5.) Does the requested amendment require new documents or changes to the approved consent
form or other documents?
E Consent/assent documents (attach revised version with changes highlighted)
El New/revised instruments (attach - if revised, highlight changes)
n New/revised advertising materials (attach - if revised, highlight changes)
Do you have a conflict of interest on this project according to Brown's policy? nyBS EnO
If YES, has this conflict been previously disclosed to the IRB? 
EynS lNO
PI signature:
".a
Date: 6/77/15

      
 
 
 
 
1) Provide a brief lay summary of the overall project. Include enough 
detail to allow the IRB to evaluate the requested change(s) within 
the context of the overall project.  
 
The World Health Organization reported that suboptimal blood pressure (BP) is responsible 
for more than half of cardiovascular disease mortality world-wide. Furthermore, greater than half 
of those with hypertension have uncontrolled BP. A 2009 Institute of Medicine report 
recommended prioritizing research to “Compare the effectiveness of mindfulness-based 
interventions (e.g. yoga, meditation, deep breathing training) and usual care in treating… 
cardiovascular risk factors.”  Evidence-based mindfulness interventions, including Mindfulness-
Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant 
effects, but evidence of heterogeneity in effect sizes. The methodologically highest quality 
studies had the smallest effect sizes (range 0-5 mmHg). Mindfulness-Based Stress Reduction 
(MBSR) has been customized to a number of disease processes, such as Mindfulness-Based 
Cognitive Therapy for patients with recurrent depression, and Mindfulness-Based Relapse 
Prevention for patients with substance use addictions. Effect sizes have been increased by 
customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive 
patients have never been investigated. Until methodologically rigorous studies to evaluate 
customized interventions for hypertension are performed, we will not know if the observed 
preliminary effects of general mindfulness interventions on blood pressure reduction could be 
much more effective with a tailored approach. Consequently, we propose to conduct a stage I 
behavioral therapy intervention study to evaluate whether MBSR customized to prehypertensive 
and hypertensive patients has the potential to provide clinically relevant reductions in BP. 
Consequently the specific aims are: 
 
Stage 1a: Therapy Development/Manual Writing 
1 
To outline and evaluate key novel elements of mindfulness-based hypertension therapy 
(MBHT), customized from the evidence-based MBSR. We hypothesize that the most 
important novel element will be generation of mindfulness skills specifically applied to 
hypertension risk factors such as diet, physical activity, obesity, alcohol consumption and 
antihypertensive medication adherence. This aim will be achieved using (1) focus groups of 
participants undergoing the MBHT behavioral intervention, (2) discussion with experts 
(including cardiologists, epidemiologists, mindfulness experts, mindfulness intervention 
instructors) prior to, and following pilot testing of MBHT in participants, and (3) clinical 
judgment of the investigators performing the intervention.  
2 
To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, 
retention rates, recruitment rates, and adverse effects) and secondary outcomes 
(hypertension risk factors such as diet, physical activity, obesity, and antihypertensive 
medication adherence) in hypertension subgroups, specifically participants with (1) 
prehypertension, (2) controlled hypertension, and (3) uncontrolled hypertension. Initial 
decisions about the targeted sample based on hypertension status will be made. 
3 
To develop an MBHT therapist manual and training program, including procedures for 
training, supervising, and evaluating therapists. Furthermore, acceptable therapist 
characteristics will be developed. The manual and training program will include themes 
such as specification of unique and common elements of MBHT vs. other interventions, 
description of interventions excluded from MBHT, and specification of key treatment 
parameters such as frequency and duration of treatment, session length, topics addressed, 

      
 
 
 
 
sequence of sessions, as well as therapist adherence and competency measures. The 
MBHT training will consist of a therapist manual, a formal didactic training seminar, and at 
least one closely supervised training session. 
 
Stage Ib: Pilot Trial 
4 
To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, 
customized from the evidence-based MBSR, has promise to be an effective behavioral 
therapy for participants with hypertension and/or prehypertension. We will perform a 
randomized controlled pilot trial for MBHT vs. enhanced usual care control. We hypothesize 
that MBHT will have adequate recruitment rates (≥10% of prehypertensive/hypertensive 
participants invited from physicians’ offices), fairly low drop out rates (<15%), and medium 
effect sizes (e.g. 5-10 mmHg systolic BP) for reduction in blood pressure.  
 
These findings will provide publishable pilot data that will inform future randomized clinical 
trials that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and 
active control groups. If proven effective, MBHT could be offered as a complementary program 
in the prehypertensive/hypertensive patient population that contributes to over half of the 
cardiovascular disease mortality world-wide.  
 
 
2) Provide a detailed description of the changes being requested (Use 
additional pages, if necessary): 
 
1. Survey software: 
a. We changed the survey software from SurveyMonkey to Qualtrics. We will ensure 
that all software options that allow for personally identifiable information to be 
automatically obtained from Qualtrics (e.g. IP addresses) have been turned off. This 
is done through the “Anonymize Response” Survey Option that ensures IP 
addresses and panel information are removed from each survey.   
 
2. Phone screening questionnaire:  
a. We updated the script for Research Assistants to use, to improve clarity. The 
changes to the script are shown in yellow highlighted text on pp. 3, 4, 5, 7, 8 of the 
Phone Screening Questionnaire in Appendix 1.  
 
3. First in-person screening assessment: 
a. We clarified the Safety Plan for the Research Assistants, shown in highlighted yellow 
on pg. 19 in Appendix 2. The protocol has not been changed; only the language so 
that the exact steps have been clarified to the Research Assistants.  
 
4. Consent form:  
a. Reference to the SurveyMonkey software was removed 
b. Reference to the control group was removed, as we are not using a control during 
the initial pilot testing of the novel intervention.  
c. The time commitment for the questionnaires has been updated to more accurately 
reflect the expected time commitment.  
d. The text now states that the class sessions “will be” audio recorded instead of “may 
be” audio recorded, as this better reflects the needs of the study to evaluate 
intervention fidelity.  
 

      
 
 
 
 
5. Baseline Survey: 
a. Three questionnaires have been added to the baseline survey, shown below. The 
specific questions are shown in yellow highlighted text in the attached Baseline 
Questionnaire on pp. 56-59 in Appendix 4.   
i. Multidimensional Assessment of Interoceptive Awareness (IA).1 
ii. Experiences Questionnaire (measure of reperceiving/decentering) (EQ).2  
iii. Cognitive Emotion Regulation Scale (CR).3 
 
6. Protocol for Physicians to Refer Patients to Mindfulness-Based Hypertension Therapy Study 
a. We were contacted by a physician named Cathleen Hood who would like to refer 
some of her patients to the study. A protocol that we will provide to her and other 
interested physicians for patient referral is attached (Appendix 5).  
 
 
References: 
 
1. 
Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The 
Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One 2012; 
7(11): e48230. 
 
2. 
Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD et al. Initial 
psychometric properties of the experiences questionnaire: validation of a self-report 
measure of decentering. Behavior therapy 2007; 38(3): 234-46. 
 
3. 
Garnefski N, Kraaij V, Spinhoven P. Negative life events, cognitive emotion regulation 
and emotional problems. Personality Indiv Differences 2001; 30: 1311-1327. 
 
 
 
3.) State the reason (justification) for the requested amendment: 
 
Amendment 1 above was done due to a respected colleague (Prof. Melissa Clark) 
recommending Qualtrics as a higher quality survey software compared to SurveyMonkey. 
Amendments 2-4 above were done to improve clarity. Amendment 5 above was done to 
improve identification of the mechanisms by which mindfulness intervention may improve blood 
pressure.  
 
 
4.) What is your assessment of how the changes will affect the overall 
risk/benefit ratio of the study and the willingness of individuals to 
participate? 
 
I do not expect any changes to the risk/benefit ratio or willingness of individuals to participate.  
 
5.) Does the requested amendment require new documents or 
changes to the approved consent form or other documents? 
 
Yes. Please see attached appendices 1-3. Changes are shown in yellow highlight or track 
changes.  

      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 1 
 
PHONE SCREENING QUESTIONNAIRE 
 
 
 
 

MBHT Phone Screening Questionnaire, Version 1.2, March 23, 2015                     Page 1 of 7 
 
 
 
 
 
 
 
PHONE-DELIVERED SCREENING 
QUESTIONNAIRE  
 
 
 
 

MBHT Phone Screening Questionnaire, Version 1.2, March 23, 2015                     Page 2 of 7 
PHONE SCREENING QUESTIONNAIRE PART 1 
 
The script is shown below in bold italics.  
 
PID. Participant ID: ___________ 
 
SQ01. Staff ID: ______________ 
 
SQ02. Today’s Date (MMDDYY): ________________ 
 
SQ03. Current Time (24 hour time, e.g. 14:45): ________ 
 
Please now call the participant.  
 
SQ04. Was the participant reached?   YES   NO 
 
Hello, my name is ____________. I am calling from the Brown University School of Public 
Health because (name of participant) expressed interest in participating in our 
mindfulness blood pressure study. Is he/she available to talk at this time? 
 
I would like to do a 10-15 minute phone interview with you to determine if you are a good 
match for this particular study.  
 
SQ05. Is now a good time to speak? 
 
[If yes, proceed to SQ05 script below] 
 
If no… When would be a good time to talk? 
 
SQ06. Day to call back (DDMMYY) ____________ 
 
SQ07. Time to call back ______ AM/PM 
OK, great. How about I give a quick overview of the study, and can then answer any 
questions you may have to see if it is a good fit for you. We will then go through a 
screening questionnaire to see if you qualify for the study. Does this sound OK? 
A basic overview of the study is that it is looking to see if mindfulness practices improve 
blood pressure, and if education about hypertension risk factors may also improve blood 
pressure. Specifically, we will provide training in meditation, mindful movements, and the 
roles of things like diet, physical activity and medication in reducing blood pressure. You 
will be taught by a very experienced teacher who in an expert in these fields. The course 
takes place weekly for 9 weeks, where you come to a class once each week for 2.5 hours 
each time. There is also a one-day retreat on a Saturday that will be 8 hours long. Also, 
we will ask you to participate in health assessments before and after the study. Health 
assessments include measures such as blood pressure, height and weight, and 
questionnaires about your health and experiences. 
 

MBHT Phone Screening Questionnaire, Version 1.2, March 23, 2015                     Page 3 of 7 
Can I answer any questions about the study that you may have? [answer any they may 
have.] 
SQ08. Does this study sound like something you would be interested in doing? Yes  No 
[If yes, proceed to next statement below. If no, politely thank the participant for considering 
being in this study, and end the call].  
Great. There are a few things that I would like to make clear before we start the interview. 
First of all, some of the questions that I will ask now to figure out if you are eligible to be 
in this study will be very personal and sensitive.  
 
SQ09. Are you in a private place to talk? 
 
[If yes, proceed to text below. If no, reschedule meeting using variables SQ04 and SQ05 above].  
 
 Because this interview is of a personal nature, it is important that you understand that 
everything you say will be kept strictly confidential.  No one outside of our project will 
ever be able to see your answers, and we will not keep your name in the same place as 
any of your answers. If you are not eligible after the phone screen, we will destroy your 
information.  If you like, though, we can keep your information on file for future studies. 
 
SQ10. Participant’s First Name:  ____________________________________ 
 
SQ11. Participant’s Last Name:______________________________________ 
 
Participant’s Address: 
SQ12a. Street address: _____________ 
SQ12b. City: ____________________ 
SQ12c: State: ________ 
SQ12d: Zip Code: ________________ 
 
SQ13a. Participant’s Phone number #1____________________________________ 
 
SQ13b. Participant’s Phone number #2____________________________________ 
 
 
SQ14. Participant’s email address (or mailing address if no email):______________________ 
 
SQ15. Notes from interviewer related to participants’ contact information (if any): 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________ 
 
 
 
 
 
 
 

MBHT Phone Screening Questionnaire, Version 1.2, March 23, 2015                     Page 4 of 7 
PHONE SCREENING QUESTIONNAIRE PART 2 
 
PID. Participant ID #: ______________ 
 
INCLUSION CRITERIA: All answers in 3rd column must be YES. If an answer is NO, 
immediately proceed to question SQ40. 
 
 
 
Comments 
SQ26. 
 What is your age?  (At least 18 years 
old) 
 
 
 
 
 
YES 
NO 
 
 
SQ27. 
Can you read and write in English? 
YES 
NO 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40.  
 
 
 
Comments 
SQ28. 
Has anyone ever told you that you have bipolar 
disorder or manic depression?  
YES 
NO  
 
SQ29. 
Has anyone ever used the word “Borderline” to 
describe you? 
YES 
NO  
 
SQ30a. 
 
 
 
SQ30b. 
Have you ever had a hallucination or seen things 
that other people can’t see, or hear things other 
people can’t hear?  
 
Have you ever been diagnosed with 
schizophrenia or psychosis? 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
SQ31_1 
SQ31_2 
SQ31_3 
SQ31_4 
SQ31_5 
SQ31_6 
SQ31_7 
SQ31_8 
Have you ever taken any of the following 
medications that I am about to read to you?  
Lithium                               
Seroquel (quetiapine) 
Abilify (aripiprazole)           
Zyprexa (olanzapine) 
Clozaril (clozapine)           
Haldol/Haloperidol 
Geodon (ziprasidone)         
Risperdal (risperidone) 
 
 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
YES 
NO 
 
SQ32a 
 
SQ32b 
 
 
SQ32c 
 
 
 
 
SQ32d 
 
 
Have you ever had a suicide attempt?  
 
[If yes, ask…] Have you considered killing 
yourself during the past month?  
 
[If yes, ask…] Are you currently suicidal? 
 
[If yes, keep participant on the phone, and follow 
suicide safety plan below] 
 
[If no, ask…] Are you getting any help for that? If 
not, then provide list of resources from Safety 
Plan including Gateway, Anchor and The 
Providence Center] Not urgent, but inform Dr. 
Flynn about what was discussed.  
YES 
NO 
 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
 
YES 
NO 
 
 
 

MBHT Phone Screening Questionnaire, Version 1.2, March 23, 2015                     Page 5 of 7 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a 
and SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40. 
SQ33a 
 
 
SQ33b 
 
 
SQ33c 
Would you say you have a trauma history?  
[If yes…]  
In the past month, have you had any problems 
with dissociation (memory loss)?  
In the past month, have you had any flashbacks 
(i.e. sudden and disturbing vivid memory) about 
the trauma?  
YES 
NO 
 
 
YES 
NO 
 
 
YES 
NO 
 
SQ34a 
 
 
 
SQ34b 
In the past month, have you had any problems 
with obsessions or compulsions, such as 
washing your hands or checking the oven over 
and over again?  
[If yes…] Has anyone diagnosed you with 
obsessive compulsive disorder? 
YES      NO 
 
 
 
 
YES 
NO 
 
SQ35 
In the past month, have you had a panic attack 
(i.e. sweating, heart palpitations, nausea, trouble 
breathing, fear of dying/choking/going crazy)?  
YES 
NO 
 
SQ36 
Have you had any problems with alcoholism or 
drug use in the past year? 
YES 
NO 
 
SQ37 
In the past year, have you had an eating disorder, 
such as starving, binge eating, or vomiting?  
YES 
NO 
 
SQ38a 
 
 
 
SQ38b 
 
 
 
 
 
SQ38c 
Do you currently have a mindfulness practice, 
such as meditation or yoga? 
 
Please tell me more about your mindfulness 
practice, including how often you practice per 
week.  
 
 
 
 
Do you currently practice meditation more than 
once per week? (yoga does not count as 
meditation in this context) 
YES 
NO 
 
 
Fill in 
response in 
comments 
section to the 
right  
 
YES 
NO 
 
 
SQ39 
This class will take place at Brown University in-
person. Do you have any medical or mobility 
issues that would affect you being able to attend 
class? 
YES 
NO 
 
SQ40 
Participant qualifies for next step of study (next step is 
1st blood pressure screening) 
YES 
NO 
 
If YES go to 
question 
SQ41.  
 
If NO, go to 
question 
SQ42.  
 
 

MBHT Phone Screening Questionnaire, Version 1.2, March 23, 2015                     Page 6 of 7 
 
SQ41. Thank you for taking the time to answer these questions. You qualify for the next 
stage of screening, which is to take your blood pressure at two different times at least a 
week apart from each other. Let’s book the in-person screening sessions [Book both 
sessions. We can cancel the second session if they do not qualify]. 
 
 
Thank you for taking the time to answer these questions, and for your interest in this 
study. We look forward to meeting you in person. Do you have any questions before we 
end this call?  
 
 
 
SQ42a. Thank you for taking the time to answer these questions. According to the 
survey, you do not qualify for the study at this time. There may be other studies you 
quality for.  
 
SQ42b. Would you like me to keep your information to pass on to these studies?  YES /  
NO 
 
SQ42c. [If yes…] OK, thank you. We will keep this information for future studies you may 
qualify for. Thank you for taking the time to talk with me today. Can I answer any 
questions before hanging up? 
 
SQ42d. [If no…] OK, our copy of this information will be destroyed. Thank you for taking 
the time to talk with me today. Can I answer any questions before hanging up? 
 
 
 
 
 
 

MBHT Phone Screening Questionnaire, Version 1.2, March 23, 2015                     Page 7 of 7 
SAFETY PLAN 
 
During the phone-based screening, if participants respond yes to “Are you currently suicidal?”, 
the interviewer should perform the following 2 steps: 
 
1. Immediately have 911 and Dr. Ellen Flynn called by a colleague who has been 
informed beforehand that this is a possibility.  
 
Specifically, while keeping the participant on the phone, show the text below in bold 
italics to a colleague.  
 
I have a study participant on the phone who is currently suicidal. Please call 911 
immediately, and tell them: 
 
“I am calling on behalf of [my name] who is performing a research study at Brown 
University. She has a participant on the phone who says they are currently suicidal.” 
Please provide the participants’ contact information to the 911 operator (i.e. name, 
address, phone #, email address) as requested. This information is on page 1 of the 
screening questionnaire right here [interviewer has this information]. 
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know what you are doing. 
Specifically, let them know we are calling our study’s psychiatrist Dr. Flynn and 911, 
and why you are doing that (i.e. because we are concerned about you). You can speak 
with participant to keep him/her on the phone, but the discussion should not be 
clinical in nature.   
 
Examples of questions that could be asked in order to keep them on the phone: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
• 
Tell me more about why you are interesting in being part of this study.  
• 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants if they state they have had 
considered killing themselves in the past month. If they are currently suicidal, the main priority is 
to keep them on the phone while 911 and Dr. Flynn are being contacted.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701; Anchor Counseling Center: 401-475-9979; 
The Providence Center: 401-276-4020 

      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 2 
 
FIRST IN-PERSON SCREENING ASSESSMENT 
 
 
 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 1 of 20 
 
 
 
 
 
 
 
 
FIRST IN-PERSON VISIT SCREENING 
QUESTIONNAIRE AND ASSESSMENT FORMS 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 2 of 20 
 
PID. Participant ID # __________ 
BA01. Staff ID # __________ 
BA02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA03g. Blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA03h. Blood pressure 4th reading, diastolic blood pressure:  __________ mmHg 
BA03i. Blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA03j. Blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA04. Were the 4th and 5th systolic blood pressure readings within 20 mmHg of each other? 
□ Yes 
□ No (repeat measurements  
 
BA05. Were the 4th and 5th diastolic blood pressure readings within 10 mmHg of each other? 
□ Yes 
□ No (repeat measurements) 
 
BA06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA06b. Repeated blood pressure1st reading, diastolic blood pressure:  __________ mmHg 
BA06c. Repeated blood pressure2nd reading, systolic blood pressure: _________ mmHg 
BA06d. Repeated blood pressure2nd reading, diastolic blood pressure:  __________ mmHg 
BA06e. Repeated blood pressure3rd reading, systolic blood pressure: _________ mmHg 
BA06f. Repeated blood pressure3rd reading, diastolic blood pressure:  __________ mmHg 
BA06g. Repeated blood pressure4th reading, systolic blood pressure: _________ mmHg 
BA06h. Repeated blood pressure4th reading, diastolic blood pressure:  __________ mmHg 
BA06i. Repeated blood pressure5th reading, systolic blood pressure: _________ mmHg 
BA06j. Repeated blood pressure5th reading, diastolic blood pressure:  __________ mmHg 
 
BA07. Blood pressure cuff size used: 
 □ S     □ Reg    □  L        □ XL 
 
BA08. Arm that cuff was placed on: 
  □ L      □  R 
 
BA09. Height: 
______ . __ cm (one decimal place) 
 
 
BA10. Weight: 
______ . __ kg (one decimal place) 
 
 
 
 
Waist Circumference:    
BA11a. Measurement 1 ______ . __ cm (one decimal place) 
BA11b. Measurement 2 ______ . __ cm (one decimal place) 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 3 of 20 
 
BA12. Is the difference between Measurement 1 and Measurement 2 greater than 1.0cm?  
□ Yes (repeat measurements 3&4)  
□ No 
 
BA13a. Measurement 3 ______ . __ cm    
BA13b. Measurement 4 ______ . __ cm 
 
Medications (ME) 
 
 
ME01. Do you take any prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
ME02a. What is the name of the first prescription medication or over-the-counter drug that you take? 
 
¨ Label product name: 
______________________________________________________________________ 
 
 
 
¨ Label generic name: 
______________________________________________________________________ 
 
 
 
¨ Don’t know  
¨ Prefer not to answer 
 
ME02b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME02c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 4 of 20 
 
ME02d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME02e. Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME02f. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME02g. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME02h. Interviewer comments: 
_______________________________________________________________________ 
 
 
ME02i. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
ME03a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
¨ Label product name: 
______________________________________________________________________ 
 
 
¨ Label generic name: 
______________________________________________________________________ 
 
 
¨ Don’t know  
¨ Prefer not to answer 
 
 
ME03b. What is the dosage form? 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 5 of 20 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME03c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME03d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.) 
 
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME03e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME3f. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME03g. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 6 of 20 
 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME03h. Interviewer comments:  
__________________________________________________________________ 
 
 
ME03i. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
 
ME04a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 
¨ Label product name: 
_____________________________________________________________________ 
 
 
¨ Label generic name: 
______________________________________________________________________ 
 
 
¨ Don’t know  
¨ Prefer not to answer 
 
ME04b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME04c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME04d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 7 of 20 
 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME04e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME04f. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME04g. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME04h. Interviewer comments: 
 
________________________________________________________________________ 
 
ME04i. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
ME05a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
¨ Label product name: 
 
______________________________________________________________________ 
 
 
 
¨ Label generic name: 
 
______________________________________________________________________ 
 
 
 
¨ Don’t know  
¨ Prefer not to answer 
 
 
ME05b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 

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            Page 8 of 20 
 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME05c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME05d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME05e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
ME05f. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
ME05g. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME05h. Interviewer comments: 
________________________________________________________________________ 
 
 
ME05i. Do you take any other prescription medications or over-the-counter drugs? 

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            Page 9 of 20 
 
¨ No à skip to end of end of 
medications questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
ME06a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
¨ Label product name: 
__________________________________________________________________ 
 
 
¨ Label generic name: 
___________________________________________________________________ 
¨ Don’t know 
 
 
¨ Prefer not to answer 
 
ME06b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
 
ME06c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME06d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME06e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)

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            Page 10 of 20 
 
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
ME06e. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
ME06f. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME06g. Interviewer comments: 
________________________________________________________________________ 
 
 
ME06h. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to next section 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
 
ME06i. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
 
 
ME07a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
¨ Label product name: 
_____________________________________________________________ 
 
 
¨ Label generic name: 
______________________________________________________________ 
 ¨ Don’t know  
 
¨ Prefer not to answer 
 
 
ME07b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 11 of 20 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME07c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME07d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME07e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME07f. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME07g For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME07h. Interviewer comments: 
____________________________________________________________________ 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 12 of 20 
 
ME07i. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
 
ME08a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
¨ Label product name: 
 
______________________________________________________________________ 
 
¨ Label generic name: 
 
______________________________________________________________________ 
 
¨ Don’t know  
 
¨ Prefer not to answer 
 
ME08b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME08c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME08d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
ME08e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)

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Version 1.2, March 23, 2015  
 
            Page 13 of 20 
 
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
ME08f. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
ME08g. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME08h. Interviewer comments: 
___________________________________________________________________ 
 
 
ME08i. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer
 
ME09a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
¨ Label product name: 
____________________________________________________________ 
 
 
¨ Label generic name: 
 
____________________________________________________________ 
 ¨ Don’t know  
¨ Prefer not to answer 
 
ME09b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 14 of 20 
 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME09c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
 
 
 
 
 
ME09d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME09e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME09f. Do you take it regularly or only as needed? 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME09g. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME09h. Interviewer comments: 
___________________________________________________________________ 
 
ME09i. Do you take any other prescription medications or over-the-counter drugs? 
¨ No à skip to end of medications 
questions 
¨ Yes 
¨ Don’t know 
¨ Prefer not to answer 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 15 of 20 
 
ME10a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
¨ Label product name: 
______________________________________________________________________ 
 ¨ Label generic name: 
______________________________________________________________________ 
 ¨ Don’t know  
¨ Prefer not to answer 
 
 
ME10b. What is the dosage form? 
 
Oral 
 
¨ Pill, tablet, or capsule 
¨ Sublingual or orally-disintegrating tablet 
¨ Liquid solution or suspension (drink, 
syrup) 
¨ Powder 
 
Topical 
¨ Liquid, cream, gel, or ointment 
¨ Ear drops (otic) 
¨ Eye drops (ophthalmic) 
¨ Skin patch (transdermal) 
 
 
Inhaled 
¨ Inhaler or nebulizer 
 
Injected 
¨ Injection 
 
Suppository 
¨ Rectal (e.g., enema) 
¨ Vaginal (e.g., douche, pessary) 
 
Other: 
¨ Don’t know 
¨ Prefer not to answer 
ME10c. How frequently do you take it? 
¨ _________ times per day  
¨ _________ times per week 
¨ _________ times per month 
¨ Don’t know 
¨ Prefer not to answer 
 
ME10d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
ME10e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
¨ _________ % 
¨ _________ mg 
¨ _________ mcg 
¨ _________ grams 
¨ _________ I.U. 
¨ _________ Other unit: 
_____________ 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME10f. Do you take it regularly or only as needed? 

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            Page 16 of 20 
 
¨ Regularly 
¨ Only as needed 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME10g. For how long have you been taking it? 
¨ For _________ days 
¨ For _________ weeks 
¨ For _________ months 
¨ For _________ years 
¨ Don’t know 
¨ Prefer not to answer 
 
 
ME10h. Interviewer comments: _______________________________________________________________ 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 17 of 20 
 
Questions for Participants to Answer on Their Own In-Person on Computer: 
For each statement, please place a mark in the column that best describes how you 
have been feeling. 
 
Not at all 
or less 
than 1 day 
last week 
1 or 2 
days 
last 
week 
3 to 4 
days 
last 
week 
5 to 7 
days 
last 
week 
Nearly 
every day 
for two 
weeks 
I do not 
know 
I prefer 
not to 
answer 
DS_1. My appetite was poor. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_2. I could not shake off 
the blues. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_3. I had trouble keeping 
my mind on what I was doing. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_4. I felt depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_5. My sleep was restless. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_6. I felt sad. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_7. I could not get going. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_8. Nothing made me 
happy. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
C_9. I felt like a bad person. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_10. I lost interest in my 
usual activities. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_11. I slept much more 
than usual. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_12. I felt like I was moving 
too slowly. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_13. I felt fidgety. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_14. I wished I were dead. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_15. I wanted to hurt 
myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_16. I was tired all the 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_17. I did not like myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_18. I lost a lot of weight 
without trying to. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_19. I had a lot of trouble 
getting to sleep. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_20. I could not focus on 
the important things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 18 of 20 
 
Below is a list of common symptoms of anxiety. Please carefully read each item in the 
list. Indicate how much you have been bothered by that symptom during the past 
month, including today, by marking the box in the corresponding space in the column 
next to each symptom.  
 
 
 
 
 
 
 
 
 
Not At All 
Mildly – it 
didn’t 
bother me 
much 
Moderately – it 
wasn’t pleasant 
at all times 
Severely – 
it bothered 
me a lot 
I do not 
know 
I prefer 
not to 
answer 
BA_1. Numbness or tingling 
□ 
□ 
□ 
□ 
□ 
□ 
BA_2. Feeling hot 
□ 
□ 
□ 
□ 
□ 
□ 
BA_3. Wobbliness in legs 
□ 
□ 
□ 
□ 
□ 
□ 
BA_4. Unable to relax 
□ 
□ 
□ 
□ 
□ 
□ 
BA_5. Fear of worst happening 
□ 
□ 
□ 
□ 
□ 
□ 
BA_6. Dizzy or lightheaded 
□ 
□ 
□ 
□ 
□ 
□ 
BA_7. Heart pounding/racing 
□ 
□ 
□ 
□ 
□ 
□ 
BA_8. Unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BA_9. Terrified or afraid 
□ 
□ 
□ 
□ 
□ 
□ 
BA_10. Nervous 
□ 
□ 
□ 
□ 
□ 
□ 
BA_11. Feeling of choking 
□ 
□ 
□ 
□ 
□ 
□ 
BA_12. Hands trembling 
□ 
□ 
□ 
□ 
□ 
□ 
BA_13. Shaky/unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BA_14. Fear of losing control 
□ 
□ 
□ 
□ 
□ 
□ 
BA_15. Difficulty in breathing 
□ 
□ 
□ 
□ 
□ 
□ 
BA_16. Fear of dying 
□ 
□ 
□ 
□ 
□ 
□ 
BA_17. Scared 
□ 
□ 
□ 
□ 
□ 
□ 
BA_18. Indigestion 
□ 
□ 
□ 
□ 
□ 
□ 
BA_19. Faint/lightheaded  
□ 
□ 
□ 
□ 
□ 
□ 
BA_20. Face flushed 
□ 
□ 
□ 
□ 
□ 
□ 
BA_21. Hot/cold sweats 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 19 of 20 
 
SAFETY PLAN 
After the participant has completed the Beck Anxiety Inventory questionnaire and the Centers 
for Epidemiologic Studies Depressive Symptomatology questionnaire, ask the participant to wait 
for a few minutes while you check that all forms and assessments are completed. While the 
participant is waiting in a different room, check the scores according to the criteria below. If any 
scores trigger the safety plan, move forward with steps below as written.  
Beck Anxiety Inventory (BA)  
 
If participant scores ≥26 on the Beck Anxiety Inventory, while having the participant wait, 
immediately notify the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to 
determine need for a psychiatric consultation. She has provided her cell phone #, and your 
phone # will be entered into her phone recognition software to indicate it is a call from the MBHT 
study. It is likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a 
phone message for her with your contact information and provide her with the Beck Anxiety 
Inventory results on the message. If Dr. Flynn is not immediately reachable, or following 
participant release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks 
(cell phone #401-369-0443).  
Depressive Symptomatology (DS) 
 
The CESD-R will be administered during the in-person assessment visits, and scores will be 
reviewed immediately upon completion of the in-person assessments. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Participants are considered to meet criteria for major depressive episode if they have anhedonia 
or dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM 
symptom groups noted as occurring nearly every day for the past two weeks. If participants 
meet criteria for major depressive episode, while having the participant wait, immediately notify 
the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to determine need 
for a psychiatric consultation.  She has provided her cell phone #, and your phone # will be 
entered into her phone recognition software to indicate it is a call from the MBHT study. It is 
likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a phone message 
for her with your contact information and provide her with the Depressive Symptomatology 
results on the message. If Dr. Flynn is not immediately reachable, or following participant 
release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks (cell phone 
#401-369-0443).  
 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.2, March 23, 2015  
 
            Page 20 of 20 
 
If participants respond having any suicidal ideation (DS questions 14 or 15), perform the 
following 2 steps: 
 
1. Immediately call 911 and Dr. Ellen Flynn.  
 
Specifically, while the participant is in the waiting room, call 911 immediately, and tell 
them: 
 
“My name is _____. I am working on a research study at Brown University. I have a study 
participant in the waiting room who has shared that he/she is currently suicidal.” Please 
provide the participants’ name to the 911 operator, as requested.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know that you have called 911 
and Dr. Flynn, and why (i.e. because we are concerned about you). You can speak 
with participant to keep him/her in the waiting room if 911 has sent assistance, but 
the discussion should not be clinical in nature.   
 
Examples of questions that could be asked in order to keep them in the waiting room: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
• 
Tell me more about why you are interesting in being part of this study.  
• 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
 

      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 3 
 
BASELINE QUESTIONNAIRE 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 1 of 60
 
 
 
 
 
 
 
 
 
 
 
QUESTIONNAIRES ANSWERED BY PARTICIPANTS 
AT BASELINE (VIA ONLINE OR PAPER FORM) 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 2 of 60
Questionnaire Table of Contents 
Introductory Questions ................................................................................................................. 3	  
Background Questions .................................................................................................................. 5	  
Physical Activity ............................................................................................................................ 8	  
Diet ................................................................................................................................................ 10	  
Eating Practices ........................................................................................................................... 16	  
Alcohol Consumption .................................................................................................................. 18	  
Smoking ........................................................................................................................................ 19	  
About You .................................................................................................................................... 20	  
Parent’s Education ...................................................................................................................... 41	  
Your Childhood Experiences ...................................................................................................... 43	  
Relationships ................................................................................................................................ 46	  
Your Sleep .................................................................................................................................... 49	  

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 3 of 60
Introduction 
We appreciate you taking the time to participate in this research study. These questionnaires will 
ask a series of questions on various aspects of your health, health behaviours, family, and other 
life circumstances. It should take approximately one hour. Please keep in mind that you can 
refuse to answer any questions that you are not comfortable with.  
 
Introductory Questions 
 
IQ1_01. Please enter the 3-digit ID number you were given. ___   ___  ___.  
 
 
 
IQ1_02. What is your main reason for participating in this study? 
 
 
 
 
 
IQ1_03. What do you care about most? 
 
 
 
 
 
IQ1_04. What gives you the most pleasure in your life? 
 
 
 
 
 
IQ1_05. What are your greatest worries? 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 4 of 60
Please list three personal goals you have for taking this mindfulness program: 
 
PG1_01.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_02.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_03.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 5 of 60
Background Questions 
 
BQ1_01. 
How many years old are you? 
 
 
 
 
BQ1_02. 
Are you Latino or Hispanic?  
 
 
 
□ No à skip to B3 
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
  
B1_02a.    Which of the following represents your family's country of origin? (check 
 
  
 
 
    all that apply) 
 
 
 
 
 
 
□ Cuba 
 
 
 
 
□ Mexico 
 
 
 
 
□ Puerto Rico 
 
 
 
 
□ Spain 
                         □ South America 
 
 
 
 
□ Columbia 
 
□ Dominican Republic 
 
□ Other Central American 
 
□ Other: _______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 
BQ1_03. 
If you were asked to put yourself into only one of these groups, in which one would 
you  place yourself? (select one only): 
 
 
 
□ Asian 
 
 
□ Pacific Islander 
 
 
□ African American/Black 
 
 
□ Caucasian/White 
 
□ Native American 
□ Other : ________________________ 
□ I do not know 
□ I prefer not to answer
BQ1_04. 
Which of the following best describes your current work situation? (select one only) 
 
 
 
□ Working full-time 
 
 
□ Working part-time  
 
 
□ Retired 
 
 
□ Unemployed:  
 
 
Looking for work 
□ Unemployed: Not currently    
      
looking for work 
 
 
□ Unemployed due to disability 
□ Keeping house or raising children  
    
full-time 
 
□ Military 
 
□ Full-time student 
 
□ Other:_______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 6 of 60
BQ1_05.    What is the highest grade or level of regular school you have completed? 
 
 
 
□ Elementary School 
 
 
□ Junior High  
 
 
□ High School 
 
 
□ College 
 
 
□ Graduate School  
 
 
□ I do not know 
 
 
□ I prefer not to answer 
     
BQ1_06.    What is the highest degree you earned? (select one only) 
 
 
 
□ Elementary school 
□ Some high school, but no GED 
□ GED 
 
 
□ High school 
 
 
□ Associate degree (Junior  
 
 
    College) 
 
 
□ Bachelor’s degree 
□ Master’s degree 
□ Doctorate (PhD, EdD, etc) 
□ Professional (MD, JD, DDS, DVM, etc.) 
□ Other: _____________________________ 
□ I do not know 
□ I prefer not to answer 
 
 
BQ1_07.    Did you ever attend any other school like a technical, vocational, or trade school? 
 
 
 
□ No 
 
 
 
□ Yes 
 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
BQ1_08.    In total, about how many full-time years of education have you had, including 1st 
grade and all years of school after 1st grade? 
 
 
 
________ years 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 7 of 60
BQ1_09a.    Do you currently live alone? 
 
 
 
□ No 
 
 
 
□ Yes à skip to BQ_10 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
 
 
BQ1_09b. 
How many people currently live in your household, including   
 
 
             yourself? 
 
 
 
 
 
_________  
      
 
 
 
 
 
 
 
 
 
 
 
BQ1_09c.    Of these people, how many are under 18? 
 
 
 
 
 
 
 _________  
 
 
 
 
 
 
 
BQ1_09d. 
  Of the adults in your household (including yourself), how many bring  
 
 
 
      
 income into the household?   
 
 
 
 
 
 
_________  
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 8 of 60
Physical Activity 
 
Physical activities are activities where you move and increase your heart rate above its resting 
rate, whether you do them for pleasure, work, or transportation. The following questions ask 
about the amount and intensity of physical activity you usually do. The intensity of the activity is 
related to the amount of energy you use doing these activities. 
 
Examples of physical activity intensity levels: 
 
Light activities 
 
Your heart beats slightly faster than normal 
You can talk and sing 
 
 
 
 
 
 
 
 
 
Moderate activities 
 
Your heart beats faster than normal 
You can talk but not sing 
 
 
 
 
 
 
 
 
 
 
Vigorous activities 
 
Your heart rate increases a lot 
You can’t talk, or your talking is broken 
up by large breaths 
 
 
 
 
 
 
 
 
Light exercise   
 
Light stretching  
 
Light vacuuming  
or yard work 
Brisk walking     Aerobics class      Strength training    Swim gently 
Aerobics classes 
 Jogging, Running,   
Singles tennis, 
or Power Walking  
 
Racquetball, Pickle ball 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 9 of 60
How physically active are you? 
 
 
YES 
NO 
I do not 
know 
I prefer 
not to 
answer 
PA1_01. I rarely or never do any physical 
activities. 
□ 
□ 
□ 
□ 
PA1_02. I do some light and/or moderate 
physical activities, but not every week. 
□ 
□ 
□ 
□ 
PA1_03. I do some light physical activity every 
week. 
□ 
□ 
□ 
□ 
PA1_04. I do moderate physical activity every 
week but less than 5 days per week or less than 
30 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_05. I do vigorous physical activities every 
week, but less than 3 days per week or less than 
20 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_06. I do 30 minutes or more per day of 
moderate physical activities 5 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_07. I do 20 minutes or more per day of 
vigorous physical activities 3 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_08. I do activities to increase muscle 
strength, such as lifting weights or calisthenics, 
once a week or more. 
□ 
□ 
□ 
□ 
PA1_09. I do activities to improve flexibility, 
such as stretching or yoga, once a week or more. 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 10 of 60
Diet  
 
The first set of questions ask about foods you usually eat or drink.  For each food, please place an 
X in the box (e.g. ý) for the answer that best matches how often you eat or drink it. Remember to 
count fruit or vegetables that were part of another dish, like a banana on cereal or vegetables in a 
stew. Also, please pay attention to the serving sizes. For example, one serving size of bread is one 
slice, so a sandwich would contain 2 servings of bread. Please include all foods you eat, both at 
home and away from home.   Enclosed are pictures of common serving sizes to assist you in 
filling out your questionnaire. 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 11 of 60
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 12 of 6
How Often You Eat or Drink This Item 
 
Never 
or less 
than 1 
per 
month 
1-3 per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3    
per 
day 
4-5    
per 
day 
More 
than 5 
per 
day 
I do 
not 
know 
DT1_01. 
Skim/low fat 
milk  (8 oz. 
glass) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_02. 
Whole milk  
(8 oz. glass) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_03. Ice 
cream (1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_04. 
Yogurt (1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_05. 
Cottage or 
ricotta cheese   
(1/2 cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_06. 
Butter, added 
to food or 
bread (1 pat), 
exclude use 
in cooking 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_07. 
Fruit (not 
including 
fruit juice. A 
serving = 1 
piece, or 1/2 
grapefruit, or 
1/2 cup 
berries) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_08. 
100% fruit 
juice, not 
including 
fruit drinks 
(small glass) 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 13 of 60
How Often You Eat or Drink This Item 
 
Never 
or less 
than 1 
per 
month 
1-3 per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3    
per 
day 
4-5    
per 
day 
More 
than 5 
per 
day 
I do 
not 
know 
I prefer 
not to 
answer 
DT1_09. 
Vegetables - 
raw and 
cooked (1/2 
cup), 
including 
mixed dishes 
such as 
soups, 
casseroles 
and lasagna. 
Do not 
include 
potatoes. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_10. 
Eggs (do not 
include egg 
beaters) (1) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_11. 
Chicken or 
turkey (4-6 
oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_12. 
Processed 
meat (1 piece 
sausage, 1 
slice salami, 
2 pieces 
bacon) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_13. Hot 
dog/ 
hamburger 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 14 of 60
How Often You Eat or Drink This Item 
 
Never or 
less than 
1 per 
month 
1-3 
per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3   
per 
day 
4-5   
per 
day 
More 
than 
5 per 
day 
I do 
not 
know 
I 
prefer 
not to 
answer 
DT1_14. Beef, pork, 
or lamb as a sandwich 
or mixed dish, e.g. 
stew, casserole, 
lasagna, etc. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_15. Beef, pork, 
or lamb as a main dish, 
e.g. steak, roast, ham, 
etc.   (4-6 oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_16. Fish 
(including canned 
tuna) (3-5 oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_17. Shellfish 
such as shrimp, 
lobster, scallops and 
clams as a main dish 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_18. White bread 
(including pita bread) 
(slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_19. Dark bread 
(including whole 
wheat and rye) (slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_20. Bakery items 
(cookies, brownies, 
doughnuts, cake) (1 
piece or slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_21. Nuts (small 
packet, 1 oz., 1 Tbs 
peanut butter) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_22. Pasta (e.g. 
spaghetti, and 
macaroni and cheese; 
1 cup cooked) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_23. Potatoes, 
baked, boiled or 
mashed (do not 
include French fries/ 
chips) (1 potato or 1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
  
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 15 of 60
                                  How Often You Eat or Drink This Item 
 
Never or 
less than 
1 per 
month 
1-3 
per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3   
per 
day 
4-5   
per 
day 
More 
than 
5 per 
day 
I do 
not 
know 
I 
prefer 
not to 
answer 
DT1_24. Regular 
soft drinks 
(including caffeine 
free, but NOT 
including diet 
colas) (consider the 
serving size as 1 
glass, bottle or can) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_25. Coffee 
(regular or decaf) (1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 16 of 60
Eating Practices 
 
 
Definitely 
True 
Mostly 
True 
Mostly 
False 
Definitely 
False 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_01. I deliberately take small 
helpings to control my weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_02. I start to eat when I feel 
anxious. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_03. Sometimes when I start 
eating, I just can’t seem to stop. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_04. When I feel sad, I often eat 
too much. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_05. I don’t eat some foods 
because they make me fat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_06. Being with someone who is 
eating, often makes me want to also 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_07. When I feel tense or 
‘‘wound up’’, I often feel I need to 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_08. I often get so hungry that 
my stomach feels like a bottomless 
pit. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_09. I’m always so hungry that 
it’s hard for me to stop eating before 
finishing all of the food on my plate. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_10. When I feel lonely, I 
console myself by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_11. I consciously hold back on 
how much I eat at meals to keep 
from gaining weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_12. When I smell a sizzling 
steak or see a juicy piece of meat, I 
find it very difficult to keep from 
eating even if I’ve just finished a 
meal. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_13. I’m always hungry enough 
to eat at any time. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_14. If I feel nervous, I try to 
calm down by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_15. When I see something that 
looks very delicious, I often get so 
hungry that I have to eat right away. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_16. When I feel depressed, I 
want to eat. 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 17 of 60
 
 
 
Almost 
Never 
Seldom 
Usually 
Almost 
Always 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_17. How often do you avoid 
‘stocking up’’ on tempting foods? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Unlikely 
A little 
likely 
Somewhat 
likely 
Very 
likely 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_18. How likely are you to 
make an effort to eat less than you 
want? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Never 
Rarely Sometimes 
At least 
once a 
week 
I Do Not 
Know 
I Prefer 
Not to 
Answer 
EE1_19. Do you go on eating 
binges even though you’re not 
hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Only at 
mealtimes 
Sometimes 
between 
meals 
Often 
between 
meals 
Almost 
always 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_20. How often do you 
feel hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_21. On a scale from 1 to 8, where 1 means 
no restraint in eating and 8 means total restraint, 
what number would you give yourself? Mark the 
number that best applies to you: 
□ □ □ □ □ □ □ □ 
□ 
□ 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 18 of 60
Alcohol Consumption  
 
A drink of alcohol is defined as 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine 
cooler, 1 cocktail, or 1 shot of liquor. 
 
AC1_01. During the past 30 days, how many days per week or per month did you have at least 1 
drink of any alcoholic beverage? [if none, STOP] 
 
_______________ 
 
 
AC1_02. On the days when you drank, about how many drinks did you drink on average?  
 
______________ 
 
 
AC1_03. Men: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 5 or more drinks on an occasion? 
Women: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 4 or more drinks on an occasion? 
 
_________________ 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 19 of 60
Smoking  
 
SM1_01. 
Have you smoked at least 100 cigarettes in your entire life? 
 
¨ Yes 
¨ No 
¨ I Do Not Know 
¨ Prefer not to answer 
 
 
SM1_02.  
Did you ever become a daily smoker (that is, smoke every day or nearly every day 
for two months or longer)? 
 
¨ Yes 
¨ No à skip to SC1_01 
¨ I Do Not Know 
¨ Prefer not to answer 
 
SM1_03.  
How old were you when you last smoked daily? 
 
  
Age ______ (in years) 
 
 
¨ I Do Not Know 
¨ Prefer not to answer  
¨ Still smoking daily 
 
 
 
SM1_04. 
Do you smoke cigarettes now? 
 
¨ Yes 
¨ No à skip to next section 
¨ I Do Not Know 
¨ Prefer not to answer 
 
 
 SM1_04a.    How many cigarettes per day do you smoke? (One pack equals 20   
 
   
 
 cigarettes) 
 
  
 
 
Number of cigarettes ________  
 
 
 
 
 
 
 
 
¨ I Do Not Know 
 
 
 
 
¨ Prefer not to answer 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 20 of 60
About You 
 
Using the scale provided, please indicate how much each of the following statements reflects how 
you typically are.  
 
 
Not 
at all 
A 
little 
Somewhat 
Fair 
Amount 
Very 
much 
I do 
not 
know 
I 
prefer 
not to 
answer 
SC1_01. I am good at resisting 
temptation. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_02. I have a hard time 
breaking bad habits. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_03. I am lazy. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_04. I say inappropriate 
things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_05. I do certain things that 
are bad for me, if they are fun.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_06. I refuse things that are 
bad for me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_07. I wish I had more self-
discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_08. People would say that 
I have iron self-discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_09. Pleasure and fun 
sometimes keep me from 
getting work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_10. I have trouble 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_11. I am able to work 
effectively toward long-term 
goals. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_12. Sometimes I can’t stop 
myself from doing something, 
even if I know it is wrong. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_13. I often act without 
thinking through all the 
alternatives.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 21 of 60
The next few statements are about certain ways you may feel about your life. Please indicate how 
strongly you agree or disagree with each of the following statements: Strongly agree; Agree; 
Neutral, Disagree, or Strongly disagree 
 
 
 
 
  
Strongly 
agree 
Agree 
Neutral 
Disagree 
Strongly 
disagree 
I Do 
Not 
Know 
Prefer 
not to 
answer 
SE1_01. I have little 
control over the things that 
happen to me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_02. There is really no 
way I can solve some of 
the problems I have. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_03. There is little I 
can do to change many of 
the important things in my 
life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_04. I often feel 
helpless in dealing with 
the problems of life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_05. Sometimes I feel 
that I am being pushed 
around in life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_06. What happens to 
me in the future mostly 
depends on me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_07. I can do just 
about anything I really set 
my mind to do. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 22 of 60
Please read each statement carefully before answering. To the left of each item, indicate how 
often you behave in the stated manner, using the following scale: 
 
 
Almo
st 
never 
Not very 
often 
Sometimes Frequently 
Almost 
always 
I Do 
Not 
Know 
Prefer not 
to answer 
C1_O1. When I fail at 
something important to 
me, I become consumed 
by feelings of inadequacy. 
 
 
 
 
 
 
 
C1_O2. I try to be 
understanding and patient 
towards those aspects of 
my personality I don’t 
like. 
 
 
 
 
 
 
 
C1_O3. When something 
painful happens I try to 
take a balanced view of 
the situation. 
 
 
 
 
 
 
 
C1_O4. When I’m feeling 
down, I tend to feel like 
most other people are 
probably happier than I 
am. 
 
 
 
 
 
 
 
C1_O5. I try to see my 
failings as part of the 
human condition. 
 
 
 
 
 
 
 
C1_O6. When I’m going 
through a very hard time, I 
give myself the caring and 
tenderness I need. 
 
 
 
 
 
 
 
C1_O7. When something 
upsets me I try to keep my 
emotions in balance. 
 
 
 
 
 
 
 
C1_O8. When I fail at 
something that’s important 
to me, I tend to feel alone 
in my failure 
 
 
 
 
 
 
 
C1_O9. When I’m feeling 
down I tend to obsess and 
fixate on everything that’s 
wrong. 
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 23 of 60
 
Almost 
never 
Not very 
often 
Sometimes Frequently 
Almost 
always 
I Do 
Not 
Know 
Prefer not 
to answer 
CO1_10. When I feel 
inadequate in some way, I 
try to remind myself that 
feelings of inadequacy are 
shared by most people. 
 
 
 
 
 
 
 
CO1_11. I’m 
disapproving and 
judgmental about my own 
flaws and inadequacies. 
 
 
 
 
 
 
 
CO1_12. I’m intolerant 
and impatient towards 
those aspects of my 
personality I don’t like. 
 
 
 
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 24 of 60
 
The questions in this scale ask you about your feelings and thoughts during the last month. In 
each case, you will be asked to indicate by circling how often you felt or thought a certain way.  
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do not 
know 
I prefer 
not to 
answer 
PS1_01. In the last month, 
how often have you been 
upset because of something 
that happened unexpectedly?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_02. In the last month, 
how often have you felt that 
you were unable to control the 
important things in your life?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_03. In the last month, 
how often have you felt 
nervous and “stressed”? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_04. In the last month, 
how often have you felt 
confident about your ability to 
handle your personal 
problems?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_05. In the last month, 
how often have you felt that 
things were going your way? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_06. In the last month, 
how often have you found that 
you could not cope with all 
the things that you had to do?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_07. In the last month, 
how often have you been able 
to control irritations in your 
life? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_08. In the last month, 
how often have you felt that 
you were on top of things? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_09. In the last month, 
how often have you been 
angered because of things that 
were outside of your control? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_10. In the last month, 
how often have you felt 
difficulties were piling up so 
high that you could not 
overcome them?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 25 of 60
Instructions: Below is a collection of statements about your everyday experience. Using the scale 
below, please indicate how frequently or infrequently you currently have each experience. Please 
answer according to what really reflects your experience rather than what you think your 
experience should be. Please treat each item separately from every other item.  
 
Please indicate the degree to which you agree with each of the following items using the scale 
below. Simply check your response to each item 
 
 
  
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
MA1_01. I could be 
experiencing some 
emotion and not be 
conscious of it until 
some time later.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_02. I break or 
spill things because 
of carelessness, not 
paying attention, or 
thinking of 
something else.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_03. I find it 
difficult to stay 
focused on what’s 
happening in the 
present. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_04. I tend to 
walk quickly to get 
where I’m going 
without paying 
attention to what I 
experience along the 
way.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_05. I tend not 
to notice feelings of 
physical tension or 
discomfort until they 
really grab my 
attention.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_06. I forget a 
person’s name almost 
as soon as I’ve been 
told it for the first 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 26 of 60
 
 
 
 
 
 
 
 
 
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
MA1_07. It seems I 
am “running on 
automatic” without 
much awareness of 
what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_08. I rush 
through activities 
without being really 
attentive to them.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_09. I get so 
focused on the goal I 
want to achieve that I 
lose touch with what 
I am doing right now 
to get there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_10. I do jobs or 
tasks automatically, 
without being aware 
of what I’m doing.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_11. I find 
myself listening to 
someone with one 
ear, doing something 
else at the same time.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_12. I drive 
places on “automatic 
pilot” and then 
wonder why I went 
there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_13. I find 
myself preoccupied 
with the future or the 
past.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_14. I find 
myself doing things 
without paying 
attention. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_15. I snack 
without being aware 
that I’m eating.    
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 27 of 60
Please rate each of the following statements using the scale provided. Write the number in the 
blank that best describes your own opinion of what is generally true for you.  
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_01. When I’m walking, I 
deliberately notice the sensations of 
my body moving.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_02. I’m good at finding words to 
describe my feelings.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_03. I criticize myself for having 
irrational or inappropriate emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_04. I perceive my feelings and 
emotions without having to react to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_05. When I do things, my mind 
wanders off and I’m easily distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_06. When I take a shower or 
bath, I stay alert to the sensations of 
water on my body.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_07. I can easily put my beliefs, 
opinions, and expectations into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_08. I don’t pay attention to what 
I’m doing because I’m daydreaming, 
worrying, or otherwise distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_09. I watch my feelings without 
getting lost in them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_10. I tell myself I shouldn’t be 
feeling the way I’m feeling.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_11. I notice how foods and 
drinks affect my thoughts, bodily 
sensations, and emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_12. It’s hard for me to find the 
words to describe what I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 28 of 60
 
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_13. I am easily distracted. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_14. I believe some of my 
thoughts are abnormal or bad and 
I shouldn’t think that way.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_15. I pay attention to 
sensations, such as the wind in 
my hair or sun on my face.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_16. I have trouble thinking 
of the right words to express how 
I feel about things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_17. I make judgments about 
whether my thoughts are good or 
bad.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_18. I find it difficult to stay 
focused on what’s happening in 
the present.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_19. When I have distressing 
thoughts or images, I “step back” 
and am aware of the thought or 
image without getting taken over 
by it.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_20. I pay attention to 
sounds, such as clocks ticking, 
birds chirping, or cars passing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_21. In difficult situations, I 
can pause without immediately 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_22. When I have a sensation 
in my body, it’s difficult for me 
to describe it because I can’t find 
the right words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_23. It seems I am “running 
on automatic” without much 
aware- ness of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_24. When I have distressing 
thoughts or images, I feel calm 
soon after.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_25. I tell myself that I 
shouldn’t be thinking the way 
I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 29 of 60
 
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_26. I notice the smells and 
aromas of things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_27. Even when I’m feeling 
terribly upset, I can find a way to 
put it into words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_28. I rush through activities 
without being really attentive to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_29. When I have distressing 
thoughts or images, I am able 
just to notice them without 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_30. I think some of my 
emotions are bad or 
inappropriate and I shouldn’t feel 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_31. I notice visual elements 
in art or nature, such as colors, 
shapes, textures, or patterns of 
light and shadow.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_32. My natural tendency is 
to put my experiences into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_33. When I have distressing 
thoughts or images, I just notice 
them and let them go.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_34. I do jobs or tasks 
automatically without being 
aware of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_35. When I have distressing 
thoughts or images, I judge 
myself as good or bad depending 
what the thought or image is 
about.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_36. I pay attention to how 
my emotions affect my thoughts 
and behavior.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_37. I can usually describe 
how I feel at the moment in 
consider- able detail.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 30 of 60
 
 
 
 
 
 
 
 
Never 
Almost 
Never 
Someti
mes 
Fairly 
Often 
Often 
I do not 
know 
I prefer 
not to 
answer 
FF1_38. I find myself doing 
things without paying attention. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_39. I disapprove of myself 
when I have irrational ideas. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 31 of 60
This Week's Experiences 
 
Instructions: Below is a collection of statements about how you find yourself reacting to 
unpleasant thoughts and feelings.  Using the scale below, please indicate how frequently or 
infrequently you experienced each of the following reactions this week.  Please answer 
according to what really reflects your experience this week rather than what you think your 
experience should be.  
 
This week, when I encountered an unpleasant thought or feeling,  
    
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_01. I tried 
to think pleasant 
thoughts instead 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_02. I 
allowed myself 
to experience it 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_03. I got 
angry or upset 
at myself for 
having the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_04. I felt 
the desire to 
make it better or 
make it go away 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_05. I 
wished I didn’t 
feel or think that 
way 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_06. I tried 
to let my 
thoughts just 
come and go 
without getting 
too entangled 
with them 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 32 of 60
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_07. I 
thought the 
mood would 
never change 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_08. I 
explored the 
body sensations 
that 
accompanied 
the emotion. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_09. I 
named the 
emotion over 
and over as long 
as it lasted 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_10. I 
turned to work 
or other 
activities to take 
my mind off 
things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_11. I 
named the 
emotion and 
then redirected 
my attention to 
the present 
moment  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_12. I 
thought "This 
mood, too, shall 
pass" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 33 of 60
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_13. I 
focused on my 
breathi 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_14. I took 
an active 
interest in how 
the experience 
changed over 
time 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_15. I 
explored my 
reactions to the 
thought or 
emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_16. I 
thought "my 
thinking is 
being distorted 
by my mood" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_17. Think 
"Why do I have 
problems that 
other people 
don't have?" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_18. I 
forgave myself 
for having the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_19. I 
challenged the 
thought’s 
validity 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_20. I 
asked myself 
questions about 
the experience 
in order to 
explore it better 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 34 of 60
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_21. I tried 
not to change it 
because I 
believe it is 
important to 
experience 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_22. I 
labelled my 
thoughts 
"images" or 
verbal "talk" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_23. I 
thought "Why 
do I always 
react this way?" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_24. I 
adopted a 
welcoming 
stance toward 
the 
emotion/thought 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_25. I went 
somewhere 
alone to think 
about my 
feelings 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_26. I sent 
out compassion 
to all people 
who struggle 
with this 
emotion  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_27. I 
restrained 
myself from 
doing anything 
too quickly 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 35 of 60
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_28. I became 
genuinely curious 
about the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_29. I laughed 
or kidded myself 
about the situation 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_30. I treated 
the repetitive 
thought like a “top 
ten radio tune” 
that's playing in 
the background 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_31. I talked 
to others about 
how I was feeling 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_32. I tried to 
forget about it 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_33.  I 
thought "Why can't 
I handle things 
better" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_34. I tried to 
come up with a 
way to make it go 
away 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_35. I said to 
myself "thinking" 
or "this is just a 
thought" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_36. I thought 
about how much I 
disliked feeling 
that way 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_37. I 
reminded myself 
thoughts are not 
accurate 
reflections of 
reality 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 36 of 60
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_38. I thought 
that that I must be 
headed into a 
downward spiral  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_39. I thought 
"What I am doing 
to deserve this? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 37 of 60
Please indicate how often the following statements apply to you by checking the box that 
best describes your experience.  
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_01.  I am clear 
about my feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_02.  I pay 
attention to how I 
feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_03.  I 
experience my 
emotions as 
overwhelming and 
out of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_04.  I have no 
idea how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_05.  I have 
difficulty making 
sense out of my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_06.  I am 
attentive to my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_07.  I know 
exactly how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_08.  I care 
about what I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_09.  I am 
confused about how 
I feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_10.  When I’m 
upset, I 
acknowledge my 
emotions. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_11.  When I’m 
upset, I become 
angry with myself 
for feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_12.  When I’m 
upset, I become 
embarrassed for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 38 of 60
 
 
 
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_13.  When I’m 
upset, I have 
difficulty getting 
work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_14. When I’m 
upset, I become out 
of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_15.  When I’m 
upset, I believe that 
I will remain that 
way for a long time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_16.  When I’m 
upset, I believe that 
I will end up feeling 
very depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_17.  When I’m 
upset, I believe that 
my feelings are 
valid and important. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_18.  When I’m 
upset, I have 
difficulty focusing 
on other things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_19.  When I’m 
upset, I feel out of 
control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_20.  When I’m 
upset, I can still get 
things done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_21.  When I’m 
upset, I feel 
ashamed at myself 
for feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_22.  When I’m 
upset, I know that I 
can find a way to 
eventually feel 
better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 39 of 60
 
 
 
 
Almost 
Never  
(0-
10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_23.  When I’m 
upset, I feel like I am 
weak. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_24.  When I’m 
upset, I feel like I can 
remain in control of my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_25. When I’m 
upset, I feel guilty for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_26. 
When 
I’m 
upset, I have difficulty 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_27.  When I’m 
upset, I have difficulty 
controlling my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_28.  When I’m 
upset, I believe there is 
nothing I can do to 
make myself feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_29.  When I’m 
upset, I become 
irritated at myself for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_30.  When I’m 
upset, I start to feel 
very bad about myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_31.  When I’m 
upset, I believe that 
wallowing in it is all I 
can do. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_32.  When I’m 
upset, I lose control 
over my behaviour. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 40 of 60
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Almost 
Never  
(0-
10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_33.  When I’m 
upset, I have difficulty 
thinking about anything 
else. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_34.  When I’m 
upset I take time to 
figure out what I’m 
really feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_35.  When I’m 
upset, it takes me a long 
time to feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_36.  When I’m 
upset, my emotions feel 
overwhelming. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 41 of 60
Parent’s Education 
 
CS1_01. Please check the box beside the highest grade or degree that your BIOLOGICAL 
MOTHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
CS1_02. Please check the box beside the highest grade or degree that your BIOLOGICAL 
FATHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 42 of 60
Now please think of the two most important adults in your home between the time you were born 
and age 18 years. Please check the category below that best described their lecel of education 
during this time period. 
 
CS1_03. First adult’s highest level of education: 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
CS1_04. Second adult’s highest level of education 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 43 of 60
Your Childhood Experiences 
The following questions ask about some difficult experiences that you might have had as a child. 
These questions may be emotionally difficult to answer. Just as a reminder, you do not need 
answer any questions that you would prefer not to. Your answers to these questions, as with all 
questions, will remain confidential.  
 
CE1_01. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Swear at you, insult you, put you down, or humiliate you? 
 
 
 
or 
Act in a way that made you afraid that you might be physically hurt? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_02. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Push, grab, slap, or throw something at you? 
 
 
 
or 
Ever hit you so hard that you had marks or were injured?  
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
CE1_03.  
Before you were 18 years old, did an adult or person at least 5 years older than you 
ever… 
 
 
Touch or fondle you or have you touch their body in a sexual way? 
 
 
 
or 
Attempt or actually have oral, anal, or vaginal intercourse with you? 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 44 of 60
CE1_04. Before you were 18 years old, did you often or very often feel that … 
 
 
No one in your family loved you or thought you were important or special? 
 
 
 
or 
Your family didn’t look out for each other, feel close to each other, or support each other? 
 
  
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
CE1_05. Before you were 18 years old, did you often or very often feel that … 
 
 
You didn’t have enough to eat, had to wear dirty clothes, and had no one to protect you? 
 
 
 
or 
Your parents were too drunk or high to take care of you or take you to the doctor if you 
needed it? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
  
 
 
CE1_06. Before you were 18 years old, was a biological parent ever lost to you through divorce, 
abandonment, or other reason?   
 
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_07. Before you were 18 years old, was your mother or stepmother:   
 
 
Often or very often pushed, grabbed, slapped, or had something thrown at her? 
 
 
 
or 
Sometimes, often, or very often kicked, bitten, hit with a fist, or hit with something hard? 
 
 
 
or 
Ever repeatedly hit over at least a few minutes or threatened with a gun or knife? 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 45 of 60
 
CE1_08. Before you were 18 years old, did you live with anyone who was a problem drinker or 
alcoholic, or who used street drugs? 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
     
 
CE1_09. Before you were 18 years old, was a household member depressed or mentally ill, or did 
a household member attempt  suicide? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_10. Before you were 18 years old, did a household member go to prison? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 46 of 60
Relationships 
 
SN1_01. How many close friends do you have? By close friends, we mean people that you feel at 
 
ease with, and that you can talk to about private matters. 
 
 
 
□ None à skip to Y2  
 
 
 
____ Number of close friends   
 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
 
Y1a.    How many of these close friends do you see at least once a month?     
 
 
 
 
 
____ Number of close friends (if none, write zero) 
 
 
 
 
 
□ I do not know  
 
 
 
 
□ I prefer not to answer  
 
 
SN1_02. Thinking about your relatives, how many relatives do you feel at ease with, and feel that 
 
you can talk to about private matters?  
 
 
 
□ None à skip to Y3 
 
 
 
____ Number of relatives  
 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
 
Y2a.    How many of these relatives do you see at least once a month?  
 
 
 
 
 
____ Number of relatives (if none, write zero) 
 
 
 
 
 
 
 
□ I do not know  
 
 
 
 
□ I prefer not to answer  
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 47 of 60
SN1_03. About how often do you participate in groups or clubs, such as religious connected 
groups,  self-help groups, charities, or a public service or community group. 
 
 
 
□ Never or almost never 
 
 
□ A few times a year 
 
 
□ Once or twice a month 
 
 
□ Once a week 
 
 
□ More than once a week 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
SN1_04. About how often do you go to religious meetings or services?  
 
 
 
□ Never or almost never 
 
 
□ A few times a year 
 
 
□ Once or twice a month 
 
 
□ Once a week 
 
 
□ More than once a week 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
 
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 48 of 60
INSTRUCTIONS: Indicate how often each of the statements below is descriptive of you. 
 
Statement 
Never 
Rarely 
Sometimes 
Often 
I Do 
Not 
Know 
Prefer 
not to 
answer 
LS1_01. I feel in tune with the people 
around me 
□ 
□ 
□ 
□ 
□ 
s 
LS1_02. I lack companionship 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_03. There is no one I can turn to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_04. I do not feel alone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_05. I feel part of a group of 
friends 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_06. I have a lot in common with 
the people around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_07. I am no longer close to 
anyone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_08. My interests and ideas are 
not shared by those around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_09. I am an outgoing person 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_10. There are people I feel close 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_11. I feel left out 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_12. My social relationships are 
superficial 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_13. No one really knows me 
well 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_14. I feel isolated from others 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_15. I can find companionship 
when I want it 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_16. There are people who really 
understand me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_17. I am unhappy being so 
withdrawn 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_18. People are around me but 
not with me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_19. There are people I can talk 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_20. There are people I can turn 
to 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 49 of 60
Your Sleep 
 
The following questions relate to your usual sleep habits during the past month only. Your 
answers should indicate the most accurate reply for the majority of days and nights in the past 
month. Please answer all questions. 
 
SL1_01. During the past month, what time have you usually gone to bed at night? 
 
 
 
BED TIME ___________ AM / PM 
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_02. During the past month, how long (in minutes) has it usually taken you to fall asleep 
each  
night? 
 
 
 
NUMBER OF MINUTES ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_03. During the past month, at what time have you usually gotten up in the morning? 
 
 
 
GETTING UP TIME ___________ AM / PM 
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_04. During the past month, how many hours of actual sleep did you get on average at night? 
 
(This may be different than the number of hours you spent in bed.) 
 
 
 
AVERAGE HOURS OF SL1_EEP PER NIGHT ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 50 of 60
 
For each of the remaining questions, check the one best response. Please answer all questions. 
 
During the past month, how often have you had trouble sleeping because you………….. 
 
 
SL1_05.  …..Could not get to sleep within 30 minutes? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer 
 
 
SL1_06. …..Woke up in the middle of the night or early morning? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_07. …..Had to get up to use the bathroom? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 51 of 60
SL1_08. …..Could not breathe comfortably? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_09. …..Coughed or snored loudly? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_10.   …..Felt too cold? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_11.   …..Felt too hot? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 52 of 60
SL1_12.   …..Had bad dreams? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_13.   …..Had pain? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_14a. 
   Other reason(s), please describe: ______________________________________ 
 
SL1_14b. How often during the past month have you had trouble sleeping because of  
 
 
 
this? 
  
 
□ Not during the past month 
  
 
□ Less than once a week  
  
 
□ Once or twice a week 
  
 
□ Three or more times a week  
  
 
□ I do not know 
  
 
□ I prefer not to answer  
 
 
SL1_15.  During the past month, how would you rate your sleep quality overall? 
 
 
 
□ Very good 
 
 
□ Fairly good  
 
 
□ Fairly bad 
 
 
□ Very bad 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 53 of 60
SL1_16. During the past month, how often have you taken medicine to help you sleep 
(prescribed  or "over the counter")? 
 
 
 
□ Not during the past month 
 
 
□ Less than once a week  
 
 
□ Once or twice a week 
 
 
□ Three or more times a week  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
SL1_17.  During the past month, how often have you had trouble staying awake while driving, 
 
     eating meals, or engaging in social activity? 
 
 
 
□ Not during the past month 
 
 
□ Less than once a week  
 
 
□ Once or twice a week 
 
 
□ Three or more times a week  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_18.  During the past month, how much of a problem has it been for you to keep up enough 
 
 enthusiasm to get things done? 
 
 
 
□ No problem at all 
 
 
□ Somewhat of a problem 
 
 
□ A very big problem 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_19.  Do you have a bed partner or a room-mate in the same room ? 
 
 
 
□ No bed partner or roommate in the same room à skip to next survey section:  
 
 
□ Partner in same bed  
 
 
 
 
 
 
 
 
 
□ Room-mate in the same room  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 54 of 60
If you have a roommate or bed partner, ask him/her how often in the past month you 
have had . . . . . . . . . . . . . . . 
  
 SL1_20.    …..Loud snoring 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 SL1_21.     ……Long pauses between breaths while asleep 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
  
 SL1_22.   …..Legs twitching or jerking while you sleep 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 
 
 
 
 
 
  

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 55 of 60
SL1_23.    …..Episodes of disorientation or confusion during sleep 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 
 
SL1_24a.   ……Other restlessness while you sleep; please describe: 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
____________________________________________________ 
  
 
 SL1_24b. 
□ Not during the past month 
  
 
□ Less than once a week  
  
 
□ Once or twice a week 
  
 
□ Three or more times a week  
  
 
□ Unable to ask him/her 
  
 
□ he/she does not know 
  
 
□ he/she prefers not to answer  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 56 of 60
Below you will find a list of statements. Please indicate how often each statement applies to you 
generally in daily life.  
 
 
0- Never 
1 
2 
3 
4 
5 - Always 
IA1_01. When I am tense I notice where the tension 
is located in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_02. I notice when I am uncomfortable in my 
body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_03. I notice where in my body I am comfortable.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_04. I notice changes in my breathing, such as 
whether it slows down or speeds up.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_05. I do not notice (I ignore) physical tension or 
discomfort  
until they become more severe.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_06. I distract myself from sensations of 
discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_07. When I feel pain or discomfort, I try to 
power through it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_08. When I feel physical pain, I become upset.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_09. I start to worry that something is wrong if I 
feel any discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_10. I can notice an unpleasant body sensation 
without worrying about it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_11. I can pay attention to my breath without 
being distracted by things happening around me.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_12. I can maintain awareness of my inner bodily 
sensations even when there is a lot going on around 
me.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_13. When I am in conversation with someone, I 
can pay attention to my posture.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_14. I can return awareness to my body if I am 
distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_15. I can refocus my attention from thinking to 
sensing my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_16. I can maintain awareness of my whole body 
even when a part of me is in pain or discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_17. I am able to consciously focus on my body 
as a whole.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_18. I notice how my body changes when I am 
angry.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_19. When something is wrong in my life I can 
feel it in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_20. I notice that my body feels different after a 
peaceful experience.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_21. I notice that my breathing becomes free 
and easy when I feel comfortable.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_22. I notice how my body changes when I feel 
happy / joyful.  
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 57 of 60
 
 
0- Never 
1 
2 
3 
4 
5 - Always 
IA1_23. When I feel overwhelmed I can find a calm 
place inside.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_24. When I bring awareness to my body I feel a 
sense of calm.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_25. I can use my breath to reduce tension.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_26. When I am caught up in thoughts, I can 
calm my mind by focusing on my body/breathing.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_27. I listen for information from my body about 
my emotional state.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_28. When I am upset, I take time to explore how 
my body feels.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_29. I listen to my body to inform me about what 
to do.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_30. I am at home in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_31. I feel my body is a safe place.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_32. I trust my body sensations.  
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 58 of 60
We are interested in your recent experiences. Below is a list of things that people sometimes 
experience. Next to each item are five choices: “never”, “rarely”, “sometimes”, “often”, and 
“all the time”. Please darken one of these to indicate how much you currently have experiences 
similar to those described. 
 
Please do not spend too long on each item–it is your first response that we are interested in. 
Please be sure to answer every item. 
 
 
Never 
Rarely 
Sometimes 
Often 
All the time 
RD1_01. I think about what will happen in 
the future. 
□ 
□ 
□ 
□ 
□ 
RD1_02. I remind myself that thoughts 
aren’t facts. 
□ 
□ 
□ 
□ 
□ 
RD1_03. I am better able to accept myself 
as I am. 
□ 
□ 
□ 
□ 
□ 
RD1_04. I notice all sorts of little things 
and details in the world around me. 
□ 
□ 
□ 
□ 
□ 
RD1_05. I am kinder to myself when things 
go wrong. 
□ 
□ 
□ 
□ 
□ 
RD1_06. I can slow my thinking at times of 
stress. 
□ 
□ 
□ 
□ 
□ 
RD1_07. I wonder what kind of person I 
really am. 
□ 
□ 
□ 
□ 
□ 
RD1_08. I am not so easily carried away 
by my thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_09. I notice that I don’t take 
difficulties so personally. 
□ 
□ 
□ 
□ 
□ 
RD1_10. I can separate myself from my 
thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_11. I analyze why things turn out the 
way they do. 
□ 
□ 
□ 
□ 
□ 
RD1_12. I can take time to respond to 
difficulties. 
□ 
□ 
□ 
□ 
□ 
RD1_13. I think over and over again about 
what others have said to me. 
□ 
□ 
□ 
□ 
□ 
RD1_14. I can treat myself kindly. 
□ 
□ 
□ 
□ 
□ 
RD1_15. I can observe unpleasant feelings 
without being drawn into them. 
□ 
□ 
□ 
□ 
□ 
RD1_16. I have the sense that I am fully 
aware of what is going on around me and 
inside me. 
□ 
□ 
□ 
□ 
□ 
RD1_17. I can actually see that I am not 
my thoughts. 
□ 
□ 
□ 
□ 
□ 
RD1_18. I am consciously aware of a 
sense of my body as a whole. 
□ 
□ 
□ 
□ 
□ 
RD1_19. I think about the ways in which I 
am different from other people. 
□ 
□ 
□ 
□ 
□ 
RD1_20. I view things from a wider 
perspective. 
□ 
□ 
□ 
□ 
□ 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 59 of 60
How do you cope with events? 
 
 
 
 
 
 
 
 
Everyone gets confronted with negative or unpleasant events now and then and everyone 
responds to them in his or her own way. By the following questions you are asked to indicate 
what you generally think, when you experience negative or unpleasant events. 
 
 
 
(Almost) 
Never 
Some-
times 
Regularly 
Often 
(Almost) 
Always 
CR1_01. I think that I have to 
accept that this has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_02. I often think about how I 
feel about what I have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_03. I think I can learn 
something from the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_04. I feel that I am the one 
who is responsible for what has 
happened. 
□ 
□ 
□ 
□ 
□ 
CR1_05. I think that I have to 
accept the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_06. I am preoccupied with 
what I think and feel about what I 
have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_07. I think of pleasant things 
that have nothing to do with it. 
□ 
□ 
□ 
□ 
□ 
CR1_08. I think that I can become 
a stronger person as a result of 
what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_09. I keep thinking about how 
terrible it is what I have 
experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_10. I feel that others are 
responsible for what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_11. I think of something nice 
instead of what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_12. I think about how to 
change the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_13. I think that it hasn’t been 
too bad compared to other things. 
□ 
□ 
□ 
□ 
□ 
CR1_14. I think that basically the 
cause must lie within myself. 
□ 
□ 
□ 
□ 
□ 
CR1_15. I think about a plan of 
what I can do best. 
□ 
□ 
□ 
□ 
□ 
CR1_16. I tell myself that there are 
worse things in life. 
□ 
□ 
□ 
□ 
□ 
CR1_17. I continually think how 
horrible the situation has been. 
□ 
□ 
□ 
□ 
□ 
CR1_18. I feel that basically the 
cause lies with others. 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Questionnaire/Assessments, Version 1.3, February 5, 2015 
Page 60 of 60
Thank you for completing this survey!  
 
Please note that these responses will not be seen immediately. Resources are shown below if you 
feel that you would like to talk with someone immediately for assistance.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
National Sexual Assault Hotline: 1-800-656-4673 
 
Other options are to: 
• Call your doctor’s office 
• Call 911 for emergency services 
• Go to the nearest hospital emergency room.  
 
 
 
 
 
  

      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 4 
 
INFORMED CONSENT FORM 
 
 

Agreement to Participate in a Research Study 
 
Investigation of the Effects of Mindfulness on Blood Pressure and Well-Being 
 
You are being asked to take part in a Brown University research study about the effects of 
mindfulness and hypertension education on blood pressure and risk factors for hypertension. 
This form will explain the purpose of the study, how the study will be carried out and what you 
will be expected to do.  It will also explain the possible risks and possible benefits of being in the 
study.  If any part of the following description is not clear to you, you are encouraged to contact 
the researcher to answer any questions before you decide whether to take part in the study. If you 
decide to participate, please fill out and sign the last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health 
education on blood pressure. You have been selected for this study because you expressed 
interest and met entrance criteria for having prehypertension or hypertension, or another 
cardiovascular risk factor that could be influenced by this program. In order to assess the effects 
of these practices, you will be asked to complete some questionnaires, and a laboratory 
assessment before and after learning the mindfulness practices. 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
1) Participate in an interview in which you will be asked questions about past and present 
mental health, including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, 
smoking, medication use, personality, emotions, attention and past experiences, including 
stressful or traumatic experiences. These questions will probe sensitive psychological areas, 
including physical, emotion and sexual abuse. These questionnaires may take up to 2 hours to 
complete. By completing the interviews and questionnaires, you are giving the researchers 
permission to use the information you have provided. You have the right not to answer any 
of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference and hip circumference.  
 
4) You will be asked to perform some cognitive tasks. One of these tasks may involve 
computer-based tests of attention or decision-making. Together these tests may take as long 
as 45 minutes. 
 
5) You will participate in the mindfulness program, which consists of 9 weekly sessions of 2.5 
hours each and will include one 8 hour weekend retreat. Daily homework assignments may 
take as long as one hour and consist of practicing mindfulness exercises with the aid of a 
guided audio CD and completing worksheets related to stress, thoughts, and common 
reactions to various types of events. 
Eric Loucks! 6/17/2015 11:58 AM
Formatted: Underline, Highlight
Eric Loucks! 6/2/2015 5:51 PM
Comment [1]: This random assignment text 
was deleted, as we are not currently using a 
control group. The control group will be added 
in future research after the initial pilot testing 
phase. 
Eric Loucks! 6/17/2015 11:58 AM
Formatted: Underline
Eric Loucks! 6/2/2015 5:48 PM
Deleted: 
... [1]
Eric Loucks! 6/17/2015 11:08 AM
Deleted: the 9-week meditation

 
6) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. 
The recordings will be transcribed so that we may analyze the text. The recordings will be 
identified by study number, will only be heard by study staff and will be destroyed after 
transcription.  
 
7) You will be asked to complete a few short questionnaires each week during the 9 week 
condition. 
 
8) After 9 weeks, you will be asked to complete questionnaires and return to the laboratory to 
repeat the same procedures for a second day of testing. 
 
9) Three months after the end of the 9 week condition, you will be asked to return to the 
laboratory to repeat the same testing procedures. 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as 
questionnaires, height, weight and waist 
circumference.  
2 hours 
Mindfulness course 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 8 
hours 
Total course time: 30.5 hours 
Home mindfulness practices assigned during 
course.  
1 hour per day, 6 days per week, for 8 
weeks.  
Total time: 48 hours. 
Health assessments, such as questionnaires, 
blood pressure, height, weight and waist 
circumference, that take place immediately 
after course completion. 
2 hours 
Health assessments, such as questionnaires, 
blood pressure, height, weight and waist 
circumference, that take place that take place 
3 months after course completion. 
2 hours 
TOTAL TIME COMMITMENT FOR 
STUDY 
85.5 hours 
 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred 
since the first assessment. Specifically, you will receive an individualized handout listing % 
change (increase or decrease) on scales of attention, stress, mood, health behaviors, weight, and 
blood pressure across the study. 
Eric LoucksĀ 6/17/2015 11:56 AM
Formatted: Underline, Highlight
Eric LoucksĀ 6/17/2015 11:57 AM
Formatted: Highlight

 
2.  Discomforts and Risks 
The questionnaires are routine, standardized forms for epidemiologic research.  Certain questions 
may be upsetting as they may probe sensitive psychological areas and inquire about upsetting or 
traumatic events, including physical, sexual or emotional abuse and/or current psychiatric 
symptoms.  Since your participation is voluntary, you have the right to skip any questions that 
make you uncomfortable.  
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, 
feelings or body sensations. Some individuals may experience an initial increase in undesirable 
feelings with increased attention to them. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this 
study.  However, participation in the study creates the potential benefit of a) identifying effective 
treatments for elevated blood pressure, b) gaining knowledge of the effects of mindfulness 
practices, c) receiving information about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical 
activity, and reducing excessive alcohol consumption may also be beneficial for reducing blood 
pressure. Education about these therapies are integrated into this course, but other forms of these 
alternative therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to 
a study ID# instead of your name.  All questionnaires in this study will be filled out through an 
online survey or a paper version of the survey if you prefer.  All of these questionnaires will be 
linked solely to your study ID#, so that your identity is protected and your answers are 
confidential.  Although these measures have been taken to protect your personal information, 
complete confidentiality cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to 
confidentiality. If your questionnaire responses indicate that you pose a serious danger to 
yourself or to another person, then a collaborator (Dr. Ellen Flynn) who is a licensed psychiatrist, 
may contact you to discuss your responses and possible referral to a treatment provider. 
Questionnaire items that may warrant follow-up include endorsements of statements about 
hurting yourself, any high scores in depression, anxiety, or other clinically significant problems. 
You should also know that there are times when the law might require the release of your 
responses without your permission.  For example, State law requires researchers to report abuse 
or neglect of children to the Department of Children, Youth and Families (DCYF).   State law 
also requires researchers to report abuse or neglect of people age 60 and older to the Division of 
Elderly Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in 
any published reports about this study. Results will be reported in a summarized manner in such 
a way that you cannot be identified. All personally identifiable information will be "de-
identified" and only a unique code number will be used. Study records will be identified with a 
Eric LoucksĀ 6/2/2015 5:47 PM
Deleted: website (SurveyMonkey) 

unique code number and initials. All study records and specimens will be stored in a secure 
storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, 
including not answering certain questions. If you decide now to participate, you can change your 
mind later and quit the study.  The decision to not participate or to withdraw from the study will 
not adversely affect current or future interactions with Brown University. The decision to not 
participate or to withdraw from the study will also not adversely affect your relationship with 
your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for 
alternative treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. 
Eric B. Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like 
more information about the rules for research studies, or the rights of people who take part in 
those studies, you may contact the Brown University Research Protections Office, telephone 
number 1-866-309-2095 or 401-863-3050. 
 

CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY 
QUESTIONS HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO 
PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
_______________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):______________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):__________________________________________________________________ 
 
Telephone:__________________________(cell)     __________________________(other) 
 
 
 
 
 
 

Page 1: [1] Deleted 
Eric Loucks 
6/2/15 5:48 PM 
 
 
You may be randomly assigned (like the flip of a coin) to enter one of two different 
8-week meditation programs. 
 
 

      
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 5 
 
PROTOCOL FOR PHYSICIANS TO REFER PATIENTS 
TO MINDFULNESS-BASED HYPERTENSION 
THERAPY STUDY 
 

Protocol for Physicians to Refer Patients to  
Mindfulness-Based Hypertension Therapy Study 
 
 
Protocol 
 
Option 1:  
1. Physicians will inform their patients about the study, and then ask if they would 
be interested in being contacted by the research study staff to explore if they 
would like to be in the study.  
2. If the patient is interested, the physician will ask if the patient would be willing to 
have their contact information shared with the researchers, including name, 
phone number and email address.  
3. If the patient agrees, the physician will forward this information to Dr. Loucks.  
 
Option 2: 
A second option is for physicians to provide an advertisement card (supplied by the 
research study staff) to their patients and invite them to contact the research study 
staff if they are interested in it. This may result in lower participant recruitment rates, 
but is a very acceptable method if the physician prefers this approach. 
 
 
Ways that physicians can inform study participants about the study 
 
1. Providing information on the study, such as the script below.  
 
“I wonder if you may be interested in a research study taking place at Brown 
University, called Mindfulness-Based Hypertension Therapy. The intervention 
includes teachings on mindfulness meditation, mindful movements, education 
about hypertension, and support for reducing hypertension risk factors. The study 
is testing whether this intervention lowers blood pressure. The program consists 
of nine weekly sessions that are 2.5 hours long, and a one-day retreat on a 
weekend that will be 8 hours long. People who have a current regular meditation 
practice (i.e. meditate more than once per week) are not eligible. Research 
participation includes interviews, questionnaires and measurements of blood 
pressure, height, weight, and waist circumference, before and after the 
meditation program.” 
 
2. Providing a handout, such as the advertisement card previously approved by the 
IRB and distributed to physicians interested in the study for their patients.   
  

Brown University
Research Protections Offi ce
Institutional Review Board
Amendment Request
Date of Request: 7 / 15 / 15 Investigator's Name and Title: Eric Loucks, Assistant profedsor
StudyTitle:Mindfulness-Based Hypertension Therapy pilot Study (#L4I2001171)
originalrypeofReview: ! Exempt 
! Expedited 
EFullBoard
1) Provide a brief lay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form) please see attached.
2) Provide a detailed description ofthe changes being requested (Use additional pages, ifnecessary):
Please see attached.
3.) State the reason (iustification) for the requested amendment. (Use additional pages, if
necessary):
Please see attached.
4.) What is your asscssment of how thc changcs will afI'ect the overall risk/bencfit ratio of thc study
and the willingncss of individuals to participatc?
Please see attached.
5.) Does the requested amendment require new documents or changes to the approved consent
form or other documents?
fl Consent/assent documents (attach revised version with changes highlighted)
E New/revised instruments (attach - if revised, highlight changes)
fl New/revised advertising materials (attach - if revised, highlight changes)
Do you have a conflict of interest on this project according to Brown's poticy? nyns
If YEs' has this conflict been previously disclosed to the IRB? 
lyns
/
PI signature:
ENIo
n¡to
Date: 7/L5/15

      
 
 
 
 
1) Provide a brief lay summary of the overall project. Include enough detail to 
allow the IRB to evaluate the requested change(s) within the context of the 
overall project.  
 
The World Health Organization reported that suboptimal blood pressure (BP) is responsible for more than 
half of cardiovascular disease mortality world-wide. Furthermore, greater than half of those with hypertension 
have uncontrolled BP. A 2009 Institute of Medicine report recommended prioritizing research to “Compare the 
effectiveness of mindfulness-based interventions (e.g. yoga, meditation, deep breathing training) and usual 
care in treating… cardiovascular risk factors.”  Evidence-based mindfulness interventions, including 
Mindfulness-Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant effects, but evidence 
of heterogeneity in effect sizes. The methodologically highest quality studies had the smallest effect sizes 
(range 0-5 mmHg). Mindfulness-Based Stress Reduction (MBSR) has been customized to a number of 
disease processes, such as Mindfulness-Based Cognitive Therapy for patients with recurrent depression, and 
Mindfulness-Based Relapse Prevention for patients with substance use addictions. Effect sizes have been 
increased by customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive patients have 
never been investigated. Until methodologically rigorous studies to evaluate customized interventions for 
hypertension are performed, we will not know if the observed preliminary effects of general mindfulness 
interventions on blood pressure reduction could be much more effective with a tailored approach. 
Consequently, we propose to conduct a stage I behavioral therapy intervention study to evaluate whether 
MBSR customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant 
reductions in BP. Consequently the specific aims are: 
 
Stage 1a: Therapy Development/Manual Writing 
1 
To outline and evaluate key novel elements of mindfulness-based hypertension therapy (MBHT), 
customized from the evidence-based MBSR. We hypothesize that the most important novel element will 
be generation of mindfulness skills specifically applied to hypertension risk factors such as diet, physical 
activity, obesity, alcohol consumption and antihypertensive medication adherence. This aim will be 
achieved using (1) focus groups of participants undergoing the MBHT behavioral intervention, (2) 
discussion with experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness 
intervention instructors) prior to, and following pilot testing of MBHT in participants, and (3) clinical 
judgment of the investigators performing the intervention.  
2 
To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, retention rates, 
recruitment rates, and adverse effects) and secondary outcomes (hypertension risk factors such as diet, 
physical activity, obesity, and antihypertensive medication adherence) in hypertension subgroups, 
specifically participants with (1) prehypertension, (2) controlled hypertension, and (3) uncontrolled 
hypertension. Initial decisions about the targeted sample based on hypertension status will be made. 
3 
To develop an MBHT therapist manual and training program, including procedures for training, supervising, 
and evaluating therapists. Furthermore, acceptable therapist characteristics will be developed. The 
manual and training program will include themes such as specification of unique and common elements of 
MBHT vs. other interventions, description of interventions excluded from MBHT, and specification of key 
treatment parameters such as frequency and duration of treatment, session length, topics addressed, 
sequence of sessions, as well as therapist adherence and competency measures. The MBHT training will 
consist of a therapist manual, a formal didactic training seminar, and at least one closely supervised 
training session. 
 
Stage Ib: Pilot Trial 
4 
To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, customized from 
the evidence-based MBSR, has promise to be an effective behavioral therapy for participants with 
hypertension and/or prehypertension. We will perform a randomized controlled pilot trial for MBHT vs. 

      
 
 
 
 
enhanced usual care control. We hypothesize that MBHT will have adequate recruitment rates (≥10% of 
prehypertensive/hypertensive participants invited from physicians’ offices), fairly low drop out rates (<15%), 
and medium effect sizes (e.g. 5-10 mmHg systolic BP) for reduction in blood pressure.  
 
These findings will provide publishable pilot data that will inform future randomized clinical trials that 
evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and active control groups. If 
proven effective, MBHT could be offered as a complementary program in the prehypertensive/hypertensive 
patient population that contributes to over half of the cardiovascular disease mortality world-wide.  
 
 
2) Provide a detailed description of the changes being requested (Use additional 
pages, if necessary): 
 
1. NEFS Recruitment Letter 
a. We plan on increasing the participant pool by recruiting participants from the Harvard/Brown 
University follow-up studies for the National Collaborative Perinatal Project, specifically the 
New England Family Study (NEFS). We will distribute letters to eligible participants of the 
NEFS providing a brief overview of the MBHT study and inquire about their interest in 
participating in the MBHT. Interested participants will then be introduced into the screening 
process and included in the study, if eligible.  
2. In-Person Screening Assessments 
a. Prior IRB applications did not provide clear documentation that there are 2 (not 1) in-person 
screening assessments. There are 2 screening assessment to allow for blood pressure to 
be assessed on two different days, at least one week apart from each other. This allows for 
daily changes in blood pressure (e.g. due to changes in stress levels) to be accounted for. 
Both in-person screening assessments are now included in Appendix 2.  
b. For the medication questions (pp. 3-17), a question was added asking participants what the 
medication is used for. This question was added to help identify participants’ intended use of 
medications. 
3. Phone Screening Questionnaire 
a. Minor wording changes were made to improve clarity to participants, shown in Appendix 3 
using track changes.  
b. We added a question to ask participants time availability for the intervention, shown on pg. 6 
of the Phone Screening Questionnaire. 
c. To the Safety Plan, we added an area to write down participant contact info (contact info is 
already provided by participants earlier in the phone screening questionnaire), so that it can 
be presented to a staff member if the safety plan is triggered (pg. 7 of the Phone Screening 
Questionnaire). This information is important to be provided to the 911 operator.  
4. Consent Form 
a. We added a footer to the consent form, showing the version number, date, and page 
numbering (Appendix 4).  
 
3.) State the reason (justification) for the requested amendment: 
 
Please see justification in Section 2 above. 
 
4.) What is your assessment of how the changes will affect the overall 
risk/benefit ratio of the study and the willingness of individuals to participate? 
 
I do not expect any changes to the risk/benefit ratio or willingness of individuals to participate.  

      
 
 
 
 
 
 
 
5.) Does the requested amendment require new documents or changes to the 
approved consent form or other documents? 
 
Yes. Please see Appendices.  
 
 
 
 
 

      
 
 
 
 
APPENDIX 1 
New England Family Study Recruitment Letter

      
 
 
 
 
 
 
 
[Date] 
 
Dear _____,  
 
     You recently participated in one of our Harvard/Brown University follow-up studies of the National 
Collaborative Perinatal Project. Our group, known as the New England Family Study, is very grateful 
for your participation and this ongoing work has been important in improving our understanding of 
long-term health and development 
     Based on your blood pressure readings from the last study we evaluated your blood pressure in, 
you may qualify for another New England Family Study research project at Brown University. The 
study is designed to evaluate effects of an intervention called Mindfulness-Based Hypertension 
Therapy (MBHT). MBHT combines mindfulness practices such as meditation and mindful movements 
with education about hypertension management and prevention. The aim of MBHT is to create a skill 
set and supportive environment to help to reduce blood pressure, and improve overall well-being. 
Your involvement in this study could help us better understand if MBHT is effective, and how it could 
be improved. The MBHT intervention will take place over 9 weeks, and would involve you attending a 
class once per week that would be 2.5 hours long. You would also be asked to participate in a full day 
mindfulness retreat that would be about 8 hours duration. Also, health assessments would be 
performed before you start the intervention, and again afterwards. The assessments would include 
measures such as blood pressure, height, weight, diet, physical activity, smoking, life experiences, 
stress, and medication use.  
At the end of the study, you will receive individual feedback about the changes in your health that 
occurred since the first assessment.  
If you think you may be interested in participating in this study, please give us a call at 401-369-
0443 or reply to this letter using the enclosed form and stamped envelope. We can then set up a time 
to give you a call to discuss the study more, and do a screening assessment to see if you quality for 
the study. Thank you for participating in the New England Family Study. We are incredibly grateful for 
your continuing contributions. We look forward to speaking with you.  
 
Sincerely yours,  
 
Eric B. Loucks, Ph.D. 
Assistant Professor 
Department of Epidemiology 
Brown University School of Public Health 
 
 
 
 

      
 
 
 
 
RESPONSE FORM 
We would appreciate knowing when a member of our staff could reach you.  It would be helpful if you 
could complete this form and return it in the enclosed self-addressed, stamped envelope.   
1. 
If you no longer go by the name                             , please make any corrections on the 
line below: 
 
____________________________________________ 
 
2. 
What is the best time of day for someone to contact you? 
______ mornings 
_____   afternoons 
______ evenings 
3. 
What is the best phone number for us to reach you during the: 
 
 
daytime__________________________________ 
 
 
evening__________________________________ 
 
4. 
Do you prefer to be contacted in person or by the telephone? 
____ In person 
____ Over the phone 
____ Either 
 
5.   Are there certain days of the week that are more convenient for you? 
 
 
_______________________________________________ 
 
6. Please mark your level of interest below (optional): 
_____ I might be interested; please contact me 
_____ I might be interested, please send me more information before contacting me 
_____ Do not contact me again at this time; you may contact me in the future to see if  
     I am interested then 
_____ Do not contact me at this time or in the future; I do not want any further  
          contact with this project  
 
You may also reach us at 401-369-0443 to further discuss the study, or your intent to participate. We 
look forward to speaking with you.  Please feel free to call us with any questions.  Thank you very 
much for your assistance. 
 
 

      
 
 
 
 
About the NCPP……………….. 
The National Collaborative Perinatal Project was conducted from 1959 through 1965 at more 
than ten sites in the United States.  Follow-up continued through the early 1970s.  More than 60,000 
women and their children participated in this study nationwide, while in the Boston area more than 
12,000 families participated.  In the Boston area the study was known as the Maternal and Infant 
Health Study.  
The National Collaborative Perinatal Project began when it became clear that events that 
occur before birth and for the first years of a person's life can have an impact on their later life.  
Information was taken on the health of the women participating in the study, their family's health, and 
their living conditions (such as whether or not the household had pets, and who else lived with the 
mother and child).  Once the children were born, they came for regular check-ups to follow their 
development.  The children were followed until they were seven years old.   
The National Collaborative Perinatal Project was a great success.  Data were collected that 
helped prove that pre-birth conditions had an influence on the life and development of children.  It 
helped to establish that conditions like low-birth weight and premature birth may increase a child's 
chances of having health problems, although this is not always the case.  It also helped to establish 
that children who were in play groups or pre-school at an early age often performed very well in 
school.  Support and funding for pre-school programs were increased in part because of the 
information provided by this study.  As a result of this study, programs were funded that helped all 
women get medical care while they were pregnant and medical care for their infants.   
There have been many follow-up studies that have used the data collected by the National 
Collaborative Perinatal Project.  One of these studies looked at whether women whose mothers had a 
difficult time during labor were more likely to have a difficult time when they themselves gave birth.  
With information from this study, doctors are now better able to help women who may have difficult 
pregnancies to take precautions and get extra medical assistance.  
Thanks to the women who participated in the National Collaborative Perinatal Project in the 
1960s and early 1970s, we now know that what happens to children before they are born and during 
their first years of life has a great effect on their development.  As a result of this study, hospitals have 
developed better ways to care for all women before they have their babies.  In addition, children 
around the country have greater access to medical care.  
In the last few years, many children who were a part of the National Collaborative Perinatal Project 
participated in an important follow-up study.  This study will also help to understand how early life 
events can affect not only early development, but also development into adulthood.   The adults who 
participated in the follow-up study were asked questions about their education, family and emotional 
health to determine how people’s lives have changed since childhood.  In addition, they were asked 
to complete numerous tasks in order to understand things such as memory and attention and how 
these factors relate to development.    This current phase of the study is still continuing and the 
results are proving to be useful, in large part because of the tremendous amount of time so many 
study children have contributed to the project.      
 

      
 
 
 
 
APPENDIX 2A 
First In-Person Screening Assessment Form

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 1 of 16 
 
PID. Participant ID # __________ 
BA2_01. Staff ID # __________ 
BA2_02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA2_03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA2_03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA2_03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA2_03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA2_03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA2_03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA2_03g. Blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA2_03h. Blood pressure 4th reading, diastolic blood pressure:  __________ mmHg 
BA2_03i. Blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA2_03j. Blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA2_04. Were the 4th and 5th systolic blood pressure readings within 20 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements  
 
BA2_05. Were the 4th and 5th diastolic blood pressure readings within 10 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements) 
 
BA2_06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA2_06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA2_06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA2_06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  __________ 
mmHg 
BA2_06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA2_06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA2_06g. Repeated blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA2_06h. Repeated blood pressure 4th reading, diastolic blood pressure:  __________ 
mmHg 
BA2_06i. Repeated blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA2_06j. Repeated blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA2_07. Blood pressure cuff size used:  □ S     □ Reg    □  L        □ XL 
 
BA2_08. Arm that cuff was placed on: 
 □ L      □  R 
 
 
Commented [EL1]: Note that height, weight, and waist 
circumference assessments previously here have been 
moved to the second in-person baseline assessment in 
order to reduce participant burden for those who do not 
meet blood pressure eligibility criteria at the first in-person 
assessment. As height and weight are not part of the 
eligibility criteria, we felt it was best to assess it after we 
determine if participants are eligible to be in study (i.e. have 
mean systolic/diastolic blood pressure ≥120/80 after first 
and second baseline assessments).  

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 2 of 16 
 
Medications (ME) 
 
 
ME01. Do you take any prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME02a. What is the name of the first prescription medication or over-the-counter drug that you take? 
 
 Label product name: 
______________________________________________________________________ 
 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
ME02b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME02c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME02d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 3 of 16 
 
 
 
ME02e. Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME02f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME02g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME02h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME02i. Interviewer comments: 
_______________________________________________________________________ 
 
 
ME02j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME03a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME03b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
Commented [EL2]: This was added to help identify 
participants’ intended use of medications.  

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 4 of 16 
 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME03c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME03d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.) 
 
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME03e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME3f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME03g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
 
 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 5 of 16 
 
ME03h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME03i. Interviewer comments:  
__________________________________________________________________ 
 
 
ME03j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME04a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 
 Label product name: 
_____________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
ME04b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME04c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME04d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 6 of 16 
 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME04g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME04h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME04i. Interviewer comments: 
 
________________________________________________________________________ 
 
ME04j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
section 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME05a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME05b. What is the dosage form? 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 7 of 16 
 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME05c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME05d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME05e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME05f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME05g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 8 of 16 
 
 
ME05h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME05i. Interviewer comments: 
________________________________________________________________________ 
 
 
ME05j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of end of 
medications questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME06a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
__________________________________________________________________ 
 
 
 Label generic name: 
___________________________________________________________________ 
 Don’t know 
 
 
 Prefer not to answer 
 
ME06b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
ME06c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
ME06d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 9 of 16 
 
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME06e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME06f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME06g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME06h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME06i. Interviewer comments: 
________________________________________________________________________ 
 
 
 
ME06i. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
ME07a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
_____________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________ 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 10 of 16 
 
  Don’t know  
 
 Prefer not to answer 
 
 
ME07b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME07c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME07d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 11 of 16 
 
 
ME07g For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME07h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME07i. Interviewer comments: 
____________________________________________________________________ 
 
ME07j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME08a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 Don’t know  
 
 Prefer not to answer 
 
ME08b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME08c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 12 of 16 
 
 Prefer not to answer 
 
 
ME08d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME08e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME08f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME08g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME08h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME08i. Interviewer comments: 
___________________________________________________________________ 
 
 
ME08j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME09a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
____________________________________________________________ 
 
 
 Label generic name: 
 
____________________________________________________________ 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 13 of 16 
 
  Don’t know  
 Prefer not to answer 
 
ME09b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME09c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 
 
ME09d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME09e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME09f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 14 of 16 
 
 Don’t know 
 Prefer not to answer 
 
 
ME09g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME09h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME09i. Interviewer comments: 
___________________________________________________________________ 
 
ME09j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer 
 
ME10a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
  Label generic name: 
______________________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
 
ME10b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME10c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 15 of 16 
 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
ME10d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME10e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME10f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer

 
MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 16 of 16 
 
ME10g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME10h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME10i. Interviewer comments: _______________________________________________________________ 
 
 
 
Commented [EL3]: Note that questionnaires on anxiety 
and depression previously here have been moved to the 
second in-person baseline assessment in order to reduce 
participant burden for those who do not meet blood 
pressure eligibility criteria at the first in-person assessment. 
As these depression and anxiety questionnaires are not part 
of the eligibility criteria, we felt it was best to assess it after 
we determine if participants are eligible to be in study (i.e. 
have mean systolic/diastolic blood pressure ≥120/80 after 
first and second baseline assessments).  
 

      
 
 
 
 
APPENDIX 2b 
Second In-Person Visit Screening Questionnaire and 
Assessment Forms

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 1 of 7 
 
 
 
 
 
 
 
 
SECOND IN-PERSON VISIT SCREENING 
QUESTIONNAIRE AND ASSESSMENT FORMS 
 
Commented [EL1]: Note that this is the second in-person 
screening. The first in-person screening is just for blood 
pressure, as it is the only inclusion/exclusion criteria for the 
in-person screening. Blood pressure will be assessed on two 
different days at least a week apart from each other, to 
account for daily variations in blood pressure due to 
conditions such as stress. The second in-person screening 
measures blood pressure, in addition to other variables 
previously approved by the IRB including height, weight, 
waist circumference, depression and anxiety.  

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 2 of 7 
 
PID. Participant ID # __________ 
BA01. Staff ID # __________ 
BA02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA03g. Blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA03h. Blood pressure 4th reading, diastolic blood pressure:  __________ mmHg 
BA03i. Blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA03j. Blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA04. Were the 4th and 5th systolic blood pressure readings within 20 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements  
 
BA05. Were the 4th and 5th diastolic blood pressure readings within 10 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements) 
 
BA06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ 
mmHg 
BA06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ 
mmHg 
BA06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ 
mmHg 
BA06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  __________ 
mmHg 
BA06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ 
mmHg 
BA06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ 
mmHg 
BA06g. Repeated blood pressure 4th reading, systolic blood pressure: _________ 
mmHg 
BA06h. Repeated blood pressure 4th reading, diastolic blood pressure:  __________ 
mmHg 
BA06i. Repeated blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA06j. Repeated blood pressure 5th reading, diastolic blood pressure:  __________ 
mmHg 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 3 of 7 
 
BA07. Blood pressure cuff size used: 
 □ S     □ Reg    □  L        □ XL 
 
BA08. Arm that cuff was placed on: 
  □ L      □  R 
 
BA09. Height: 
______ . __ cm (one decimal place) 
 
 
BA10. Weight: 
______ . __ kg (one decimal place) 
 
 
 
 
Waist Circumference:    
BA11a. Measurement 1 ______ . __ cm (one decimal place) 
BA11b. Measurement 2 ______ . __ cm (one decimal place) 
 
BA12. Is the difference between Measurement 1 and Measurement 2 greater than 
1.0cm?  
□ Yes (repeat measurements 3&4)  
□ No 
 
BA13a. Measurement 3 ______ . __ cm    
BA13b. Measurement 4 ______ . __ cm 
 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 4 of 7 
 
Questions for Participants to Answer on Their Own In-Person on Paper: 
For each statement, please place a mark in the column that best describes how you 
have been feeling. 
 
Not at all 
or less 
than 1 day 
last week 
1 or 2 
days 
last 
week 
3 to 4 
days 
last 
week 
5 to 7 
days 
last 
week 
Nearly 
every day 
for two 
weeks 
I do not 
know 
I prefer 
not to 
answer 
DS_1. My appetite was poor. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_2. I could not shake off 
the blues. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_3. I had trouble keeping 
my mind on what I was doing. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_4. I felt depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_5. My sleep was restless. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_6. I felt sad. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_7. I could not get going. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_8. Nothing made me 
happy. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
C_9. I felt like a bad person. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_10. I lost interest in my 
usual activities. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_11. I slept much more 
than usual. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_12. I felt like I was moving 
too slowly. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_13. I felt fidgety. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_14. I wished I were dead. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_15. I wanted to hurt 
myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_16. I was tired all the 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_17. I did not like myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_18. I lost a lot of weight 
without trying to. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_19. I had a lot of trouble 
getting to sleep. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_20. I could not focus on 
the important things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 5 of 7 
 
Below is a list of common symptoms of anxiety. Please carefully read each item in the 
list. Indicate how much you have been bothered by that symptom during the past 
month, including today, by marking the box in the corresponding space in the column 
next to each symptom.  
 
 
 
 
 
 
 
 
 
Not At All 
Mildly – it 
didn’t 
bother me 
much 
Moderately – it 
wasn’t pleasant 
at all times 
Severely – 
it bothered 
me a lot 
I do not 
know 
I prefer 
not to 
answer 
BE_1. Numbness or tingling 
□ 
□ 
□ 
□ 
□ 
□ 
BE_2. Feeling hot 
□ 
□ 
□ 
□ 
□ 
□ 
BE _3. Wobbliness in legs 
□ 
□ 
□ 
□ 
□ 
□ 
BE _4. Unable to relax 
□ 
□ 
□ 
□ 
□ 
□ 
BE _5. Fear of worst happening 
□ 
□ 
□ 
□ 
□ 
□ 
BE _6. Dizzy or lightheaded 
□ 
□ 
□ 
□ 
□ 
□ 
BE _7. Heart pounding/racing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _8. Unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _9. Terrified or afraid 
□ 
□ 
□ 
□ 
□ 
□ 
BE _10. Nervous 
□ 
□ 
□ 
□ 
□ 
□ 
BE _11. Feeling of choking 
□ 
□ 
□ 
□ 
□ 
□ 
BE _12. Hands trembling 
□ 
□ 
□ 
□ 
□ 
□ 
BE _13. Shaky/unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _14. Fear of losing control 
□ 
□ 
□ 
□ 
□ 
□ 
BE _15. Difficulty in breathing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _16. Fear of dying 
□ 
□ 
□ 
□ 
□ 
□ 
BE _17. Scared 
□ 
□ 
□ 
□ 
□ 
□ 
BE _18. Indigestion 
□ 
□ 
□ 
□ 
□ 
□ 
BE _19. Faint/lightheaded  
□ 
□ 
□ 
□ 
□ 
□ 
BE _20. Face flushed 
□ 
□ 
□ 
□ 
□ 
□ 
BE _21. Hot/cold sweats 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 6 of 7 
 
SAFETY PLAN 
After the participant has completed the Beck Anxiety Inventory questionnaire and the Centers 
for Epidemiologic Studies Depressive Symptomatology questionnaire, ask the participant to wait 
for a few minutes while you check that all forms and assessments are completed. While the 
participant is waiting in a different room, check the scores according to the criteria below. If any 
scores trigger the safety plan, move forward with steps below as written.  
Beck Anxiety Inventory (BA)  
 
If participant scores ≥26 on the Beck Anxiety Inventory, while having the participant wait, 
immediately notify the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to 
determine need for a psychiatric consultation. She has provided her cell phone #, and your 
phone # will be entered into her phone recognition software to indicate it is a call from the MBHT 
study. It is likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a 
phone message for her with your contact information and provide her with the Beck Anxiety 
Inventory results on the message. If Dr. Flynn is not immediately reachable, or following 
participant release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks 
(cell phone #401-369-0443).  
Depressive Symptomatology (DS) 
 
The CESD-R will be administered during the in-person assessment visits, and scores will be 
reviewed immediately upon completion of the in-person assessments. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Participants are considered to meet criteria for major depressive episode if they have anhedonia 
or dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM 
symptom groups noted as occurring nearly every day for the past two weeks. If participants 
meet criteria for major depressive episode, while having the participant wait, immediately notify 
the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to determine need 
for a psychiatric consultation.  She has provided her cell phone #, and your phone # will be 
entered into her phone recognition software to indicate it is a call from the MBHT study. It is 
likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a phone message 
for her with your contact information and provide her with the Depressive Symptomatology 
results on the message. If Dr. Flynn is not immediately reachable, or following participant 
release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks (cell phone 
#401-369-0443).  
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.3, July 15, 2015  
 
            Page 7 of 7 
 
If participants respond having any suicidal ideation (DS questions 14 or 15), perform the 
following 2 steps: 
 
1. Immediately call 911 and Dr. Ellen Flynn.  
 
Specifically, while the participant is in the waiting room, call 911 immediately, and tell 
them: 
 
“My name is _____. I am working on a research study at Brown University. I have a study 
participant in the waiting room who has shared that he/she is currently suicidal.” Please 
provide the participants’ name to the 911 operator, as requested.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know that you have called 911 
and Dr. Flynn, and why (i.e. because we are concerned about you). You can speak 
with participant to keep him/her in the waiting room if 911 has sent assistance, but 
the discussion should not be clinical in nature.   
 
Examples of questions that could be asked in order to keep them in the waiting room: 
 
“Tell me what is going on.” 
 
“What’s happening right now?” 
 
Tell me more about why you are interesting in being part of this study.  
 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
 
Call your doctor’s office 
 
Call 911 for emergency services 
 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
 

      
 
 
 
 
APPENDIX 3 
Phone-Delivered Screening Questionnaire

 
MBHT Phone Screening Questionnaire, Version 1.3, July 15, 2015                     Page 1 of 7 
PHONE SCREENING QUESTIONNAIRE PART 1 
 
The script is shown below in bold italics.  
 
PID. Participant ID: ___________ 
 
SQ01. Staff ID: ______________ 
 
SQ02. Today’s Date (MMDDYY): ________________ 
 
SQ03. Current Time (24 hour time, e.g. 14:45): ________ 
 
Please now call the participant.  
 
SQ04. Was the participant reached?   YES   NO 
 
Hello, my name is ____________. I am calling from the Brown University School of Public 
Health because (name of participant) expressed interest in participating in our 
mindfulness blood pressure study. Is he/she available to talk at this time? 
 
I would like to do a 10-15 minute phone interview with you to determine if you are a good 
match for this particular study.  
 
SQ05. Is now a good time to speak? 
 
[If yes, proceed to SQ05 script below] 
 
If no… When would be a good time to talk? 
 
SQ06. Day to call back (DDMMYY) ____________ 
 
SQ07. Time to call back ______ AM/PM 
OK, great. How about I give a quick overview of the study, and can then answer any 
questions you may have to see if it is a good fit for you. We will then go through a 
screening questionnaire to see if you qualify for the study. Does this sound OK? 
A basic overview of the study is that it is looking to see if mindfulness practices improve 
blood pressure, and if education about hypertension risk factors may also improve blood 
pressure. Specifically, we will provide training in meditation, mindful movements, and the 
roles of things like diet, physical activity and medication in reducing blood pressure. You 
will be taught by a very experienced teacher who in an expert in these fields. The course 
takes place over a 9-week period, where you come to a class once each week for 2.5 
hours each time. There is also a one-day retreat on a Saturday that will be 8 hours long. 
Also, we will ask you to participate in health assessments before and after the study. 
Health assessments include measures such as blood pressure, height and weight, and 
questionnaires about your health and experiences. 
 

 
MBHT Phone Screening Questionnaire, Version 1.3, July 15, 2015                     Page 2 of 7 
Can I answer any questions about the study that you may have? [answer any they may 
have.] 
SQ08. Does this study sound like something you would be interested in doing? Yes  No 
[If yes, proceed to next statement below. If no, politely thank the participant for considering 
being in this study, and end the call].  
Great. There are a few things that I would like to make clear before we start the interview. 
First of all, some of the questions that I will ask now to figure out if you are eligible to be 
in this study will be of personal nature, including asking about your mental health and 
life’s experiences.  
 
SQ09. Are you in a private place to talk? 
 
[If yes, proceed to text below. If no, reschedule meeting using variables SQ04 and SQ05 above].  
 
 Because this interview is of a personal nature, it is important that you understand that 
everything you say will be kept strictly confidential.  No one outside of our project will 
ever be able to see your answers, and we will not keep your name in the same place as 
any of your answers. If you are not eligible after the phone screen, we will destroy your 
information.  If you like, though, we can keep your information on file for future studies. 
 
SQ10. Participant’s First Name:  ____________________________________ 
 
SQ11. Participant’s Last Name:______________________________________ 
 
Participant’s Address (in case we need to send any study materials to you): 
SQ12a. Street address: _____________ 
SQ12b. City: ____________________ 
SQ12c: State: ________ 
SQ12d: Zip Code: ________________ 
 
SQ13a. Participant’s Phone number #1 (in case we need to contact you by phone) 
____________________________________ 
 
SQ13b. Participant’s Phone number #2____________________________________ 
 
 
SQ14. Participant’s email address (or mailing address if no email):______________________ 
 
SQ15. Notes from interviewer related to participants’ contact information (if any): 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________ 
 
 
 
 
 
Commented [EL1]: We added this to help participants 
understand why we are asking for their personal 
information.  
Commented [EL2]: We added this to help participants 
understand why we are asking for their personal 
information. 

 
MBHT Phone Screening Questionnaire, Version 1.3, July 15, 2015                     Page 3 of 7 
PHONE SCREENING QUESTIONNAIRE PART 2 
PID. Participant ID #: ______________ 
 
INCLUSION CRITERIA: All answers in 3rd column must be YES. If an answer is NO, 
immediately proceed to question SQ40. 
 
 
 
Comments 
SQ26. 
 
What is your age? [Is age at least 18 
years?] 
 
 
 
 
YES 
NO 
 
 
SQ27. 
Can you read and write in English? 
YES 
NO 
 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40.  
 
 
 
Comments 
I will now start to ask some questions about your mental health. 
 
SQ28. 
Has anyone ever told you that you have bipolar 
disorder or manic depression?  
YES 
NO  
 
SQ29. 
Has anyone ever used the word “Borderline” to 
describe you? 
YES 
NO  
 
SQ30a. 
 
 
 
SQ30b. 
Have you ever had a hallucination or seen things 
that other people can’t see, or hear things other 
people can’t hear?  
 
Have you ever been diagnosed with 
schizophrenia or psychosis? 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
SQ31_1 
SQ31_2 
SQ31_3 
SQ31_4 
SQ31_5 
SQ31_6 
SQ31_7 
SQ31_8 
Have you ever taken any of the following 
medications that I am about to read to you?  
Lithium                               
Seroquel (quetiapine) 
Abilify (aripiprazole)           
Zyprexa (olanzapine) 
Clozaril (clozapine)           
Haldol/Haloperidol 
Geodon (ziprasidone)         
Risperdal (risperidone) 
 
 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
 
SQ32a 
 
SQ32b 
 
 
SQ32c 
 
 
 
 
SQ32d 
 
 
Have you ever had a suicide attempt?  
 
[If yes, ask…] Have you considered killing 
yourself during the past month?  
 
[If yes, ask…] Are you currently suicidal? 
 
[If yes, keep participant on the phone, and follow 
suicide safety plan below] 
 
[If no, ask…] Are you getting any help for that? If 
not, then provide list of resources from Safety 
Plan including Gateway, Anchor and The 
Providence Center] Not urgent, but inform Dr. 
Flynn about what was discussed.  
YES 
NO 
 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
 
YES 
NO 
 
 
 

 
MBHT Phone Screening Questionnaire, Version 1.3, July 15, 2015                     Page 4 of 7 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40. 
SQ33a 
 
SQ33b 
 
SQ33c 
Would you say you have a trauma history?  
[If yes…]  
In the past month, have you had any 
problems with dissociation (memory loss)?  
In the past month, have you had any 
flashbacks (i.e. sudden and disturbing vivid 
memory) about the trauma?  
YES 
NO 
 
YES 
NO 
 
YES 
NO 
 
 
 
SQ34a 
 
 
 
 
SQ34b 
In the past month, have you had any 
problems with obsessions or compulsions, 
such as washing your hands or checking the 
oven over and over again?  
[If yes…] Has anyone diagnosed you with 
obsessive compulsive disorder? 
YES      NO 
 
 
 
 
YES 
NO 
 
SQ35 
In the past month, have you had a panic 
attack (i.e. sweating, heart palpitations, 
nausea, trouble breathing, fear of 
dying/choking/going crazy)?  
YES 
NO 
 
SQ36 
Have you had any problems with alcoholism 
or drug use in the past year? 
YES 
NO 
 
SQ37 
In the past year, have you had an eating 
disorder, such as starving, binge eating, or 
vomiting?  
YES 
NO 
 
SQ38a 
 
 
 
SQ38b 
 
 
 
 
 
 
SQ38c 
Do you currently have a mindfulness practice, 
such as meditation or yoga? 
 
Please tell me more about your mindfulness 
practice, including how often you practice per 
week.  
 
 
 
 
Do you currently practice meditation more 
than once per week? (yoga does not count as 
meditation in this context) 
YES 
NO 
 
 
Fill in 
response 
in 
comments 
section to 
the right  
 
YES 
NO 
 
 
SQ39 
This class will take place at Brown University 
in-person. Do you have any medical or 
mobility issues that would affect you being 
able to attend class? 
YES 
NO 
 
SQ40 
Participant qualifies for next step of study (next 
step is 1st blood pressure screening) 
YES 
NO 
 
If YES go 
to SQ41.  
 
If NO, go to 
SQ42.  
 
 

 
MBHT Phone Screening Questionnaire, Version 1.3, July 15, 2015                     Page 5 of 7 
SQ41a. Thank you for taking the time to answer these questions. You qualify for the next 
stage of screening, which is to take your blood pressure at two different times at least a 
week apart from each other. Let’s book the in-person screening sessions [Book both 
sessions. We can cancel the second session if they do not qualify]. 
 
SQ41b. We will be scheduling the mindfulness intervention at a time that works best with 
most of the participants. What days and times of the week typically work best with your 
schedule? Please keep in mind that the sessions are 2.5 hours long, and take place once 
per week for 9 weeks.  
 
Thank you for your time and interest in this study. We look forward to meeting you in 
person. Do you have any questions before we end this call?  
 
 
SQ42a. Thank you for taking the time to answer these questions. According to the 
survey, you do not qualify for the study at this time. There may be other studies you 
quality for.  
 
SQ42b. Would you like me to keep your information to pass on to these studies?  YES /  
NO 
 
SQ42c. [If yes…] OK, thank you. We will keep this information for future studies you may 
qualify for. Thank you for taking the time to talk with me today. Can I answer any 
questions before hanging up? 
 
SQ42d. [If no…] OK, our copy of this information will be destroyed. Thank you for taking 
the time to talk with me today. Can I answer any questions before hanging up? 
 
 
 
 
 
 
 
Commented [EL3]: This was added to help schedule 
the intervention at a time best for most participants. 

 
MBHT Phone Screening Questionnaire, Version 1.3, July 15, 2015                     Page 6 of 7 
SAFETY PLAN 
 
Enter details below on paper during screening (These variables should are also be entered in 
the survey via questions SQ10-SQ13). Destroy this paper after screening is complete.  
 
Participant’s First Name:  ____________________________________ 
 
Participant’s Last Name:______________________________________ 
 
Participant’s Address: 
 
Street address: _____________ 
 
City: ____________________ 
 
State: ________ 
 
Zip Code: ________________ 
 
Participant’s Phone number #1: ____________________________________ 
 
Participant’s Phone number #2____________________________________ 
 
During the phone-based screening, if participants respond yes to “Are you currently suicidal?”, 
the interviewer should perform the following 2 steps: 
 
1. Immediately have 911 and Dr. Ellen Flynn called by a colleague who has been 
informed beforehand that this is a possibility.  
 
Specifically, while keeping the participant on the phone, show the text below in the box 
to a colleague.  
 
I have a study participant on the phone who is currently suicidal. Please call 911 
immediately, and tell them: 
 
“I am calling on behalf of [my name] who is performing a research study at Brown 
University. He has a participant on the phone who says they are currently suicidal.” 
Please provide the participants’ contact information to the 911 operator (i.e. name, 
address, phone #, email address) as requested. This information is shown above.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know what you are doing. 
Specifically, let them know we are calling our study’s psychiatrist Dr. Flynn and 911, 
and why you are doing that (i.e. because we are concerned about you). You can speak 
with participant to keep him/her on the phone, but the discussion should not be 
clinical in nature.   
 
Commented [EL4]: This is data entered by staff on 
paper as participants provide this information above. If 
participants state they are currently suicidal, we can 
then bring this paper to another staff member to call 
911, and it will have the participants’ contact info 
immediately available for the 911 operator.  
Commented [EL5]: This box was added to increase 
clarity to person who would make 911 call.  

 
MBHT Phone Screening Questionnaire, Version 1.3, July 15, 2015                     Page 7 of 7 
Examples of questions that could be asked in order to keep them on the phone: 
 
“Tell me what is going on.” 
 
“What’s happening right now?” 
 
Tell me more about why you are interesting in being part of this study.  
 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants if they state they have had 
considered killing themselves in the past month. If they are currently suicidal, the main priority is 
to keep them on the phone while 911 and Dr. Flynn are being contacted.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
 
Call your doctor’s office 
 
Call 911 for emergency services 
 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 

      
 
 
 
 
 
APPENDIX 4 
Informed Consent Form 
 

 
MBHT Consent Form, Version 1.2, July 15, 2015  
  Page 1 of 5 
 
Agreement to Participate in a Research Study 
 
Investigation of the Effects of Mindfulness on Blood Pressure and Well-Being 
 
You are being asked to take part in a Brown University research study about the effects of 
mindfulness and hypertension education on blood pressure and risk factors for hypertension. 
This form will explain the purpose of the study, how the study will be carried out and what you 
will be expected to do.  It will also explain the possible risks and possible benefits of being in the 
study.  If any part of the following description is not clear to you, you are encouraged to contact 
the researcher to answer any questions before you decide whether to take part in the study. If you 
decide to participate, please fill out and sign the last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health 
education on blood pressure. You have been selected for this study because you expressed 
interest and met entrance criteria for having prehypertension or hypertension, or another 
cardiovascular risk factor that could be influenced by this program. In order to assess the effects 
of these practices, you will be asked to complete some questionnaires, and a laboratory 
assessment before and after learning the mindfulness practices. 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
1) Participate in an interview in which you will be asked questions about past and present 
mental health, including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, 
smoking, medication use, personality, emotions, attention and past experiences, including 
stressful or traumatic experiences. These questions will probe sensitive psychological areas, 
including physical, emotion and sexual abuse. These questionnaires may take up to 2 hours to 
complete. By completing the interviews and questionnaires, you are giving the researchers 
permission to use the information you have provided. You have the right not to answer any 
of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference and hip circumference.  
 
4) You will be asked to perform some cognitive tasks. One of these tasks may involve 
computer-based tests of attention or decision-making. Together these tests may take as long 
as 45 minutes. 
 
5) You will participate in the mindfulness program, which consists of 9 weekly sessions of 2.5 
hours each and will include one 8 hour weekend retreat. Daily homework assignments may 
take as long as one hour and consist of practicing mindfulness exercises with the aid of a 
guided audio CD and completing worksheets related to stress, thoughts, and common 
reactions to various types of events. 

 
MBHT Consent Form, Version 1.2, July 15, 2015  
  Page 2 of 5 
 
 
6) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. 
The recordings will be transcribed so that we may analyze the text. The recordings will be 
identified by study number, will only be heard by study staff and will be destroyed after 
transcription.  
 
7) You will be asked to complete a few short questionnaires each week during the 9 week 
condition. 
 
8) After 9 weeks, you will be asked to complete questionnaires and return to the laboratory to 
repeat the same procedures for a second day of testing. 
 
9) Three months after the end of the 9 week condition, you will be asked to return to the 
laboratory to repeat the same testing procedures. 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as 
questionnaires, height, weight and waist 
circumference.  
2 hours 
Mindfulness course 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 8 
hours 
Total course time: 30.5 hours 
Home mindfulness practices assigned during 
course.  
1 hour per day, 6 days per week, for 8 
weeks.  
Total time: 48 hours. 
Health assessments, such as questionnaires, 
blood pressure, height, weight and waist 
circumference, that take place immediately 
after course completion. 
2 hours 
Health assessments, such as questionnaires, 
blood pressure, height, weight and waist 
circumference, that take place that take place 
3 months after course completion. 
2 hours 
TOTAL TIME COMMITMENT FOR 
STUDY 
85.5 hours 
 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred 
since the first assessment. Specifically, you will receive an individualized handout listing % 
change (increase or decrease) on scales of attention, stress, mood, health behaviors, weight, and 
blood pressure across the study. 

 
MBHT Consent Form, Version 1.2, July 15, 2015  
  Page 3 of 5 
 
 
2.  Discomforts and Risks 
The questionnaires are routine, standardized forms for epidemiologic research.  Certain questions 
may be upsetting as they may probe sensitive psychological areas and inquire about upsetting or 
traumatic events, including physical, sexual or emotional abuse and/or current psychiatric 
symptoms.  Since your participation is voluntary, you have the right to skip any questions that 
make you uncomfortable.  
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, 
feelings or body sensations. Some individuals may experience an initial increase in undesirable 
feelings with increased attention to them. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this 
study.  However, participation in the study creates the potential benefit of a) identifying effective 
treatments for elevated blood pressure, b) gaining knowledge of the effects of mindfulness 
practices, c) receiving information about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical 
activity, and reducing excessive alcohol consumption may also be beneficial for reducing blood 
pressure. Education about these therapies are integrated into this course, but other forms of these 
alternative therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to 
a study ID# instead of your name.  All questionnaires in this study will be filled out through an 
online survey or a paper version of the survey if you prefer.  All of these questionnaires will be 
linked solely to your study ID#, so that your identity is protected and your answers are 
confidential.  Although these measures have been taken to protect your personal information, 
complete confidentiality cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to 
confidentiality. If your questionnaire responses indicate that you pose a serious danger to 
yourself or to another person, then a collaborator (Dr. Ellen Flynn) who is a licensed psychiatrist, 
may contact you to discuss your responses and possible referral to a treatment provider. 
Questionnaire items that may warrant follow-up include endorsements of statements about 
hurting yourself, any high scores in depression, anxiety, or other clinically significant problems. 
You should also know that there are times when the law might require the release of your 
responses without your permission.  For example, State law requires researchers to report abuse 
or neglect of children to the Department of Children, Youth and Families (DCYF).   State law 
also requires researchers to report abuse or neglect of people age 60 and older to the Division of 
Elderly Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in 
any published reports about this study. Results will be reported in a summarized manner in such 
a way that you cannot be identified. All personally identifiable information will be "de-
identified" and only a unique code number will be used. Study records will be identified with a 

 
MBHT Consent Form, Version 1.2, July 15, 2015  
  Page 4 of 5 
 
unique code number and initials. All study records and specimens will be stored in a secure 
storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, 
including not answering certain questions. If you decide now to participate, you can change your 
mind later and quit the study.  The decision to not participate or to withdraw from the study will 
not adversely affect current or future interactions with Brown University. The decision to not 
participate or to withdraw from the study will also not adversely affect your relationship with 
your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for 
alternative treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. 
Eric B. Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like 
more information about the rules for research studies, or the rights of people who take part in 
those studies, you may contact the Brown University Research Protections Office, telephone 
number 1-866-309-2095 or 401-863-3050. 
 

 
MBHT Consent Form, Version 1.2, July 15, 2015  
  Page 5 of 5 
 
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY 
QUESTIONS HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO 
PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
_______________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):______________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):__________________________________________________________________ 
 
Telephone:__________________________(cell)     __________________________(other) 
 
 
 
 
 
 

Brown University
Research protections Office
Institutional Review Board
Amendment Request
Date of Request: 9 / r / 15 Investigator's Name and ritre: Eric Loucks ,
study Titte: Mindfulness-Based Hypertension Therapy pilot
Original Type of Review: n Exempt 
! 
Expedited
1) Provide a brief lay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form) please see attached.
2) Provide a detailed description of the changes being requested (use additional pages, ifnecessary):
P1ease see attached.
3') State the reason (iustification) for the requested amendment. (Use additional pages, if
necessary):
Please see attached.
4') What is your assessment of how the changes will afI'ect the ovcrall risk/bcnefit ratio of the study
and the willingness of individuals to participate?
P1ease see attached.
5') Does the requested amendment require new documents or changes to the approved consent
form or other documents?
E Consent/assent documents (attach revised version with changes hightighted)
[l New/revised instruments (attach - if revised, highlight changes)
n New/revised advertising materials (attach - if revised, highright changes)
Do you have a conflict of interest on this project according to Brown's policy? nyns
If YES, has this conflict been previously disclosed to the IRB? 
nyns
Assistant professor
Study (#L4L2001171)
El Full Board
PI signature:
ENo
nno
Date: 9/I/L5

      
 
 
 
 
1) Provide a brief lay summary of the overall project. Include enough detail to 
allow the IRB to evaluate the requested change(s) within the context of the 
overall project.  
 
The World Health Organization reported that suboptimal blood pressure (BP) is responsible for more than 
half of cardiovascular disease mortality world-wide. Furthermore, greater than half of those with hypertension 
have uncontrolled BP. A 2009 Institute of Medicine report recommended prioritizing research to “Compare the 
effectiveness of mindfulness-based interventions (e.g. yoga, meditation, deep breathing training) and usual 
care in treating… cardiovascular risk factors.”  Evidence-based mindfulness interventions, including 
Mindfulness-Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant effects, but evidence 
of heterogeneity in effect sizes. The methodologically highest quality studies had the smallest effect sizes 
(range 0-5 mmHg). Mindfulness-Based Stress Reduction (MBSR) has been customized to a number of 
disease processes, such as Mindfulness-Based Cognitive Therapy for patients with recurrent depression, and 
Mindfulness-Based Relapse Prevention for patients with substance use addictions. Effect sizes have been 
increased by customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive patients have 
never been investigated. Until methodologically rigorous studies to evaluate customized interventions for 
hypertension are performed, we will not know if the observed preliminary effects of general mindfulness 
interventions on blood pressure reduction could be much more effective with a tailored approach. 
Consequently, we propose to conduct a stage I behavioral therapy intervention study to evaluate whether 
MBSR customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant 
reductions in BP. Consequently the specific aims are: 
 
Stage 1a: Therapy Development/Manual Writing 
1 
To outline and evaluate key novel elements of mindfulness-based hypertension therapy (MBHT), 
customized from the evidence-based MBSR. We hypothesize that the most important novel element will 
be generation of mindfulness skills specifically applied to hypertension risk factors such as diet, physical 
activity, obesity, alcohol consumption and antihypertensive medication adherence. This aim will be 
achieved using (1) focus groups of participants undergoing the MBHT behavioral intervention, (2) 
discussion with experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness 
intervention instructors) prior to, and following pilot testing of MBHT in participants, and (3) clinical 
judgment of the investigators performing the intervention.  
2 
To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, retention rates, 
recruitment rates, and adverse effects) and secondary outcomes (hypertension risk factors such as diet, 
physical activity, obesity, and antihypertensive medication adherence) in hypertension subgroups, 
specifically participants with (1) prehypertension, (2) controlled hypertension, and (3) uncontrolled 
hypertension. Initial decisions about the targeted sample based on hypertension status will be made. 
3 
To develop an MBHT therapist manual and training program, including procedures for training, supervising, 
and evaluating therapists. Furthermore, acceptable therapist characteristics will be developed. The 
manual and training program will include themes such as specification of unique and common elements of 
MBHT vs. other interventions, description of interventions excluded from MBHT, and specification of key 
treatment parameters such as frequency and duration of treatment, session length, topics addressed, 
sequence of sessions, as well as therapist adherence and competency measures. The MBHT training will 
consist of a therapist manual, a formal didactic training seminar, and at least one closely supervised 
training session. 
 
Stage Ib: Pilot Trial 
4 
To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, customized from 
the evidence-based MBSR, has promise to be an effective behavioral therapy for participants with 
hypertension and/or prehypertension. We will perform a randomized controlled pilot trial for MBHT vs. 

      
 
 
 
 
enhanced usual care control. We hypothesize that MBHT will have adequate recruitment rates (≥10% of 
prehypertensive/hypertensive participants invited from physicians’ offices), fairly low drop out rates (<15%), 
and medium effect sizes (e.g. 5-10 mmHg systolic BP) for reduction in blood pressure.  
 
These findings will provide publishable pilot data that will inform future randomized clinical trials that 
evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and active control groups. If 
proven effective, MBHT could be offered as a complementary program in the prehypertensive/hypertensive 
patient population that contributes to over half of the cardiovascular disease mortality world-wide.  
 
 
2) Provide a detailed description of the changes being requested (Use additional 
pages, if necessary): 
 
1. Change in funding source 
a. We have an NIH grant application (1 UH2 AT009145-01 entitled “Mindfulness Influences on 
Self-Regulation: Mental and Physical Health Implications”) pending that would provide funding 
to this project.  
2. Change in scope  
a. The NIH grant would provide approximately $5 million over 5 years to support secondary data 
analyses on data for which personally identifiable information is removed, and hence not human 
subjects-related. Furthermore, the grant would provide additional measures to the MBHT study 
above, as well as potentially providing additional measures to three other studies named in the 
grant application as Concurrent Study B1, B2 and C (more details below). Note that Concurrent 
Study A in the grant (currently approved by Brown IRB) is nearing completion, and no additional 
measures will be added. All of these studies are currently funded and underway. IRB approval 
has been obtained for all studies by the host institutions (IRB approval certificates shown in 
Appendix 1). The current grant will add some fairly low participant burden measures to each 
study. Each of the study’s host institutions proposes to perform the following additional 
measures, with associated timeline. IRB approval will be obtained by the host institutions prior 
to any additional measures being assessed. 
i. Concurrent Study B1: Yoga Program and Dietary Health Behaviors  (PI: Sara Lazar, 
Massachusetts General Hospital, Harvard Medical School) 
1. The grant proposes to add neuroimaging to study participants. This imaging is 
scheduled to take place no earlier than January 2016.  
ii. Concurrent Study B2: Mindfulness-Based Stress Reduction and Dietary Health 
Behaviors (PI: Carl Fulwiler, UMass Medical School, Worcester).  
1. Additional measures may not be needed for this study, as the major variables are 
being assessed. If it appears that additional variables are needed, IRB approval 
will be obtained.  
iii. Concurrent Study C: MINDFUL-PC Study (PI: Zev Schuman-Olivier, Cambridge Health 
Alliance, Harvard Medical School). All of the following additional measures proposed in 
the grant will go through IRB approval at the host institution, and should represent a 
fairly low increase in participant burden. 
1. During Phase 1 (years 2016-2017), we will adapt and pilot mechanistic targets 
that we found to be associated with successful behavioral self-regulation during 
MBI trials for addiction (smoking cessation).250,251 We will pilot an fMRI-
compatible stop-signal task measuring inhibitory control,252 self-report measures 
of self-management self-efficacy, as well as self-report106,151 and neuroimaging 
tasks assessing self-compassion253 and trait non-judgment of self.254 We will 
adapt and test these targets in this primary care population in order to assess 

      
 
 
 
 
their applicability to medical regimen adherence, and assess them for relevance 
and feasibility in the context of the MTPC study. 
2. During Phase 2 (2016-2018), we will test the best performing targets from the 
three domain working groups by recruiting patients with poor medical regimen 
adherence and difficulty with daily medication adherence with the most promising 
self-report, behavioral, physiologic, and neuroimaging targets. These targets will 
be identified in Phase 1, and appropriate IRB amendments will be submitted as 
the targets are identified.  
3. Measures to be added to Concurrent Study C beginning in January 2016 are as 
follows: 
a. The Edinburgh Handedness Inventory (EHI)1 is used to document the 
degree of right handedness. A score of >40 is a reliable indicator of right 
handedness. Participants must be right handed for admission into fMRI 
study. This will be completed at screening visit in subjects otherwise 
eligible for fMRI experiment. (3 min) 
b. Urine or Saliva toxicology: We will conduct urine or saliva toxicology 
screens for alcohol and illicit drugs at screening visit and before each MRI 
session. (5 min) 
c. Urine pregnancy screen: We will conduct a urine pregnancy screen at 
screening visit and before each MRI session. (2 min) 
d. Body Mass Index: Weight and height will be measured during screening 
visit and BMI will be calculated. (2 min) 
e. Stop-Signal Task (SST)2 The SST is a two-choice reaction time task in 
which participants are required to respond to one or more go stimuli. At 
irregular intervals and unpredictably for the participants, a stop signal is 
presented.3 Following this stop signal, participants are required to attempt 
to inhibit their response to the go signal. We will use two versions of the 
SST. The first (original SST) is similar to previous versions of the task 
used in neuroimaging studies. A second version (controlled SST) was 
designed to control for the attentional confound inherent in the original 
version. In both versions, subjects are presented with an initial fixation 
cross for 350 ms. This is followed by a go signal lasting 1,400 ms in the 
form of a left- or right-pointing arrow in the direction of the required 
response. Finger presses are made with the index finger of each hand. 
Unpredictably, on 20% of the trials, a red circle (the stop signal) appears 
above the location of the go stimulus. This stop signal indicates the need 
to attempt to inhibit the button press. The delay between the presentation 
of the go and stop signals is termed the stop signal delay (SSD). The 
ability to stop a response is a function of the length of the SSD. The 
longer the SSD, the more difficult it is to stop. The SSD will be varied from 
trial to trial using a staircase procedure that converges subjects toward an 
overall performance of 50% for each run. In the controlled version of the 
SST, a continue signal is introduced in the form of a green circle 
presented below the go signal. Subjects are instructed that, on some 
trials, this continue signal will appear unpredictably, but this should not 
alter their response, i.e., the initiated response to the go signal should be 
completed. The continue signal occurs on the same number of trials 
(20%) as the stop signal and with the same timing as the previous stop 
signal. The duration of both stop and continue cues is 1,400 msec minus 
the current SSD. Continue trials thus provide a control condition for the 
attentional processing associated with the presentation of an unexpected 

      
 
 
 
 
perceptual event in a context in which response inhibition is not required. 
(10 min) 
f. 
Barratt Impulsiveness Scale (BIS-11)4 is a 30-item scale of impulsiveness 
(rated on 4-point scales from 1-rarely/never to 4-almost always/always). 
The BIS-11 provides three sub-scores: attentional impulsivity (inability to 
focus on the task at hand and having intrusive, racing thoughts), motor 
impulsivity (acting without thinking and lacking perseverance), and non-
planning impulsivity (inability to plan or think carefully about or do 
challenging tasks). It also provides a total impulsivity score that is 
reported to be an internally consistent measure of impulsiveness with 
clinical utility for differentiating normal individuals from psychiatric patients, 
substance abusers, and prison inmates. (4 min) 
g. Behavioral Inhibition System/Behavioral Activation System (BIS/BAS)5 is 
a 24-item questionnaire rated on a 4-point scale (strong agreement – 
strong disagreement) measuring several domains of impulsivity based on 
Gray’s model of personality. In Gray’s view, there are two basic brain 
systems that control behavior and emotions: the aversive system or 
behavioral inhibition system (BIS) and the appetitive system or behavioral 
approach system (BAS). BIS is activated by conditioned stimuli 
associated with punishment or the termination of reward. BAS is activated 
by stimuli associated with reward or termination of punishment in order to 
guide the organism to appetitive stimuli. Gray’s personality theory is 
based on the principle that individual differences in personality reflect the 
variation in sensitivity toward stimuli associated with negative and positive 
reinforcement, respectively BIS and BAS. The BIS/BAS scales consist of 
20 items that can be allocated to two primary scales: the Behavioral 
Inhibition System scale (BIS; 7 items) and the Behavioral Approach 
System scale (BAS; 13 items). The BAS can be divided into 3 subscales: 
fun seeking (BAS fun), reward responsiveness (BAS reward), and drive 
(BAS drive). Drug addicts have higher scores on BAS drive, BAS fun, and 
BAS total score than controls6. (4 min) 
h. MRI Neuroimaging Experiments will be conducted at week 0 and/or 
weeks 8-9 sessions. Participants enrolled into the neuroimaging 
experiment may undergo fMRI brain imaging sessions. These sessions 
may include resting state functional connectivity,7 two fMRI-compatible 
Stop-Signal Tasks2,8  for response inhibition, as well as fMRI tasks 
measuring self-compassion9 and trait non-judgment of self.10 Total 
duration is approximately 60 minutes. 
i. 
Electronic Medication Adherence Monitoring will be measured 
continuously after screening visit for the add-on pilot study using 
electronic medication bottle caps. Participants taking daily medication for 
chronic illness will be included. Medication adherence is calculated as the 
percent of days during which medication was taken as prescribed. These 
devices simply replace the pill bottle caps of study participants’ normal 
medication bottles. Participants will be trained in the use of the devices, 
which should take no longer than 5-10 minutes. The rationale for this 
assessment is that medication use for chronic illness has large impacts 
on outcome, and directly assessed measures are more accurate than 
self-report.11 By embedding a CPU within a cap designed to fit a standard 
medication vial, the cap records each time the vial is opened to take a 
tablet or capsule. The cap is reusable at the time of refilling. Patients will 
be asked to bring in all current medication bottles to each study visit. At 

      
 
 
 
 
the time of each study visit, the adherence data are downloaded via 
a RFID desktop Reader. The Software can display the information 
immediately on a PC via an intuitive interface. No patient information is 
stored on the devices, ensuring confidentiality. Download session may 
take 15 minutes, but can be completed while participants are completing 
self-report measures. 
b. The NIH grant would somewhat expand the scope of the MBHT intervention, as follows: 
i. Addition of an active control group. This control group will be Mindfulness-Based Stress 
Reduction (MBSR), which is time- and attention-matched with MBHT. MBHT is based on 
MBSR, but MBHT customizes MBSR to hypertension and hypertension risk factors. This 
control group is not expected to be added until approximately 2018. MBSR will be 
performed by certified instructors. MBSR teacher certification is fairly extensive, and 
accreditation occurs through the University of Massachusetts Medical School Center for 
Mindfulness in Medicine, Health Care and Society. MBSR will consist of nine 2.5-hour 
weekly group sessions and an 8-hour one-day session. MBSR sessions contain 
instruction and practice in mindfulness meditation, and conversations about stress and 
coping. Students learn a range of mindfulness skills including body scan exercises, 
meditation and yoga. Homework consists of practicing skills for ≥45 min/day, 6 
days/week. The MBSR classes will be composed only of study participants. The 
rationale for adding this control group is that MBSR already exists in hundreds of 
medical centers around the USA and worldwide. If MBHT is not more effective than an 
existing manualized, standardized, general mindfulness-based intervention such as 
MBSR, it is not needed.  
ii. Addition of electronically-measured medication adherence monitoring: measured 
continuously after randomization using electronic medication bottle caps. Participants 
taking medication to treat hypertension will qualify. Medication adherence is calculated 
as the percent of days during which medication was taken as prescribed. These devices 
simply replace the pill bottle caps of study participants’ normal medication bottles. 
Participants will be trained in the use of the devices, which should take no longer than 5-
10 minutes. The rationale for this assessment is that antihypertensive medication use 
has large impacts on blood pressure, and directly assessed measures are more 
accurate than self-report.  
iii. Addition of actigraphy monitoring devices. Participants will be asked to wear actigraphy 
monitoring devices at baseline and follow-up assessments for one week duration each 
time. These devices provide direct assessments of physical activity. The rationale for 
this assessment is that physical activity influences blood pressure, and directly assessed 
physical activity is more accurate than self-report.  
iv. Fidelity of MBSR and MBHT treatment: We will assess participants’ perceptions of 
provider warmth and credibility using brief measures based on the validated Working 
Alliance Inventory,12 and Empathy Scale.13 These have been added to the assessments 
at Weeks 4 and 8 of the intervention. Please see Appendix 2 for the questionnaires. 
The rationale for these assessments is that it is important to evaluate fidelity of the 
intervention, and these are standard measures of instructor effectiveness.  
v. Participants’ mindfulness practice diaries will assess regularity of meditation and 
mindfulness practices. Please see Appendix 3 for the diaries. The rationale for these 
assessments is that it has been shown that those who perform greater amounts of 
mindfulness practices outside of the classroom tend to have greater effects on mental 
health outcomes. The same may be true of blood pressure.  
vi. Focus group assessments of experts (including cardiologists, epidemiologists, 
mindfulness experts, mindfulness intervention instructors) will occur prior to, and 
following pilot testing of MBHT in participants. The rationale for doing these focus groups 
is to maximize MBHT efficacy, drawing on the knowledge of experts in relevant fields. 

      
 
 
 
 
Adaptions may include, for example, types of specific mindfulness exercises, sequence 
in which modules are introduced, and relative emphasis on different types of modules 
(e.g. mindfulness practices customized to prehypertension/hypertension risk factors vs. 
general mindfulness practices). Inclusion criteria for the focus groups will be the experts 
being one of the professions listed above. Questions will include topics such as those 
shown below.  
1. What about this intervention do think is most valuable, and has the greatest 
likelihood of influencing blood pressure, and determinants of blood pressure such 
as physical activity, diet and antihypertensive medication use? 
2. Are there any elements of the intervention you feel could be pruned out, as they 
may be unlikely to have an effect on blood pressure and determinants of blood 
pressure? If so, what are they? Why do you think they would not have an effect? 
3. All interventions can be improved. How do you think this intervention could be 
improved? 
vii. Focus groups of participants undergoing the MBHT behavioral intervention will take 
place following the final week of class. The rationale of doing these focus groups is to 
better adapt MBHT to the unique needs of this population, and maximize intervention 
efficacy. Adaptions may include, for example, types of specific mindfulness exercises, 
sequence in which modules are introduced, relative emphasis on different types of 
modules (e.g. mindfulness practices customized to prehypertension/hypertension risk 
factors vs. general mindfulness practices), and class duration. Inclusion criteria for the 
focus groups will be being study participants. Questions will include topics such as those 
shown below.  
1. Think back to the beginning of the course. Have you noticed some changes in 
yourself or your life since then? If yes, what have you noticed?  
2. Can use card sort that will be anonymous – e.g. cards showing different modules. 
“Put cards for modules you really liked in one pile, modules you didn’t like in 
another pile, and modules you thought were OK but not great in a 3rd pile. Then 
have buckets for people to put their cards in for “liked module” “didn’t like module” 
or “module was OK”.  
3. What did you most like about this course? What was most helpful?  
4. We want to make this intervention better. You have been through it once. How do 
you think we can make it better?”  
5. Take a vote – raise your hand if you think the session should be 2 h, 2.5 h; same 
for 3 hours. Same for retreat day – 5 h, 6 h, 7 h, 8 h. 
6. Every instructor can improve. How can this instructor improve?  
 
3.) State the reason (justification) for the requested amendment: 
 
Please see justifications in Section 2 above. 
 
4.) What is your assessment of how the changes will affect the overall 
risk/benefit ratio of the study and the willingness of individuals to participate? 
 
These assessments should add some participant burden, primarily time associated with questionnaire 
completion, training and use of medication adherence devices and actigraphy, neuroimaging, and partaking in 
the focus group.  
Potential benefits to participants include that completing the meditation diaries in the MBHT study may 
increase intervention effectiveness, as participants may feel more committed to complete the mindfulness 
exercises because their “homework” is being checked and followed up on. A participant in the most recent 
cycle of the MBHT intervention shared with me that she felt she would have done more of the assigned home 

      
 
 
 
 
mindfulness practices if she was asked to fill out such a diary. In addition, MBHT participants receive feedback 
on their health pre- vs. post intervention. The direct assessments of physical activity and medication adherence 
will provide more accurate and higher quality feedback to participants.  
I do not expect these changes to influence participation or risk/benefit ratio in meaningful ways.  
 
5.) Does the requested amendment require new documents or changes to the 
approved consent form or other documents? 
 
Yes. Please see Appendices 2-4.  We have not added the MBHT control group to the consent form at this 
time, as it will not be offered until approximately 2017. The consent form will be modified accordingly, prior to 
including this control group. 
 
 
 
References 
 
1. 
Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 
1971;9(1):97-113. 
2. 
Sharp DJ, Bonnelle V, De Boissezon X, et al. Distinct frontal systems for response inhibition, attentional 
capture, and error processing. Proc Natl Acad Sci U S A.107(13):6106-6111. 
3. 
Aron AR, Fletcher PC, Bullmore ET, Sahakian BJ, Robbins TW. Stop-signal inhibition disrupted by 
damage to right inferior frontal gyrus in humans. Nat Neurosci. 2003;6(2):115-116. 
4. 
Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 
1995;51(6):768-774. 
5. 
Carver CS. Negative affects deriving from the behavioral approach system. Emotion. 2004;4(1):3-22. 
6. 
Franken IH, Muris P, Georgieva I. Gray's model of personality and addiction. Addict Behav. 
2006;31(3):399-403. 
7. 
Cordes D, Haughton VM, Arfanakis K, et al. Mapping functionally related regions of brain with functional 
connectivity MR imaging. AJNR Am J Neuroradiol. 2000;21(9):1636-1644. 
8. 
Aron AR, Poldrack RA. Cortical and subcortical contributions to Stop signal response inhibition: role of 
the subthalamic nucleus. J Neurosci. 2006;26(9):2424-2433. 
9. 
Simon-Thomas ER, Godzik J, Castle E, et al. An fMRI study of caring vs self-focus during induced 
compassion and pride. Soc Cogn Affect Neurosci. 2012;7(6):635-648. 
10. 
Longe O, Maratos FA, Gilbert P, et al. Having a word with yourself: neural correlates of self-criticism 
and self-reassurance. Neuroimage. 2010;49(2):1849-1856. 
11. 
Wiens MO, MacLeod S, Musiime V, et al. Adherence to antiretroviral therapy in HIV-positive 
adolescents in Uganda assessed by multiple methods: a prospective cohort study. Paediatric drugs. 
2012;14(5):331-335. 
12. 
Horvath AO, Greenberg LS. Development and Validation of the Working Alliance Inventory. J Couns 
Psychol. 1989;36(2):223-233. 
13. 
Burns DD, Auerbach A. Therapeutic empathy in cognitive-behavioural therapy: does it really make a 
difference? In: Salkovskis P, ed. Frontiers of Cognitive Therapy. New York: Guilford; 1996. 
 
 
 

      
 
 
 
 
 
 
 
 
 
 
APPENDIX 1 
IRB Approval Documents for Concurrent Studies 
 
 
 

 
Partners Human Research Committee 
116 Huntington Avenue, Suite 1002 
Boston, MA 02116 
Tel: (617) 424-4100 
Fax: (617) 424-4199 
 
Official Version Generated from the Partners Human Research Committee Database 
06/17/2015 14:38 PM 
1 
 
  
Continuing Review: Notification of IRB Approval/Activation 
Protocol #:    2013P001153/MGH  
 
Date:  
June 17, 2015 
 
To:  
Sara W Lazar, Ph.D 
MGH  
Psychiatry 
 
From:  Partners Human Research Committee 
 
116 Huntington Avenue, Suite 1002 
Boston, MA 02116 
 
Title of Protocol:  
Psychological mechanisms of change in a mind-body training program 
Version/Number:  
v2 
Version Date:  
6/12/2015 
Sponsor/Funding Support:  
NIH-NCCAM National Center for Complementary and Alternative Medicine 
 
 
Study Population:  
Adults 
Consent/Authorization:  
Required (Mild deception with appropriate debriefing)  
Documentation of Consent:  
Written 
Informed Consent From:  
Adult Subject 
Informed Consent By:  
Other Study Staff (PS page 8 (study coordinator or study staff))  
IRB Continuing Review #:  
3 
IRB Review Type:  
Expedited 
Expedited Category/ies:  
(7) 
IRB Approval Date:  
6/17/2015 
Approval Activation Date:  
6/17/2015 
IRB Expiration Date:  
6/24/2016 
 
This project has been reviewed by MGH IRB . During the review of this project, the IRB specifically 
considered (i) the risks and anticipated benefits, if any, to subjects; (ii) the selection of subjects; (iii) the 
procedures for obtaining and documenting informed consent; (iv) the safety of subjects; and (v) the privacy of 
subjects and confidentiality of the data.  
 
Please note that if an IRB member had a conflict of interest with regard to the review of this project, consistent 
with IRB policies and procedures, the member was required to leave the room during the discussion and vote 
on this project except to provide information requested by the IRB.  
 
The following protocol documents have been approved and supporting documents noted by 

 
Partners Human Research Committee 
116 Huntington Avenue, Suite 1002 
Boston, MA 02116 
Tel: (617) 424-4100 
Fax: (617) 424-4199 
 
Official Version Generated from the Partners Human Research Committee Database 
06/17/2015 14:38 PM 
2 
 
the IRB:  
Protocol summary (v. 06/12/2015) 
Detailed protocol (v. 06/12/2015) 
Consent form 
Advertisements (2) 
Flyer  
Recruitment letter  
Instruments/ questionnaires (25) 
Diaries 
Manual of operations 
Debriefing script 
Data collection form  
  
 
As Principal Investigator, you are responsible for ensuring that this project is conducted in compliance with all 
applicable federal, state and local laws and regulations, institutional policies, and requirements of the IRB, 
which include, but are not limited to, the following:  
 1. Submission of any and all proposed changes to this project (e.g., protocol, recruitment materials, consent 
form, status of the study, etc.) to the IRB for review and approval prior to initiation of the change(s), 
except where necessary to eliminate apparent immediate hazards to the subject(s). Changes made to 
eliminate apparent immediate hazards to subjects must be reported to the IRB as an unanticipated 
problem.  
 2. Submission of continuing review submissions for re-approval of the project prior to expiration of IRB 
approval and a final continuing review submission when the project has been completed.  
 3. Submission of any and all unanticipated problems, including adverse event(s) in accordance with the 
IRB’s policy on reporting unanticipated problems including adverse events.  
 4. Obtaining informed consent from subjects or their legally authorized representative prior to initiation of 
research procedures when and as required by the IRB and, when applicable, documenting informed 
consent using the current IRB approved consent form(s)with the IRB-approval stamp in the document 
footer.  
 5. Informing all investigators and study staff listed on the project of changes and unanticipated problems, 
including adverse events, involving risks to subjects or others.  
 6. When investigator financial disclosure forms are required, updating your financial interests in Insight and 
for informing all site responsible investigators, co-investigators and any other members of the study staff 
identified by you as being responsible for the design, conduct, or reporting of this research study of their 
obligation to update their financial interest disclosures in Insight if (a) they have acquired new financial 
interests related to the study and/or (b) any of their previously reported financial interests related to the 
study have changed.  
 
The IRB has the authority to terminate projects that are not in compliance with these 
requirements.  
Questions related to this project may be directed to Ednice Depina-
Monteiro, EEMONTEIRO@PARTNERS.ORG, 617-424-4144.  
 
CC:  
Thomas Dylan Calahan, MGH - Psychiatry, Non-Study Staff 

 
Partners Human Research Committee 
116 Huntington Avenue, Suite 1002 
Boston, MA 02116 
Tel: (617) 424-4100 
Fax: (617) 424-4199 
 
Official Version Generated from the Partners Human Research Committee Database 
06/17/2015 14:38 PM 
3 
 
Thomas Dylan Calahan, MGH - Psychiatry, Non-Study Staff 
 
 

      
 
 
 
 
 
 
 
 
APPENDIX 2 
Working Alliance Inventory (WA) 
Empathy Scale (EA) 
 
 
Administered to participants at intervention weeks 4 and 8. 
 
 

MBHT Week 4 and 8 Questionnaire, Version 1.1, August 30, 2015 
 
 
Page 1 of 2 
Please answer the questions below about your experiences with the group leader.  
 
 
 
0 
strongly 
disagree 
1 
moderately 
disagree 
2 
somewhat 
disagree 
3 
no 
opinion 
4 
slightly 
agree 
5 
moderately 
agree 
6 
strongly 
agree 
ES1_01. I felt that I could trust the group leader 
during today’s session. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_02. The group leader felt I was worthwhile. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_03. The group leader was friendly and warm 
towards me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_04. The group leader understood what I 
said during today’s session. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_05. The group leader was sympathetic and 
concerned about me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_06. Sometimes the group leader did not 
seem to be completely genuine. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_07. The group leader pretended to like me 
more than he/she really does. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_08. The group leader did not always seem 
to care about me.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_09. The group leader did not always 
understand the way I felt inside. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ES1_10. The group leader acted condescending 
and talked down to me.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Week 4 and 8 Questionnaire, Version 1.1, August 30, 2015 
 
 
Page 2 of 2
 
 
 
Not 
At All 
True 
 
 
 
 
 
Very 
True 
 
1 
2 
3 
4 
5 
6 
7 
WA1_01. I feel uncomfortable with the group leader. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_02. What I am doing in the mindfulness intervention gives me new ways of 
looking at my problem. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_03. The group leader and I understand each other. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_04. I believe the group leader likes me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_05. I believe the group leader is genuinely concerned for my welfare. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_06. The group leader and I respect each other. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_07. I feel that the group leader is not totally honest about his/her feelings 
towards me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_08. I am confident in the group leader’s ability to help me.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_09. I feel that the group leader appreciates me.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_10. The group leader and I trust one another.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_11. My relationship with the group leader is very important to me.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_12. I have the feeling that if I say or do the wrong things, the group leader 
will stop working with me.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
WA1_13. I feel the group leader cares about me even when I do things that he/she 
does not approve of.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 

      
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 3 
 
Participants’ Mindfulness Practice Diaries 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  1,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  1	  of	  1	  
Daily Practice Record Form – MBHT Week 1                       ID #:___________   
 
 
Please record each time you practice. Please make a note of anything that comes up in the homework so that we can talk about it at 
the next meeting.  
Day/ 
Date 
1.) Body Scan  
2.) Mindful Eating/Meals 
3.) Comments 
# Minutes 
Meal 
# Minutes 
Mon 
Date: 
W1_D1_1. 
 # Minutes 
W1_D1_2a.  
Meal 
W1_D1_2b.  
# Minutes 
W1_D1_3. 
Tues 
Date: 
W1_D2_1.  
# Minutes 
W1_D2_2a.  
Meal 
W1_D2_2b.  
# Minutes 
W1_D2_3. 
Wed 
Date: 
W1_D3_1.  
# Minutes 
W1_D3_2a.  
Meal 
W1_D3_2b.  
# Minutes 
W1_D3_3. 
Thurs 
Date: 
W1_D4_1.  
# Minutes 
W1_D4_2a.  
Meal 
W1_D4_2b.  
# Minutes 
W1_D4_3. 
Fri 
Date: 
W1_D5_1.  
# Minutes 
W1_D5_2a.  
Meal 
W1_D5_2b.  
# Minutes 
W1_D5_3. 
Sat 
Date: 
W1_D6_1.  
# Minutes 
W1_D6_2a.  
Meal 
W1_D6_2b.  
# Minutes 
W1_D6_3. 
Sun 
Date: 
W1_D7_1.  
# Minutes 
W1_D7_2a.  
Meal 
W1_D7_2b.  
# Minutes 
W1_D7_3. 
 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  2,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  1	  of	  1	  
Daily Practice Record Form – MBHT Week 2                       ID #:___________   
 
 
Please record each time you practice. Please make a note of anything that comes up in the homework so that we can talk about it at 
the next meeting.  
Day/ 
Date 
1.) Body Scan 
Meditation 
2.) Breath Awareness 
Practice 
3.) Mindful Activity 
4.) Comments 
# Minutes  
# Minutes 
Activity 
# Minutes 
Mon 
Date: 
W2_D1_1. 
# Minutes 
W2_D1_2. 
# Minutes 
W2_D1_3a.  
Activity 
W2_D1_3b.  
# Minutes 
W2_D1_4. 
Tues 
Date: 
W2_D2_1.  
# Minutes 
W2_D2_2.  
# Minutes 
W2_D2_3a.  
Activity 
W2_D2_3b.  
# Minutes 
W2_D2_4. 
Wed 
Date: 
W2_D3_1.  
# Minutes 
W2_D3_2.  
# Minutes 
W2_D3_3a.  
Activity 
W2_D3_3b.  
# Minutes 
W2_D3_4. 
Thurs 
Date: 
W2_D4_1.  
# Minutes 
W2_D4_2.  
# Minutes 
W2_D4_3a.  
Activity 
W2_D4_3b.  
# Minutes 
W2_D4_4. 
Fri 
Date: 
W2_D5_1.  
# Minutes 
W2_D5_2.  
# Minutes 
W2_D5_3a.  
Activity 
W2_D5_3b.  
# Minutes 
W2_D5_4. 
Sat 
Date: 
W2_D6_1.  
# Minutes 
W2_D6_2.  
# Minutes 
W2_D6_3a.  
Activity 
W2_D6_3b.  
# Minutes 
W2_D6_4. 
Sun 
Date: 
W2_D7_1.  
# Minutes 
W2_D7_2.  
# Minutes 
W2_D7_3a.  
Activity 
W2_D7_3b.  
# Minutes 
W2_D7_4. 
 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  3,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  1	  of	  1	  
	  
Daily Practice Record Form – MBHT Week 3                       ID #:___________   
 
 
Please record each time you practice. Please make a note of anything that comes up in the homework so that we can talk about it at 
the next meeting.  
Day/ 
Date 
1.) Body Scan  
2.) Yoga 
3.) Breath 
Awareness  
4.) Physical Activity 
5.) Comments 
# Minutes  
# Minutes 
# Minutes 
Activity 
# Minutes 
Mon 
Date: 
W3_D1_1. 
# Minutes 
W3_D1_2. 
# Minutes 
W3_D1_2. 
# Minutes 
W3_D1_3a.  
Activity 
W3_D1_3b.  
# Minutes 
W3_D1_4. 
Tues 
Date: 
W3_D2_1.  
# Minutes 
W3_D2_2.  
# Minutes 
W3_D2_2.  
# Minutes 
W3_D2_3a.  
Activity 
W3_D2_3b.  
# Minutes 
W3_D2_4. 
Wed 
Date: 
W3_D3_1.  
# Minutes 
W3_D3_2.  
# Minutes 
W3_D3_2.  
# Minutes 
W3_D3_3a.  
Activity 
W3_D3_3b.  
# Minutes 
W3_D3_4. 
Thurs 
Date: 
W3_D4_1.  
# Minutes 
W3_D4_2.  
# Minutes 
W3_D4_2.  
# Minutes 
W3_D4_3a.  
Activity 
W3_D4_3b.  
# Minutes 
W3_D4_4. 
Fri 
Date: 
W3_D5_1.  
# Minutes 
W3_D5_2.  
# Minutes 
W3_D5_2.  
# Minutes 
W3_D5_3a.  
Activity 
W3_D5_3b.  
# Minutes 
W3_D5_4. 
Sat 
Date: 
W3_D6_1.  
# Minutes 
W3_D6_2.  
# Minutes 
W3_D6_2.  
# Minutes 
W3_D6_3a.  
Activity 
W3_D6_3b.  
# Minutes 
W3_D6_4. 
Sun 
Date: 
W3_D7_1.  
# Minutes 
W3_D7_2.  
# Minutes 
W3_D7_2.  
# Minutes 
W3_D7_3a.  
Activity 
W3_D7_3b.  
# Minutes 
W3_D7_4. 
 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  4,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  1	  of	  1	  
Daily Practice Record Form – MBHT Week 4                       ID #:___________   
 
 
Please record each time you practice. Please make a note of anything that comes up in the homework so that we can talk about it at 
the next meeting.  
Day/ 
Date 
1.) Body Scan  
2.) Yoga 
3.) Sitting 
Meditation  
4.) Physical Activity 
5.) Comments 
# Minutes  
# Minutes 
# Minutes 
Activity 
# Minutes 
Mon 
Date: 
W4_D1_1. 
# Minutes 
W4_D1_2. 
# Minutes 
W4_D1_3. 
# Minutes 
W4_D1_4a.  
Activity 
W4_D1_4b.  
# Minutes 
W4_D1_5. 
Tues 
Date: 
W4_D2_1.  
# Minutes 
W4_D2_2.  
# Minutes 
W4_D2_3.  
# Minutes 
W4_D2_4a.  
Activity 
W4_D2_4b.  
# Minutes 
W4_D2_5. 
Wed 
Date: 
W4_D3_1.  
# Minutes 
W4_D3_2.  
# Minutes 
W4_D3_3.  
# Minutes 
W4_D3_4a.  
Activity 
W4_D3_4b.  
# Minutes 
W4_D3_5. 
Thurs 
Date: 
W4_D4_1.  
# Minutes 
W4_D4_2.  
# Minutes 
W4_D4_3.  
# Minutes 
W4_D4_4a.  
Activity 
W4_D4_4b.  
# Minutes 
W4_D4_5. 
Fri 
Date: 
W4_D5_1.  
# Minutes 
W4_D5_2.  
# Minutes 
W4_D5_3.  
# Minutes 
W4_D5_4a.  
Activity 
W4_D5_4b.  
# Minutes 
W4_D5_5. 
Sat 
Date: 
W4_D6_1.  
# Minutes 
W4_D6_2.  
# Minutes 
W4_D6_3.  
# Minutes 
W4_D6_4a.  
Activity 
W4_D6_4b.  
# Minutes 
W4_D6_5. 
Sun 
Date: 
W4_D7_1.  
# Minutes 
W4_D7_2.  
# Minutes 
W4_D7_3.  
# Minutes 
W4_D7_4a.  
Activity 
W4_D7_4b.  
# Minutes 
W4_D7_5. 
 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  5,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  1	  of	  1	  
Daily Practice Record Form – MBHT Week 5                       ID #:___________   
 
 
Please record each time you practice. Please make a note of anything that comes up in the homework so that we can talk about it at 
the next meeting.  
Day/ 
Date 
1.) Body Scan  
2.) Yoga 
3.) Sitting 
Meditation  
4.) S-T-O-P 
Practice 
5.) Comments 
# Minutes  
# Minutes 
# Minutes 
# Minutes 
Mon 
Date: 
W5_D1_1. 
# Minutes 
W5_D1_2. 
# Minutes 
W5_D1_3. 
# Minutes 
W5_D1_4.  
# Minutes 
W5_D1_5. 
Tues 
Date: 
W5_D2_1.  
# Minutes 
W5_D2_2.  
# Minutes 
W5_D2_3.  
# Minutes 
W5_D2_4.  
# Minutes 
W5_D2_5. 
Wed 
Date: 
W5_D3_1.  
# Minutes 
W5_D3_2.  
# Minutes 
W5_D3_3.  
# Minutes 
W5_D3_4.  
# Minutes 
W5_D3_5. 
Thurs 
Date: 
W5_D4_1.  
# Minutes 
W5_D4_2.  
# Minutes 
W5_D4_3.  
# Minutes 
W5_D4_4.  
# Minutes 
W5_D4_5. 
Fri 
Date: 
W5_D5_1.  
# Minutes 
W5_D5_2.  
# Minutes 
W5_D5_3.  
# Minutes 
W5_D5_4.  
# Minutes 
W5_D5_5. 
Sat 
Date: 
W5_D6_1.  
# Minutes 
W5_D6_2.  
# Minutes 
W5_D6_3.  
# Minutes 
W5_D6_4.  
# Minutes 
W5_D6_5. 
Sun 
Date: 
W5_D7_1.  
# Minutes 
W5_D7_2.  
# Minutes 
W5_D7_3.  
# Minutes 
W5_D7_4.  
# Minutes 
W5_D7_5. 
 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  6,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  1	  of	  1	  
Daily Practice Record Form – MBHT Week 6                        
ID #:___________  
 
 
Please record each time you practice. Please make a note of anything that comes up in the homework so that we can talk about it at 
the next meeting.  
Day/ 
Date 
1.) Body Scan  
2.) Yoga 
3.) Sitting 
Meditation  
4.) Comments 
# Minutes  
# Minutes 
# Minutes 
Mon 
Date: 
W6_D1_1. 
# Minutes 
W6_D1_2. 
# Minutes 
W6_D1_3. 
# Minutes 
W6_D1_4. 
Tues 
Date: 
W6_D2_1.  
# Minutes 
W6_D2_2.  
# Minutes 
W6_D2_3.  
# Minutes 
W6_D2_4. 
Wed 
Date: 
W6_D3_1.  
# Minutes 
W6_D3_2.  
# Minutes 
W6_D3_3.  
# Minutes 
W6_D3_4. 
Thurs 
Date: 
W6_D4_1.  
# Minutes 
W6_D4_2.  
# Minutes 
W6_D4_3.  
# Minutes 
W6_D4_4. 
Fri 
Date: 
W6_D5_1.  
# Minutes 
W6_D5_2.  
# Minutes 
W6_D5_3.  
# Minutes 
W6_D5_4. 
Sat 
Date: 
W6_D6_1.  
# Minutes 
W6_D6_2.  
# Minutes 
W6_D6_3.  
# Minutes 
W6_D6_4. 
Sun 
Date: 
W6_D7_1.  
# Minutes 
W6_D7_2.  
# Minutes 
W6_D7_3.  
# Minutes 
W6_D7_4. 
 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  7,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  1	  of	  2	  
Daily Practice Record Form – MBHT Week 7                        
ID #:___________   
 
Please record each time you practice. Please make a note of anything that comes up in the homework so that we can talk about it at the next 
meeting.  
 
Day/ 
Date 
1.) Mindfulness Practice 
2.) Nourishing Activity 
3.) Refraining-From-
Poisoning Activity 
4.) Accepting-What-I-
Can’t-Control Activity 
5.) Comments 
Practice 
Type(s) 
# 
Minutes 
Activity 
# 
Minutes 
Activity 
# 
Minutes 
Activity 
# Minutes 
Mon 
Date: 
W7_D1_1a.  
Type(s) 
W7_D1_1b.  
# Min 
W7_D1_2a.  
Activity 
W7_D1_2b.  
# Min 
W7_D1_3a.  
Activity 
W7_D1_3b.  
# Min 
W7_D1_4a.  
Activity 
W7_D1_4b.  
# Min 
W7_D1_5. 
Tues 
Date: 
W7_D2_1a.  
Type(s) 
W7_D2_1b.  
# Min 
W7_D2_2a.  
Activity 
W7_D2_2b.  
# Min 
W7_D2_3a.  
Activity 
W7_D2_3b.  
# Min 
W7_D2_4a.  
Activity 
W7_D2_4b.  
# Min 
W7_D2_5. 
Wed 
Date: 
W7_D3_1a.  
Type(s) 
W7_D3_1b.  
# Min 
W7_D3_2a.  
Activity 
W7_D3_2b.  
# Min 
W7_D3_3a.  
Activity 
W7_D3_3b.  
# Min 
W7_D3_4a.  
Activity 
W7_D3_4b.  
# Min 
W7_D3_5. 
 
 
 

	  
MBHT	  Daily	  Practice	  Record	  Form	  –	  MBHT	  Week	  7,	  Version	  1.0,	  August	  31,	  2015	  
	  
	  
	  
	  
Page	  2	  of	  2	  
Day/ 
Date 
1.) Mindfulness 
Practice 
2.) Nourishing Activity 
3.) Refraining-From-
Poisoning Activity 
4.) Accepting-What-I-
Can’t-Control Activity 
5.) Comments 
Practice 
Type(s) 
# 
Minutes 
Activity 
# 
Minutes 
Activity 
# 
Minutes 
Activity 
# Minutes 
Thurs 
Date: 
W7_D4_1a.  
Type(s) 
W7_D4_1b.  
# Min 
W7_D4_2a.  
Activity 
W7_D4_2b.  
# Min 
W7_D4_3a.  
Activity 
W7_D4_3b.  
# Min 
W7_D4_4a.  
Activity 
W7_D4_4b.  
# Min 
W7_D4_5. 
Fri 
Date: 
W7_D5_1a.  
Type(s) 
W7_D5_1b.  
# Min 
W7_D5_2a.  
Activity 
W7_D5_2b.  
# Min 
W7_D5_3a.  
Activity 
W7_D5_3b.  
# Min 
W7_D5_4a.  
Activity 
W7_D5_4b.  
# Min 
W7_D5_5. 
Sat 
Date: 
W7_D6_1a.  
Type(s) 
W7_D6_1b.  
# Min 
W7_D6_2a.  
Activity 
W7_D6_2b.  
# Min 
W7_D6_3a.  
Activity 
W7_D6_3b.  
# Min 
W7_D6_4a.  
Activity 
W7_D6_4b.  
# Min 
W7_D6_5. 
Sun 
Date: 
W7_D7_1a.  
Type(s) 
W7_D7_1b.  
# Min 
W7_D7_2a.  
Activity 
W7_D7_2b.  
# Min 
W7_D7_3a.  
Activity 
W7_D7_3b.  
# Min 
W7_D7_4a.  
Activity 
W7_D7_4b.  
# Min 
W7_D7_5. 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 2 of 5 
W4_GO_7. Goal for This Week Related to Diet, Alcohol Consumption, Physical Activity or Stress Reaction/Response: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
W4_GO_8. How Goal Will Be Measured: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
 
 
Day/Date 
Event related 
to goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were there 
before, during and after 
this event? 
How did it 
contribute, or not, 
to achieving the 
goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Mon 
Date: 
W4_GO_D1_1. 
 
 
 
W4_GO_D1_2a. 
Before: 
 
 
 
W4_GO_D1_2b. 
During: 
 
 
 
 
W4_GO_D1_2c. 
After: 
 
 
 
 
W4_GO_D1_3a. 
Before: 
 
 
 
W4_GO_D1_3b. 
During: 
 
 
 
 
W4_GO_D1_3c. 
After: 
 
 
 
 
W4_GO_D1_4. 
 
W4_GO_D1_5. 
 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 3 of 5 
 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Tues 
Date: 
W4_GO_D2_1. 
 
W4_GO_D2_1. 
 
 
 
W4_GO_D2_2a. 
Before: 
 
 
 
W4_GO_D2_2b. 
During: 
 
 
 
W4_GO_D2_2c. 
After: 
 
 
W4_GO_D2_3a. 
Before: 
 
 
 
W4_GO_D2_3b. 
During: 
 
 
 
W4_GO_D2_3c. 
After: 
 
W4_GO_D2_4. 
 
Wed 
Date: 
W4_GO_D3_1. 
 
W4_GO_D3_1. 
 
 
 
W4_GO_D3_2a. 
Before: 
 
 
 
W4_GO_D3_2b. 
During: 
 
 
 
 
W4_GO_D3_2c. 
After: 
 
 
 
 
W4_GO_D3_3a. 
Before: 
 
 
 
W4_GO_D3_3b. 
During: 
 
 
 
 
W4_GO_D3_3c. 
After: 
 
 
 
 
W4_GO_D3_4. 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 4 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Thurs 
Date: 
W4_GO_D4_1. 
 
W4_GO_D4_1. 
 
 
 
W4_GO_D4_2a. 
Before: 
 
 
 
W4_GO_D4_2b. 
During: 
 
 
 
 
W4_GO_D4_2c. 
After: 
 
 
 
W4_GO_D4_3a. 
Before: 
 
 
 
W4_GO_D4_3b. 
During: 
 
 
 
 
W4_GO_D4_3c. 
After: 
 
 
 
W4_GO_D4_4. 
 
Fri 
Date: 
W4_GO_D5_1. 
 
W4_GO_D5_1. 
 
 
 
W4_GO_D5_2a. 
Before: 
 
 
 
W4_GO_D5_2b. 
During: 
 
 
 
 
W4_GO_D5_2c. 
After: 
 
 
 
 
W4_GO_D5_3a. 
Before: 
 
 
 
W4_GO_D5_3b. 
During: 
 
 
 
 
W4_GO_D5_3c. 
After: 
 
 
 
 
W4_GO_D5_4. 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 5 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Sat 
Date: 
W4_GO_D6_1. 
 
W4_GO_D6_1. 
 
 
 
W4_GO_D6_2a. 
Before: 
 
 
 
W4_GO_D6_2b. 
During: 
 
 
 
W4_GO_D6_2c. 
After: 
 
 
W4_GO_D6_3a. 
Before: 
 
 
 
W4_GO_D6_3b. 
During: 
 
 
 
W4_GO_D6_3c. 
After: 
 
 
 
W4_GO_D6_4. 
 
Sun 
Date: 
W4_GO_D7_1. 
 
W4_GO_D7_1. 
 
 
 
W4_GO_D7_2a. 
Before: 
 
 
 
W4_GO_D7_2b. 
During: 
 
 
 
 
W4_GO_D7_2c. 
After: 
 
 
 
 
W4_GO_D7_3a. 
Before: 
 
 
 
W4_GO_D7_3b. 
During: 
 
 
 
 
W4_GO_D7_3c. 
After: 
 
 
 
 
W4_GO_D7_4. 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 1 of 5 
ID#________ 
 
Week 4: Goal Related to Diet, Alcohol Consumption, Physical Activity, 
or Stress Reaction/Response 
 
 
W4_GO_1. What is your goal related to diet, alcohol consumption, physical activity, or stress 
reaction/response for the week?  
 
 
 
W4_GO_2. On a scale of 1-10, where 10 is high, how MOTIVATED are you to achieve this goal?  
 
 
 
 
W4_GO_3. On a scale of 1-10, how CONFIDENT are you that you will achieve the goal?  
 
 
 
 
 
W4_GO_4. What could you do that would bring your motivation or confidence a little higher?  
 
 
 
 
 
 
 
W4_GO_5. What might make it difficult to achieve the goal this week, and if that happens, what will 
you do?  
 
 
 
 
 
 
 
W4_GO_6. What is a way to measure this goal that resonates with you? 
 
 
 
 
 

 
Goal Daily Record Form – MBHT Week 5, Version 1.0, August 31, 2015 
Page 2 of 5 
W5_GO_7. Goal for This Week Related to Diet, Alcohol Consumption, Physical Activity, Stress Reaction/Response, or Antihypertensive 
Medication Use: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
W5_GO_8. How Goal Will Be Measured: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
 
 
Day/Date 
Event related 
to goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were there 
before, during and after 
this event? 
How did it 
contribute, or not, 
to achieving the 
goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Mon 
Date: 
W5_GO_D1_1. 
 
 
 
W5_GO_D1_2a. 
Before: 
 
 
 
W5_GO_D1_2b. 
During: 
 
 
 
 
W5_GO_D1_2c. 
After: 
 
 
 
 
W5_GO_D1_3a. 
Before: 
 
 
 
W5_GO_D1_3b. 
During: 
 
 
 
 
W5_GO_D1_3c. 
After: 
 
 
 
 
W5_GO_D1_4. 
 
W5_GO_D1_5. 
 
 
 

 
Goal Daily Record Form – MBHT Week 5, Version 1.0, August 31, 2015 
Page 3 of 5 
 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Tues 
Date: 
W5_GO_D2_1. 
 
W5_GO_D2_1. 
 
 
 
W5_GO_D2_2a. 
Before: 
 
 
 
W5_GO_D2_2b. 
During: 
 
 
 
W5_GO_D2_2c. 
After: 
 
 
W5_GO_D2_3a. 
Before: 
 
 
 
W5_GO_D2_3b. 
During: 
 
 
 
W5_GO_D2_3c. 
After: 
 
W5_GO_D2_4. 
 
Wed 
Date: 
W5_GO_D3_1. 
 
W5_GO_D3_1. 
 
 
 
W5_GO_D3_2a. 
Before: 
 
 
 
W5_GO_D3_2b. 
During: 
 
 
 
 
W5_GO_D3_2c. 
After: 
 
 
 
 
W5_GO_D3_3a. 
Before: 
 
 
 
W5_GO_D3_3b. 
During: 
 
 
 
 
W5_GO_D3_3c. 
After: 
 
 
 
 
W5_GO_D3_4. 
 

 
Goal Daily Record Form – MBHT Week 5, Version 1.0, August 31, 2015 
Page 4 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Thurs 
Date: 
W5_GO_D4_1. 
 
W5_GO_D4_1. 
 
 
 
W5_GO_D4_2a. 
Before: 
 
 
 
W5_GO_D4_2b. 
During: 
 
 
 
 
W5_GO_D4_2c. 
After: 
 
 
 
W5_GO_D4_3a. 
Before: 
 
 
 
W5_GO_D4_3b. 
During: 
 
 
 
 
W5_GO_D4_3c. 
After: 
 
 
 
W5_GO_D4_4. 
 
Fri 
Date: 
W5_GO_D5_1. 
 
W5_GO_D5_1. 
 
 
 
W5_GO_D5_2a. 
Before: 
 
 
 
W5_GO_D5_2b. 
During: 
 
 
 
 
W5_GO_D5_2c. 
After: 
 
 
 
 
W5_GO_D5_3a. 
Before: 
 
 
 
W5_GO_D5_3b. 
During: 
 
 
 
 
W5_GO_D5_3c. 
After: 
 
 
 
 
W5_GO_D5_4. 
 

 
Goal Daily Record Form – MBHT Week 5, Version 1.0, August 31, 2015 
Page 5 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Sat 
Date: 
W5_GO_D6_1. 
 
W5_GO_D6_1. 
 
 
 
W5_GO_D6_2a. 
Before: 
 
 
 
W5_GO_D6_2b. 
During: 
 
 
 
W5_GO_D6_2c. 
After: 
 
 
W5_GO_D6_3a. 
Before: 
 
 
 
W5_GO_D6_3b. 
During: 
 
 
 
W5_GO_D6_3c. 
After: 
 
 
 
W5_GO_D6_4. 
 
Sun 
Date: 
W5_GO_D7_1. 
 
W5_GO_D7_1. 
 
 
 
W5_GO_D7_2a. 
Before: 
 
 
 
W5_GO_D7_2b. 
During: 
 
 
 
 
W5_GO_D7_2c. 
After: 
 
 
 
 
W5_GO_D7_3a. 
Before: 
 
 
 
W5_GO_D7_3b. 
During: 
 
 
 
 
W5_GO_D7_3c. 
After: 
 
 
 
 
W5_GO_D7_4. 
 
 

 
Goal Daily Record Form – MBHT Week 5, Version 1.0, August 31, 2015 
Page 1 of 5 
ID#________ 
 
Week 5: Goal Related to Diet, Alcohol Consumption, Physical Activity, 
Stress Reaction/Response, or Antihypertensive Medication Use 
 
 
W5_GO_1. What is your goal related to diet, alcohol consumption, physical activity, or stress 
reaction/response, or antihypertensive medication use for the week?  
 
 
 
W5_GO_2. On a scale of 1-10, where 10 is high, how MOTIVATED are you to achieve this goal?  
 
 
 
 
W5_GO_3. On a scale of 1-10, how CONFIDENT are you that you will achieve the goal?  
 
 
 
 
 
W5_GO_4. What could you do that would bring your motivation or confidence a little higher?  
 
 
 
 
 
 
 
W5_GO_5. What might make it difficult to achieve the goal this week, and if that happens, what will 
you do?  
 
 
 
 
 
 
 
W5_GO_6. What is a way to measure this goal that resonates with you? 
 
 
 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 2 of 5 
W6_GO_7. Goal for This Week Related to Diet, Alcohol Consumption, Physical Activity, Stress Reaction/Response, Antihypertensive 
Medication Use, or Social Support: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
W6_GO_8. How Goal Will Be Measured: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
 
 
Day/Date 
Event related 
to goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were there 
before, during and after 
this event? 
How did it 
contribute, or not, 
to achieving the 
goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Mon 
Date: 
W6_GO_D1_1. 
 
 
 
W6_GO_D1_2a. 
Before: 
 
 
 
W6_GO_D1_2b. 
During: 
 
 
 
 
W6_GO_D1_2c. 
After: 
 
 
 
 
W6_GO_D1_3a. 
Before: 
 
 
 
W6_GO_D1_3b. 
During: 
 
 
 
 
W6_GO_D1_3c. 
After: 
 
 
 
 
W6_GO_D1_4. 
 
W6_GO_D1_5. 
 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 3 of 5 
 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Tues 
Date: 
W6_GO_D2_1. 
 
W6_GO_D2_1. 
 
 
 
W6_GO_D2_2a. 
Before: 
 
 
 
W6_GO_D2_2b. 
During: 
 
 
 
W6_GO_D2_2c. 
After: 
 
 
W6_GO_D2_3a. 
Before: 
 
 
 
W6_GO_D2_3b. 
During: 
 
 
 
W6_GO_D2_3c. 
After: 
 
W6_GO_D2_4. 
 
Wed 
Date: 
W6_GO_D3_1. 
 
W6_GO_D3_1. 
 
 
 
W6_GO_D3_2a. 
Before: 
 
 
 
W6_GO_D3_2b. 
During: 
 
 
 
 
W6_GO_D3_2c. 
After: 
 
 
 
 
W6_GO_D3_3a. 
Before: 
 
 
 
W6_GO_D3_3b. 
During: 
 
 
 
 
W6_GO_D3_3c. 
After: 
 
 
 
 
W6_GO_D3_4. 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 4 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Thurs 
Date: 
W6_GO_D4_1. 
 
W6_GO_D4_1. 
 
 
 
W6_GO_D4_2a. 
Before: 
 
 
 
W6_GO_D4_2b. 
During: 
 
 
 
 
W6_GO_D4_2c. 
After: 
 
 
 
W6_GO_D4_3a. 
Before: 
 
 
 
W6_GO_D4_3b. 
During: 
 
 
 
 
W6_GO_D4_3c. 
After: 
 
 
 
W6_GO_D4_4. 
 
Fri 
Date: 
W6_GO_D5_1. 
 
W6_GO_D5_1. 
 
 
 
W6_GO_D5_2a. 
Before: 
 
 
 
W6_GO_D5_2b. 
During: 
 
 
 
 
W6_GO_D5_2c. 
After: 
 
 
 
 
W6_GO_D5_3a. 
Before: 
 
 
 
W6_GO_D5_3b. 
During: 
 
 
 
 
W6_GO_D5_3c. 
After: 
 
 
 
 
W6_GO_D5_4. 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 5 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Sat 
Date: 
W6_GO_D6_1. 
 
W6_GO_D6_1. 
 
 
 
W6_GO_D6_2a. 
Before: 
 
 
 
W6_GO_D6_2b. 
During: 
 
 
 
W6_GO_D6_2c. 
After: 
 
 
W6_GO_D6_3a. 
Before: 
 
 
 
W6_GO_D6_3b. 
During: 
 
 
 
W6_GO_D6_3c. 
After: 
 
 
 
W6_GO_D6_4. 
 
Sun 
Date: 
W6_GO_D7_1. 
 
W6_GO_D7_1. 
 
 
 
W6_GO_D7_2a. 
Before: 
 
 
 
W6_GO_D7_2b. 
During: 
 
 
 
 
W6_GO_D7_2c. 
After: 
 
 
 
 
W6_GO_D7_3a. 
Before: 
 
 
 
W6_GO_D7_3b. 
During: 
 
 
 
 
W6_GO_D7_3c. 
After: 
 
 
 
 
W6_GO_D7_4. 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 1 of 5 
ID#________ 
 
Week 6: Goal Related to Diet, Alcohol Consumption, Physical Activity, 
Stress Reaction/Response, Antihypertensive Medication Use,  
or Social Support 
 
 
W6_GO_1. What is your goal related to diet, alcohol consumption, physical activity, stress 
reaction/response, antihypertensive medication use, or social support for the week?  
 
 
 
W6_GO_2. On a scale of 1-10, where 10 is high, how MOTIVATED are you to achieve this goal?  
 
 
 
 
W6_GO_3. On a scale of 1-10, how CONFIDENT are you that you will achieve the goal?  
 
 
 
 
 
W6_GO_4. What could you do that would bring your motivation or confidence a little higher?  
 
 
 
 
 
 
 
W6_GO_5. What might make it difficult to achieve the goal this week, and if that happens, what will 
you do?  
 
 
 
 
 
 
 
W6_GO_6. What is a way to measure this goal that resonates with you? 
 
 
 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 2 of 5 
W7_GO_7. Goal for This Week Related to Diet, Alcohol Consumption, Physical Activity, Stress Reaction/Response, Antihypertensive 
Medication Use, or Social Support: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
W7_GO_8. How Goal Will Be Measured: 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________ 
 
 
 
Day/Date 
Event related 
to goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were there 
before, during and after 
this event? 
How did it 
contribute, or not, 
to achieving the 
goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Mon 
Date: 
W7_GO_D1_1. 
 
 
 
W7_GO_D1_2a. 
Before: 
 
 
 
W7_GO_D1_2b. 
During: 
 
 
 
 
W7_GO_D1_2c. 
After: 
 
 
 
 
W7_GO_D1_3a. 
Before: 
 
 
 
W7_GO_D1_3b. 
During: 
 
 
 
 
W7_GO_D1_3c. 
After: 
 
 
 
 
W7_GO_D1_4. 
 
W7_GO_D1_5. 
 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 3 of 5 
 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Tues 
Date: 
W7_GO_D2_1. 
 
W7_GO_D2_1. 
 
 
 
W7_GO_D2_2a. 
Before: 
 
 
 
W7_GO_D2_2b. 
During: 
 
 
 
W7_GO_D2_2c. 
After: 
 
 
W7_GO_D2_3a. 
Before: 
 
 
 
W7_GO_D2_3b. 
During: 
 
 
 
W7_GO_D2_3c. 
After: 
 
W7_GO_D2_4. 
 
Wed 
Date: 
W7_GO_D3_1. 
 
W7_GO_D3_1. 
 
 
 
W7_GO_D3_2a. 
Before: 
 
 
 
W7_GO_D3_2b. 
During: 
 
 
 
 
W7_GO_D3_2c. 
After: 
 
 
 
 
W7_GO_D3_3a. 
Before: 
 
 
 
W7_GO_D3_3b. 
During: 
 
 
 
 
W7_GO_D3_3c. 
After: 
 
 
 
 
W7_GO_D3_4. 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 4 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Thurs 
Date: 
W7_GO_D4_1. 
 
W7_GO_D4_1. 
 
 
 
W7_GO_D4_2a. 
Before: 
 
 
 
W7_GO_D4_2b. 
During: 
 
 
 
 
W7_GO_D4_2c. 
After: 
 
 
 
W7_GO_D4_3a. 
Before: 
 
 
 
W7_GO_D4_3b. 
During: 
 
 
 
 
W7_GO_D4_3c. 
After: 
 
 
 
W7_GO_D4_4. 
 
Fri 
Date: 
W7_GO_D5_1. 
 
W7_GO_D5_1. 
 
 
 
W7_GO_D5_2a. 
Before: 
 
 
 
W7_GO_D5_2b. 
During: 
 
 
 
 
W7_GO_D5_2c. 
After: 
 
 
 
 
W7_GO_D5_3a. 
Before: 
 
 
 
W7_GO_D5_3b. 
During: 
 
 
 
 
W7_GO_D5_3c. 
After: 
 
 
 
 
W7_GO_D5_4. 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 5 of 5 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Sat 
Date: 
W7_GO_D6_1. 
 
W7_GO_D6_1. 
 
 
 
W7_GO_D6_2a. 
Before: 
 
 
 
W7_GO_D6_2b. 
During: 
 
 
 
W7_GO_D6_2c. 
After: 
 
 
W7_GO_D6_3a. 
Before: 
 
 
 
W7_GO_D6_3b. 
During: 
 
 
 
W7_GO_D6_3c. 
After: 
 
 
 
W7_GO_D6_4. 
 
Sun 
Date: 
W7_GO_D7_1. 
 
W7_GO_D7_1. 
 
 
 
W7_GO_D7_2a. 
Before: 
 
 
 
W7_GO_D7_2b. 
During: 
 
 
 
 
W7_GO_D7_2c. 
After: 
 
 
 
 
W7_GO_D7_3a. 
Before: 
 
 
 
W7_GO_D7_3b. 
During: 
 
 
 
 
W7_GO_D7_3c. 
After: 
 
 
 
 
W7_GO_D7_4. 
 
 

 
Goal Daily Record Form – MBHT Week 4, Version 1.0, August 31, 2015 
Page 1 of 5 
ID#________ 
 
Week 7: Goal Related to Diet, Alcohol Consumption, Physical Activity, 
Stress Reaction/Response, Antihypertensive Medication Use,  
or Social Support 
 
 
W7_GO_1. What is your goal related to diet, alcohol consumption, physical activity, stress 
reaction/response, antihypertensive medication use, or social support for the week?  
 
 
 
W7_GO_2. On a scale of 1-10, where 10 is high, how MOTIVATED are you to achieve this goal?  
 
 
 
 
W7_GO_3. On a scale of 1-10, how CONFIDENT are you that you will achieve the goal?  
 
 
 
 
 
W7_GO_4. What could you do that would bring your motivation or confidence a little higher?  
 
 
 
 
 
 
 
W7_GO_5. What might make it difficult to achieve the goal this week, and if that happens, what will 
you do?  
 
 
 
 
 
 
 
W7_GO_6. What is a way to measure this goal that resonates with you? 
 
 
 
 
 

      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 4 
 
Informed Consent Form 
 
 

MBHT Consent Form, Version 1.3, September 1, 2015  
  Page 1 of 5 
 
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Deleted: July 15
Agreement to Participate in a Research Study 
 
Investigation of the Effects of Mindfulness on Blood Pressure and Well-Being 
 
You are being asked to take part in a Brown University research study about the effects of 
mindfulness and hypertension education on blood pressure and risk factors for hypertension. 
This form will explain the purpose of the study, how the study will be carried out and what you 
will be expected to do.  It will also explain the possible risks and possible benefits of being in the 
study.  If any part of the following description is not clear to you, you are encouraged to contact 
the researcher to answer any questions before you decide whether to take part in the study. If you 
decide to participate, please fill out and sign the last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health 
education on blood pressure. You have been selected for this study because you expressed 
interest and met entrance criteria for having prehypertension or hypertension, or another 
cardiovascular risk factor that could be influenced by this program. In order to assess the effects 
of these practices, you will be asked to complete some questionnaires, and a laboratory 
assessment before and after learning the mindfulness practices. 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
1) Participate in an interview in which you will be asked questions about past and present 
mental health, including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, 
smoking, medication use, personality, emotions, attention and past experiences, including 
stressful or traumatic experiences. These questions will probe sensitive psychological areas, 
including physical, emotion and sexual abuse. These questionnaires may take up to 2 hours to 
complete. By completing the interviews and questionnaires, you are giving the researchers 
permission to use the information you have provided. You have the right not to answer any 
of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference, hip circumference, 
physical activity, and antihypertensive medication use.  
 
4) You will be asked to perform some cognitive tasks. One of these tasks may involve 
computer-based tests of attention or decision-making. Together these tests may take as long 
as 45 minutes. 
 
5) You will participate in the mindfulness program, which consists of 9 weekly sessions of 2.5 
hours each and will include one 8 hour weekend retreat. Daily homework assignments may 
take as long as one hour and consist of practicing mindfulness exercises with the aid of a 
Eric LoucksĀ 9/1/2015 9:23 PM
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MBHT Consent Form, Version 1.3, September 1, 2015  
  Page 2 of 5 
 
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guided audio CD and completing worksheets related to stress, thoughts, and common 
reactions to various types of events. 
 
6) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. 
The recordings will be transcribed so that we may analyze the text. The recordings will be 
identified by study number, will only be heard by study staff and will be destroyed after 
transcription.  
 
7) You will be asked to complete a few short questionnaires each week during the 9 week 
condition. 
 
8) After 9 weeks, you will be asked to complete questionnaires and return to the laboratory to 
repeat the same procedures for a second day of testing. You will also be invited to participate 
in a focus group to share any advice you may have on how to improve the intervention.  
 
9) Three months after the end of the 9 week condition, you will be asked to return to the 
laboratory to repeat the same testing procedures. 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as 
questionnaires, height, weight and waist 
circumference.  
2 hours 
Mindfulness course 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 8 
hours 
Total course time: 30.5 hours 
Home mindfulness practices assigned during 
course.  
1 hour per day, 6 days per week, for 8 
weeks.  
Total time: 48 hours. 
Health assessments, such as questionnaires, 
blood pressure, height, weight and waist 
circumference, that take place immediately 
after course completion. 
2 hours 
Health assessments, such as questionnaires, 
blood pressure, height, weight and waist 
circumference, that take place that take place 
3 months after course completion. 
2 hours 
Participate in focus group after intervention 
completion to share any advice you may have 
on how to improve the intervention. 
1.5 hours 
TOTAL TIME COMMITMENT FOR 
STUDY 
87.0 hours 
 
Eric LoucksĀ 9/1/2015 9:23 PM
Deleted: 5.5

MBHT Consent Form, Version 1.3, September 1, 2015  
  Page 3 of 5 
 
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Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred 
since the first assessment. Specifically, you will receive an individualized handout listing % 
change (increase or decrease) on scales of attention, stress, mood, health behaviors, weight, and 
blood pressure across the study. 
 
2.  Discomforts and Risks 
The questionnaires are routine, standardized forms for epidemiologic research.  Certain questions 
may be upsetting as they may probe sensitive psychological areas and inquire about upsetting or 
traumatic events, including physical, sexual or emotional abuse and/or current psychiatric 
symptoms.  Since your participation is voluntary, you have the right to skip any questions that 
make you uncomfortable.  
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, 
feelings or body sensations. Some individuals may experience an initial increase in undesirable 
feelings with increased attention to them. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this 
study.  However, participation in the study creates the potential benefit of a) identifying effective 
treatments for elevated blood pressure, b) gaining knowledge of the effects of mindfulness 
practices, c) receiving information about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical 
activity, and reducing excessive alcohol consumption may also be beneficial for reducing blood 
pressure. Education about these therapies are integrated into this course, but other forms of these 
alternative therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to 
a study ID# instead of your name.  All questionnaires in this study will be filled out through an 
online survey or a paper version of the survey if you prefer.  All of these questionnaires will be 
linked solely to your study ID#, so that your identity is protected and your answers are 
confidential.  Although these measures have been taken to protect your personal information, 
complete confidentiality cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to 
confidentiality. If your questionnaire responses indicate that you pose a serious danger to 
yourself or to another person, then a collaborator (Dr. Ellen Flynn) who is a licensed psychiatrist, 
may contact you to discuss your responses and possible referral to a treatment provider. 
Questionnaire items that may warrant follow-up include endorsements of statements about 
hurting yourself, any high scores in depression, anxiety, or other clinically significant problems. 
You should also know that there are times when the law might require the release of your 
responses without your permission.  For example, State law requires researchers to report abuse 
or neglect of children to the Department of Children, Youth and Families (DCYF).   State law 

MBHT Consent Form, Version 1.3, September 1, 2015  
  Page 4 of 5 
 
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also requires researchers to report abuse or neglect of people age 60 and older to the Division of 
Elderly Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in 
any published reports about this study. Results will be reported in a summarized manner in such 
a way that you cannot be identified. All personally identifiable information will be "de-
identified" and only a unique code number will be used. Study records will be identified with a 
unique code number and initials. All study records and specimens will be stored in a secure 
storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, 
including not answering certain questions. If you decide now to participate, you can change your 
mind later and quit the study.  The decision to not participate or to withdraw from the study will 
not adversely affect current or future interactions with Brown University. The decision to not 
participate or to withdraw from the study will also not adversely affect your relationship with 
your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for 
alternative treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. 
Eric B. Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like 
more information about the rules for research studies, or the rights of people who take part in 
those studies, you may contact the Brown University Research Protections Office, telephone 
number 1-866-309-2095 or 401-863-3050. 
 

MBHT Consent Form, Version 1.3, September 1, 2015  
  Page 5 of 5 
 
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CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY 
QUESTIONS HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO 
PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
_______________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):______________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):__________________________________________________________________ 
 
Telephone:__________________________(cell)     __________________________(other) 
 
 
 
 
 
 

Brown University
Research Protections Office
Institutional Review Board
Amendment Request
Date of Request:11 /1,1,/L5Investigator's Name and Title: Eric Loucks, Assistant Prof essor
StudyTitle:Mindfulness-Based Hlpert,ensíon Therapy Pilot Study (#l+t2001171)
OriginalTypeof Review: ! Exempt 
! Expedited 
E Fu[Board
1) Provide a brief lay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form) PIease see attached.
2) Provide a detailed descripfion of the changes being requested (Use additional pages, if necessary):
Please see attached.
3.) State the reason (iustÍfication) for the requested amendment. (Use additional pages, if
necessary):
Please see attached.
4.) What is your assessmcut of how the changes rvill afTect the overall rish/benefit ratio of the study
and thc rvillingncss of individuals to partÍcipate?
Please see attached.
5.) Does the requested amendment require new documents or changes to the approved consent
form or other documents?
El Consent/assent documents (attach revised version with changes highlighted)
fl Nedrevised instruments (attach - if revised, highlight changes)
n Nedrevised advertising materials (attach - if revised, highlight changes)
Do you have a conflict of interest on this project according to Brown's policy? lVnS ENO
If YES, has this conflict been previously disclosed to the IRB? 
EynS nNO
PI signature:
a.
,,'l
t
Date: It / I7 / L5

1. Provide a brief lay summary of the overall project. Include enough 
detail to allow the IRB to evaluate the requested change(s) within 
the context of the overall project.   
  
The World Health Organization reported that suboptimal blood pressure (BP) is responsible 
for more than half of cardiovascular disease mortality world-wide. Furthermore, greater than half 
of those with hypertension have uncontrolled BP. A 2009 Institute of Medicine report 
recommended prioritizing research to “Compare the effectiveness of mindfulness-based 
interventions (e.g. yoga, meditation, deep breathing training) and usual care in treating… 
cardiovascular risk factors.”  Evidence-based mindfulness interventions, including Mindfulness-
Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant 
effects, but evidence of heterogeneity in effect sizes. The methodologically highest quality 
studies had the smallest effect sizes (range 0-5 mmHg). Mindfulness-Based Stress Reduction 
(MBSR) has been customized to a number of disease processes, such as Mindfulness-Based 
Cognitive Therapy for patients with recurrent depression, and Mindfulness-Based Relapse 
Prevention for patients with substance use addictions. Effect sizes have been increased by 
customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive 
patients have never been investigated. Until methodologically rigorous studies to evaluate 
customized interventions for hypertension are performed, we will not know if the observed 
preliminary effects of general mindfulness interventions on blood pressure reduction could be 
much more effective with a tailored approach. Consequently, we propose to conduct a stage I 
behavioral therapy intervention study to evaluate whether MBSR customized to prehypertensive 
and hypertensive patients has the potential to provide clinically relevant reductions in BP. 
Consequently the specific aims are:  
  
Stage 1a: Therapy Development/Manual Writing  
1. To outline and evaluate key novel elements of mindfulness-based hypertension therapy 
(MBHT), customized from the evidence-based MBSR. We hypothesize that the most 
important novel element will be generation of mindfulness skills specifically applied to 
hypertension risk factors such as diet, physical activity, obesity, alcohol consumption 
and antihypertensive medication adherence. This aim will be achieved using (1) focus 
groups of participants undergoing the MBHT behavioral intervention, (2) discussion with 
experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness 
intervention instructors) prior to, and following pilot testing of MBHT in participants, and 
(3) clinical judgment of the investigators performing the intervention.   
2. To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, 
retention rates, recruitment rates, and adverse effects) and secondary outcomes 
(hypertension risk factors such as diet, physical activity, obesity, and antihypertensive 
medication adherence) in hypertension subgroups, specifically participants with (1) 
prehypertension, (2) controlled hypertension, and (3) uncontrolled hypertension. Initial 
decisions about the targeted sample based on hypertension status will be made.  
3. To develop an MBHT therapist manual and training program, including procedures for 
training, supervising, and evaluating therapists. Furthermore, acceptable therapist 
characteristics will be developed. The manual and training program will include themes 
such as specification of unique and common elements of MBHT vs. other interventions, 
description of interventions excluded from MBHT, and specification of key treatment 
parameters such as frequency and duration of treatment, session length, topics 
addressed, sequence of sessions, as well as therapist adherence and competency 

measures. The MBHT training will consist of a therapist manual, a formal didactic 
training seminar, and at least one closely supervised training session.  
  
Stage Ib: Pilot Trial  
4. To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, 
customized from the evidence-based MBSR, has promise to be an effective behavioral 
therapy for participants with hypertension and/or prehypertension. We will perform a 
randomized controlled pilot trial for MBHT vs. enhanced usual care control. We 
hypothesize that MBHT will have adequate recruitment rates (≥10% of 
prehypertensive/hypertensive participants invited from physicians’ offices), fairly low 
drop out rates (<15%), and medium effect sizes (e.g. 5-10 mmHg systolic BP) for 
reduction in blood pressure.   
  
These findings will provide publishable pilot data that will inform future randomized clinical 
trials that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and 
active control groups. If proven effective, MBHT could be offered as a complementary program 
in the prehypertensive/hypertensive patient population that contributes to over half of the 
cardiovascular disease mortality world-wide.   
  
 
  
2. Provide a detailed description of the changes being requested (Use 
additional pages, if necessary): 
 
Study Protocol 
 
We would like to update you on the following changes made to the overall study protocol… 
 
 
NIH funding – On September 14, 2015, we received notification from the NIH that our grant 
[Award # 1UH2AT009145-01] has been approved and will be funded in full. 
 
 
Control group – we had initially thought we would introduce a control group further down the 
road in 2017 or 2018, but our funding agency (NCCIH) has asked that we add a control group at 
this time.  For this reason, we will be randomly selecting eligible participants to take part in the 
intervention.  Those not selected, will receive enhanced usual care and will be invited to 
participate in the mindfulness training program around six months after the intervention group.  
Enhanced usual care in the setting of this study refers to participants obtaining hypertensive 
treatment through the services typically available to them. However, we will help participants 
access these services if needed. 
 
 
Participant incentive – we now have sufficient funds to offer participants a small participant 
incentive for their involvement in the study.  Study participants will be given a participant 
incentive of $100 USD at the time of their last follow up.  Only participants who have completed 
the study will be given the incentive. 
 
 
Safety Monitoring – as part of the NCCIH submission, a formal Safety Monitoring Protocol was 
created.  We have included that here as part of the study protocol (see Appendix 1). 
 

 
Assessment Name Changes - Several of the assessment document names have been changed.  
We did this both for internal consistency and in order to clarify the timing and purpose of each 
assessment.  Specific name changes are noted below. 
 
 
Consent Form Modifications – we have modified the consent form (see below for details as well 
as Appendix 3 for the revised consent form, v.1.4) 
 
 
Additional Follow-up Added – we have decided to add an additional follow up to the study, 
which will take place at 1 year post-baseline.  The assessments conducted at this follow up will 
be identical to those administered at the 10 week and 6 month follow up visits. 
 
 
Questionnaire Revisions - we have made changes to several of the individual Assessments (see 
below for details as well as Appendices 4-7 for revised assessments) 
 
 
Consent Form (v.1.4, See Appendix 3) 
We have made the following changes to the study consent form: 
 
Added clarifying language on study procedures. 
 
Added in language about a control group.  We had initially thought we would hold off on 
including a control group until a later date, but our funding agency (NCCIH) has asked that we 
add a control group at this time.  For this reason, we will be randomly selecting eligible 
participants to take part in the intervention.  Those not selected, will receive enhanced usual 
care and will be invited to participate in the mindfulness training program around six months 
after the intervention group. 
 
Added more detail about physical activity monitoring (i.e., use of actigraphy monitors) as well 
medication use monitoring (i.e., the use of electronic bottle caps). 
 
Added information about focus group involvement post-intervention. 
 
Added language on risk of physical injury. 
 
We have decided to offer a participant incentive in the amount of $100 USD, paid at the time of 
final follow up visit.  This has been added to the consent form. 
 
Added information about the 1 year follow up assessment. 
 
Updated the Table Summarizing Activities and Time Commitment for the study 
 
 
Phone Screener: (v.1.4, See Appendix 4) 
 
Modified language to make more concise and clear 
 
Added information about the randomization process / control group 
 
Added in information about the participant incentive 
 
Corrected typos  
 
Removed the script about scheduling the second In-Person visit.  This will be done at the time of 
the In-Person screener, if the person is found to be eligible for the study and is still interested in 
participating. 
 
 
 
 

In-Person Screening: (v.1.4, See Appendix 5) 
 
Changed the name.  It was formally called the “First In-Person Visit Screening Assessment Form” 
 
Moved “Medication Use” to the In-Person Baseline Assessment – the primary purpose of the 
In-Person Screening Assessment is to determine whether or not an individual is eligible for the 
study (i.e., have mean systolic/diastolic blood pressure ≥120/80 after first and second baseline 
assessments).  For this reason, we decided to move medication use, which was originally found 
in the “First In-Person Visit Assessment Form” to the In-Person Baseline Assessment since it is 
not part of the eligibility criteria.  This will help to reduce participant burden for those 
individuals who are not eligible. 
 
NOTE that the only assessment conducted during the In-Person Screening is Blood Pressure 
measurements. 
 
 
Home Baseline Assessment: (v.1.4, See Appendix 6) 
 
Changed the name.  It was formally called the “Baseline Questionnaire” 
 
Corrected typos, including skip errors 
 
Updated the Table of Contents and Sub-headings in questionnaire 
 
Removed Diet questions (DT1_01 – DT1_25); we will assess diet during the In-Person Baseline 
Assessment using the Harvard University 80-out Food Frequency Questionnaire 
 
Added a question (TS01_01) on table salt use 
 
Added the 11 item validated Craving Experience Questionnaire (CEQ) 
 
Moved around some of the sub-scales for ease of administration (noted in text). 
 
Removed Social Network questions (SN1_01 – SN1_04) and replaced with the validated 12-item 
Interpersonal Support Evaluation List (ISEL-12) 
 
Removed the Social Network questions (SN1_01 – SN1_04) 
 
Added Blood Pressure Medication Use questions (BM1_01 – BM1_09), which includes the 
validated Morisky 8-item questionnaire1. 
 
Added questions that measure “Readiness to change for hypertension risk factors” (RC1_01 – 
RC1_14) 
 
Added Family History of Hypertension questions (FH1_01 – FH1_04), which assess biological 
parents’ history of having hypertension, based on questions from New England Family Study 
LEAP Project. 
 
Dropped several of the sleep items (SL1_05 – SL1_14a; SL1_16 – SL1_21b) to reduce ppt burden. 
 
 
 
 

In-Person Baseline Assessment (v.1.4, See Appendix 7) 
 
Changed the name.  It was formally called the “Second In-Person Visit Screening Assessment” 
 
Added Medication use questions (ME01 – ME10i) 
 
Added the validated Harvard University three page Food Frequency Questionnaire, known as 
“80-out”.  It is designed to take around 20 minutes to complete and is self-administered with 
paper and pencil.  A proof of the questionnaire is included in this Amendment Request. 
 
Added two computer-based tests that measure Attention Control.  They are: 
The Attention Network Test (ANT) is a brief computerized battery measuring three 
independent behavioral components of attention: Conflict resolution (ability to 
overcome distracting stimuli), spatial Orienting (the benefit of valid spatial pre-cues), 
and Alerting (the benefit of temporal pre-cues). Efficiency of orienting is examined by 
changes in RT that accompany cues indicating where the target will occur. The efficiency 
of the executive conflict resolution network is examined by requiring the subject to 
respond by pressing two keys indicating the direction (left or right) of a central arrow 
surrounded by congruent, incongruent or neutral flankers. Moderate to high reliabilities 
are found for all networks.  The ANT takes around 20min to complete. 
 
The Sustained Attention to Response Task (SART) is a computerized test of sustained 
attention, response inhibition (executive function) and self-regulation. Subjects are 
instructed to press a key in response to rapidly displayed integers (1-9) and withhold 
response to a designated "no-go" integer. SART errors consist of summed commission 
errors (button press on no-go trial) and omission errors (button not pressed on "go" 
integers). SART performance is associated with prefrontal cortex functioning, has been 
found to increase with mindfulness training and is correlated with scores on 
mindfulness questionnaires (specifically, the Mindful Attention Awareness Scale). The 
SART takes around 15min to complete. 
 
 
3. State the reason (justification) for the requested amendment:  
  
Please see justifications in Section 2 above.  
  
 
4. What is your assessment of how the changes will affect the overall 
risk/benefit ratio of the study and the willingness of individuals to 
participate?  
  
Overall the changes we have made in this amendment affect the risk/benefit ratio in small 
ways.  We have added some question items to the assessments, but have also removed some 
items in order to minimize participant burden. Assessment time has increased by about 1 hour 
per assessment. 
The addition of a participant incentive adds a tangible benefit to participants and serves as a 
potential motivation to complete the study. 
 The inclusion of a formalized Safety Monitoring protocol helps reduce participant risk by 
predicting potential areas of concern and by outlining clear procedures with how to manage 
incidents that may come up. 
 
  

5. Does the requested amendment require new documents or changes 
to the approved consent form or other documents?  
  
Yes. Please see Appendices 1-7. 
 
 
 
Appendix 1 
Safety Monitoring Protocol 
 
Appendix 2 
Summary of Assessments 
 
Appendix 3 
Consent Form (v.1.4) 
 
Appendix 4 
Phone Screener (v.1.4) 
 
Appendix 5 
In-person Screener (v.1.4) 
 
Appendix 6 
Home Baseline Assessment (v.1.4) 
 
Appendix 7 
In-Person Baseline Assessment (v.1.4) 
  
 
References 
1 Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported 
measure of medication adherence. Med Care. 1986;24(1):67-74. 
 
 

 
 
 
 
 
 
 
Appendix 1:  
Safety Monitoring Protocol 
 
(Language Taken from the NCCIH Protocol Submission) 
 
 

Safety Monitoring - as part of the NCCIH submission, a formal Safety Monitoring Protocol was 
created.  It is outlined below. 
Oversight of internal monitoring of the participants’ safety will be conducted by the PIs, Dr. 
Eric Loucks and Dr. Willoughby Britton. Oversight of the external Data and Safety Monitoring 
Committee will be conducted by the chair (Dr. Edmondson). The Data and Safety Monitoring 
Committee will include experts in cardiology, psychology/psychiatry, epidemiology, and 
biostatistics.  
 
Entities Conducting Monitoring 
 
The Institutional Review Board (IRBs) at Brown University will review all research 
procedures, and will provide oversight. Internal monitoring will be done by the Brown University 
principal investigators (Dr. Loucks and Dr. Britton) and the Brown University IRB. The Data 
Safety Monitoring Committee will provide external monitoring, and will meet every six months by 
phone or in-person. They will be provided data every six months to evaluate potential effects of 
the RCT on major outcomes (e.g. medical regimen adherence). Any serious adverse effects will 
be immediately reported to the principal investigators (Loucks, Britton) and the committee chair.  
 
What is Monitored 
 
Monitoring is done of all procedures to ensure that they conform to the approved protocol; of 
unforeseen circumstances that might arise and affect safety; of all reports of serious adverse 
events as defined in US Department of Health and Human Services regulations for the 
protection of human research subjects 45 CFR Part 46, and the FDA 312.32 (death, life-
threatening experience, new or prolonged hospitalization, persistent or significant 
disability/incapacity); of other significant adverse events (adverse events that lead to drop out by 
participant or termination by the investigator); of unexpected adverse events resulting from the 
study; and of expected adverse events.  
 
Monitoring is done of all study inclusion and exclusion criteria. During this clinical trial, we 
will notify officials, as mandated by law, if a participant reports intentions to harm him/herself or 
others, or reports child abuse or abuse of an elder. Dr. Ellen Flynn, a licensed psychiatrist, will 
be available to advise on any psychological events that occur, and provide referrals for 
treatment if needed. 
 
Frequency of Monitoring 
 
All adverse events will be continuously monitored by the PI. Participants will be given 
contact information so that they can inform us of events that occur in between study visits. Dr. 
Loucks will conduct daily oversight of participant safety. He will meet weekly with staff to review 
participant progress and their experiences with the experimental procedures, including adverse 
events. Any adverse events that are observed and/or reported will be immediately reported to 
Dr. Loucks, Dr. Britton, and the Data Safety Monitoring Committee chair. The Investigators and 
Data Safety Monitoring Committee will be available to meet outside of the regularly scheduled 
meetings (scheduled semiannually), if necessary, due to concerns regarding a particular 
participant or any problems that may arise for participants. If necessary, they will make 
appropriate recommendations for changes in protocol, or terminate the study.  
The Brown 
University IRB conducts the monitoring at the continuing reviews as scheduled, whenever 
modification requests are considered, and upon receiving reports of serious adverse events 
from the PI or anyone else.  
 
Reporting Plan 
Any serious adverse events that are observed and/or reported will be immediately reported 
to Dr. Loucks and the Data Safety Monitoring Committee Chair. Serious adverse events are 

then reported to the Brown University IRB and to NIH. Brown’s IRB requires fatalities related to 
the study be reported within 24 hours. All serious adverse events related to this study will be 
reported to the Brown University IRB immediately by telephone and by written report within 48 
hours of our receipt of information regarding the event. All other adverse events related to the 
study will be reported at the continuing review. Serious adverse events will also be reported in 
writing to the NIH Project Officer within 48 hours. All serious adverse events related to the study 
will be reported annually in the Progress Report sent to the NIH Project Officer.  
Any actions taken by the IRB, other than acceptance of the adverse event report, will be 
reported to the NIH along with any changes or amendments to the protocol requested by the 
IRB in response to these reports. Proposed changes or amendments to the protocol in general 
must be requested first in writing to the Brown and IRB, which will then grant or deny permission 
to make the requested change or amendment in protocol. NIH will subsequently be informed of 
any substantive changes or amendments in approved protocol. 
 
Injury due to physical activities: It is possible that injuries could be sustained from (1) the gentle 
mindful movements (yoga), or (2) physical activities that participants engage in as a result of the 
intervention encouraging exploration of physical activity as a way to reduce blood pressure. 
 
(1) Mindful movements: Participants receive a handout during the orientation showing the 
yoga poses that will be offered during the course. They are encouraged to explore limits 
in their body related to movement, but not to go beyond those limits Participants are 
asked to listen to what their body is telling them more closely than what the mindful 
movement instructor is telling them. Modifications of poses are available, including for 
those limited to chairs or wheelchairs. Participants are encouraged to bring the handout 
of poses to their health care providers if they have any physical limitations, so that the 
providers can advise on which poses to do, and which to avoid. 
(2) Physical activities: Participants are encouraged to explore physical activities that 
promote strength and conditioning as a way to reduce blood pressure. As with the 
mindful movements, they are encouraged to explore limits in their body related to 
movement, but not to go beyond those limits. Participants are asked to listen to what 
their body is telling them more closely than what the mindful movement instructor is 
telling them. Furthermore, they are encouraged to ask their healthcare provider about 
advised physical activities if they have any physical limitations.  
 
All patients will be monitored by study staff at weekly intervals in person or by telephone and 
assessed every two weeks with questionnaires about physical injuries, specifically the following 
questions: 
 
1. Have you sustained any physical injuries during the past 2 weeks?  
 
If yes,  
(a) please describe the injury 
(b) please describe what happened to cause the injury.  
(c) did this injury include  
i. 
Broken bone(s) yes/no 
ii. 
Lacerations requiring stiches yes/no 
iii. 
Concussion yes/no 
 
If injuries include any of the following, it will be reported to Data Safety Monitoring Committee 
member Dr. Hank Wu, MD, who is a practicing physician and researcher. He will advise on any 
follow-up needed. It will also be reported to the chair of the Data Safety Monitoring Board.  

 
a. Broken bone(s) 
b. Lacerations requiring stiches 
c. Concussion 
 
Non-Response to Treatment: The possibility that the treatment will not yield benefit is 
another possible risk and will be explained during informed consent procedures. Non-
responders (identified as minimal change in medical regimen adherence from baseline 
assessment) will be provided with referrals to other treatment, if desired.  
INTERVENTION DISCONTINUATION  
If serious adverse events are significantly higher in the treatment vs. control groups, the study 
will be terminated. 
COMMITTEES 
Data Safety Monitoring Board: 
Oversight of internal monitoring of the participants’ safety will be conducted by the PIs, Dr. 
Eric Loucks and Dr. Willoughby Britton. Investigators on this application have extensive 
experience with clinical trials for mindfulness-based interventions and cardiovascular outcomes. 
Oversight of the external Data and Safety Monitoring Committee will be conducted by the chair, 
Dr. Donald Edmondson, PhD, is Assistant Professor of Behavioral Medicine at Columbia 
University Medical Center. He is a Psychologist, and has extensive research experience in 
evaluating effects of stress and psychsocial factors on cardiovascular disease outcomes.246-264 
The Data and Safety Monitoring committee will also include Dr. Wen-Chih (Hank) Wu and Dr. 
Tao Liu. Dr. Wu, MD, is Associate Professor of Medicine and Associate Professor of 
Epidemiology at Brown University. He is a practicing clinical cardiologist with research in 
preventive cardiology,265-272 and will be able to advise on clinical outcomes and any 
cardiovascular complications arising from the study, in addition to methodological concerns. Dr. 
Liu, PhD, is an Assistant Professor of Biostatistics at Brown University, experienced in clinical 
trials.273,274 He will receive all preliminary analyses from the primary statistician, and will have 
access to all data from the study, to evaluate any evidence of serious adverse effects or other 
concerns.  
 
Entities Conducting Monitoring 
 
The Institutional Review Board (IRBs) at Brown University will review all research 
procedures, and will provide oversight. Internal monitoring will be done by the principal 
investigators (Dr. Loucks and Dr. Britton) and the Brown University IRB. The Data Safety 
Monitoring Committee will provide external monitoring, and will meet every six months by phone 
or in-person. During the randomized-controlled trial phase (phase 4), they will be provided data 
every six months to evaluate potential effects of the RCT on the primary outcome (i.e. medical 
regimen adherence). Any serious adverse effects will be immediately reported to the principal 
investigator (Loucks) and the committee chair (Edmondson). 
 
 

 
 
 
 
 
 
 
Appendix 2: 
Summary of Assessments 
 
 

Summary of Assessments (e.g., timing and intent of assessment): 
 
 (1) Phone Screener 
 
Previously called the “Phone Screening Questionnaire” 
 
Completed by phone any time prior to the intervention 
 
Used to screen individuals for the following eligibility criteria: age, language, mental health, and 
mindfulness practices (see protocol for details on eligibility requirements).  Blood pressure, the 
primary eligibility criteria of interest, will be measured in person at the in-person screening. 
 
Phone screener provides talking guidelines for the RA to use in order to set up appointments for 
the in-person screening and to find out about general availability.  Also provides the interested 
individual with information about the study. 
 
(2) In-Person Screening 
 
Previously called the “First In-Person Visit Screening Assessment Form” 
 
Completed up to three months prior to intervention 
 
1st BP reading taken in order to determine eligibility 
 
Takes place at 121 South Main Street (office/laboratory) 
 
If eligible, Consent Form is completed at this visit 
 
Estimated time to complete is 20-30 minutes 
 
(3) Home Baseline Assessment 
 
Previously called the “Baseline Questionnaire” 
 
Completed up to three weeks prior to commencement of intervention 
 
Done online by participant at home or other location of choice. Participant will be sent a link to 
the online survey or will be provided with a paper version (if preferred). 
 
Questionnaire will take around 2-2.5 hrs to complete 
 
(4) In-Person Baseline Assessment 
 
Previously called the “Second In-Person Visit Screening Assessment” 
 
Completed up to three weeks prior to intervention 
 
2nd BP reading will be taken as well as the following assessments: 
o Height, weight, and hip and waist circumference 
o Medication use 
o Diet 
o Anxiety and depressive symptomology 
o Attention control activities (ANT and SART) 
 
Takes place at 121 South Main Street (office/laboratory) 
 
Estimated time to complete is around 1.5 to 2 hrs 
 
(5) Mindfulness Course 
 
9 sessions that are 2.5 hrs each as well as 1 retreat day on a Saturday that will be 8hrs long 
 
Participants will be given mindfulness ‘homework’ to practice daily (around 1hr per day, 6 days 
per week for 8 weeks) 
 
Participants will be asked to complete mindfulness assignments from home during the course.  
These assessments have already been approved by the IRB. 
 
Also approved are Teacher Fidelity assessments that will be administered during weeks 4 and 8. 

 
 
(6)  10 Week Post-Intervention Assessments (HOME and IN-PERSON) 
 
To take place roughly 10 weeks from Baseline, after the Mindfulness Training is complete. 
 
Similar to assessments administered at Baseline, there will be both an online component that 
can be completed by the participant at home, and an in-person component that will take place 
at 121 South Main Street (office/laboratory) 
 
Questionnaires and assessments to be completed at this visit are identical to those administered 
at the In-Person Baseline Assessment, with the exception of question items for which the 
answers should not change or be informative (e.g., age, race/ethnicity, education, adverse 
childhood experiences, family history of hypertension). 
 
Additionally, adverse events are monitored at the 10 week, 6 month and 1 year follow-ups. 
 
Estimated time to complete is up to 3 hrs 
 
(7)  Focus Group 
 
Participants will be invited to take part in a  focus group after the intervention is complete in 
order to share any advice they may have on how to improve the intervention 
 
Takes place at 121 South Main Street 
 
Estimated time is 1.5 hrs 
 
(8)  6 Month Post-Intervention Assessments (HOME and IN-PERSON) 
 
To take place roughly 6 months from Baseline, after the Mindfulness Training is complete. 
 
Similar to assessments administered at Baseline, there will be both an online component that 
can be completed by the participant at home, and an in-person component that will take place 
at 121 South Main Street (office/laboratory) 
 
Questionnaires and assessments to be completed at this visit are identical to those administered 
at the In-Person Baseline Assessment, with the exception of question items for which the 
answers should not change or be informative (e.g., age, race/ethnicity, education, adverse 
childhood experiences, family history of hypertension). 
 
Additionally, adverse events are monitored at this follow up. 
 
Estimated time to complete is up to 3 hrs 
 
(9)  1 Year Post-Intervention Assessments (HOME and IN-PERSON) **NEW 
 
To take place roughly 1 year from Baseline, after the Mindfulness Training is complete. 
 
Similar to assessments administered at Baseline, there will be both an online component that 
can be completed by the participant at home, and an in-person component that will take place 
at 121 South Main Street (office/laboratory) 
 
Questionnaires and assessments to be completed at this visit are identical to those administered 
at the In-Person Baseline Assessment, with the exception of question items for which the 
answers should not change or be informative (e.g., age, race/ethnicity, education, adverse 
childhood experiences, family history of hypertension). 
 
Additionally, adverse events are monitored at this follow up. 
 
Estimated time to complete is up to 3 hrs 
 
 
 

 
 
 
 
 
 
 
 
Appendix 3: 
Revised Consent Form 
with Track Changes 
 
(v.1.4 – November 6, 2015) 
 
 

MBHT Consent Form, Version 1.4, November 6, 2015  
  Page 1 of 6 
 
Agreement to Participate in a Research Study 
 
Investigation of the Effects of Mindfulness on Blood Pressure and Well-Being 
 
You are being asked to take part in a Brown University research study about the effects of 
mindfulness and hypertension education on blood pressure and risk factors for hypertension. 
This form will explain the purpose of the study, how the study will be carried out and what you 
will be expected to do.  It will also explain the possible risks and possible benefits of being in the 
study.  If any part of the following description is not clear to you, you are encouraged to contact 
the researcher to answer any questions before you decide whether to take part in the study. If you 
decide to participate, please fill out and sign the last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health 
education on blood pressure. You have been selected for this study because you expressed 
interest in the project and because you met entrance criteria for having prehypertension or 
hypertension, or another cardiovascular risk factor that could be influenced by this program.  
In order to assess the effects of these practices, you will be asked to complete some 
questionnaires and laboratory assessments before and after learning the mindfulness practices.  
Assessments will be completed at: baseline, 10 weeks, 6 months and 1 year.  If you complete the 
study, you will be given $100 USD at the time of completion for your participation, to express 
our gratitude. 
Participation in this study involves receiving training in mindfulness practices as well as health 
education on blood pressure.  If eligible, you will be randomly assigned to either receive the 
training now or in about six months from now (if still available and interested). 
 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
1) Participate in an interview in which you will be asked questions about past and present 
mental health, including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, 
smoking, medication use, personality, emotions, attention and past experiences, including 
stressful or traumatic experiences. These questions will probe sensitive psychological areas, 
including physical, emotion and sexual abuse. These questionnaires may take up to 3 hours to 
complete. By completing the interviews and questionnaires, you are giving the researchers 
permission to use the information you have provided. You have the right not to answer any 
of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference, hip circumference, 
physical activity, and antihypertensive (blood pressure) medication use at baseline and after 
the mindfulness course. Physical activity will be assessed for a week at a time using small 
Deleted: a 
Deleted: 2 
Deleted:  and 
Deleted: . 

MBHT Consent Form, Version 1.4, November 6, 2015  
  Page 2 of 6 
 
actigraphy monitors that attach to your wrist and hip. If you take antihypertensive 
medication, we will provide you with an electronic bottle cap that will automatically record 
when the pill bottle is opened during the study. This will help us measure how often the 
medication is used. 
 
4) You will be asked to perform some cognitive tasks. Some of these tasks may involve 
computer-based tests of attention or decision-making. Together these tests may take as long 
as 45 minutes. 
 
5) You will participate in the mindfulness program, which consists of 9 weekly sessions of 2.5 
hours each and will include one 8 hour weekend retreat. Daily homework assignments may 
take as long as one hour and consist of practicing mindfulness exercises with the aid of a 
guided audio CD and completing worksheets related to stress, thoughts, and common 
reactions to various types of events. 
 
6) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. 
The recordings will be transcribed so that we may analyze the text. The recordings will be 
identified by study number, will only be heard by study staff and will be destroyed after 
transcription.  
 
7) You will be asked to complete a few short questionnaires each week during the 9 week 
condition. 
 
8) After 10 weeks, you will be asked to complete questionnaires and return to the laboratory to 
repeat the same procedures for a second day of testing. You will also be invited to participate 
in a focus group to share any advice you may have on how to improve the intervention.  
 
9) Six months and one year after the beginning of the study, you will be asked to return to the 
laboratory to repeat the same testing procedures. 
 
 
Deleted: One 
Deleted: 9 
Deleted: Three 
Deleted: the end of the 9 week condition

MBHT Consent Form, Version 1.4, November 6, 2015  
  Page 3 of 6 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as questionnaires, 
height, weight and waist circumference.  
3 hours 
Mindfulness course 
In-person 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 
8 hours  Total course time: 30.5 hours 
Home practices assigned during mindfulness course.  
1 hour per day, 6 days per week, for 8 
weeks.  Total practice time: 48 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, that 
take place immediately after course completion. 
3 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, that 
begin 6 months after baseline. 
3 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, that 
begin 1 year after baseline. 
3 hours 
Participate in focus group after intervention completion 
to share any advice you may have on how to improve 
the intervention. 
1.5 hours 
TOTAL TIME COMMITMENT FOR STUDY 
93.0 hours 
 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred 
since the first assessment. Specifically, you will receive an individualized handout listing % 
change (increase or decrease) on scales of attention, stress, mood, health behaviours, weight, and 
blood pressure across the study. 
 
2.  Discomforts and Risks 
The risks to you in this study are small.  The questionnaires used in the study are routine, 
standardized forms for epidemiologic research.  Certain questions may be upsetting as they may 
probe sensitive psychological areas and inquire about upsetting or traumatic events, including 
physical, sexual or emotional abuse and/or current psychiatric symptoms.  Since your 
participation is voluntary, you have the right to skip any questions that make you uncomfortable. 
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, 
feelings or body sensations. Some individuals may experience an initial increase in undesirable 
feelings with increased attention to them. 
 
Deleted: 2 hours
Deleted: mindfulness 
Deleted: 2 hours
Deleted: take place that take place 3 
Deleted: course completion
Deleted: 2 hours
Deleted: 87.0 hours

MBHT Consent Form, Version 1.4, November 6, 2015  
  Page 4 of 6 
 
It is possible that injuries could be sustained during the study either from the gentle mindful 
movements (i.e., yoga), or from physical activities that participants engage in as a way to reduce 
blood pressure.  To help limit this, you will receive a handout showing the yoga poses that will 
be offered during the course that you can show your health care provider so that they can advise 
on which poses to do, and which to avoid. Modifications of poses will be available as needed. 
None of the poses (or the yoga as a whole) are mandatory to be done. You will also be 
encouraged to explore physical activities that promote strength and conditioning as a way to 
reduce blood pressure. You will be encouraged to not go beyond any physical limits of your 
body, and will be encouraged to ask your healthcare provider about advised physical activities 
and mindful movements if you have any physical limitations. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this 
study.  However, participation in the study creates the potential benefit of a) identifying effective 
treatments for elevated blood pressure, b) gaining knowledge of the effects of mindfulness 
practices, c) receiving information about your psychological and physical functioning. 
 
To express our gratitude, at the end of your last follow-up visit, you will receive $100 USD for 
your participation in the study.  
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical 
activity, and reducing excessive alcohol consumption may also be beneficial for reducing blood 
pressure. Education about these therapies are integrated into this course, but other forms of these 
alternative therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to 
a study ID# instead of your name.  All questionnaires in this study will be filled out through an 
online survey or a paper version of the survey if you prefer.  All of these questionnaires will be 
linked solely to your study ID#, so that your identity is protected and your answers are 
confidential.  Although these measures have been taken to protect your personal information, 
complete confidentiality cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to 
confidentiality. If your questionnaire responses indicate that you pose a serious danger to 
yourself or to another person, then a collaborator (Dr. Ellen Flynn) who is a licensed psychiatrist, 
may contact you to discuss your responses and possible referral to a treatment provider. 
Questionnaire items that may warrant follow-up include endorsements of statements about 
hurting yourself, any high scores in depression, anxiety, or other clinically significant problems. 
You should also know that there are times when the law might require the release of your 
responses without your permission.  For example, State law requires researchers to report abuse 
or neglect of children to the Department of Children, Youth and Families (DCYF).   State law 

MBHT Consent Form, Version 1.4, November 6, 2015  
  Page 5 of 6 
 
also requires researchers to report abuse or neglect of people age 60 and older to the Division of 
Elderly Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in 
any published reports about this study. Results will be reported in a summarized manner in such 
a way that you cannot be identified. All personally identifiable information will be "de-
identified" and only a unique code number will be used. Study records will be identified with a 
unique code number and initials. All study records and specimens will be stored in a secure 
storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, 
including not answering certain questions. If you decide now to participate, you can change your 
mind later and quit the study.  The decision to not participate or to withdraw from the study will 
not adversely affect current or future interactions with Brown University. The decision to not 
participate or to withdraw from the study will also not adversely affect your relationship with 
your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for 
alternative treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. 
Eric B. Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like 
more information about the rules for research studies, or the rights of people who take part in 
those studies, you may contact the Brown University Research Protections Office, telephone 
number 1-866-309-2095 or 401-863-3050. 
 

MBHT Consent Form, Version 1.4, November 6, 2015  
  Page 6 of 6 
 
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY 
QUESTIONS HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO 
PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
_______________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):______________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):__________________________________________________________________ 
 
Telephone:__________________________(cell)     __________________________(other) 
 
 
 
 
 
 

 
 
 
 
 
 
 
Appendix 4: 
Revised Phone Screener 
with Track Changes 
 
(v.1.4 – November 6, 2015) 
 
 

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 1 of 8 
 
 
 
 
 
 
 
PHONE-DELIVERED SCREENING 
QUESTIONNAIRE  
 
 
 
 

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 2 of 8 
PHONE SCREENING QUESTIONNAIRE PART 1 
 
The script is shown below in bold italics.  
 
PID. Participant ID: ___________ 
 
SQ01. Staff ID: ______________ 
 
SQ02. Today’s Date (MMDDYY): ________________ 
 
SQ03. Current Time (24 hour time, e.g. 14:45): ________ 
 
Please now call the participant.  
 
SQ04. Was the participant reached?   YES   NO 
 
Hello, my name is ____________. I am calling from the Brown University School of Public 
Health because (name of participant) expressed interest in participating in our 
mindfulness blood pressure study. Is he/she available to talk at this time? 
 
I would like to do a 10-15 minute phone interview with you to determine if you are a good 
match for this particular study.  
 
SQ05. Is now a good time to speak? 
 
[If yes, proceed to SQ05 script below] 
 
If no… When would be a good time to talk? 
 
SQ06. Day to call back (DDMMYY) ____________ 
 
SQ07. Time to call back ______ AM/PM 
OK, great. How about I give a quick overview of the study, and can then answer any 
questions you may have to see if it is a good fit for you. We will then go through a 
screening questionnaire to see if you qualify for the study. Does this sound OK? 
In this study, we are looking to see if mindfulness practices improve blood pressure, and 
if education about hypertension risk factors may also improve blood pressure. If eligible 
and if selected to participate, we will provide you with training in meditation, mindful 
movements, and the roles of things like diet, physical activity and medication in reducing 
blood pressure. You will be taught by a very experienced teacher who is an expert in 
these fields. The course is free and will take place over a 9-week period, where you come 
to a class once each week for 2.5 hours each time. There is also a one-day retreat on a 
Saturday that will be 8 hours long. As part of the project, we will also ask you to 
participate in health assessments before and after the study. Health assessments include 
measures such as blood pressure, height and weight, and questionnaires about your 
health and experiences.  At the end of the study, you will be given $100 USD to express 
our gratitude.  
Deleted: A basic overview of the study 
is that it is
Deleted: Specifically
Deleted: Y
Deleted: s
Deleted: Also, w

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 3 of 8 
 
Do you have any questions about the study? [answer questions] 
SQ08. Does this study sound like something you would be interested in doing? Yes  No 
[If yes, proceed to next statement below. If no, politely thank the participant for considering 
being in this study, and end the call].  
Great. There are a few things that I would like to make clear before we start the interview. 
First of all, some of the questions that I will ask now to figure out if you are eligible to be 
in this study will be of personal nature, including asking about your mental health and 
life’s experiences.  
 
SQ09. Are you in a private place to talk? 
 
[If yes, proceed to text below. If no, reschedule meeting using variables SQ06 and SQ07 above].  
 
 Because this interview is of a personal nature, it is important that you understand that 
everything you say will be kept strictly confidential.  No one outside of our project will 
ever be able to see your answers, and we will not keep your name in the same place as 
any of your answers. If you are not eligible after the phone screen, we will destroy your 
information.  If you like, though, we can keep your information on file for future studies. 
 
SQ10. Participant’s First Name:  ____________________________________ 
 
SQ11. Participant’s Last Name:______________________________________ 
 
Participant’s Address (in case we need to send any study materials to you): 
SQ12a. Street address: _____________ 
SQ12b. City: ____________________ 
SQ12c: State: ________ 
SQ12d: Zip Code: ________________ 
 
SQ13a. Participant’s Phone number #1 (in case we need to contact you by phone) 
____________________________________ 
 
SQ13b. Participant’s Phone number #2____________________________________ 
 
 
SQ14. Participant’s email address (or mailing address if no email):______________________ 
 
SQ15. Notes from interviewer related to participants’ contact information (if any): 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________ 
 
 
 
PHONE SCREENING QUESTIONNAIRE PART 2 
Deleted: Can I answer any questions 
about the study that you may have
Deleted: SQ04 
Deleted: SQ05 

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 4 of 8 
PID. Participant ID #: ______________ 
 
INCLUSION CRITERIA: All answers in 3rd column must be YES. If an answer is NO, 
immediately proceed to question SQ40. 
 
 
 
Comments 
SQ26. 
 
What is your age? [Is age at least 18 
years?] 
 
 
 
 
YES 
NO 
 
 
SQ27. 
Can you read and write in English? 
YES 
NO 
 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40.  
 
 
 
Comments 
I will now start to ask some questions about your mental health. 
 
SQ28. 
Has anyone ever told you that you have bipolar 
disorder or manic depression?  
YES 
NO  
 
SQ29. 
Has anyone ever used the word “Borderline” to 
describe you? 
YES 
NO  
 
SQ30a. 
 
 
 
SQ30b. 
Have you ever had a hallucination or seen things 
that other people can’t see, or hear things other 
people can’t hear?  
 
Have you ever been diagnosed with 
schizophrenia or psychosis? 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
SQ31_1 
SQ31_2 
SQ31_3 
SQ31_4 
SQ31_5 
SQ31_6 
SQ31_7 
SQ31_8 
Have you ever taken any of the following 
medications that I am about to read to you?  
Lithium                               
Seroquel (quetiapine) 
Abilify (aripiprazole)           
Zyprexa (olanzapine) 
Clozaril (clozapine)           
Haldol/Haloperidol 
Geodon (ziprasidone)         
Risperdal (risperidone) 
 
 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
 
SQ32a 
 
SQ32b 
 
 
SQ32c 
 
 
 
 
SQ32d 
 
 
Have you ever had a suicide attempt?  
 
[If yes, ask…] Have you considered killing 
yourself during the past month?  
 
[If yes, ask…] Are you currently suicidal? 
 
[If yes, keep participant on the phone, and follow 
suicide safety plan below] 
 
[If no, ask…] Are you getting any help for that? If 
not, then provide list of resources from Safety 
Plan including Gateway, Anchor and The 
Providence Center] Not urgent, but inform Dr. 
Flynn about what was discussed.  
YES 
NO 
 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
 
YES 
NO 
 
 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 5 of 8 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40. 
SQ33a 
 
SQ33b 
 
SQ33c 
Would you say you have a trauma history?  
[If yes…]  
In the past month, have you had any 
problems with dissociation (memory loss)?  
In the past month, have you had any 
flashbacks (i.e. sudden and disturbing vivid 
memory) about the trauma?  
YES 
NO 
 
YES 
NO 
 
YES 
NO 
 
 
 
SQ34a 
 
 
 
 
SQ34b 
In the past month, have you had any 
problems with obsessions or compulsions, 
such as washing your hands or checking the 
oven over and over again?  
[If yes…] Has anyone diagnosed you with 
obsessive compulsive disorder? 
YES      NO 
 
 
 
 
YES 
NO 
 
SQ35 
In the past month, have you had a panic 
attack (i.e. sweating, heart palpitations, 
nausea, trouble breathing, fear of 
dying/choking/going crazy)?  
YES 
NO 
 
SQ36 
Have you had any problems with alcoholism 
or drug use in the past year? 
YES 
NO 
 
SQ37 
In the past year, have you had an eating 
disorder, such as starving, binge eating, or 
vomiting?  
YES 
NO 
 
SQ38a 
 
 
 
SQ38b 
 
 
 
 
 
 
SQ38c 
Do you currently have a mindfulness practice, 
such as meditation or yoga? 
 
Please tell me more about your mindfulness 
practice, including how often you practice per 
week.  
 
 
 
 
Do you currently practice meditation more 
than once per week? (yoga does not count as 
meditation in this context) 
YES 
NO 
 
 
Fill in 
response 
in 
comments 
section to 
the right  
 
YES 
NO 
 
 
SQ39 
This class will take place at Brown University 
in-person. Do you have any medical or 
mobility issues that would affect you being 
able to attend class? 
YES 
NO 
 
SQ40 
Participant qualifies for next step of study (next 
step is 1st blood pressure screening) 
YES 
NO 
 
If YES go 
to SQ41.  
 
If NO, go to 
SQ42.  
 
 

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 6 of 8 
SQ41a. Thank you for taking the time to answer these questions. You qualify for the next 
stage of screening, which is to take your blood pressure at our office. If you’re still 
interested, we’d like to schedule a time to have you come in to complete the in-person 
screener.  It will only take 30 minutes or less and will involve taking your blood pressure 
3-5 times.  Is there a day or time that works best for you?  [Schedule the In-Person 
Screening visit now] 
 
SQ41b. As I mentioned earlier, there is a mindfulness intervention that is part of this 
study.  If you are eligible based on the In-Person screening AND are one of the 
individuals randomly selected to receive the intervention, you will then be invited to take 
part in a 9 week Mindfulness Course.  We will be scheduling the mindfulness intervention 
at a time that works best with most of the participants. What days and times of the week 
typically work best with your schedule? Please keep in mind that the sessions are 2.5 
hours long, and take place once per week for 9 weeks.  
 
[Record participant’s availability for Intervention and then proceed with the script] 
 
 
Thank you for your time and interest in this study. We look forward to meeting you in 
person on [DATE / TIME]. Do you have any questions before we end this call?  
 
 
 
 
 
 IF INELIGIBLE: 
SQ42a. Thank you for taking the time to answer these questions. According to the 
survey, you do not qualify for the study at this time. There may be other studies you 
quality for.  
 
SQ42b. Would you like me to keep your information to pass on to these studies?  YES /  
NO 
 
SQ42c. [If yes…] OK, thank you. We will keep this information for future studies you 
may qualify for. Thank you for taking the time to talk with me today. Can I answer any 
questions before hanging up? 
 
SQ42d. [If no…] OK, our copy of this information will be destroyed. Thank you for 
taking the time to talk with me today. Can I answer any questions before hanging up? 
 
 
 
 
 
 
Deleted:  at two different times at least 
a week apart from each other. Let’s 
book the in-person screening 
sessions [Book both sessions. We can 
cancel the second session if they do not 
qualify].
Deleted: 

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 7 of 8 
SAFETY PLAN 
 
Enter details below on paper during screening (These variables should are also be entered in 
the survey via questions SQ10-SQ13). Destroy this paper after screening is complete.  
 
Participant’s First Name:  ____________________________________ 
 
Participant’s Last Name:______________________________________ 
 
Participant’s Address: 
 
Street address: _____________ 
 
City: ____________________ 
 
State: ________ 
 
Zip Code: ________________ 
 
Participant’s Phone number #1: ____________________________________ 
 
Participant’s Phone number #2____________________________________ 
 
During the phone-based screening, if participants respond yes to “Are you currently suicidal?”, 
the interviewer should perform the following 2 steps: 
 
1. Immediately have 911 and Dr. Ellen Flynn called by a colleague who has been 
informed beforehand that this is a possibility.  
 
Specifically, while keeping the participant on the phone, show the text below in the box 
to a colleague.  
 
I have a study participant on the phone who is currently suicidal. Please call 911 
immediately, and tell them: 
 
“I am calling on behalf of [my name] who is performing a research study at Brown 
University. He has a participant on the phone who says they are currently suicidal.” 
Please provide the participants’ contact information to the 911 operator (i.e. name, 
address, phone #, email address) as requested. This information is shown above.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know what you are doing. 
Specifically, let them know we are calling our study’s psychiatrist Dr. Flynn and 911, 
and why you are doing that (i.e. because we are concerned about you). You can speak 
with participant to keep him/her on the phone, but the discussion should not be 
clinical in nature.   
 

MBHT Phone Screening, Version 1.4, November 6, 2015      
                Page 8 of 8 
Examples of questions that could be asked in order to keep them on the phone: 
 
“Tell me what is going on.” 
 
“What’s happening right now?” 
 
Tell me more about why you are interesting in being part of this study.  
 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants if they state they have had 
considered killing themselves in the past month. If they are currently suicidal, the main priority is 
to keep them on the phone while 911 and Dr. Flynn are being contacted.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
 
Call your doctor’s office 
 
Call 911 for emergency services 
 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 

 
 
 
 
 
 
 
Appendix 5: 
Revised In-Person Screener  
with Track Changes 
 
(v.1.4 – November 6, 2015) 
 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.43, July 15November 6,, 2015  
 
            Page 1 of 17 
 
 
 
 
 
 
 
 
FIRST IN-PERSON VISIT SCREENING  
ASSESSMENT FORM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.43, July 15November 6,, 2015  
 
            Page 2 of 17 
 
PID. Participant ID # __________ 
BA2_01. Staff ID # __________ 
BA2_02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA2_03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA2_03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA2_03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA2_03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA2_03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA2_03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA2_03g. Blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA2_03h. Blood pressure 4th reading, diastolic blood pressure:  __________ mmHg 
BA2_03i. Blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA2_03j. Blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA2_04. Were the 4th and 5th systolic blood pressure readings within 20 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements  
 
BA2_05. Were the 4th and 5th diastolic blood pressure readings within 10 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements) 
 
BA2_06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA2_06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA2_06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA2_06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  __________ 
mmHg 
BA2_06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA2_06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA2_06g. Repeated blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA2_06h. Repeated blood pressure 4th reading, diastolic blood pressure:  __________ 
mmHg 
BA2_06i. Repeated blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA2_06j. Repeated blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA2_07. Blood pressure cuff size used:  □ S     □ Reg    □  L        □ XL 
 
BA2_08. Arm that cuff was placed on: 
 □ L      □  R 
 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.43, July 15November 6,, 2015  
 
            Page 3 of 17 
 
Medications (ME) 
 
 
ME01. Do you take any prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME02a. What is the name of the first prescription medication or over-the-counter drug that you take? 
 
 Label product name: 
______________________________________________________________________ 
 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
ME02b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME02c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME02d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
Comment [SF1]: In order to reduce 
participant burden, Medication Use has been 
moved to the In-Person baseline assessment 
since it is not part of the eligibility criteria. 

MBHT First In-Person Screening Questionnaire/Assessments,  
Version 1.43, July 15November 6,, 2015  
 
            Page 4 of 17 
 
 
 
ME02e. Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME02f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME02g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME02h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME02i. Interviewer comments: 
_______________________________________________________________________ 
 
 
ME02j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME03a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME03b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 

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            Page 5 of 17 
 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME03c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME03d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.) 
 
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME03e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME3f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME03g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
 
 

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            Page 6 of 17 
 
ME03h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME03i. Interviewer comments:  
__________________________________________________________________ 
 
 
ME03j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME04a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 
 Label product name: 
_____________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
ME04b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME04c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME04d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 

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            Page 7 of 17 
 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME04g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME04h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME04i. Interviewer comments: 
 
________________________________________________________________________ 
 
ME04j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
section 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME05a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME05b. What is the dosage form? 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 8 of 17 
 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME05c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME05d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME05e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME05f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME05g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 9 of 17 
 
 
ME05h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME05i. Interviewer comments: 
________________________________________________________________________ 
 
 
ME05j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of end of 
medications questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME06a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
__________________________________________________________________ 
 
 
 Label generic name: 
___________________________________________________________________ 
 Don’t know 
 
 
 Prefer not to answer 
 
ME06b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
ME06c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
ME06d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)

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            Page 10 of 17 
 
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME06e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME06f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME06g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME06h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME06i. Interviewer comments: 
________________________________________________________________________ 
 
 
 
ME06i. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
ME07a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
_____________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________ 

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            Page 11 of 17 
 
  Don’t know  
 
 Prefer not to answer 
 
 
ME07b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME07c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME07d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 

MBHT First In-Person Screening Questionnaire/Assessments,  
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            Page 12 of 17 
 
 
ME07g For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME07h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME07i. Interviewer comments: 
____________________________________________________________________ 
 
ME07j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME08a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 Don’t know  
 
 Prefer not to answer 
 
ME08b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME08c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 

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            Page 13 of 17 
 
 Prefer not to answer 
 
 
ME08d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME08e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME08f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME08g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME08h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME08i. Interviewer comments: 
___________________________________________________________________ 
 
 
ME08j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME09a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
____________________________________________________________ 
 
 
 Label generic name: 
 
____________________________________________________________ 

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            Page 14 of 17 
 
  Don’t know  
 Prefer not to answer 
 
ME09b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME09c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 
 
ME09d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME09e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME09f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 

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            Page 15 of 17 
 
 Don’t know 
 Prefer not to answer 
 
 
ME09g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME09h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME09i. Interviewer comments: 
___________________________________________________________________ 
 
ME09j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer 
 
ME10a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
  Label generic name: 
______________________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
 
ME10b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME10c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 

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            Page 16 of 17 
 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
ME10d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME10e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME10f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer

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            Page 17 of 17 
 
ME10g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME10h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME10i. Interviewer comments: _______________________________________________________________ 
 
 
 

 
 
 
 
 
 
 
Appendix 6: 
Revised Home Baseline Assessment 
with Track Changes 
 
(v.1.4 – November 11, 2015) 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 1 of 56 
 
 
 
 
 
 
HOME BASELINE ASSESSMENT 
 
 
 
 
QUESTIONNAIRES ANSWERED BY PARTICIPANTS 
AT BASELINE (VIA ONLINE OR PAPER FORM) 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 2 of 56 
Questionnaire Table of Contents 
Introductory Questions .................................................................................................................. 3 
Background Questions ................................................................................................................... 5 
Physical Activity ............................................................................................................................. 8 
Eating Practices ............................................................................................................................ 10 
Alcohol Consumption ................................................................................................................... 13 
Smoking ......................................................................................................................................... 14 
About You ..................................................................................................................................... 15 
Parent’s Education ....................................................................................................................... 43 
Your Childhood Experiences ...................................................................................................... 45 
Blood Pressure Medication Use .................................................................................................. 48 
More About You ........................................................................................................................... 49 
Family History of Hypertension  ................................................................................................ 53 
Your Sleep ..................................................................................................................................... 54 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 3 of 56 
Introduction 
We appreciate you taking the time to participate in this research study. These questionnaires will 
ask a series of questions on various aspects of your health, health behaviours, family, and other 
life circumstances. It should take approximately one hour. Please keep in mind that you can 
refuse to answer any questions that you are not comfortable with.  
 
Introductory Questions 
 
IQ1_01. Please enter the 4-digit ID number you were given.   ___   ___   ___  ___.  
 
 
 
IQ1_02. What is your main reason for participating in this study? 
 
 
 
 
 
IQ1_03. What do you care about most? 
 
 
 
 
 
IQ1_04. What gives you the most pleasure in your life? 
 
 
 
 
 
IQ1_05. What are your greatest worries? 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 4 of 56 
Please list three personal goals you have for taking this mindfulness program: 
 
PG1_01.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_02.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_03.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 5 of 56 
Background Questions 
 
BQ1_01. 
How many years old are you? 
 
 
 
 
BQ1_02. 
Are you Latino or Hispanic?  
 
 
 
□ No  skip to B3 
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
  
B1_02a.    Which of the following represents your family's country of origin? (check 
 
  
 
 
    all that apply) 
 
 
 
 
 
 
□ Cuba 
 
 
 
 
□ Mexico 
 
 
 
 
□ Puerto Rico 
 
 
 
 
□ Spain 
                         □ South America 
 
 
 
 
□ Columbia 
 
□ Dominican Republic 
 
□ Other Central American 
 
□ Other: _______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 
BQ1_03. 
If you were asked to put yourself into only one of these groups, in which one would 
you  place yourself? (select one only): 
 
 
 
□ Asian 
 
 
□ Pacific Islander 
 
 
□ African American/Black 
 
 
□ Caucasian/White 
 
□ Native American 
□ Other : ________________________ 
□ I do not know 
□ I prefer not to answer
BQ1_04. 
Which of the following best describes your current work situation? (select one only) 
 
 
 
□ Working full-time 
 
 
□ Working part-time  
 
 
□ Retired 
 
 
□ Unemployed:  
 
 
Looking for work 
□ Unemployed: Not currently    
      
looking for work 
 
 
□ Unemployed due to disability 
□ Keeping house or raising children  
    
full-time 
 
□ Military 
 
□ Full-time student 
 
□ Other:_______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 6 of 56 
BQ1_05.    What is the highest grade or level of regular school you have completed? 
 
 
 
□ Elementary School 
 
 
□ Junior High  
 
 
□ High School 
 
 
□ College 
 
 
□ Graduate School  
 
 
□ I do not know 
 
 
□ I prefer not to answer 
     
 
BQ1_06.    What is the highest degree you earned? (select one only) 
 
 
 
□ Elementary school 
□ Some high school, but no GED 
□ GED 
□ High school 
□ Associate degree (Junior College) 
□ Bachelor’s degree 
□ Master’s degree 
□ Doctorate (PhD, EdD, etc) 
□ Professional (MD, JD, DDS, DVM, etc.) 
□ Other: _____________________________ 
□ I do not know 
□ I prefer not to answer 
 
 
 
BQ1_07.    Did you ever attend any other school like a technical, vocational, or trade school? 
 
 
 
□ No 
 
 
 
□ Yes 
 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
BQ1_08.    In total, about how many full-time years of education have you had, including 1st 
grade and all years of school after 1st grade? 
 
 
 
________ years 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 7 of 56 
BQ1_09a.    Do you currently live alone? 
 
 
 
□ No 
 
 
 
□ Yes  skip to next section 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
 
 
BQ1_09b. 
How many people currently live in your household, including   
 
 
             yourself? 
 
 
 
 
 
_________  
      
 
 
 
 
 
 
 
 
 
 
 
BQ1_09c.    Of these people, how many are under 18? 
 
 
 
 
 
 
 _________  
 
 
 
 
 
 
 
BQ1_09d. 
  Of the adults in your household (including yourself), how many bring  
 
 
 
      
 income into the household?   
 
 
 
 
 
 
_________  
 
 
 
 
 
 
 
Deleted: BQ_10

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 8 of 56 
Physical Activity 
 
Physical activities are activities where you move and increase your heart rate above its resting 
rate, whether you do them for pleasure, work, or transportation. The following questions ask 
about the amount and intensity of physical activity you usually do. The intensity of the activity is 
related to the amount of energy you use doing these activities. 
 
Examples of physical activity intensity levels: 
 
Light activities 
 
Your heart beats slightly faster than normal 
You can talk and sing 
 
 
 
 
 
 
 
 
 
Moderate activities 
 
Your heart beats faster than normal 
You can talk but not sing 
 
 
 
 
 
 
 
 
 
 
Vigorous activities 
 
Your heart rate increases a lot 
You can’t talk, or your talking is broken 
up by large breaths 
 
 
 
 
 
 
 
 
Light exercise   
 
Light stretching  
 
Light vacuuming  
or yard work 
Brisk walking     Aerobics class      Strength training    Swim gently 
Aerobics classes 
 Jogging, Running,   
Singles tennis, 
or Power Walking  
 
Racquetball, Pickle ball 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 9 of 56 
How physically active are you? 
 
 
YES 
NO 
I do not 
know 
I prefer 
not to 
answer 
PA1_01. I rarely or never do any physical 
activities. 
□ 
□ 
□ 
□ 
PA1_02. I do some light and/or moderate 
physical activities, but not every week. 
□ 
□ 
□ 
□ 
PA1_03. I do some light physical activity every 
week. 
□ 
□ 
□ 
□ 
PA1_04. I do moderate physical activity every 
week but less than 5 days per week or less than 
30 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_05. I do vigorous physical activities every 
week, but less than 3 days per week or less than 
20 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_06. I do 30 minutes or more per day of 
moderate physical activities 5 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_07. I do 20 minutes or more per day of 
vigorous physical activities 3 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_08. I do activities to increase muscle 
strength, such as lifting weights or calisthenics, 
once a week or more. 
□ 
□ 
□ 
□ 
PA1_09. I do activities to improve flexibility, 
such as stretching or yoga, once a week or more. 
□ 
□ 
□ 
□ 
 
 
 
 
 
Deleted: Diet ¶
The first set of questions ask about foods you usually 
eat or drink.  For each food, please place an X in the 
box (e.g. ) for the answer that best matches how 
often you eat or drink it. Remember to count fruit or 
vegetables that were part of another dish, like a 
banana on cereal or vegetables in a stew. Also, 
please pay attention to the serving sizes. For 
example, one serving size of bread is one slice, so a 
sandwich would contain 2 servings of bread. Please 
include all foods you eat, both at home and away 
from home.   Enclosed are pictures of common 
serving sizes to assist you in filling out your 
questionnaire. ¶
Deleted: How Often You Eat or Drink This 
Item
...

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 10 of 56 
Eating Practices 
 
 
Definitely 
True 
Mostly 
True 
Mostly 
False 
Definitely 
False 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_01. I deliberately take small 
helpings to control my weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_02. I start to eat when I feel 
anxious. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_03. Sometimes when I start 
eating, I just can’t seem to stop. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_04. When I feel sad, I often eat 
too much. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_05. I don’t eat some foods 
because they make me fat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_06. Being with someone who is 
eating, often makes me want to also 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_07. When I feel tense or 
‘‘wound up’’, I often feel I need to 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_08. I often get so hungry that 
my stomach feels like a bottomless 
pit. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_09. I’m always so hungry that 
it’s hard for me to stop eating before 
finishing all of the food on my plate. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_10. When I feel lonely, I 
console myself by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_11. I consciously hold back on 
how much I eat at meals to keep 
from gaining weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_12. When I smell a sizzling 
steak or see a juicy piece of meat, I 
find it very difficult to keep from 
eating even if I’ve just finished a 
meal. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_13. I’m always hungry enough 
to eat at any time. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_14. If I feel nervous, I try to 
calm down by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_15. When I see something that 
looks very delicious, I often get so 
hungry that I have to eat right away. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_16. When I feel depressed, I 
want to eat. 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 11 of 56 
 
 
 
Almost 
Never 
Seldom 
Usually 
Almost 
Always 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_17. How often do you avoid 
‘stocking up’’ on tempting foods? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Unlikely 
A little 
likely 
Somewhat 
likely 
Very 
likely 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_18. How likely are you to 
make an effort to eat less than you 
want? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Never 
Rarely Sometimes 
At least 
once a 
week 
I Do Not 
Know 
I Prefer 
Not to 
Answer 
EE1_19. Do you go on eating 
binges even though you’re not 
hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Only at 
mealtimes 
Sometimes 
between 
meals 
Often 
between 
meals 
Almost 
always 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_20. How often do you 
feel hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_21. On a scale from 1 to 8, where 1 means 
no restraint in eating and 8 means total restraint, 
what number would you give yourself? Mark the 
number that best applies to you: 
□ □ □ □ □ □ □ □ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 12 of 56 
Table Salt Use: 
 
TS1_01 
Please report your average total use, during the past year, of “salt added at the table”.  
Would you say… 
 
Never ...................................................................... □ 
Less than once per month ....................................... □ 
1-3 shakes per month .............................................. □ 
1 shake per week .................................................... □ 
2-4 shakes per week ............................................... □ 
5-6 shakes per week ............................................... □ 
1 shake per day ....................................................... □ 
2-3 shakes per day .................................................. □ 
4-5 shakes per day .................................................. □ 
6+ shakes per day ................................................... □ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 13 of 56 
Alcohol Consumption  
 
A drink of alcohol is defined as 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine 
cooler, 1 cocktail, or 1 shot of liquor. 
 
AC1_01. During the past 30 days, how many days per week or per month did you have at least 1 
drink of any alcoholic beverage? [if none, skip to next section] 
 
_______________ 
 
 
AC1_02. On the days when you drank, about how many drinks did you drink on average?  
 
______________ 
 
 
AC1_03. Men: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 5 or more drinks on an occasion? 
 
Women: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 4 or more drinks on an occasion? 
 
_________________ 
 
 
Deleted: STOP

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 14 of 56 
Smoking  
 
SM1_01. 
Have you smoked at least 100 cigarettes in your entire life? 
 
 Yes 
 No 
 I Do Not Know 
 Prefer not to answer 
 
 
SM1_02.  
Did you ever become a daily smoker (that is, smoke every day or nearly every day 
for two months or longer)? 
 
 Yes 
 No  skip to next section 
 I Do Not Know 
 Prefer not to answer 
 
SM1_03.  
How old were you when you last smoked daily? 
 
  
Age ______ (in years) 
 
 
 I Do Not Know 
 Prefer not to answer  
 Still smoking daily 
 
 
 
SM1_04. 
Do you smoke cigarettes now? 
 
 Yes 
 No  skip to next section 
 I Do Not Know 
 Prefer not to answer 
 
 
 SM1_04a.    How many cigarettes per day do you smoke? (One pack equals 20   
 
   
 
 cigarettes) 
 
  
 
 
Number of cigarettes ________  
 
 
 
 
 
 
 
 
 I Do Not Know 
 
 
 
 
 Prefer not to answer 
 
 
 
Deleted: SC1_01

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 15 of 56 
About You 
 
Please bring to mind a type of very tasty food that may contribute to hypertension through high 
salt intake or through eating too many calories (e.g., sweet sugary dessert, salty snack foods, etc.).   
 
Think about the LAST WEEK you MOST WANTED this type of food.  For each item, select a 
number (0 to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine its taste? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
6. …imagine its smell? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …imagine what it would feel like in 
your mouth or throat? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
9. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
10. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
11. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 16 of 56 
Please bring to mind any times in the LAST WEEK when you had a desire to do sedentary 
activities (e.g., read a book, watch a movie, be on the computer, etc.) instead of physical activities 
(e.g., walking, gardening, exercise). 
 
Think about the LAST WEEK you MOST WANTED to do a sedentary activity.  For each item, 
select a number (0 to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
6. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Please bring to mind any times in the LAST WEEK when you had a desire to drink alcohol, such 
as wine, beer or spirits.   
 
Think about the LAST WEEK you MOST WANTED alcohol.  For each item, select a number (0 
to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine its taste? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
6. …imagine its smell? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …imagine what it would feel like in 
your mouth or throat? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
9. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
10. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
11. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 17 of 56 
Using the scale provided, please indicate how much each of the following statements reflects how 
you typically are.  
 
 
Not 
at all 
A 
little 
Somewhat 
Fair 
Amount 
Very 
much 
I do 
not 
know 
I 
prefer 
not to 
answer 
SC1_01. I am good at resisting 
temptation. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_02. I have a hard time 
breaking bad habits. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_03. I am lazy. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_04. I say inappropriate 
things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_05. I do certain things that 
are bad for me, if they are fun.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_06. I refuse things that are 
bad for me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_07. I wish I had more self-
discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_08. People would say that 
I have iron self-discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_09. Pleasure and fun 
sometimes keep me from 
getting work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_10. I have trouble 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_11. I am able to work 
effectively toward long-term 
goals. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_12. Sometimes I can’t stop 
myself from doing something, 
even if I know it is wrong. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_13. I often act without 
thinking through all the 
alternatives.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 18 of 56 
The next few statements are about certain ways you may feel about your life. Please indicate how 
strongly you agree or disagree with each of the following statements: Strongly agree; Agree; 
Neutral, Disagree, or Strongly disagree 
 
 
 
 
  
Strongly 
agree 
Agree 
Neutral 
Disagree 
Strongly 
disagree 
I Do 
Not 
Know 
Prefer 
not to 
answer 
SE1_01. I have little 
control over the things that 
happen to me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_02. There is really no 
way I can solve some of 
the problems I have. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_03. There is little I 
can do to change many of 
the important things in my 
life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_04. I often feel 
helpless in dealing with 
the problems of life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_05. Sometimes I feel 
that I am being pushed 
around in life. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_06. What happens to 
me in the future mostly 
depends on me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SE1_07. I can do just 
about anything I really set 
my mind to do. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 19 of 56 
Please read each statement carefully before answering. To the left of each item, indicate how 
often you behave in the stated manner, using the following scale: 
 
 
Almost 
never 
Not very 
often 
Sometimes Frequently 
Almost 
always 
I Do 
Not 
Know 
Prefer not 
to answer 
CO1_O1. When I fail at 
something important to me, 
I become consumed by 
feelings of inadequacy. 
 
 
 
 
 
 
 
CO1_02. I try to be 
understanding and patient 
towards those aspects of 
my personality I don’t like. 
 
 
 
 
 
 
 
CO1_O3. When something 
painful happens I try to 
take a balanced view of the 
situation. 
 
 
 
 
 
 
 
CO1_O4. When I’m 
feeling down, I tend to feel 
like most other people are 
probably happier than I am. 
 
 
 
 
 
 
 
CO1_O5. I try to see my 
failings as part of the 
human condition. 
 
 
 
 
 
 
 
CO1_O6. When I’m going 
through a very hard time, I 
give myself the caring and 
tenderness I need. 
 
 
 
 
 
 
 
CO1_O7. When something 
upsets me I try to keep my 
emotions in balance. 
 
 
 
 
 
 
 
CO1_O8. When I fail at 
something that’s important 
to me, I tend to feel alone 
in my failure 
 
 
 
 
 
 
 
CO1_O9. When I’m 
feeling down I tend to 
obsess and fixate on 
everything that’s wrong. 
 
 
 
 
 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 20 of 56 
 
Almost 
never 
Not very 
often 
Sometimes Frequently 
Almost 
always 
I Do 
Not 
Know 
Prefer not 
to answer 
CO1_10. When I feel 
inadequate in some way, I 
try to remind myself that 
feelings of inadequacy are 
shared by most people. 
 
 
 
 
 
 
 
CO1_11. I’m disapproving 
and judgmental about my 
own flaws and 
inadequacies. 
 
 
 
 
 
 
 
CO1_12. I’m intolerant and 
impatient towards those 
aspects of my personality I 
don’t like. 
 
 
 
 
 
 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 21 of 56 
The questions in this scale ask you about your feelings and thoughts during the last month. In 
each case, you will be asked to indicate by circling how often you felt or thought a certain way.  
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do not 
know 
I prefer 
not to 
answer 
PS1_01. In the last month, how 
often have you been upset 
because of something that 
happened unexpectedly?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_02. In the last month, how 
often have you felt that you 
were unable to control the 
important things in your life?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_03. In the last month, how 
often have you felt nervous and 
“stressed”? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_04. In the last month, how 
often have you felt confident 
about your ability to handle 
your personal problems?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_05. In the last month, how 
often have you felt that things 
were going your way? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_06. In the last month, how 
often have you found that you 
could not cope with all the 
things that you had to do?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_07. In the last month, how 
often have you been able to 
control irritations in your life? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_08. In the last month, how 
often have you felt that you 
were on top of things? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_09. In the last month, how 
often have you been angered 
because of things that were 
outside of your control? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_10. In the last month, how 
often have you felt difficulties 
were piling up so high that you 
could not overcome them?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 22 of 56 
Please indicate how often the following statements apply to you by checking the box that 
best describes your experience.  
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_01.  I am clear 
about my feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_02.  I pay 
attention to how I 
feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_03.  I 
experience my 
emotions as 
overwhelming and 
out of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_04.  I have no 
idea how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_05.  I have 
difficulty making 
sense out of my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_06.  I am 
attentive to my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_07.  I know 
exactly how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_08.  I care 
about what I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_09.  I am 
confused about how 
I feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_10.  When I’m 
upset, I acknowledge 
my emotions. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_11.  When I’m 
upset, I become 
angry with myself 
for feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_12.  When I’m 
upset, I become 
embarrassed for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Comment [D1]: This section (ER1) was moved up 
in the questionnaire. None of the individual items 
have changed. 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 23 of 56 
 
 
 
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_13.  When I’m 
upset, I have 
difficulty getting 
work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_14. When I’m 
upset, I become out 
of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_15.  When I’m 
upset, I believe that I 
will remain that way 
for a long time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_16.  When I’m 
upset, I believe that I 
will end up feeling 
very depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_17.  When I’m 
upset, I believe that 
my feelings are valid 
and important. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_18.  When I’m 
upset, I have 
difficulty focusing 
on other things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_19.  When I’m 
upset, I feel out of 
control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_20.  When I’m 
upset, I can still get 
things done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_21.  When I’m 
upset, I feel ashamed 
at myself for feeling 
that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_22.  When I’m 
upset, I know that I 
can find a way to 
eventually feel 
better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 24 of 56 
 
 
 
 
Almost 
Never  
(0-
10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_23.  When I’m 
upset, I feel like I am 
weak. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_24.  When I’m 
upset, I feel like I can 
remain in control of my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_25. When I’m 
upset, I feel guilty for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_26. 
When 
I’m 
upset, I have difficulty 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_27.  When I’m 
upset, I have difficulty 
controlling my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_28.  When I’m 
upset, I believe there is 
nothing I can do to 
make myself feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_29.  When I’m 
upset, I become 
irritated at myself for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_30.  When I’m 
upset, I start to feel 
very bad about myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_31.  When I’m 
upset, I believe that 
wallowing in it is all I 
can do. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_32.  When I’m 
upset, I lose control 
over my behaviour. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 25 of 56 
 
 
 
 
Almost 
Never  
(0-
10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_33.  When I’m 
upset, I have difficulty 
thinking about anything 
else. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_34.  When I’m 
upset I take time to 
figure out what I’m 
really feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_35.  When I’m 
upset, it takes me a long 
time to feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_36.  When I’m 
upset, my emotions feel 
overwhelming. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 26 of 56 
This scale is made up of a list of statements each of which may or may not be true about you. For 
each statement, select “definitely true” if you are sure it is true about you and “probably true” if 
you think it is true but are not absolutely certain. Similarly, you should select “definitely false” if 
you are sure the statement is false and “probably false” if you think it is false but are not 
absolutely certain. 
 
 
 
 
 
Definitely 
False 
Probably 
False 
Probably 
True 
Definitely 
True 
I do not 
know 
I prefer not 
to answer 
IS1_01  If I wanted to go on a trip 
for a day (for example, to the 
country or mountains), I would have 
a hard time finding someone to go 
with me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_02  I feel that there is no one I 
can share my most private worries 
and fears with. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_03   If I were sick, I could easily 
find someone to help me with my 
daily chores. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_04   There is someone I can turn 
to for advice about handling 
problems with my family. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_05   If I decide one afternoon 
that I would like to go to a movie 
that evening, I could easily find 
someone to go with me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_06   When I need suggestions 
on how to deal with a personal 
problem, I know someone I can turn 
to. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_07   I don’t often get invited to 
do things with others. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_08   If I had to go out of town 
for a few weeks, it would be difficult 
to find someone who would look 
after my house or apartment (the 
plants, pets, garden, etc.). 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_09   If I wanted to have lunch 
with someone, I could easily find 
someone to join me. 
□ 
□ 
□ 
□ 
□ 
□ 
Comment [SF2]: NEW section 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 27 of 56 
 
 
 
 
Definitely 
False 
Probably 
False 
Probably 
True 
Definitely 
True 
I do not 
know 
I prefer not 
to answer 
IS1_10   If I was stranded 10 miles 
from home, there is someone I could 
call who could come and get me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_11   If a family crisis arose, it 
would be difficult to find someone 
who could give me good advice 
about how to handle it. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_12   If I needed some help in 
moving to a new house or apartment, 
I would have a hard time finding 
someone to help me. 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 28 of 56 
Please indicate how often each of the statements below is descriptive of you. 
 
Statement 
Never 
Rarely 
Sometimes 
Often 
I Do 
Not 
Know 
Prefer 
not to 
answer 
LS1_01. I feel in tune with the people 
around me 
□ 
□ 
□ 
□ 
□ 
s 
LS1_02. I lack companionship 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_03. There is no one I can turn to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_04. I do not feel alone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_05. I feel part of a group of 
friends 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_06. I have a lot in common with 
the people around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_07. I am no longer close to 
anyone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_08. My interests and ideas are 
not shared by those around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_09. I am an outgoing person 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_10. There are people I feel close 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_11. I feel left out 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_12. My social relationships are 
superficial 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_13. No one really knows me 
well 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_14. I feel isolated from others 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_15. I can find companionship 
when I want it 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_16. There are people who really 
understand me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_17. I am unhappy being so 
withdrawn 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_18. People are around me but 
not with me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_19. There are people I can talk 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_20. There are people I can turn 
to 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Deleted: INSTRUCTIONS: I
Comment [D3]: This section (LS1) was moved 
here.  None of the individual items have changed. 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 29 of 56 
Below you will find a list of statements. Please indicate how often each statement applies to you 
generally in daily life.  
 
 
0- 
Never 
1 
2 
3 
4 
5 - Always 
IA1_01. When I am tense I notice where the tension is 
located in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_02. I notice when I am uncomfortable in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_03. I notice where in my body I am comfortable.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_04. I notice changes in my breathing, such as 
whether it slows down or speeds up.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_05. I do not notice (I ignore) physical tension or 
discomfort  
until they become more severe.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_06. I distract myself from sensations of 
discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_07. When I feel pain or discomfort, I try to power 
through it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_08. When I feel physical pain, I become upset.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_09. I start to worry that something is wrong if I 
feel any discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_10. I can notice an unpleasant body sensation 
without worrying about it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_11. I can pay attention to my breath without being 
distracted by things happening around me.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_12. I can maintain awareness of my inner bodily 
sensations even when there is a lot going on around me.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_13. When I am in conversation with someone, I 
can pay attention to my posture.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_14. I can return awareness to my body if I am 
distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_15. I can refocus my attention from thinking to 
sensing my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_16. I can maintain awareness of my whole body 
even when a part of me is in pain or discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_17. I am able to consciously focus on my body as 
a whole.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_18. I notice how my body changes when I am 
angry.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_19. When something is wrong in my life I can feel 
it in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_20. I notice that my body feels different after a 
peaceful experience.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_21. I notice that my breathing becomes free and 
easy when I feel comfortable.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_22. I notice how my body changes when I feel 
happy / joyful.  
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Comment [D4]: The following three sections 
(IA1, RD1, and CR1) were moved here from later in 
the survey.  None of the individual items have 
changed. 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 30 of 56 
 
 
0- Never 
1 
2 
3 
4 
5 - Always 
IA1_23. When I feel overwhelmed I can find a calm 
place inside.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_24. When I bring awareness to my body I feel a 
sense of calm.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_25. I can use my breath to reduce tension.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_26. When I am caught up in thoughts, I can 
calm my mind by focusing on my body/breathing.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_27. I listen for information from my body about 
my emotional state.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_28. When I am upset, I take time to explore how 
my body feels.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_29. I listen to my body to inform me about what 
to do.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_30. I am at home in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_31. I feel my body is a safe place.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_32. I trust my body sensations.  
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 31 of 56 
We are interested in your recent experiences. Below is a list of things that people sometimes 
experience. Next to each item are five choices: “never”, “rarely”, “sometimes”, “often”, and 
“all the time”. Please choose one of these to indicate how much you currently have experiences 
similar to those described. 
 
Please do not spend too long on each item–it is your first response that we are interested in. 
Please be sure to answer every item. 
 
 
Never 
Rarely 
Sometimes 
Often 
All the time 
RD1_01. I think about what will happen in 
the future. 
□ 
□ 
□ 
□ 
□ 
RD1_02. I remind myself that thoughts 
aren’t facts. 
□ 
□ 
□ 
□ 
□ 
RD1_03. I am better able to accept myself 
as I am. 
□ 
□ 
□ 
□ 
□ 
RD1_04. I notice all sorts of little things 
and details in the world around me. 
□ 
□ 
□ 
□ 
□ 
RD1_05. I am kinder to myself when things 
go wrong. 
□ 
□ 
□ 
□ 
□ 
RD1_06. I can slow my thinking at times of 
stress. 
□ 
□ 
□ 
□ 
□ 
RD1_07. I wonder what kind of person I 
really am. 
□ 
□ 
□ 
□ 
□ 
RD1_08. I am not so easily carried away 
by my thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_09. I notice that I don’t take 
difficulties so personally. 
□ 
□ 
□ 
□ 
□ 
RD1_10. I can separate myself from my 
thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_11. I analyze why things turn out the 
way they do. 
□ 
□ 
□ 
□ 
□ 
RD1_12. I can take time to respond to 
difficulties. 
□ 
□ 
□ 
□ 
□ 
RD1_13. I think over and over again about 
what others have said to me. 
□ 
□ 
□ 
□ 
□ 
RD1_14. I can treat myself kindly. 
□ 
□ 
□ 
□ 
□ 
RD1_15. I can observe unpleasant feelings 
without being drawn into them. 
□ 
□ 
□ 
□ 
□ 
RD1_16. I have the sense that I am fully 
aware of what is going on around me and 
inside me. 
□ 
□ 
□ 
□ 
□ 
RD1_17. I can actually see that I am not 
my thoughts. 
□ 
□ 
□ 
□ 
□ 
RD1_18. I am consciously aware of a 
sense of my body as a whole. 
□ 
□ 
□ 
□ 
□ 
RD1_19. I think about the ways in which I 
am different from other people. 
□ 
□ 
□ 
□ 
□ 
RD1_20. I view things from a wider 
perspective. 
□ 
□ 
□ 
□ 
□ 
Deleted: darken 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 32 of 56 
How do you cope with events?  Everyone gets confronted with negative or unpleasant 
events now and then and everyone responds to them in his or her own way. By the following 
questions you are asked to indicate what you generally think, when you experience negative or 
unpleasant events. 
 
 
(Almost) 
Never 
Some-
times 
Regularly 
Often 
(Almost) 
Always 
CR1_01. I think that I have to 
accept that this has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_02. I often think about how I 
feel about what I have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_03. I think I can learn 
something from the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_04. I feel that I am the one 
who is responsible for what has 
happened. 
□ 
□ 
□ 
□ 
□ 
CR1_05. I think that I have to 
accept the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_06. I am preoccupied with 
what I think and feel about what I 
have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_07. I think of pleasant things 
that have nothing to do with it. 
□ 
□ 
□ 
□ 
□ 
CR1_08. I think that I can become 
a stronger person as a result of 
what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_09. I keep thinking about how 
terrible it is what I have 
experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_10. I feel that others are 
responsible for what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_11. I think of something nice 
instead of what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_12. I think about how to 
change the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_13. I think that it hasn’t been 
too bad compared to other things. 
□ 
□ 
□ 
□ 
□ 
CR1_14. I think that basically the 
cause must lie within myself. 
□ 
□ 
□ 
□ 
□ 
CR1_15. I think about a plan of 
what I can do best. 
□ 
□ 
□ 
□ 
□ 
CR1_16. I tell myself that there are 
worse things in life. 
□ 
□ 
□ 
□ 
□ 
CR1_17. I continually think how 
horrible the situation has been. 
□ 
□ 
□ 
□ 
□ 
CR1_18. I feel that basically the 
cause lies with others. 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 33 of 56 
Instructions: Below is a collection of statements about your everyday experience. Using the scale 
below, please indicate how frequently or infrequently you currently have each experience. Please 
answer according to what really reflects your experience rather than what you think your 
experience should be. Please treat each item separately from every other item.  
 
Please indicate the degree to which you agree with each of the following items using the scale 
below. Simply check your response to each item 
 
 
  
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
MA1_01. I could be 
experiencing some 
emotion and not be 
conscious of it until 
some time later.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_02. I break or 
spill things because 
of carelessness, not 
paying attention, or 
thinking of 
something else.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_03. I find it 
difficult to stay 
focused on what’s 
happening in the 
present. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_04. I tend to 
walk quickly to get 
where I’m going 
without paying 
attention to what I 
experience along the 
way.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_05. I tend not 
to notice feelings of 
physical tension or 
discomfort until they 
really grab my 
attention.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_06. I forget a 
person’s name almost 
as soon as I’ve been 
told it for the first 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 34 of 56 
 
 
 
 
 
 
 
 
 
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
MA1_07. It seems I 
am “running on 
automatic” without 
much awareness of 
what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_08. I rush 
through activities 
without being really 
attentive to them.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_09. I get so 
focused on the goal I 
want to achieve that I 
lose touch with what 
I am doing right now 
to get there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_10. I do jobs or 
tasks automatically, 
without being aware 
of what I’m doing.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_11. I find 
myself listening to 
someone with one 
ear, doing something 
else at the same time.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_12. I drive 
places on “automatic 
pilot” and then 
wonder why I went 
there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_13. I find 
myself preoccupied 
with the future or the 
past.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_14. I find 
myself doing things 
without paying 
attention. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_15. I snack 
without being aware 
that I’m eating.    
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 35 of 56 
Please rate each of the following statements using the scale provided. Write the number in the 
blank that best describes your own opinion of what is generally true for you.  
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_01. When I’m walking, I 
deliberately notice the sensations of 
my body moving.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_02. I’m good at finding words to 
describe my feelings.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_03. I criticize myself for having 
irrational or inappropriate emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_04. I perceive my feelings and 
emotions without having to react to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_05. When I do things, my mind 
wanders off and I’m easily distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_06. When I take a shower or 
bath, I stay alert to the sensations of 
water on my body.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_07. I can easily put my beliefs, 
opinions, and expectations into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_08. I don’t pay attention to what 
I’m doing because I’m daydreaming, 
worrying, or otherwise distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_09. I watch my feelings without 
getting lost in them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_10. I tell myself I shouldn’t be 
feeling the way I’m feeling.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_11. I notice how foods and 
drinks affect my thoughts, bodily 
sensations, and emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_12. It’s hard for me to find the 
words to describe what I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_13. I am easily distracted. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_14. I believe some of my 
thoughts are abnormal or bad and I 
shouldn’t think that way.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_15. I pay attention to sensations, 
such as the wind in my hair or sun on 
my face.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 36 of 56 
 
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_16. I have trouble thinking 
of the right words to express how 
I feel about things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_17. I make judgments about 
whether my thoughts are good or 
bad.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_18. I find it difficult to stay 
focused on what’s happening in 
the present.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_19. When I have distressing 
thoughts or images, I “step back” 
and am aware of the thought or 
image without getting taken over 
by it.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_20. I pay attention to 
sounds, such as clocks ticking, 
birds chirping, or cars passing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_21. In difficult situations, I 
can pause without immediately 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_22. When I have a sensation 
in my body, it’s difficult for me 
to describe it because I can’t find 
the right words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_23. It seems I am “running 
on automatic” without much 
aware- ness of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_24. When I have distressing 
thoughts or images, I feel calm 
soon after.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_25. I tell myself that I 
shouldn’t be thinking the way 
I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_26. I notice the smells and 
aromas of things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_27. Even when I’m feeling 
terribly upset, I can find a way to 
put it into words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_28. I rush through activities 
without being really attentive to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 37 of 56 
 
 
 
 
 
 
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_29. When I have distressing 
thoughts or images, I am able 
just to notice them without 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_30. I think some of my 
emotions are bad or 
inappropriate and I shouldn’t feel 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_31. I notice visual elements 
in art or nature, such as colors, 
shapes, textures, or patterns of 
light and shadow.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_32. My natural tendency is 
to put my experiences into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_33. When I have distressing 
thoughts or images, I just notice 
them and let them go.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_34. I do jobs or tasks 
automatically without being 
aware of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_35. When I have distressing 
thoughts or images, I judge 
myself as good or bad depending 
what the thought or image is 
about.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_36. I pay attention to how 
my emotions affect my thoughts 
and behavior.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_37. I can usually describe 
how I feel at the moment in 
consider- able detail.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_38. I find myself doing 
things without paying attention. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_39. I disapprove of myself 
when I have irrational ideas. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 38 of 56 
This Week's Experiences 
 
Instructions: Below is a collection of statements about how you find yourself reacting to 
unpleasant thoughts and feelings.  Using the scale below, please indicate how frequently or 
infrequently you experienced each of the following reactions this week.  Please answer 
according to what really reflects your experience this week rather than what you think your 
experience should be.  
 
This week, when I encountered an unpleasant thought or feeling,  
    
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_01. I tried 
to think pleasant 
thoughts instead 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_02. I 
allowed myself 
to experience it 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_03. I got 
angry or upset 
at myself for 
having the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_04. I felt 
the desire to 
make it better or 
make it go away 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_05. I 
wished I didn’t 
feel or think that 
way 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_06. I tried 
to let my 
thoughts just 
come and go 
without getting 
too entangled 
with them 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 39 of 56 
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_07. I 
thought the 
mood would 
never change 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_08. I 
explored the 
body sensations 
that 
accompanied 
the emotion. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_09. I 
named the 
emotion over 
and over as long 
as it lasted 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_10. I 
turned to work 
or other 
activities to take 
my mind off 
things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_11. I 
named the 
emotion and 
then redirected 
my attention to 
the present 
moment  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_12. I 
thought "This 
mood, too, shall 
pass" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_13. I 
focused on my 
breathing 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_14. I took 
an active 
interest in how 
the experience 
changed over 
time 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 40 of 56 
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_15. I 
explored my 
reactions to the 
thought or 
emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_16. I 
thought "my 
thinking is 
being distorted 
by my mood" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_17. Think 
"Why do I have 
problems that 
other people 
don't have?" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_18. I 
forgave myself 
for having the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_19. I 
challenged the 
thought’s 
validity 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_20. I 
asked myself 
questions about 
the experience 
in order to 
explore it better 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_21. I tried 
not to change it 
because I 
believe it is 
important to 
experience 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_22. I 
labelled my 
thoughts 
"images" or 
verbal "talk" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 41 of 56 
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_23. I 
thought "Why 
do I always 
react this way?" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_24. I 
adopted a 
welcoming 
stance toward 
the 
emotion/thought 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_25. I went 
somewhere 
alone to think 
about my 
feelings 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_26. I sent 
out compassion 
to all people 
who struggle 
with this 
emotion  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_27. I 
restrained 
myself from 
doing anything 
too quickly 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_28. I 
became 
genuinely 
curious about 
the 
thought/emotion 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_29. I 
laughed or 
kidded myself 
about the 
situation 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 42 of 56 
 
 
 
 
 
Almost 
Never 
Very 
Infrequently 
Somewhat 
Infrequently 
Somewhat 
Frequently 
Very 
Frequently 
Almost 
Always 
I do 
not 
know 
I prefer 
not to 
answer 
MS1_30. I treated 
the repetitive 
thought like a “top 
ten radio tune” 
that's playing in 
the background 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_31. I talked 
to others about 
how I was feeling 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_32. I tried to 
forget about it 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_33.  I 
thought "Why can't 
I handle things 
better" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_34. I tried to 
come up with a 
way to make it go 
away 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_35. I said to 
myself "thinking" 
or "this is just a 
thought" 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_36. I thought 
about how much I 
disliked feeling 
that way 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_37. I 
reminded myself 
thoughts are not 
accurate 
reflections of 
reality 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_38. I thought 
that that I must be 
headed into a 
downward spiral  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MS1_39. I thought 
"What I am doing 
to deserve this? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 43 of 56 
Parent’s Education 
 
CS1_01. Please check the box beside the highest grade or degree that your BIOLOGICAL 
MOTHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
CS1_02. Please check the box beside the highest grade or degree that your BIOLOGICAL 
FATHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 44 of 56 
Now please think of the two most important adults in your home between the time you were born 
and age 18 years. Please check the category below that best described their level of education 
during this time period. 
 
CS1_03. First adult’s highest level of education: 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
CS1_04. Second adult’s highest level of education 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 
Deleted: lecel

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 45 of 56 
Your Childhood Experiences 
 
The following questions ask about some difficult experiences that you might have had as a child. 
These questions may be emotionally difficult to answer. Just as a reminder, you do not need 
answer any questions that you would prefer not to. Your answers to these questions, as with all 
questions, will remain confidential.  
 
CE1_01. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Swear at you, insult you, put you down, or humiliate you? 
 
 
 
or 
Act in a way that made you afraid that you might be physically hurt? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_02. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Push, grab, slap, or throw something at you? 
 
 
 
or 
Ever hit you so hard that you had marks or were injured?  
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
CE1_03.  
Before you were 18 years old, did an adult or person at least 5 years older than you 
ever… 
 
 
Touch or fondle you or have you touch their body in a sexual way? 
 
 
 
or 
Attempt or actually have oral, anal, or vaginal intercourse with you? 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 46 of 56 
CE1_04. Before you were 18 years old, did you often or very often feel that … 
 
 
No one in your family loved you or thought you were important or special? 
 
 
 
or 
Your family didn’t look out for each other, feel close to each other, or support each other? 
 
  
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
CE1_05. Before you were 18 years old, did you often or very often feel that … 
 
 
You didn’t have enough to eat, had to wear dirty clothes, and had no one to protect you? 
 
 
 
or 
Your parents were too drunk or high to take care of you or take you to the doctor if you 
needed it? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
  
 
 
CE1_06. Before you were 18 years old, was a biological parent ever lost to you through divorce, 
abandonment, or other reason?   
 
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_07. Before you were 18 years old, was your mother or stepmother:   
 
 
Often or very often pushed, grabbed, slapped, or had something thrown at her? 
 
 
 
or 
Sometimes, often, or very often kicked, bitten, hit with a fist, or hit with something hard? 
 
 
 
or 
Ever repeatedly hit over at least a few minutes or threatened with a gun or knife? 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 47 of 56 
 
CE1_08. Before you were 18 years old, did you live with anyone who was a problem drinker or 
alcoholic, or who used street drugs? 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
     
 
CE1_09. Before you were 18 years old, was a household member depressed or mentally ill, or did 
a household member attempt  suicide? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_10. Before you were 18 years old, did a household member go to prison? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deleted: SN1_01. How many close friends do 
you have? By close friends, we mean people that you 
feel at ease with, and that you can talk to about 
private matters.¶
¶
□ None  skip to Y2 ¶
¶
____ Number of close friends  ¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_01a.    How many of these close friends do 
you see at least once a month?   ¶
¶
____ Number of close friends (if none, write 
zero)¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_02. Thinking about your relatives, how many 
relatives do you feel at ease with, and feel that you 
can talk to about private matters? ¶
¶
□ None  skip to Y3¶
¶
____ Number of relatives ¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_02a.    How many of these relatives do you 
see at least once a month? ¶
¶
____ Number of relatives (if none, write 
zero)¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
¶
¶
¶
SN1_03. About how often do you participate in 
groups or clubs, such as religious connected groups, 
self-help groups, charities, or a public service or 
community group.¶
¶
□ Never or almost never¶
□ A few times a year¶
□ Once or twice a month¶
□ Once a week¶
□ More than once a week¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_04. About how often do you go to religious 
meetings or services? ¶
¶
□ Never or almost never¶
□ A few times a year¶
□ Once or twice a month¶
□ Once a week¶
□ More than once a week¶
...

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 48 of 56 
Blood Pressure Medication Use 
 
BM1_01. Do you currently take medication for your blood pressure? 
□ Yes 
□ No (if responding “no”, please skip to the next page).  
 
 
 
 
Yes 
No 
BM1_02. Do you sometimes forget to take your blood pressure pills? 
 
□ 
□ 
BM1_03. People sometimes miss taking their medications for reasons 
other than forgetting. Thinking over the past two weeks, were there 
any days when you did not take your blood pressure medicine? 
 
□ 
□ 
BM1_04. Have you ever cut back or stopped taking your blood 
pressure medicine without telling your doctor because you felt worse 
when you took it? 
 
□ 
□ 
BM1_05. When you travel or leave home, do you sometimes forget to 
bring along your blood pressure medicine? 
 
□ 
□ 
BM1_06. Did you take all your blood pressure medicine yesterday? 
 
□ 
□ 
BM1_07. When you feel like your symptoms are under control, do you 
sometimes stop taking your blood pressure medicine? 
 
□ 
□ 
BM1_08. Taking blood pressure medicine every day is a real 
inconvenience for some people. Do you ever feel hassled about 
sticking to your treatment plan? 
 
□ 
□ 
 
BM1_09. How often do you have difficulty remembering to take all your blood pressure 
medicine?  
□ Never/rarely 
□ Once in a while 
□ Sometimes 
□ Usually 
□ All the time 
 
 
 
Comment [SF5]: New Section 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 49 of 56 
More About You 
Below are some modifiable factors that likely influence blood pressure. These may not all apply 
to you, as you may already have excellent levels of these factors.  
 
Physical activity: 
The United States Office of Disease Prevention and Health Promotion 2008 Physical Activity 
Guidelines for Americans states that  “Most health benefits occur with at least 150 minutes (2 
hours and 30 minutes) a week of moderate intensity physical activity, such as brisk walking. 
Additional benefits occur with more physical activity. Both aerobic (endurance) and muscle-
strengthening (resistance) physical activity are beneficial.” 
 
RC1_01. How motivated are you to make changes to your physical activity, using a scale of one 
to ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_02. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your physical activity? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Diet: 
 
The Dietary Approaches to Stop Hypertension (DASH) diet eating plan is a diet rich in fruits, 
vegetables, low fat or nonfat dairy. It also includes mostly whole grains; lean meats, fish and 
poultry; nuts and beans. It is high fiber and low to moderate in fat. It is a plan that follows US 
guidelines for sodium content, along with vitamins and minerals. It can be considered to be an 
Americanized version of the Mediterranean diet. 
 
RC1_03. How motivated are you to make changes to your diet to be consistent with the DASH 
diet, using a scale of one to ten, where one = definitely not ready to change, and 10 = definitely 
ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_04. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your diet to be more consistent with the DASH diet? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Comment [SF6]: New Section – readiness to 
change 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 50 of 56 
Salt Intake: 
 
The 2010 Dietary Guidelines for Americans recommend that everyone age 2 years and up 
should consume less than 2,300 milligrams (mg) of sodium each day. Some groups of people 
should further limit sodium intake to 1,500 mg per day, including: 
• 
Adults age 51 years or older. 
• 
All African Americans. 
• 
Anyone who has high blood pressure, diabetes, or chronic kidney disease. 
 
RC1_05. How motivated are you to make changes to your salt intake, using a scale of one to 
ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_06. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your salt intake? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Overweight/Obesity: 
 
Extensive scientific evidence shows that being overweight or obese increases risk of having high 
blood pressure.  
 
RC1_07. How motivated are you to make changes to your body weight, using a scale of one to 
ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_08. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your body weight? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 51 of 56 
Stress, and Stress Response: 
 
Several studies showed that stress, and being slower at emotionally recovering from stressful 
events, increase risk of hypertension.  
 
RC1_09. How motivated are you to make changes to the amount of stress in your life, or your 
response to that stress, using a scale of one to ten, where one = definitely not ready to change, 
and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
RC1_10. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in the amount of stress in your life, or your response to that stress? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Alcohol Consumption: 
 
Heavy and regular use of alcohol can increase blood pressure substantially. The American Heart 
Association recommends limiting alcohol consumption to no more than two drinks per day for 
men and one drink per day for women. 
 
RC1_11. How motivated are you to make changes to the amount of alcohol you consume, using 
a scale of one to ten, where one = definitely not ready to change, and 10 = definitely ready to 
change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
RC1_12. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in the amount of alcohol you consume? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 52 of 56 
Blood Pressure (Antihypertensive) Medication Use: 
 
Blood pressure medication has been shown in many studies to be very effective at lowering 
blood pressure.  
 
RC1_13. How motivated are you to make changes to your blood pressure medication use, using 
a scale of one to ten, where one = definitely not ready to change, and 10 = definitely ready to 
change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_14. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes your blood pressure medication use? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 53 of 56 
Family History of Hypertension  
 
FH1_01. Did your biological mother ever have hypertension? 
 
 
 
□ No 
 
 
□ Yes 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
FH1_02. Did your biological father ever have hypertension? 
 
 
 
□ No 
 
 
□ Yes 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
  
 
FH1_03. How many full brothers and sisters do you have (Please include any brothers or 
sisters who may have died, but do not include half or step brothers and sisters). 
 
 
 
□ I do not have any brothers or sisters  Skip to the page 
 
 
____ brothers,  ______ sisters 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
FH1_04. Of these brothers and sisters, how many have ever had hypertension? 
 
 
 
________ (if none, write 0) 
 
□ I do not know   
 
□ I prefer not to answer  
 
 
 
 
Comment [SF7]: New section 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 54 of 56 
Your Sleep 
 
The following questions relate to your usual sleep habits during the past month only. Your 
answers should indicate the most accurate reply for the majority of days and nights in the past 
month. Please answer all questions. 
 
SL1_01. During the past month, what time have you usually gone to bed at night? 
 
 
 
BED TIME ___________ AM / PM 
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_02. During the past month, how long (in minutes) has it usually taken you to fall asleep 
each  
night? 
 
 
 
NUMBER OF MINUTES ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_03. During the past month, at what time have you usually gotten up in the morning? 
 
 
 
GETTING UP TIME ___________ AM / PM 
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_04. During the past month, how many hours of actual sleep did you get on average at 
night?  (This may be different than the number of hours you spent in bed.) 
 
 
 
AVERAGE HOURS OF SL1_EEP PER NIGHT ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
Comment [D8]: This section (Sleep) was moved 
to the end of the survey.  Several of the items were 
dropped to reduce participant burden. 

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 55 of 56 
 
SL1_15.  During the past month, how would you rate your sleep quality overall? 
 
 
 
□ Very good 
 
 
□ Fairly good  
 
 
□ Fairly bad 
 
 
□ Very bad 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
Deleted: For each of the remaining questions, 
check the one best response. Please answer all 
questions.¶
¶
During the past month, how often have you had 
trouble sleeping because you…………..¶
¶
SL1_05.  …..Could not get to sleep within 30 
minutes?¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer¶
¶
¶
SL1_06. …..Woke up in the middle of the night or 
early morning?¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
¶
SL1_07. …..Had to get up to use the bathroom?¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
¶
...
Deleted: SL1_16. During the past month, how 
often have you taken medicine to help you sleep 
(prescribed or "over the counter")?¶
¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
SL1_17.  During the past month, how often have 
you had trouble staying awake while driving,     
eating meals, or engaging in social activity?¶
¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
¶
SL1_18.  During the past month, how much of a 
problem has it been for you to keep up enough  
enthusiasm to get things done?¶
¶
□ No problem at all¶
□ Somewhat of a problem¶
□ A very big problem¶
□ I do not know¶
□ I prefer not to answer ¶
¶
¶
...

MBHT Home Baseline Assessment, Version 1.4, November 11, 2015 
Page 56 of 56 
Thank you for completing this survey!  
 
Please note that these responses will not be seen immediately. Resources are shown below if you 
feel that you would like to talk with someone immediately for assistance.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
National Sexual Assault Hotline: 1-800-656-4673 
 
Other options are to: 
• Call your doctor’s office 
• Call 911 for emergency services 
• Go to the nearest hospital emergency room.  
 
 
 
 
 
  

 
 
 
 
 
 
 
Appendix 7: 
Revised In-Person Baseline Assessment 
with Track Changes 
 
(v.1.4 – November 6, 2015) 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 1 of 26 
 
 
 
 
 
 
 
 
SECOND IN-PERSON VISIT SCREENING BASELINE  
QUESTIONNAIRE AND ASSESSMENT FORMS 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 2 of 26 
 
PID. Participant ID # __________ 
BA01. Staff ID # __________ 
BA02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA03g. Blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA03h. Blood pressure 4th reading, diastolic blood pressure:  __________ mmHg 
BA03i. Blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA03j. Blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA04. Were the 4th and 5th systolic blood pressure readings within 20 mmHg of each other? 
□ Yes 
□ No (repeat measurements  
 
BA05. Were the 4th and 5th diastolic blood pressure readings within 10 mmHg of each other? 
□ Yes 
□ No (repeat measurements) 
 
BA06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
BA06g. Repeated blood pressure 4th reading, systolic blood pressure: _________ mmHg 
BA06h. Repeated blood pressure 4th reading, diastolic blood pressure:  __________ mmHg 
BA06i. Repeated blood pressure 5th reading, systolic blood pressure: _________ mmHg 
BA06j. Repeated blood pressure 5th reading, diastolic blood pressure:  __________ mmHg 
 
BA07. Blood pressure cuff size used: 
 □ S     □ Reg    □  L        □ XL 
 
BA08. Arm that cuff was placed on: 
  □ L      □  R 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 3 of 26 
 
BA09. Height: 
______ . __ cm (one decimal place) 
 
 
BA10. Weight: 
______ . __ kg (one decimal place) 
 
 
 
 
Waist Circumference:    
BA11a. Measurement 1 ______ . __ cm (one decimal place) 
BA11b. Measurement 2 ______ . __ cm (one decimal place) 
 
BA12. Is the difference between Measurement 1 and Measurement 2 greater than 1.0cm?  
□ Yes (repeat measurements 3&4)  
□ No 
 
BA13a. Measurement 3 ______ . __ cm    
BA13b. Measurement 4 ______ . __ cm 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 4 of 26 
 
Medications (ME) 
 
 
ME01. Do you take any prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME02a. What is the name of the first prescription medication or over-the-counter drug that you take? 
 
 Label product name: 
______________________________________________________________________ 
 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
ME02b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME02c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 
Comment [SF1]: Moved here from In-
Person Screener 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 5 of 26 
 
ME02d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME02e. Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME02f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME02g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME02h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME02i. Interviewer comments: 
_______________________________________________________________________ 
 
 
ME02j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 6 of 26 
 
ME03a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME03b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME03c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME03d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.) 
 
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 7 of 26 
 
ME03e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME3f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME03g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
 
 
ME03h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME03i. Interviewer comments:  
__________________________________________________________________ 
 
 
ME03j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME04a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 
 Label product name: 
_____________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 8 of 26 
 
ME04b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME04c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME04d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 9 of 26 
 
ME04g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME04h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME04i. Interviewer comments: 
 
________________________________________________________________________ 
 
ME04j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
section 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME05a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME05b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 10 of 26 
 
ME05c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME05d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME05e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME05f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME05g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME05h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME05i. Interviewer comments: 
________________________________________________________________________ 
 
 
ME05j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of end of 
medications questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 11 of 26 
 
ME06a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
__________________________________________________________________ 
 
 
 Label generic name: 
___________________________________________________________________ 
 Don’t know 
 
 
 Prefer not to answer 
 
ME06b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
ME06c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
ME06d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 12 of 26 
 
ME06e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME06f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME06g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME06h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME06i. Interviewer comments: 
________________________________________________________________________ 
 
 
 
ME06i. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
ME07a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
_____________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________ 
  Don’t know  
 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 13 of 26 
 
ME07b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME07c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME07d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 14 of 26 
 
ME07g For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME07h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME07i. Interviewer comments: 
____________________________________________________________________ 
 
ME07j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME08a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 Don’t know  
 
 Prefer not to answer 
 
ME08b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 15 of 26 
 
ME08c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME08d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME08e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME08f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME08g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME08h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME08i. Interviewer comments: 
___________________________________________________________________ 
 
 
ME08j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 16 of 26 
 
ME09a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
____________________________________________________________ 
 
 
 Label generic name: 
 
____________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
ME09b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME09c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 
 
ME09d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 17 of 26 
 
ME09e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME09f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME09g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME09h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME09i. Interviewer comments: 
___________________________________________________________________ 
 
ME09j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer 
 
ME10a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
  Label generic name: 
______________________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, November 6, 2015  
 
            Page 18 of 26 
 
ME10b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME10c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
ME10d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME10e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME10f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 19 of 26 
 
ME10g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME10h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME10i. Interviewer comments: 
_______________________________________________________________ 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 20 of 26 
 
FOOD FREQUENCY QUESTIONNAIRE:  
 
RA Script to be read to participants: At this time, we are going to have you complete a 
few forms on your own.  The first is a Food Frequency Questionnaire that will ask you 
about the types of foods and drinks that you consume.  It should take around 20 minutes 
to complete.  Please let me know if you have any questions. 
 
Comment [SF2]: At this time, participants 
will be directed to complete the three page 
Harvard University Food Frequency 
Questionnaire (see proof included), known 
as the “80-out”.  It is designed to take 
around 20 minutes to complete and is self-
administered with paper and pencil.  Once 
completed, they will proceed to the next 
section of this assessment (DS_1). 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 21 of 26 
 
Questions for Participants to Answer on Their Own In-Person on Paper: 
For each statement, please place a mark in the column that best describes how you 
have been feeling. 
 
Not at all 
or less 
than 1 day 
last week 
1 or 2 
days 
last 
week 
3 to 4 
days 
last 
week 
5 to 7 
days 
last 
week 
Nearly 
every day 
for two 
weeks 
I do not 
know 
I prefer 
not to 
answer 
DS_1. My appetite was poor. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_2. I could not shake off 
the blues. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_3. I had trouble keeping 
my mind on what I was doing. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_4. I felt depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_5. My sleep was restless. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_6. I felt sad. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_7. I could not get going. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_8. Nothing made me 
happy. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
C_9. I felt like a bad person. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_10. I lost interest in my 
usual activities. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_11. I slept much more 
than usual. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_12. I felt like I was moving 
too slowly. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_13. I felt fidgety. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_14. I wished I were dead. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_15. I wanted to hurt 
myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_16. I was tired all the 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_17. I did not like myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_18. I lost a lot of weight 
without trying to. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_19. I had a lot of trouble 
getting to sleep. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_20. I could not focus on 
the important things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 22 of 26 
 
Below is a list of common symptoms of anxiety. Please carefully read each item in the 
list. Indicate how much you have been bothered by that symptom during the past 
month, including today, by marking the box in the corresponding space in the column 
next to each symptom.  
 
 
 
 
 
 
 
 
 
Not At All 
Mildly – it 
didn’t 
bother me 
much 
Moderately – it 
wasn’t pleasant 
at all times 
Severely – 
it bothered 
me a lot 
I do not 
know 
I prefer 
not to 
answer 
BE_1. Numbness or tingling 
□ 
□ 
□ 
□ 
□ 
□ 
BE_2. Feeling hot 
□ 
□ 
□ 
□ 
□ 
□ 
BE _3. Wobbliness in legs 
□ 
□ 
□ 
□ 
□ 
□ 
BE _4. Unable to relax 
□ 
□ 
□ 
□ 
□ 
□ 
BE _5. Fear of worst happening 
□ 
□ 
□ 
□ 
□ 
□ 
BE _6. Dizzy or lightheaded 
□ 
□ 
□ 
□ 
□ 
□ 
BE _7. Heart pounding/racing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _8. Unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _9. Terrified or afraid 
□ 
□ 
□ 
□ 
□ 
□ 
BE _10. Nervous 
□ 
□ 
□ 
□ 
□ 
□ 
BE _11. Feeling of choking 
□ 
□ 
□ 
□ 
□ 
□ 
BE _12. Hands trembling 
□ 
□ 
□ 
□ 
□ 
□ 
BE _13. Shaky/unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _14. Fear of losing control 
□ 
□ 
□ 
□ 
□ 
□ 
BE _15. Difficulty in breathing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _16. Fear of dying 
□ 
□ 
□ 
□ 
□ 
□ 
BE _17. Scared 
□ 
□ 
□ 
□ 
□ 
□ 
BE _18. Indigestion 
□ 
□ 
□ 
□ 
□ 
□ 
BE _19. Faint/lightheaded  
□ 
□ 
□ 
□ 
□ 
□ 
BE _20. Face flushed 
□ 
□ 
□ 
□ 
□ 
□ 
BE _21. Hot/cold sweats 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 23 of 26 
 
After questionnaires are complete, participants will be asked to perform the following two 
computer-based tests: 
Attention Control: Attention Network Test (20 minutes) 
 
Attention Network Test (ANT) is a brief computerized battery measuring three independent 
behavioral components of attention: Conflict resolution (ability to overcome distracting stimuli), 
spatial Orienting (the benefit of valid spatial pre-cues), and Alerting (the benefit of temporal pre-
cues). Efficiency of orienting is examined by changes in RT that accompany cues indicating 
where the target will occur. The efficiency of the executive conflict resolution network is 
examined by requiring the subject to respond by pressing two keys indicating the direction (left 
or right) of a central arrow surrounded by congruent, incongruent or neutral flankers. Moderate 
to high reliabilities are found for all networks. 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 24 of 26 
 
Sustained Attention to Response Task (15 minutes) 
 
The Sustained Attention to Response Task (SART) is a computerized test of sustained 
attention, response inhibition (executive function) and self-regulation. Subjects are instructed to 
press a key in response to rapidly displayed integers (1-9) and withhold response to a 
designated "no-go" integer. SART errors consist of summed commission errors (button press on 
no-go trial) and omission errors (button not pressed on "go" integers). SART performance is 
associated with prefrontal cortex functioning, has been found to increase with mindfulness 
training and is correlated with scores on mindfulness questionnaires (specifically, the Mindful 
Attention Awareness Scale).  
 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 25 of 26 
 
SAFETY PLAN 
After the participant has completed the Beck Anxiety Inventory questionnaire and the Centers 
for Epidemiologic Studies Depressive Symptomatology questionnaire, ask the participant to wait 
for a few minutes while you check that all forms and assessments are completed. While the 
participant is waiting in a different room, check the scores according to the criteria below. If any 
scores trigger the safety plan, move forward with steps below as written.  
Beck Anxiety Inventory (BA)  
 
If participant scores ≥26 on the Beck Anxiety Inventory, while having the participant wait, 
immediately notify the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to 
determine need for a psychiatric consultation. She has provided her cell phone #, and your 
phone # will be entered into her phone recognition software to indicate it is a call from the MBHT 
study. It is likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a 
phone message for her with your contact information and provide her with the Beck Anxiety 
Inventory results on the message. If Dr. Flynn is not immediately reachable, or following 
participant release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks 
(cell phone #401-369-0443).  
Depressive Symptomatology (DS) 
 
The CESD-R will be administered during the in-person assessment visits, and scores will be 
reviewed immediately upon completion of the in-person assessments. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Participants are considered to meet criteria for major depressive episode if they have anhedonia 
or dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM 
symptom groups noted as occurring nearly every day for the past two weeks. If participants 
meet criteria for major depressive episode, while having the participant wait, immediately notify 
the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to determine need 
for a psychiatric consultation.  She has provided her cell phone #, and your phone # will be 
entered into her phone recognition software to indicate it is a call from the MBHT study. It is 
likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a phone message 
for her with your contact information and provide her with the Depressive Symptomatology 
results on the message. If Dr. Flynn is not immediately reachable, or following participant 
release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks (cell phone 
#401-369-0443).  
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.34, July 15November xx, 2015  
 
            Page 26 of 26 
 
If participants respond having any suicidal ideation (DS questions 14 or 15), perform the 
following 2 steps: 
 
1. Immediately call 911 and Dr. Ellen Flynn.  
 
Specifically, while the participant is in the waiting room, call 911 immediately, and tell 
them: 
 
“My name is _____. I am working on a research study at Brown University. I have a study 
participant in the waiting room who has shared that he/she is currently suicidal.” Please 
provide the participants’ name to the 911 operator, as requested.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know that you have called 911 
and Dr. Flynn, and why (i.e. because we are concerned about you). You can speak 
with participant to keep him/her in the waiting room if 911 has sent assistance, but 
the discussion should not be clinical in nature.   
 
Examples of questions that could be asked in order to keep them in the waiting room: 
 
“Tell me what is going on.” 
 
“What’s happening right now?” 
 
Tell me more about why you are interesting in being part of this study.  
 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
 
Call your doctor’s office 
 
Call 911 for emergency services 
 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
 

E. Loucks responses to 12/4/15 email from Ita Irizarry – RE: "MINDFULNESS-BASED HYPERTENSION 
THERAPY PILOT STUDY," Amendment #4 submission. 
 
Questions/Requests:  
1. 
Regarding the request to add a control group, please confirm if this population will be identified, 
recruited, and consented with the same currently-approved procedures as the intervention group. 
Based on additional feedback from NCCIH on the study protocol, we have decided to hold off at 
this time on implementing the RCT.  We have removed all language discussing the RCT and have 
attached an updated consent form (v.1.5) and Phone Screener.  We will submit a new amendment 
to the IRB once the RCT is incorporated into the study protocol. 
2. Will the new $100 compensation be provided to all participants who complete the study, both 
intervention and control groups? Will the compensation be given at the 1-year follow-up? 
Yes, all study participants will receive the $100.  It will be given out at the time of the 1-year 
follow-up.  We will not be including a control group at this time. 
3. What is the rationale for adding the 1-year follow-up visit? 
There is early evidence in other mindfulness studies that have shown increases in effect by 1 year 
follow-up that were not present at 6 months. This longer follow-up time will allow us to determine 
longer term effectiveness of the intervention.  
4. What is the rationale for revising the screening and baseline assessments? 
The screening assessments were revised to reduce participant burden. We removed all 
assessments in the first in-person screening that do not influence if the person qualifies for the 
study or not. For the in-person baseline assessment, we included items moved from the first in-
person screening, as well as added some additional measures that are central to the objectives of 
the recent NIH grant to evaluation impacts of the intervention on measures of self regulation.  
5. 
For the In-Person Screening Assessment Form, question BA2_08 (pg. 2) is marked as track-
changed, but this was approved with Amendment #2. Was the question revised? 
No, it was not revised.  It was marked in error. 
6. If you haven't already, please register your study on the Clinical Trials website, per the terms of your 
NIH grant. Section 6 (pg. 254) states that the study must be registered within 21 days of the first 
participant enrollment. 
We will register the study on the Clinical Trials website within 21 days of the first participant 
enrollment for the NIH-funded study.  
 
 

Consent Document Revisions: 
1. 
The Nature and Purpose of the Study section (pg. 1, 3rd paragraph) only briefly mentions that 
participants may be randomized into the control group. To the Explanation of Procedures section, 
please add how that randomized will occur, and provide a further explanation of what participants 
in the control group will be asked to do at the baseline and 10-week visits. 
No longer applicable. We have decided to not implement the RCT at this time. 
2. Portions of the consent are marked as track-changed, although they were approved with 
Amendment #3. For example, the Explanation of Procedures section (pgs. 2-3, #3) and the 
procedure table (pg. 3, focus group) are marked. Were changes made to these sections? 
No, these two sections were not revised.  They were marked in error.  We have removed the track 
changes. 
3. To the Discomforts and Risks section (pg. 4, 3rd paragraph), please add an explanation of what will 
happen if a participant has a research-related injury. 
We have added the following language to the consent form (see v.1.5 attached):  
“While physical and mental injury is always a possibility the potential for harm is limited.  Note 
that a research injury is any physical or mental injury or illness caused by your participation in 
the study. If you are injured by a medical treatment or procedure that you would have received 
even if you were not in the study, that is not a research injury.  To help avoid research injury and 
potential added medical expenses, it is important to follow all study directions carefully. If you 
are covered by insurance and suffer a research injury, it is possible that some or all of the costs of 
treating your condition could appropriately be billed to your insurance company.  If such costs 
are not covered your health insurance company, it is possible you would have to pay for these 
costs out of pocket. Brown University’s policies do not cover payment for such things as lost 
wages, medical care expenses, or pain and suffering. 
 
Precautions should be taken to avoid injuries.  If you do become injured during the study, you 
should call your doctor immediately.  You should also alert the study staff that you have been 
injured.  Heart attack and sudden death related to heart problems have been known to occur in 
people while they are exercising.  This is very rare, however.  Estimates of sudden cardiac death 
range from 0 to 2 per 100,000 hours.  However, the researchers cannot guarantee that no 
complications will happen to you.” 
 
4. In the Benefits section (pg. 4), please remove the added compensation description. Compensation is 
not considered a benefit, and this information was already added to the Nature and Purpose of the 
Study section (pg. 1). 
This has been removed. 
5. 
As this is clinical trial, please add the required language regarding the Clinical Trials website: "A 
description of this clinical trial will be available on http://www.Clinical Trials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time."  This language must be 
added verbatim and cannot be changed, per NIH regulations. 
We have added this language to the last section of the consent. 
 
 

See below for a summary of changes made to the MBHT study documents since Amendment #4 was 
originally submitted.  These changes were made per discussion with the Brown University IRB; some 
additional changes have been made in order to reduce participant burden.  All modified documents 
have been included in this email.  
 
INFORMED CONSENT FORM  
 
Removed language regarding the RCT 
 
Removed compensation description from the "Benefit" section 
 
Added language regarding research-related injuries 
 
Updated the IRB contact information 
 
Added the required language regarding clinical trials 
 
PHONE SCREENER 
 
Removed language regarding the RCT 
 
IN-PERSON SCREENER 
 
Removed the 4th and 5th Blood Pressure readings, such that BP will be taken three 
times in-person rather than five times. 
 
IN-PERSON BASELINE 
 
Removed the 4th and 5th Blood Pressure readings, such that BP will be taken three 
times in-person rather than five times. 
 
Added the data entry variables for the Attention Network Test (see p.23).  This data will 
be entered by the RA at the end of the test. 
 
HOME BASELINE 
 
Removed all sleep questions except for SL1_04 
 
Removed the sense of control scale (SE1) 
 
Removed the Mindfulness Skill Acquisition Scale (MS1) 
 

MBHT Consent Form, Version 1.5, December 23, 2015  
  Page 1 of 7 
 
Agreement to Participate in a Research Study 
 
Investigation of the Effects of Mindfulness on Blood Pressure and Well-Being 
 
You are being asked to take part in a Brown University research study about the effects of 
mindfulness and hypertension education on blood pressure and risk factors for hypertension. 
This form will explain the purpose of the study, how the study will be carried out and what you 
will be expected to do.  It will also explain the possible risks and possible benefits of being in the 
study.  If any part of the following description is not clear to you, you are encouraged to contact 
the researcher to answer any questions before you decide whether to take part in the study. If you 
decide to participate, please fill out and sign the last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health 
education on blood pressure. You have been selected for this study because you expressed 
interest in the project and because you met entrance criteria for having prehypertension or 
hypertension, or another cardiovascular risk factor that could be influenced by this program.  
In order to assess the effects of these practices, you will be asked to complete some 
questionnaires and a laboratory assessments before and after learning the mindfulness practices.  
Assessments will be completed at: baseline, 10 weeks, 6 months and 1 year.  If you complete the 
study, you will be given $100 USD at the time of completion for your participation, to express 
our gratitude. 
Participation in this study involves receiving training in mindfulness practices as well as health 
education on blood pressure. 
 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
1) Participate in an interview in which you will be asked questions about past and present 
mental health, including depression and suicide. 
 
2) Complete questionnaires about a wide range of topics, including your diet, physical activity, 
smoking, medication use, personality, emotions, attention and past experiences, including 
stressful or traumatic experiences. These questions will probe sensitive psychological areas, 
including physical, emotion and sexual abuse. These questionnaires may take up to 2 3 hours 
to complete. By completing the interviews and questionnaires, you are giving the researchers 
permission to use the information you have provided. You have the right not to answer any 
of the questions.  
 
3) Directly assessed blood pressure, height, weight, waist circumference, hip circumference, 
physical activity, and antihypertensive (blood pressure) medication use at baseline and after 
the mindfulness course. Physical activity will be assessed for a week at a time using small 
actigraphy monitors that attach to your wrist and hip. If you take antihypertensive 

MBHT Consent Form, Version 1.5, December 23, 2015  
  Page 2 of 7 
 
medication, we will provide you with an electronic bottle cap that will automatically record 
when the pill bottle is opened during the study. This will help us measure how often the 
medication is used. 
 
4) You will be asked to perform some cognitive tasks. One Some of these tasks may involve 
computer-based tests of attention or decision-making. Together these tests may take as long 
as 45 minutes. 
 
5) You will participate in the mindfulness program, which consists of 9 weekly sessions of 2.5 
hours each and will include one 8 hour weekend retreat. Daily homework assignments may 
take as long as one hour and consist of practicing mindfulness exercises with the aid of a 
guided audio CD and completing worksheets related to stress, thoughts, and common 
reactions to various types of events. 
 
6) Class sessions will be audio taped so we can analyze the quality of the treatment you receive. 
The recordings will be transcribed so that we may analyze the text. The recordings will be 
identified by study number, will only be heard by study staff and will be destroyed after 
transcription.  
 
7) You will be asked to complete a few short questionnaires each week during the 9 week 
condition. 
 
8) After 9 10 weeks, you will be asked to complete questionnaires and return to the laboratory 
to repeat the same procedures for a second day of testing. You will also be invited to 
participate in a focus group to share any advice you may have on how to improve the 
intervention.  
 
9) Three Six months and one year after the end of the 9 week conditionthe beginning of the 
study, you will be asked to return to the laboratory to repeat the same testing procedures. 
 
 

MBHT Consent Form, Version 1.5, December 23, 2015  
  Page 3 of 7 
 
Table Summarizing Activities and Time Commitment for this Study.  
Activity 
Time Commitment 
First blood pressure screen 
30 minutes 
Second blood pressure screen 
30 minutes 
Baseline health assessments, such as questionnaires, 
height, weight and waist circumference.  
2 hours3 hours 
Mindfulness course 
In-person 
9 sessions that are 2.5 hours each.  
1 retreat day on a Saturday that will be 
8 hours  Total course time: 30.5 hours 
Home mindfulness practices assigned during 
mindfulness course.  
1 hour per day, 6 days per week, for 8 
weeks.  Total practice time: 48 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, that 
take place immediately after course completion. 
2 hours3 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, that 
begin take place that take place 3 6 months after 
baselinecourse completion. 
2 hours3 hours 
Health assessments, such as questionnaires, blood 
pressure, height, weight and waist circumference, that 
begin 1 year after baseline. 
3 hours 
Participate in focus group after intervention completion 
to share any advice you may have on how to improve 
the intervention. 
1.5 hours 
TOTAL TIME COMMITMENT FOR STUDY 
87.0 hours93.0 hours 
 
 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred 
since the first assessment. Specifically, you will receive an individualized handout listing % 
change (increase or decrease) on scales of attention, stress, mood, health behaviours, weight, and 
blood pressure across the study. 
 
2.  Discomforts and Risks 
The risks to you in this study are small.  The questionnaires used in the study are routine, 
standardized forms for epidemiologic research.  Certain questions may be upsetting as they may 
probe sensitive psychological areas and inquire about upsetting or traumatic events, including 
physical, sexual or emotional abuse and/or current psychiatric symptoms.  Since your 
participation is voluntary, you have the right to skip any questions that make you uncomfortable. 
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, 
feelings or body sensations. Some individuals may experience an initial increase in undesirable 
feelings with increased attention to them. 
 

MBHT Consent Form, Version 1.5, December 23, 2015  
  Page 4 of 7 
 
It is possible that injuries could be sustained during the study either from the gentle mindful 
movements (i.e., yoga), or from physical activities that participants engage in as a way to reduce 
blood pressure.  To help limit this, you will receive a handout showing the yoga poses that will 
be offered during the course that you can show your health care provider so that they can advise 
on which poses to do, and which to avoid. Modifications of poses will be available as needed. 
None of the poses (or the yoga as a whole) are mandatory to be done. You will also be 
encouraged to explore physical activities that promote strength and conditioning as a way to 
reduce blood pressure. You will be encouraged to not go beyond any physical limits of your 
body, and will be encouraged to ask your healthcare provider about advised physical activities 
and mindful movements if you have any physical limitations. 
 
While physical and mental injury is always a possibility the potential for harm is limited.  Note 
that a research injury is any physical or mental injury or illness caused by your participation in 
the study. If you are injured by a medical treatment or procedure that you would have received 
even if you were not in the study, that is not a research injury.  To help avoid research injury and 
potential added medical expenses, it is important to follow all study directions carefully. If you 
are covered by insurance and suffer a research injury, it is possible that some or all of the costs of 
treating your condition could appropriately be billed to your insurance company.  If such costs 
are not covered your health insurance company, it is possible you would have to pay for these 
costs out of pocket. Brown University’s policies do not cover payment for such things as lost 
wages, medical care expenses, or pain and suffering. 
 
Precautions should be taken to avoid injuries.  If you do become injured during the study, you 
should call your doctor immediately.  You should also alert the study staff that you have been 
injured.  Heart attack and sudden death related to heart problems have been known to occur in 
people while they are exercising.  This is very rare, however.  Estimates of sudden cardiac death 
range from 0 to 2 per 100,000 hours.  However, the researchers cannot guarantee that no 
complications will happen to you. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this 
study.  However, participation in the study creates the potential benefit of a) identifying effective 
treatments for elevated blood pressure, b) gaining knowledge of the effects of mindfulness 
practices, c) receiving information about your psychological and physical functioning. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical 
activity, and reducing excessive alcohol consumption may also be beneficial for reducing blood 
pressure. Education about these therapies are integrated into this course, but other forms of these 
alternative therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to a 
study ID# instead of your name.  All questionnaires in this study will be filled out through an 

MBHT Consent Form, Version 1.5, December 23, 2015  
  Page 5 of 7 
 
online survey or a paper version of the survey if you prefer.  All of these questionnaires will be 
linked solely to your study ID#, so that your identity is protected and your answers are confidential.  
Although these measures have been taken to protect your personal information, complete 
confidentiality cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to 
confidentiality. If your questionnaire responses indicate that you pose a serious danger to 
yourself or to another person, then a collaborator (Dr. Ellen Flynn) who is a licensed psychiatrist, 
may contact you to discuss your responses and possible referral to a treatment provider. 
Questionnaire items that may warrant follow-up include endorsements of statements about 
hurting yourself, any high scores in depression, anxiety, or other clinically significant problems. 
You should also know that there are times when the law might require the release of your 
responses without your permission.  For example, State law requires researchers to report abuse 
or neglect of children to the Department of Children, Youth and Families (DCYF).   State law 
also requires researchers to report abuse or neglect of people age 60 and older to the Division of 
Elderly Affairs. 
The findings of the study may be used for medical publication. Your name will not be used in 
any published reports about this study. Results will be reported in a summarized manner in such 
a way that you cannot be identified. All personally identifiable information will be "de-
identified" and only a unique code number will be used. Study records will be identified with a 
unique code number and initials. All study records and specimens will be stored in a secure 
storage area. 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
 
6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, 
including not answering certain questions. If you decide now to participate, you can change your 
mind later and quit the study.  The decision to not participate or to withdraw from the study will 
not adversely affect current or future interactions with Brown University. The decision to not 
participate or to withdraw from the study will also not adversely affect your relationship with 
your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for 
alternative treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. 
Eric B. Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like 
more information about the rules for research studies, or the rights of people who take part in 
those studies, you may contact the Brown University Human Research Protection 
OfficeProgram, telephone number 1-866-309-2095 or 401-863-3050. 
 

MBHT Consent Form, Version 1.5, December 23, 2015  
  Page 6 of 7 
 
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 

MBHT Consent Form, Version 1.5, December 23, 2015  
  Page 7 of 7 
 
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY 
QUESTIONS HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO 
PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
_______________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
CONTACT INFORMATION 
 
Name (print):______________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):__________________________________________________________________ 
 
Telephone:__________________________(cell)     __________________________(other) 
 
 
 
 
 
 

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 1 of 8 
 
 
 
 
 
 
 
PHONE-DELIVERED SCREENING 
QUESTIONNAIRE  
 
 
 
 

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 2 of 8 
PHONE SCREENING QUESTIONNAIRE PART 1 
 
The script is shown below in bold italics.  
 
PID. Participant ID: ___________ 
 
SQ01. Staff ID: ______________ 
 
SQ02. Today’s Date (MMDDYY): ________________ 
 
SQ03. Current Time (24 hour time, e.g. 14:45): ________ 
 
Please now call the participant.  
 
SQ04. Was the participant reached?   YES   NO 
 
Hello, my name is ____________. I am calling from the Brown University School of Public 
Health because (name of participant) expressed interest in participating in our 
mindfulness blood pressure study. Is he/she available to talk at this time? 
 
I would like to do a 10-15 minute phone interview with you to determine if you are a good 
match for this particular study.  
 
SQ05. Is now a good time to speak? 
 
[If yes, proceed to SQ05 script below] 
 
If no… When would be a good time to talk? 
 
SQ06. Day to call back (DDMMYY) ____________ 
 
SQ07. Time to call back ______ AM/PM 
OK, great. How about I give a quick overview of the study, and can then answer any 
questions you may have to see if it is a good fit for you. We will then go through a 
screening questionnaire to see if you qualify for the study. Does this sound OK? 
In this study, we are looking to see if mindfulness practices improve blood pressure, and 
if education about hypertension risk factors may also improve blood pressure. If eligible, 
we will provide you with training in meditation, mindful movements, and the roles of 
things like diet, physical activity and medication in reducing blood pressure. You will be 
taught by a very experienced teacher who is an expert in these fields. The course is free 
and will take place over a 9-week period, where you come to a class once each week for 
2.5 hours each time. There is also a one-day retreat on a Saturday that will be 8 hours 
long. As part of the project, we will also ask you to participate in health assessments 
before and after the study. Health assessments include measures such as blood 
pressure, height and weight, and questionnaires about your health and experiences.  At 
the end of the study, you will be given $100 USD to express our gratitude.  
 
Deleted: A basic overview of the study 
is that it is
Deleted: Specifically
Deleted: Y
Deleted: s
Deleted: Also, w

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 3 of 8 
Do you have any questions about the study? [answer questions] 
SQ08. Does this study sound like something you would be interested in doing? Yes  No 
[If yes, proceed to next statement below. If no, politely thank the participant for considering 
being in this study, and end the call].  
Great. There are a few things that I would like to make clear before we start the interview. 
First of all, some of the questions that I will ask now to figure out if you are eligible to be 
in this study will be of personal nature, including asking about your mental health and 
life’s experiences.  
 
SQ09. Are you in a private place to talk? 
 
[If yes, proceed to text below. If no, reschedule meeting using variables SQ06 and SQ07 above].  
 
 Because this interview is of a personal nature, it is important that you understand that 
everything you say will be kept strictly confidential.  No one outside of our project will 
ever be able to see your answers, and we will not keep your name in the same place as 
any of your answers. If you are not eligible after the phone screen, we will destroy your 
information.  If you like, though, we can keep your information on file for future studies. 
 
SQ10. Participant’s First Name:  ____________________________________ 
 
SQ11. Participant’s Last Name:______________________________________ 
 
Participant’s Address (in case we need to send any study materials to you): 
SQ12a. Street address: _____________ 
SQ12b. City: ____________________ 
SQ12c: State: ________ 
SQ12d: Zip Code: ________________ 
 
SQ13a. Participant’s Phone number #1 (in case we need to contact you by phone) 
____________________________________ 
 
SQ13b. Participant’s Phone number #2____________________________________ 
 
 
SQ14. Participant’s email address (or mailing address if no email):______________________ 
 
SQ15. Notes from interviewer related to participants’ contact information (if any): 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________ 
 
 
 
 
 
Deleted: Can I answer any questions 
about the study that you may have
Deleted: SQ04 
Deleted: SQ05 

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 4 of 8 
PHONE SCREENING QUESTIONNAIRE PART 2 
PID. Participant ID #: ______________ 
 
INCLUSION CRITERIA: All answers in 3rd column must be YES. If an answer is NO, 
immediately proceed to question SQ40. 
 
 
 
Comments 
SQ26. 
 
What is your age? [Is age at least 18 
years?] 
 
 
 
 
YES 
NO 
 
SQ27. 
Can you read and write in English? 
YES 
NO 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40.  
 
 
 
Comments 
I will now start to ask some questions about your mental health. 
 
SQ28. 
Has anyone ever told you that you have bipolar 
disorder or manic depression?  
YES
NO 
 
SQ29. 
Has anyone ever used the word “Borderline” to 
describe you? 
YES
NO 
 
SQ30a. 
 
 
 
SQ30b. 
Have you ever had a hallucination or seen things 
that other people can’t see, or hear things other 
people can’t hear?  
 
Have you ever been diagnosed with 
schizophrenia or psychosis? 
YES
NO
 
 
 
YES 
NO 
 
 
 
SQ31_1 
SQ31_2 
SQ31_3 
SQ31_4 
SQ31_5 
SQ31_6 
SQ31_7 
SQ31_8 
Have you ever taken any of the following 
medications that I am about to read to you?  
Lithium                               
Seroquel (quetiapine) 
Abilify (aripiprazole)           
Zyprexa (olanzapine) 
Clozaril (clozapine)           
Haldol/Haloperidol 
Geodon (ziprasidone)         
Risperdal (risperidone) 
 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
 
SQ32a 
 
SQ32b 
 
 
SQ32c 
 
 
 
 
SQ32d 
 
 
Have you ever had a suicide attempt?  
 
[If yes, ask…] Have you considered killing 
yourself during the past month?  
 
[If yes, ask…] Are you currently suicidal? 
 
[If yes, keep participant on the phone, and follow 
suicide safety plan below] 
 
[If no, ask…] Are you getting any help for that? If 
not, then provide list of resources from Safety 
Plan including Gateway, Anchor and The 
Providence Center] Not urgent, but inform Dr. 
Flynn about what was discussed.  
YES
NO
 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
 
YES 
NO 
 
 
 

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 5 of 8 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40. 
SQ33a 
 
SQ33b 
 
SQ33c 
Would you say you have a trauma history?  
[If yes…]  
In the past month, have you had any 
problems with dissociation (memory loss)?  
In the past month, have you had any 
flashbacks (i.e. sudden and disturbing vivid 
memory) about the trauma?  
YES
NO
 
YES 
NO 
 
YES 
NO 
 
 
 
SQ34a 
 
 
 
 
SQ34b 
In the past month, have you had any 
problems with obsessions or compulsions, 
such as washing your hands or checking the 
oven over and over again?  
[If yes…] Has anyone diagnosed you with 
obsessive compulsive disorder? 
YES      NO
 
 
 
 
YES 
NO 
 
SQ35 
In the past month, have you had a panic 
attack (i.e. sweating, heart palpitations, 
nausea, trouble breathing, fear of 
dying/choking/going crazy)?  
YES
NO
 
SQ36 
Have you had any problems with alcoholism 
or drug use in the past year? 
YES
NO
 
SQ37 
In the past year, have you had an eating 
disorder, such as starving, binge eating, or 
vomiting?  
YES
NO
 
SQ38a 
 
 
 
SQ38b 
 
 
 
 
 
 
SQ38c 
Do you currently have a mindfulness practice, 
such as meditation or yoga? 
 
Please tell me more about your mindfulness 
practice, including how often you practice per 
week.  
 
 
 
 
Do you currently practice meditation more 
than once per week? (yoga does not count as 
meditation in this context) 
YES
NO
 
 
Fill in 
response 
in 
comments 
section to 
the right  
 
YES 
NO 
 
 
SQ39 
This class will take place at Brown University 
in-person. Do you have any medical or 
mobility issues that would affect you being 
able to attend class? 
YES
NO
 
SQ40 
Participant qualifies for next step of study (next 
step is 1st blood pressure screening) 
YES
NO
 
If YES go 
to SQ41.  
 
If NO, go to 
SQ42.  
 
 

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 6 of 8 
SQ41a. Thank you for taking the time to answer these questions. You qualify for the next 
stage of screening, which is to take your blood pressure at our office. If you’re still 
interested, we’d like to schedule a time to have you come in to complete the in-person 
screener.  It will only take 30 minutes or less and will involve taking your blood pressure 
3-5 times.  Is there a day or time that works best for you?  [Schedule the In-Person 
Screening visit now] 
 
SQ41b. As I mentioned earlier, there is a mindfulness intervention that is part of this 
study.  If you are eligible based on the In-Person screening, you will then be invited to 
take part in a 9 week Mindfulness Course.  We will be scheduling the mindfulness 
intervention at a time that works best with most of the participants. What days and times 
of the week typically work best with your schedule? Please keep in mind that the 
sessions are 2.5 hours long, and take place once per week for 9 weeks.  
 
[Record participant’s availability for Intervention and then proceed with the script] 
 
 
Thank you for your time and interest in this study. We look forward to meeting you in 
person on [DATE / TIME]. Do you have any questions before we end this call?  
 
 
 
 
 
 IF INELIGIBLE: 
SQ42a. Thank you for taking the time to answer these questions. According to the 
survey, you do not qualify for the study at this time. There may be other studies you 
quality for.  
 
SQ42b. Would you like me to keep your information to pass on to these studies?  YES /  
NO 
 
SQ42c. [If yes…] OK, thank you. We will keep this information for future studies you 
may qualify for. Thank you for taking the time to talk with me today. Can I answer any 
questions before hanging up? 
 
SQ42d. [If no…] OK, our copy of this information will be destroyed. Thank you for 
taking the time to talk with me today. Can I answer any questions before hanging up? 
 
 
 
 
 
 
Deleted:  at two different times at least 
a week apart from each other. Let’s 
book the in-person screening 
sessions [Book both sessions. We can 
cancel the second session if they do not 
qualify].
Deleted: 

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 7 of 8 
SAFETY PLAN 
 
Enter details below on paper during screening (These variables should are also be entered in 
the survey via questions SQ10-SQ13). Destroy this paper after screening is complete.  
 
Participant’s First Name:  ____________________________________ 
 
Participant’s Last Name:______________________________________ 
 
Participant’s Address: 
 
Street address: _____________ 
 
City: ____________________ 
 
State: ________ 
 
Zip Code: ________________ 
 
Participant’s Phone number #1: ____________________________________ 
 
Participant’s Phone number #2____________________________________ 
 
During the phone-based screening, if participants respond yes to “Are you currently suicidal?”, 
the interviewer should perform the following 2 steps: 
 
1. Immediately have 911 and Dr. Ellen Flynn called by a colleague who has been 
informed beforehand that this is a possibility.  
 
Specifically, while keeping the participant on the phone, show the text below in the box 
to a colleague.  
 
I have a study participant on the phone who is currently suicidal. Please call 911 
immediately, and tell them: 
 
“I am calling on behalf of [my name] who is performing a research study at Brown 
University. He has a participant on the phone who says they are currently suicidal.” 
Please provide the participants’ contact information to the 911 operator (i.e. name, 
address, phone #, email address) as requested. This information is shown above.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know what you are doing. 
Specifically, let them know we are calling our study’s psychiatrist Dr. Flynn and 911, 
and why you are doing that (i.e. because we are concerned about you). You can speak 
with participant to keep him/her on the phone, but the discussion should not be 
clinical in nature.   
 

MBHT Phone Screening, Version 1.4, December 21, 2015      
                Page 8 of 8 
Examples of questions that could be asked in order to keep them on the phone: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
• 
Tell me more about why you are interesting in being part of this study.  
• 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants if they state they have had 
considered killing themselves in the past month. If they are currently suicidal, the main priority is 
to keep them on the phone while 911 and Dr. Flynn are being contacted.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 

MBHT In-Person Screening, Version 1.4, December 21, 2015      
                Page 1 of 2 
 
 
 
 
 
 
 
IN-PERSON SCREENING  
ASSESSMENT FORM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deleted: FIRST 
Deleted: VISIT 

MBHT In-Person Screening, Version 1.4, December 21, 2015      
                Page 2 of 2 
PID. Participant ID # __________ 
BA2_01. Staff ID # __________ 
BA2_02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA2_03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA2_03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA2_03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA2_03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA2_03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA2_03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
BA2_04. Were the 2nd and 3rd systolic blood pressure readings within 20 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements  
 
BA2_05. Were the 2nd and 3rd diastolic blood pressure readings within 10 mmHg of each 
other? 
□ Yes 
□ No (repeat measurements) 
 
BA2_06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA2_06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA2_06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA2_06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  _________ mmHg 
BA2_06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA2_06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
BA2_07. Blood pressure cuff size used:  □ S     □ Reg    □  L        □ XL 
 
BA2_08. Arm that cuff was placed on: 
 □ L      □  R 
 
 
 
Deleted: BA2_03g. Blood pressure 4th 
reading, systolic blood pressure: 
_________ mmHg¶
BA2_03h. Blood pressure 4th reading, 
diastolic blood pressure:  __________ 
mmHg¶
BA2_03i. Blood pressure 5th reading, 
systolic blood pressure: _________ mmHg¶
BA2_03j. Blood pressure 5th reading, 
diastolic blood pressure:  __________ 
mmHg¶
Deleted: 4th and 5th
Deleted: 4th and 5th
Deleted: BA2_06g. Repeated blood 
pressure 4th reading, systolic blood 
pressure: _________ mmHg¶
BA2_06h. Repeated blood pressure 4th 
reading, diastolic blood pressure:  
__________ mmHg¶
BA2_06i. Repeated blood pressure 5th 
reading, systolic blood pressure: 
_________ mmHg¶
BA2_06j. Repeated blood pressure 5th 
reading, diastolic blood pressure:  
__________ mmHg¶
Deleted: Medications (ME)
Comment [SF1]: In order to reduce 
participant burden, Medication Use has been 
moved to the In‐Person baseline assessment 
since it is not part of the eligibility criteria. 
Deleted: ¶
¶
¶
ME01. Do you take any prescription 
medications or over-the-counter drugs?¶
<#>
Section Break (Continuous)
<#>No  skip to end of 
medications questions¶
<#>Yes¶
<#>Don’t know¶
<#>Prefer not to answer
Section Break (Continuous)
Section Break (Continuous)
¶
ME02a. What is the name of the first 
prescription medication or over-the-
counter drug that you take?¶
¶
 Label product name: 
_________________________________
_________________________________
____¶
¶
 Label generic name: 
__________________________________
__________________________________
__¶
¶
 Don’t know
 Prefer not to 
answer¶
¶
ME02b. What is the dosage form?¶ ... [1]

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 1 of 25 
 
 
 
 
 
 
 
 
IN-PERSON BASELINE  
QUESTIONNAIRE AND ASSESSMENT FORMS 
 
Deleted: SECOND 
Deleted: VISIT SCREENING 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 2 of 25 
 
PID. Participant ID # __________ 
BA01. Staff ID # __________ 
BA02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
 
BA04. Were the 2nd and 3rd systolic blood pressure readings within 20 mmHg of each other? 
□ Yes 
□ No (repeat measurements  
 
BA05. Were the 2nd and 3rd diastolic blood pressure readings within 10 mmHg of each other? 
□ Yes 
□ No (repeat measurements) 
 
BA06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
BA07. Blood pressure cuff size used: 
 □ S     □ Reg    □  L        □ XL 
 
BA08. Arm that cuff was placed on: 
  □ L      □  R 
 
 
 
Deleted: BA03g. Blood pressure 4th 
reading, systolic blood pressure: 
_________ mmHg¶
BA03h. Blood pressure 4th reading, 
diastolic blood pressure:  __________ 
mmHg¶
BA03i. Blood pressure 5th reading, systolic 
blood pressure: _________ mmHg¶
BA03j. Blood pressure 5th reading, 
diastolic blood pressure:  __________ 
mmHg
Deleted: 4th and 5th
Deleted: 4th and 5th
Deleted: BA06g. Repeated blood 
pressure 4th reading, systolic blood 
pressure: _________ mmHg¶
BA06h. Repeated blood pressure 4th 
reading, diastolic blood pressure:  
__________ mmHg¶
BA06i. Repeated blood pressure 5th 
reading, systolic blood pressure: 
_________ mmHg¶
BA06j. Repeated blood pressure 5th 
reading, diastolic blood pressure:  
__________ mmHg¶

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 3 of 25 
 
BA09. Height: 
______ . __ cm (one decimal place) 
 
 
BA10. Weight: 
______ . __ kg (one decimal place) 
 
 
 
 
Waist Circumference:    
BA11a. Measurement 1 ______ . __ cm (one decimal place) 
BA11b. Measurement 2 ______ . __ cm (one decimal place) 
 
BA12. Is the difference between Measurement 1 and Measurement 2 greater than 1.0cm?  
□ Yes (repeat measurements 3&4)  
□ No 
 
BA13a. Measurement 3 ______ . __ cm    
BA13b. Measurement 4 ______ . __ cm 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 4 of 25 
 
Medications (ME) 
 
 
ME01. Do you take any prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME02a. What is the name of the first prescription medication or over-the-counter drug that you take? 
 
 Label product name: 
______________________________________________________________________ 
 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
ME02b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME02c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 
Comment [SF1]: Moved here from In‐
Person Screener 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 5 of 25 
 
ME02d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME02e. Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME02f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME02g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME02h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME02i. Interviewer comments: 
_______________________________________________________________________ 
 
 
ME02j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 6 of 25 
 
ME03a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME03b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME03c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME03d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.) 
 
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 7 of 25 
 
ME03e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME3f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME03g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
 
 
ME03h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME03i. Interviewer comments:  
__________________________________________________________________ 
 
 
ME03j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME04a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 
 Label product name: 
_____________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 8 of 25 
 
ME04b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME04c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME04d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME04f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 9 of 25 
 
ME04g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME04h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME04i. Interviewer comments: 
 
________________________________________________________________________ 
 
ME04j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
section 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME05a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME05b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 10 of 25 
 
ME05c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME05d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME05e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME05f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME05g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME05h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME05i. Interviewer comments: 
________________________________________________________________________ 
 
 
ME05j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of end of 
medications questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 11 of 25 
 
ME06a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
__________________________________________________________________ 
 
 
 Label generic name: 
___________________________________________________________________ 
 Don’t know 
 
 
 Prefer not to answer 
 
ME06b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
ME06c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
ME06d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 12 of 25 
 
ME06e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME06f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME06g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME06h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME06i. Interviewer comments: 
________________________________________________________________________ 
 
 
 
ME06i. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
ME07a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
_____________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________ 
  Don’t know  
 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 13 of 25 
 
ME07b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME07c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME07d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME07f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 14 of 25 
 
ME07g For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME07h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME07i. Interviewer comments: 
____________________________________________________________________ 
 
ME07j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME08a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 Don’t know  
 
 Prefer not to answer 
 
ME08b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 15 of 25 
 
ME08c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME08d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME08e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME08f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME08g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME08h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME08i. Interviewer comments: 
___________________________________________________________________ 
 
 
ME08j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 16 of 25 
 
ME09a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
____________________________________________________________ 
 
 
 Label generic name: 
 
____________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
ME09b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME09c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 
 
ME09d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 17 of 25 
 
ME09e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME09f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME09g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME09h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME09i. Interviewer comments: 
___________________________________________________________________ 
 
ME09j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer 
 
ME10a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
  Label generic name: 
______________________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
 
 
 

MBHT In-Person Baseline Assessment 
Version 1.4, December 21, 2015  
 
            Page 18 of 25 
 
ME10b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME10c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
ME10d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
ME10e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME10f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.4, December 17, 2015  
 
            Page 19 of 25 
 
ME10g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME10h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME10i. Interviewer comments: 
_______________________________________________________________ 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.4, December 17, 2015  
 
            Page 20 of 25 
 
FOOD FREQUENCY QUESTIONNAIRE:  
 
RA Script to be read to participants: At this time, we are going to have you complete a 
few forms on your own.  The first is a Food Frequency Questionnaire that will ask you 
about the types of foods and drinks that you consume.  It should take around 20 minutes 
to complete.  Please let me know if you have any questions. 
 
Comment [SF2]: At this time, participants 
will be directed to complete the three page 
Harvard University Food Frequency 
Questionnaire (see proof included), known 
as the “80-out”.  It is designed to take 
around 20 minutes to complete and is self-
administered with paper and pencil.  Once 
completed, they will proceed to the next 
section of this assessment (DS_1).

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.4, December 17, 2015  
 
            Page 21 of 25 
 
Questions for Participants to Answer on Their Own In-Person on Paper: 
For each statement, please place a mark in the column that best describes how you 
have been feeling. 
 
Not at all 
or less 
than 1 day 
last week 
1 or 2 
days 
last 
week 
3 to 4 
days 
last 
week 
5 to 7 
days 
last 
week 
Nearly 
every day 
for two 
weeks 
I do not 
know 
I prefer 
not to 
answer 
DS_1. My appetite was poor. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_2. I could not shake off 
the blues. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_3. I had trouble keeping 
my mind on what I was doing. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_4. I felt depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_5. My sleep was restless. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_6. I felt sad. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_7. I could not get going. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_8. Nothing made me 
happy. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
C_9. I felt like a bad person. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_10. I lost interest in my 
usual activities. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_11. I slept much more 
than usual. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_12. I felt like I was moving 
too slowly. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_13. I felt fidgety. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_14. I wished I were dead. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_15. I wanted to hurt 
myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_16. I was tired all the 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_17. I did not like myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_18. I lost a lot of weight 
without trying to. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_19. I had a lot of trouble 
getting to sleep. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_20. I could not focus on 
the important things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.4, December 17, 2015  
 
            Page 22 of 25 
 
Below is a list of common symptoms of anxiety. Please carefully read each item in the 
list. Indicate how much you have been bothered by that symptom during the past 
month, including today, by marking the box in the corresponding space in the column 
next to each symptom.  
 
 
 
 
 
 
 
 
 
Not At All 
Mildly – it 
didn’t 
bother me 
much
Moderately – it 
wasn’t pleasant 
at all times
Severely – 
it bothered 
me a lot
I do not 
know
I prefer 
not to 
answer 
BE_1. Numbness or tingling 
□ 
□ 
□ 
□ 
□ 
□ 
BE_2. Feeling hot 
□ 
□ 
□ 
□ 
□ 
□ 
BE _3. Wobbliness in legs 
□ 
□ 
□ 
□ 
□ 
□ 
BE _4. Unable to relax 
□ 
□ 
□ 
□ 
□ 
□ 
BE _5. Fear of worst happening 
□ 
□ 
□ 
□ 
□ 
□ 
BE _6. Dizzy or lightheaded 
□ 
□ 
□ 
□ 
□ 
□ 
BE _7. Heart pounding/racing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _8. Unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _9. Terrified or afraid 
□ 
□ 
□ 
□ 
□ 
□ 
BE _10. Nervous 
□ 
□ 
□ 
□ 
□ 
□ 
BE _11. Feeling of choking 
□ 
□ 
□ 
□ 
□ 
□ 
BE _12. Hands trembling 
□ 
□ 
□ 
□ 
□ 
□ 
BE _13. Shaky/unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _14. Fear of losing control 
□ 
□ 
□ 
□ 
□ 
□ 
BE _15. Difficulty in breathing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _16. Fear of dying 
□ 
□ 
□ 
□ 
□ 
□ 
BE _17. Scared 
□ 
□ 
□ 
□ 
□ 
□ 
BE _18. Indigestion 
□ 
□ 
□ 
□ 
□ 
□ 
BE _19. Faint/lightheaded  
□ 
□ 
□ 
□ 
□ 
□ 
BE _20. Face flushed 
□ 
□ 
□ 
□ 
□ 
□ 
BE _21. Hot/cold sweats 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.4, December 17, 2015  
 
            Page 23 of 25 
 
After questionnaires are complete, participants will be asked to perform the following two 
computer-based tests: 
Attention Control: Attention Network Test (20 minutes) 
 
Attention Network Test (ANT) is a brief computerized battery measuring three independent 
behavioral components of attention: Conflict resolution (ability to overcome distracting stimuli), 
spatial Orienting (the benefit of valid spatial pre-cues), and Alerting (the benefit of temporal pre-
cues). Efficiency of orienting is examined by changes in RT that accompany cues indicating 
where the target will occur. The efficiency of the executive conflict resolution network is 
examined by requiring the subject to respond by pressing two keys indicating the direction (left 
or right) of a central arrow surrounded by congruent, incongruent or neutral flankers. Moderate 
to high reliabilities are found for all networks. 
 
ANT data to be entered by RA prior to ANT: 
PPT Age: ______ 
PPT Sex: Male / Female 
Category: Normal 
Diagonal of “subject info” window: 10” 
Press “distance between eyes and screen” button to calculate.  Should be 23.2. 
 
ANT data to be entered by RA after ANT: 
PPT Age: ______ 
Alerting effect (ms): ______ 
Orienting effect (ms): ______ 
Conflict effect (ms): ______ 
Mean RT for correct trials (ms): ______ 
Mean accuracy (%):______ 
 
 
Sustained Attention to Response Task (15 minutes) 
 
The Sustained Attention to Response Task (SART) is a computerized test of sustained 
attention, response inhibition (executive function) and self-regulation. Subjects are instructed to 
press a key in response to rapidly displayed integers (1-9) and withhold response to a 
designated "no-go" integer. SART errors consist of summed commission errors (button press on 
no-go trial) and omission errors (button not pressed on "go" integers). SART performance is 
associated with prefrontal cortex functioning, has been found to increase with mindfulness 
training and is correlated with scores on mindfulness questionnaires (specifically, the Mindful 
Attention Awareness Scale).  
 
 
 
Deleted: 
Page Break

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.4, December 17, 2015  
 
            Page 24 of 25 
 
SAFETY PLAN 
After the participant has completed the Beck Anxiety Inventory questionnaire and the Centers 
for Epidemiologic Studies Depressive Symptomatology questionnaire, ask the participant to wait 
for a few minutes while you check that all forms and assessments are completed. While the 
participant is waiting in a different room, check the scores according to the criteria below. If any 
scores trigger the safety plan, move forward with steps below as written.  
Beck Anxiety Inventory (BA)  
 
If participant scores ≥26 on the Beck Anxiety Inventory, while having the participant wait, 
immediately notify the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to 
determine need for a psychiatric consultation. She has provided her cell phone #, and your 
phone # will be entered into her phone recognition software to indicate it is a call from the MBHT 
study. It is likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a 
phone message for her with your contact information and provide her with the Beck Anxiety 
Inventory results on the message. If Dr. Flynn is not immediately reachable, or following 
participant release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks 
(cell phone #401-369-0443).  
Depressive Symptomatology (DS) 
 
The CESD-R will be administered during the in-person assessment visits, and scores will be 
reviewed immediately upon completion of the in-person assessments. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Participants are considered to meet criteria for major depressive episode if they have anhedonia 
or dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM 
symptom groups noted as occurring nearly every day for the past two weeks. If participants 
meet criteria for major depressive episode, while having the participant wait, immediately notify 
the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to determine need 
for a psychiatric consultation.  She has provided her cell phone #, and your phone # will be 
entered into her phone recognition software to indicate it is a call from the MBHT study. It is 
likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a phone message 
for her with your contact information and provide her with the Depressive Symptomatology 
results on the message. If Dr. Flynn is not immediately reachable, or following participant 
release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks (cell phone 
#401-369-0443).  
 
 

MBHT Second In-Person Screening Questionnaire/Assessments,  
Version 1.4, December 17, 2015  
 
            Page 25 of 25 
 
If participants respond having any suicidal ideation (DS questions 14 or 15), perform the 
following 2 steps: 
 
1. Immediately call 911 and Dr. Ellen Flynn.  
 
Specifically, while the participant is in the waiting room, call 911 immediately, and tell 
them: 
 
“My name is _____. I am working on a research study at Brown University. I have a study 
participant in the waiting room who has shared that he/she is currently suicidal.” Please 
provide the participants’ name to the 911 operator, as requested.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know that you have called 911 
and Dr. Flynn, and why (i.e. because we are concerned about you). You can speak 
with participant to keep him/her in the waiting room if 911 has sent assistance, but 
the discussion should not be clinical in nature.   
 
Examples of questions that could be asked in order to keep them in the waiting room: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
• 
Tell me more about why you are interesting in being part of this study.  
• 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 1 of 48
 
 
 
 
 
 
HOME BASELINE ASSESSMENT 
 
 
 
 
QUESTIONNAIRES ANSWERED BY PARTICIPANTS 
AT BASELINE (VIA ONLINE OR PAPER FORM) 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 2 of 48
Questionnaire Table of Contents 
Introductory Questions .................................................................................................................. 3 
Background Questions ................................................................................................................... 5 
Physical Activity ............................................................................................................................. 8 
Eating Practices ............................................................................................................................ 10 
Alcohol Consumption ................................................................................................................... 13 
Smoking ......................................................................................................................................... 14 
About You ..................................................................................................................................... 15 
Parent’s Education ....................................................................................................................... 37 
Your Childhood Experiences ...................................................................................................... 39 
Blood Pressure Medication Use .................................................................................................. 42 
More About You ........................................................................................................................... 43 
Family History of Hypertension  ................................................................................................ 47 
Your Sleep ..................................................................................................................................... 48 
END SCRIPT ................................................................................................................................ 48 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 3 of 48
Introduction 
We appreciate you taking the time to participate in this research study. These questionnaires will 
ask a series of questions on various aspects of your health, health behaviours, family, and other 
life circumstances. It should take approximately one hour. Please keep in mind that you can 
refuse to answer any questions that you are not comfortable with.  
 
Introductory Questions 
 
IQ1_01. Please enter the 4-digit ID number you were given.   ___   ___   ___  ___.  
 
 
 
IQ1_02. What is your main reason for participating in this study? 
 
 
 
 
 
IQ1_03. What do you care about most? 
 
 
 
 
 
IQ1_04. What gives you the most pleasure in your life? 
 
 
 
 
 
IQ1_05. What are your greatest worries? 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 4 of 48
Please list three personal goals you have for taking this mindfulness program: 
 
PG1_01.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_02.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_03.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 5 of 48
Background Questions 
 
BQ1_01. 
How many years old are you? 
 
 
 
 
BQ1_02. 
Are you Latino or Hispanic?  
 
 
 
□ No  skip to B3 
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
  
B1_02a.    Which of the following represents your family's country of origin? (check 
 
  
 
 
    all that apply) 
 
 
 
 
 
 
□ Cuba 
 
 
 
 
□ Mexico 
 
 
 
 
□ Puerto Rico 
 
 
 
 
□ Spain 
                         □ South America 
 
 
 
 
□ Columbia 
 
□ Dominican Republic 
 
□ Other Central American 
 
□ Other: _______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 
BQ1_03. 
If you were asked to put yourself into only one of these groups, in which one would 
you  place yourself? (select one only): 
 
 
 
□ Asian 
 
 
□ Pacific Islander 
 
 
□ African American/Black 
 
 
□ Caucasian/White 
 
□ Native American 
□ Other : ________________________ 
□ I do not know 
□ I prefer not to answer
BQ1_04. 
Which of the following best describes your current work situation? (select one only) 
 
 
 
□ Working full-time 
 
 
□ Working part-time  
 
 
□ Retired 
 
 
□ Unemployed:  
 
 
Looking for work 
□ Unemployed: Not currently    
      
looking for work 
 
 
□ Unemployed due to disability 
□ Keeping house or raising children  
    
full-time 
 
□ Military 
 
□ Full-time student 
 
□ Other:_______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 6 of 48
BQ1_05.    What is the highest grade or level of regular school you have completed? 
 
 
 
□ Elementary School 
 
 
□ Junior High  
 
 
□ High School 
 
 
□ College 
 
 
□ Graduate School  
 
 
□ I do not know 
 
 
□ I prefer not to answer 
     
 
BQ1_06.    What is the highest degree you earned? (select one only) 
 
 
 
□ Elementary school 
□ Some high school, but no GED 
□ GED 
□ High school 
□ Associate degree (Junior College) 
□ Bachelor’s degree 
□ Master’s degree 
□ Doctorate (PhD, EdD, etc) 
□ Professional (MD, JD, DDS, DVM, etc.) 
□ Other: _____________________________ 
□ I do not know 
□ I prefer not to answer 
 
 
 
BQ1_07.    Did you ever attend any other school like a technical, vocational, or trade school? 
 
 
 
□ No 
 
 
 
□ Yes 
 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
BQ1_08.    In total, about how many full-time years of education have you had, including 1st 
grade and all years of school after 1st grade? 
 
 
 
________ years 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 7 of 48
BQ1_09a.    Do you currently live alone? 
 
 
 
□ No 
 
 
 
□ Yes  skip to next section 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
 
 
BQ1_09b. 
How many people currently live in your household, including   
 
 
             yourself? 
 
 
 
 
 
_________  
      
 
 
 
 
 
 
 
 
 
 
 
BQ1_09c.    Of these people, how many are under 18? 
 
 
 
 
 
 
 _________  
 
 
 
 
 
 
 
BQ1_09d. 
  Of the adults in your household (including yourself), how many bring  
 
 
 
      
 income into the household?   
 
 
 
 
 
 
_________  
 
 
 
 
 
 
 
Deleted: BQ_10

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 8 of 48
Physical Activity 
 
Physical activities are activities where you move and increase your heart rate above its resting 
rate, whether you do them for pleasure, work, or transportation. The following questions ask 
about the amount and intensity of physical activity you usually do. The intensity of the activity is 
related to the amount of energy you use doing these activities. 
 
Examples of physical activity intensity levels: 
 
Light activities 
 
Your heart beats slightly faster than normal 
You can talk and sing 
 
 
 
 
 
 
 
 
 
Moderate activities 
 
Your heart beats faster than normal 
You can talk but not sing 
 
 
 
 
 
 
 
 
 
 
Vigorous activities 
 
Your heart rate increases a lot 
You can’t talk, or your talking is broken 
up by large breaths 
 
 
 
 
 
 
 
 
Light exercise   
 
Light stretching  
 
Light vacuuming  
or yard work 
Brisk walking     Aerobics class      Strength training    Swim gently 
Aerobics classes 
 Jogging, Running,   
Singles tennis, 
or Power Walking  
 
Racquetball, Pickle ball 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 9 of 48
How physically active are you? 
 
 
YES 
NO 
I do not 
know 
I prefer 
not to 
answer 
PA1_01. I rarely or never do any physical 
activities. 
□ 
□ 
□ 
□ 
PA1_02. I do some light and/or moderate 
physical activities, but not every week. 
□ 
□ 
□ 
□ 
PA1_03. I do some light physical activity every 
week. 
□ 
□ 
□ 
□ 
PA1_04. I do moderate physical activity every 
week but less than 5 days per week or less than 
30 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_05. I do vigorous physical activities every 
week, but less than 3 days per week or less than 
20 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_06. I do 30 minutes or more per day of 
moderate physical activities 5 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_07. I do 20 minutes or more per day of 
vigorous physical activities 3 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_08. I do activities to increase muscle 
strength, such as lifting weights or calisthenics, 
once a week or more. 
□ 
□ 
□ 
□ 
PA1_09. I do activities to improve flexibility, 
such as stretching or yoga, once a week or more. 
□ 
□ 
□ 
□ 
 
 
 
 
 
Deleted: Diet ¶
The first set of questions ask about foods you usually 
eat or drink.  For each food, please place an X in the 
box (e.g. ) for the answer that best matches how 
often you eat or drink it. Remember to count fruit or 
vegetables that were part of another dish, like a 
banana on cereal or vegetables in a stew. Also, 
please pay attention to the serving sizes. For 
example, one serving size of bread is one slice, so a 
sandwich would contain 2 servings of bread. Please 
include all foods you eat, both at home and away 
from home.   Enclosed are pictures of common 
serving sizes to assist you in filling out your 
questionnaire. ¶
Deleted: How Often You Eat or Drink This 
Item
... [1]

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 10 of 48
Eating Practices 
 
 
Definitely 
True 
Mostly 
True 
Mostly 
False 
Definitely 
False 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_01. I deliberately take small 
helpings to control my weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_02. I start to eat when I feel 
anxious. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_03. Sometimes when I start 
eating, I just can’t seem to stop. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_04. When I feel sad, I often eat 
too much. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_05. I don’t eat some foods 
because they make me fat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_06. Being with someone who is 
eating, often makes me want to also 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_07. When I feel tense or 
‘‘wound up’’, I often feel I need to 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_08. I often get so hungry that 
my stomach feels like a bottomless 
pit. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_09. I’m always so hungry that 
it’s hard for me to stop eating before 
finishing all of the food on my plate. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_10. When I feel lonely, I 
console myself by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_11. I consciously hold back on 
how much I eat at meals to keep 
from gaining weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_12. When I smell a sizzling 
steak or see a juicy piece of meat, I 
find it very difficult to keep from 
eating even if I’ve just finished a 
meal. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_13. I’m always hungry enough 
to eat at any time. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_14. If I feel nervous, I try to 
calm down by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_15. When I see something that 
looks very delicious, I often get so 
hungry that I have to eat right away. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_16. When I feel depressed, I 
want to eat. 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 11 of 48
 
 
 
Almost 
Never 
Seldom
Usually 
Almost 
Always
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_17. How often do you avoid 
‘stocking up’’ on tempting foods? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Unlikely 
A little 
likely 
Somewhat 
likely 
Very 
likely 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_18. How likely are you to 
make an effort to eat less than you 
want? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Never 
Rarely
Sometimes
At least 
once a 
week 
I Do Not 
Know 
I Prefer 
Not to 
Answer 
EE1_19. Do you go on eating 
binges even though you’re not 
hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Only at 
mealtimes 
Sometimes 
between 
meals 
Often 
between 
meals 
Almost 
always 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_20. How often do you 
feel hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
1
2
3
4
5
6
7
8
I Do 
Not 
Know
I Prefer 
Not to 
Answer 
EE1_21. On a scale from 1 to 8, where 1 means 
no restraint in eating and 8 means total restraint, 
what number would you give yourself? Mark the 
number that best applies to you: 
□□□□□□□□
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 12 of 48
Table Salt Use: 
 
TS1_01 
Please report your average total use, during the past year, of “salt added at the table”.  
Would you say… 
 
Never ...................................................................... □ 
Less than once per month ....................................... □ 
1-3 shakes per month .............................................. □ 
1 shake per week .................................................... □ 
2-4 shakes per week ............................................... □ 
5-6 shakes per week ............................................... □ 
1 shake per day ....................................................... □ 
2-3 shakes per day .................................................. □ 
4-5 shakes per day .................................................. □ 
6+ shakes per day ................................................... □ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 13 of 48
Alcohol Consumption  
 
A drink of alcohol is defined as 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine 
cooler, 1 cocktail, or 1 shot of liquor. 
 
AC1_01. During the past 30 days, how many days per week or per month did you have at least 1 
drink of any alcoholic beverage? [if none, skip to next section] 
 
_______________ 
 
 
AC1_02. On the days when you drank, about how many drinks did you drink on average?  
 
______________ 
 
 
AC1_03. Men: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 5 or more drinks on an occasion? 
 
Women: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 4 or more drinks on an occasion? 
 
_________________ 
 
 
Deleted: STOP

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 14 of 48
Smoking  
 
SM1_01. 
Have you smoked at least 100 cigarettes in your entire life? 
 
 Yes 
 No 
 I Do Not Know 
 Prefer not to answer 
 
 
SM1_02.  
Did you ever become a daily smoker (that is, smoke every day or nearly every day 
for two months or longer)? 
 
 Yes 
 No  skip to next section 
 I Do Not Know 
 Prefer not to answer 
 
SM1_03.  
How old were you when you last smoked daily? 
 
  
Age ______ (in years) 
 
 
 I Do Not Know 
 Prefer not to answer  
 Still smoking daily 
 
 
 
SM1_04. 
Do you smoke cigarettes now? 
 
 Yes 
 No  skip to next section 
 I Do Not Know 
 Prefer not to answer 
 
 
 SM1_04a.    How many cigarettes per day do you smoke? (One pack equals 20   
 
   
 
 cigarettes) 
 
  
 
 
Number of cigarettes ________  
 
 
 
 
 
 
 
 
 I Do Not Know 
 
 
 
 
 Prefer not to answer 
 
 
 
Deleted: SC1_01

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 15 of 48
About You 
 
Please bring to mind a type of very tasty food that may contribute to hypertension through high 
salt intake or through eating too many calories (e.g., sweet sugary dessert, salty snack foods, etc.).   
 
Think about the LAST WEEK you MOST WANTED this type of food.  For each item, select a 
number (0 to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine its taste? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
6. …imagine its smell? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …imagine what it would feel like in 
your mouth or throat? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
9. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
10. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
11. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 16 of 48
Please bring to mind any times in the LAST WEEK when you had a desire to do sedentary 
activities (e.g., read a book, watch a movie, be on the computer, etc.) instead of physical activities 
(e.g., walking, gardening, exercise). 
 
Think about the LAST WEEK you MOST WANTED to do a sedentary activity.  For each item, 
select a number (0 to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
6. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Please bring to mind any times in the LAST WEEK when you had a desire to drink alcohol, such 
as wine, beer or spirits.   
 
Think about the LAST WEEK you MOST WANTED alcohol.  For each item, select a number (0 
to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine its taste? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
6. …imagine its smell? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …imagine what it would feel like in 
your mouth or throat? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
9. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
10. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
11. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 17 of 48
Using the scale provided, please indicate how much each of the following statements reflects how 
you typically are.  
 
 
Not 
at all 
A 
little 
Somewhat
Fair 
Amount 
Very 
much 
I do 
not 
know 
I 
prefer 
not to 
answer 
SC1_01. I am good at resisting 
temptation. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_02. I have a hard time 
breaking bad habits. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_03. I am lazy. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_04. I say inappropriate 
things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_05. I do certain things that 
are bad for me, if they are fun.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_06. I refuse things that are 
bad for me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_07. I wish I had more self-
discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_08. People would say that 
I have iron self-discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_09. Pleasure and fun 
sometimes keep me from 
getting work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_10. I have trouble 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_11. I am able to work 
effectively toward long-term 
goals. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_12. Sometimes I can’t stop 
myself from doing something, 
even if I know it is wrong. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_13. I often act without 
thinking through all the 
alternatives.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 18 of 48
Please read each statement carefully before answering. To the left of each item, indicate how 
often you behave in the stated manner, using the following scale: 
 
 
Almost 
never 
Not very 
often 
Sometimes
Frequently
Almost 
always 
I Do 
Not 
Know
Prefer not 
to answer 
CO1_O1. When I fail at 
something important to me, 
I become consumed by 
feelings of inadequacy. 
 
 
 
 
 
 
 
CO1_02. I try to be 
understanding and patient 
towards those aspects of 
my personality I don’t like. 
 
 
 
 
 
 
 
CO1_O3. When something 
painful happens I try to 
take a balanced view of the 
situation. 
 
 
 
 
 
 
 
CO1_O4. When I’m 
feeling down, I tend to feel 
like most other people are 
probably happier than I am. 
 
 
 
 
 
 
 
CO1_O5. I try to see my 
failings as part of the 
human condition. 
 
 
 
 
 
 
 
CO1_O6. When I’m going 
through a very hard time, I 
give myself the caring and 
tenderness I need. 
 
 
 
 
 
 
 
CO1_O7. When something 
upsets me I try to keep my 
emotions in balance. 
 
 
 
 
 
 
 
CO1_O8. When I fail at 
something that’s important 
to me, I tend to feel alone 
in my failure 
 
 
 
 
 
 
 
CO1_O9. When I’m 
feeling down I tend to 
obsess and fixate on 
everything that’s wrong. 
 
 
 
 
 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 19 of 48
 
Almost 
never 
Not very 
often 
Sometimes
Frequently
Almost 
always 
I Do 
Not 
Know 
Prefer not 
to answer 
CO1_10. When I feel 
inadequate in some way, I 
try to remind myself that 
feelings of inadequacy are 
shared by most people. 
 
 
 
 
 
 
 
CO1_11. I’m disapproving 
and judgmental about my 
own flaws and 
inadequacies. 
 
 
 
 
 
 
 
CO1_12. I’m intolerant and 
impatient towards those 
aspects of my personality I 
don’t like. 
 
 
 
 
 
 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 20 of 48
The questions in this scale ask you about your feelings and thoughts during the last month. In 
each case, you will be asked to indicate by circling how often you felt or thought a certain way.  
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do not 
know 
I prefer 
not to 
answer 
PS1_01. In the last month, how 
often have you been upset 
because of something that 
happened unexpectedly?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_02. In the last month, how 
often have you felt that you 
were unable to control the 
important things in your life?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_03. In the last month, how 
often have you felt nervous and 
“stressed”? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_04. In the last month, how 
often have you felt confident 
about your ability to handle 
your personal problems?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_05. In the last month, how 
often have you felt that things 
were going your way? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_06. In the last month, how 
often have you found that you 
could not cope with all the 
things that you had to do?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_07. In the last month, how 
often have you been able to 
control irritations in your life? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_08. In the last month, how 
often have you felt that you 
were on top of things? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_09. In the last month, how 
often have you been angered 
because of things that were 
outside of your control? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_10. In the last month, how 
often have you felt difficulties 
were piling up so high that you 
could not overcome them?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 21 of 48
Please indicate how often the following statements apply to you by checking the box that 
best describes your experience.  
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%)
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_01.  I am clear 
about my feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_02.  I pay 
attention to how I 
feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_03.  I 
experience my 
emotions as 
overwhelming and 
out of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_04.  I have no 
idea how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_05.  I have 
difficulty making 
sense out of my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_06.  I am 
attentive to my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_07.  I know 
exactly how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_08.  I care 
about what I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_09.  I am 
confused about how 
I feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_10.  When I’m 
upset, I acknowledge 
my emotions. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_11.  When I’m 
upset, I become 
angry with myself 
for feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_12.  When I’m 
upset, I become 
embarrassed for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Comment [D1]: This section (ER1) was moved up 
in the questionnaire. None of the individual items 
have changed. 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 22 of 48
 
 
 
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%)
Most of 
the Time 
(66-90%)
Almost 
Always 
(91-100%)
I Do 
Not 
Know
I Prefer 
Not to 
Answer 
ER1_13.  When I’m 
upset, I have 
difficulty getting 
work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_14. When I’m 
upset, I become out 
of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_15.  When I’m 
upset, I believe that I 
will remain that way 
for a long time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_16.  When I’m 
upset, I believe that I 
will end up feeling 
very depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_17.  When I’m 
upset, I believe that 
my feelings are valid 
and important. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_18.  When I’m 
upset, I have 
difficulty focusing 
on other things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_19.  When I’m 
upset, I feel out of 
control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_20.  When I’m 
upset, I can still get 
things done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_21.  When I’m 
upset, I feel ashamed 
at myself for feeling 
that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_22.  When I’m 
upset, I know that I 
can find a way to 
eventually feel 
better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 23 of 48
 
 
 
 
Almost 
Never  
(0-
10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%)
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_23.  When I’m 
upset, I feel like I am 
weak. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_24.  When I’m 
upset, I feel like I can 
remain in control of my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_25. When I’m 
upset, I feel guilty for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_26. 
When 
I’m 
upset, I have difficulty 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_27.  When I’m 
upset, I have difficulty 
controlling my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_28.  When I’m 
upset, I believe there is 
nothing I can do to 
make myself feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_29.  When I’m 
upset, I become 
irritated at myself for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_30.  When I’m 
upset, I start to feel 
very bad about myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_31.  When I’m 
upset, I believe that 
wallowing in it is all I 
can do. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_32.  When I’m 
upset, I lose control 
over my behaviour. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 24 of 48
 
 
 
 
Almost 
Never  
(0-
10%)
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%)
Most of 
the Time 
(66-90%)
Almost 
Always 
(91-100%)
I Do 
Not 
Know
I Prefer 
Not to 
Answer 
ER1_33.  When I’m 
upset, I have difficulty 
thinking about anything 
else. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_34.  When I’m 
upset I take time to 
figure out what I’m 
really feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_35.  When I’m 
upset, it takes me a long 
time to feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_36.  When I’m 
upset, my emotions feel 
overwhelming. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 25 of 48
This scale is made up of a list of statements each of which may or may not be true about you. For 
each statement, select “definitely true” if you are sure it is true about you and “probably true” if 
you think it is true but are not absolutely certain. Similarly, you should select “definitely false” if 
you are sure the statement is false and “probably false” if you think it is false but are not 
absolutely certain. 
 
 
 
 
 
Definitely 
False 
Probably 
False 
Probably 
True 
Definitely 
True 
I do not 
know 
I prefer not 
to answer 
IS1_01  If I wanted to go on a trip 
for a day (for example, to the 
country or mountains), I would have 
a hard time finding someone to go 
with me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_02  I feel that there is no one I 
can share my most private worries 
and fears with. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_03   If I were sick, I could easily 
find someone to help me with my 
daily chores. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_04   There is someone I can turn 
to for advice about handling 
problems with my family. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_05   If I decide one afternoon 
that I would like to go to a movie 
that evening, I could easily find 
someone to go with me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_06   When I need suggestions 
on how to deal with a personal 
problem, I know someone I can turn 
to. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_07   I don’t often get invited to 
do things with others. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_08   If I had to go out of town 
for a few weeks, it would be difficult 
to find someone who would look 
after my house or apartment (the 
plants, pets, garden, etc.). 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_09   If I wanted to have lunch 
with someone, I could easily find 
someone to join me. 
□ 
□ 
□ 
□ 
□ 
□ 
Comment [SF2]: NEW section 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 26 of 48
 
 
 
 
Definitely 
False 
Probably 
False 
Probably 
True 
Definitely 
True 
I do not 
know 
I prefer not 
to answer 
IS1_10   If I was stranded 10 miles 
from home, there is someone I could 
call who could come and get me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_11   If a family crisis arose, it 
would be difficult to find someone 
who could give me good advice 
about how to handle it. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_12   If I needed some help in 
moving to a new house or apartment, 
I would have a hard time finding 
someone to help me. 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 27 of 48
Please indicate how often each of the statements below is descriptive of you. 
 
Statement 
Never 
Rarely 
Sometimes
Often 
I Do 
Not 
Know
Prefer 
not to 
answer 
LS1_01. I feel in tune with the people 
around me 
□ 
□ 
□ 
□ 
□ 
s 
LS1_02. I lack companionship 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_03. There is no one I can turn to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_04. I do not feel alone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_05. I feel part of a group of 
friends 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_06. I have a lot in common with 
the people around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_07. I am no longer close to 
anyone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_08. My interests and ideas are 
not shared by those around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_09. I am an outgoing person 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_10. There are people I feel close 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_11. I feel left out 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_12. My social relationships are 
superficial 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_13. No one really knows me 
well 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_14. I feel isolated from others 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_15. I can find companionship 
when I want it 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_16. There are people who really 
understand me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_17. I am unhappy being so 
withdrawn 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_18. People are around me but 
not with me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_19. There are people I can talk 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_20. There are people I can turn 
to 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Deleted: INSTRUCTIONS: I
Comment [D3]: This section (LS1) was moved 
here.  None of the individual items have changed. 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 28 of 48
Below you will find a list of statements. Please indicate how often each statement applies to you 
generally in daily life.  
 
 
0- 
Never 
1 
2 
3 
4 
5 - Always 
IA1_01. When I am tense I notice where the tension is 
located in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_02. I notice when I am uncomfortable in my body. 
□ 
□ 
□ 
□ 
□ 
□ 
IA1_03. I notice where in my body I am comfortable. 
□ 
□ 
□ 
□ 
□ 
□ 
IA1_04. I notice changes in my breathing, such as 
whether it slows down or speeds up.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_05. I do not notice (I ignore) physical tension or 
discomfort  
until they become more severe.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_06. I distract myself from sensations of 
discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_07. When I feel pain or discomfort, I try to power 
through it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_08. When I feel physical pain, I become upset.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_09. I start to worry that something is wrong if I 
feel any discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_10. I can notice an unpleasant body sensation 
without worrying about it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_11. I can pay attention to my breath without being 
distracted by things happening around me.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_12. I can maintain awareness of my inner bodily 
sensations even when there is a lot going on around me. 
□ 
□ 
□ 
□ 
□ 
□ 
IA1_13. When I am in conversation with someone, I 
can pay attention to my posture. 
□ 
□ 
□ 
□ 
□ 
□ 
IA1_14. I can return awareness to my body if I am 
distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_15. I can refocus my attention from thinking to 
sensing my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_16. I can maintain awareness of my whole body 
even when a part of me is in pain or discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_17. I am able to consciously focus on my body as 
a whole.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_18. I notice how my body changes when I am 
angry.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_19. When something is wrong in my life I can feel 
it in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_20. I notice that my body feels different after a 
peaceful experience.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_21. I notice that my breathing becomes free and 
easy when I feel comfortable.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_22. I notice how my body changes when I feel 
happy / joyful.  
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Comment [D4]: The following three sections 
(IA1, RD1, and CR1) were moved here from later in 
the survey.  None of the individual items have 
changed. 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 29 of 48
 
 
0- Never
1
2
3
4
5 - Always 
IA1_23. When I feel overwhelmed I can find a calm 
place inside.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_24. When I bring awareness to my body I feel a 
sense of calm.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_25. I can use my breath to reduce tension.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_26. When I am caught up in thoughts, I can 
calm my mind by focusing on my body/breathing. 
□ 
□ 
□ 
□ 
□ 
□ 
IA1_27. I listen for information from my body about 
my emotional state.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_28. When I am upset, I take time to explore how 
my body feels.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_29. I listen to my body to inform me about what 
to do.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_30. I am at home in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_31. I feel my body is a safe place.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_32. I trust my body sensations.  
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 30 of 48
We are interested in your recent experiences. Below is a list of things that people sometimes 
experience. Next to each item are five choices: “never”, “rarely”, “sometimes”, “often”, and 
“all the time”. Please choose one of these to indicate how much you currently have experiences 
similar to those described. 
 
Please do not spend too long on each item–it is your first response that we are interested in. 
Please be sure to answer every item. 
 
 
Never 
Rarely 
Sometimes 
Often 
All the time 
RD1_01. I think about what will happen in 
the future. 
□ 
□ 
□ 
□ 
□ 
RD1_02. I remind myself that thoughts 
aren’t facts. 
□ 
□ 
□ 
□ 
□ 
RD1_03. I am better able to accept myself 
as I am. 
□ 
□ 
□ 
□ 
□ 
RD1_04. I notice all sorts of little things 
and details in the world around me. 
□ 
□ 
□ 
□ 
□ 
RD1_05. I am kinder to myself when things 
go wrong. 
□ 
□ 
□ 
□ 
□ 
RD1_06. I can slow my thinking at times of 
stress. 
□ 
□ 
□ 
□ 
□ 
RD1_07. I wonder what kind of person I 
really am. 
□ 
□ 
□ 
□ 
□ 
RD1_08. I am not so easily carried away 
by my thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_09. I notice that I don’t take 
difficulties so personally. 
□ 
□ 
□ 
□ 
□ 
RD1_10. I can separate myself from my 
thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_11. I analyze why things turn out the 
way they do. 
□ 
□ 
□ 
□ 
□ 
RD1_12. I can take time to respond to 
difficulties. 
□ 
□ 
□ 
□ 
□ 
RD1_13. I think over and over again about 
what others have said to me. 
□ 
□ 
□ 
□ 
□ 
RD1_14. I can treat myself kindly. 
□ 
□ 
□ 
□ 
□ 
RD1_15. I can observe unpleasant feelings 
without being drawn into them. 
□ 
□ 
□ 
□ 
□ 
RD1_16. I have the sense that I am fully 
aware of what is going on around me and 
inside me. 
□ 
□ 
□ 
□ 
□ 
RD1_17. I can actually see that I am not 
my thoughts. 
□ 
□ 
□ 
□ 
□ 
RD1_18. I am consciously aware of a 
sense of my body as a whole. 
□ 
□ 
□ 
□ 
□ 
RD1_19. I think about the ways in which I 
am different from other people. 
□ 
□ 
□ 
□ 
□ 
RD1_20. I view things from a wider 
perspective. 
□ 
□ 
□ 
□ 
□ 
Deleted: darken 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 31 of 48
How do you cope with events?  Everyone gets confronted with negative or unpleasant 
events now and then and everyone responds to them in his or her own way. By the following 
questions you are asked to indicate what you generally think, when you experience negative or 
unpleasant events. 
 
 
(Almost) 
Never 
Some-
times 
Regularly 
Often 
(Almost) 
Always 
CR1_01. I think that I have to 
accept that this has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_02. I often think about how I 
feel about what I have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_03. I think I can learn 
something from the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_04. I feel that I am the one 
who is responsible for what has 
happened. 
□ 
□ 
□ 
□ 
□ 
CR1_05. I think that I have to 
accept the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_06. I am preoccupied with 
what I think and feel about what I 
have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_07. I think of pleasant things 
that have nothing to do with it. 
□ 
□ 
□ 
□ 
□ 
CR1_08. I think that I can become 
a stronger person as a result of 
what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_09. I keep thinking about how 
terrible it is what I have 
experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_10. I feel that others are 
responsible for what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_11. I think of something nice 
instead of what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_12. I think about how to 
change the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_13. I think that it hasn’t been 
too bad compared to other things. 
□ 
□ 
□ 
□ 
□ 
CR1_14. I think that basically the 
cause must lie within myself. 
□ 
□ 
□ 
□ 
□ 
CR1_15. I think about a plan of 
what I can do best. 
□ 
□ 
□ 
□ 
□ 
CR1_16. I tell myself that there are 
worse things in life. 
□ 
□ 
□ 
□ 
□ 
CR1_17. I continually think how 
horrible the situation has been. 
□ 
□ 
□ 
□ 
□ 
CR1_18. I feel that basically the 
cause lies with others. 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 32 of 48
Instructions: Below is a collection of statements about your everyday experience. Using the scale 
below, please indicate how frequently or infrequently you currently have each experience. Please 
answer according to what really reflects your experience rather than what you think your 
experience should be. Please treat each item separately from every other item.  
 
Please indicate the degree to which you agree with each of the following items using the scale 
below. Simply check your response to each item 
 
 
  
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
MA1_01. I could be 
experiencing some 
emotion and not be 
conscious of it until 
some time later.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_02. I break or 
spill things because 
of carelessness, not 
paying attention, or 
thinking of 
something else.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_03. I find it 
difficult to stay 
focused on what’s 
happening in the 
present. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_04. I tend to 
walk quickly to get 
where I’m going 
without paying 
attention to what I 
experience along the 
way.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_05. I tend not 
to notice feelings of 
physical tension or 
discomfort until they 
really grab my 
attention.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_06. I forget a 
person’s name almost 
as soon as I’ve been 
told it for the first 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 33 of 48
 
 
 
 
 
 
 
 
 
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know
I prefer 
not to 
answer
MA1_07. It seems I 
am “running on 
automatic” without 
much awareness of 
what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_08. I rush 
through activities 
without being really 
attentive to them.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_09. I get so 
focused on the goal I 
want to achieve that I 
lose touch with what 
I am doing right now 
to get there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_10. I do jobs or 
tasks automatically, 
without being aware 
of what I’m doing.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_11. I find 
myself listening to 
someone with one 
ear, doing something 
else at the same time.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_12. I drive 
places on “automatic 
pilot” and then 
wonder why I went 
there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_13. I find 
myself preoccupied 
with the future or the 
past.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_14. I find 
myself doing things 
without paying 
attention. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_15. I snack 
without being aware 
that I’m eating.    
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 34 of 48
Please rate each of the following statements using the scale provided. Write the number in the 
blank that best describes your own opinion of what is generally true for you.  
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_01. When I’m walking, I 
deliberately notice the sensations of 
my body moving.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_02. I’m good at finding words to 
describe my feelings.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_03. I criticize myself for having 
irrational or inappropriate emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_04. I perceive my feelings and 
emotions without having to react to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_05. When I do things, my mind 
wanders off and I’m easily distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_06. When I take a shower or 
bath, I stay alert to the sensations of 
water on my body.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_07. I can easily put my beliefs, 
opinions, and expectations into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_08. I don’t pay attention to what 
I’m doing because I’m daydreaming, 
worrying, or otherwise distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_09. I watch my feelings without 
getting lost in them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_10. I tell myself I shouldn’t be 
feeling the way I’m feeling.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_11. I notice how foods and 
drinks affect my thoughts, bodily 
sensations, and emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_12. It’s hard for me to find the 
words to describe what I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_13. I am easily distracted. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_14. I believe some of my 
thoughts are abnormal or bad and I 
shouldn’t think that way.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_15. I pay attention to sensations, 
such as the wind in my hair or sun on 
my face.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 35 of 48
 
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often
I do 
not 
know 
I prefer 
not to 
answer 
FF1_16. I have trouble thinking 
of the right words to express how 
I feel about things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_17. I make judgments about 
whether my thoughts are good or 
bad.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_18. I find it difficult to stay 
focused on what’s happening in 
the present.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_19. When I have distressing 
thoughts or images, I “step back” 
and am aware of the thought or 
image without getting taken over 
by it.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_20. I pay attention to 
sounds, such as clocks ticking, 
birds chirping, or cars passing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_21. In difficult situations, I 
can pause without immediately 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_22. When I have a sensation 
in my body, it’s difficult for me 
to describe it because I can’t find 
the right words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_23. It seems I am “running 
on automatic” without much 
aware- ness of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_24. When I have distressing 
thoughts or images, I feel calm 
soon after.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_25. I tell myself that I 
shouldn’t be thinking the way 
I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_26. I notice the smells and 
aromas of things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_27. Even when I’m feeling 
terribly upset, I can find a way to 
put it into words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_28. I rush through activities 
without being really attentive to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 36 of 48
 
 
 
 
 
 
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often
I do 
not 
know 
I prefer 
not to 
answer 
FF1_29. When I have distressing 
thoughts or images, I am able 
just to notice them without 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_30. I think some of my 
emotions are bad or 
inappropriate and I shouldn’t feel 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_31. I notice visual elements 
in art or nature, such as colors, 
shapes, textures, or patterns of 
light and shadow.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_32. My natural tendency is 
to put my experiences into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_33. When I have distressing 
thoughts or images, I just notice 
them and let them go.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_34. I do jobs or tasks 
automatically without being 
aware of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_35. When I have distressing 
thoughts or images, I judge 
myself as good or bad depending 
what the thought or image is 
about.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_36. I pay attention to how 
my emotions affect my thoughts 
and behavior.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_37. I can usually describe 
how I feel at the moment in 
consider- able detail.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_38. I find myself doing 
things without paying attention. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_39. I disapprove of myself 
when I have irrational ideas. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 37 of 48
Parent’s Education 
 
CS1_01. Please check the box beside the highest grade or degree that your BIOLOGICAL 
MOTHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
CS1_02. Please check the box beside the highest grade or degree that your BIOLOGICAL 
FATHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 38 of 48
Now please think of the two most important adults in your home between the time you were born 
and age 18 years. Please check the category below that best described their level of education 
during this time period. 
 
CS1_03. First adult’s highest level of education: 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
CS1_04. Second adult’s highest level of education 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 
Deleted: lecel

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 39 of 48
Your Childhood Experiences 
 
The following questions ask about some difficult experiences that you might have had as a child. 
These questions may be emotionally difficult to answer. Just as a reminder, you do not need 
answer any questions that you would prefer not to. Your answers to these questions, as with all 
questions, will remain confidential.  
 
CE1_01. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Swear at you, insult you, put you down, or humiliate you? 
 
 
 
or 
Act in a way that made you afraid that you might be physically hurt? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_02. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Push, grab, slap, or throw something at you? 
 
 
 
or 
Ever hit you so hard that you had marks or were injured?  
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
CE1_03.  
Before you were 18 years old, did an adult or person at least 5 years older than you 
ever… 
 
 
Touch or fondle you or have you touch their body in a sexual way? 
 
 
 
or 
Attempt or actually have oral, anal, or vaginal intercourse with you? 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 40 of 48
CE1_04. Before you were 18 years old, did you often or very often feel that … 
 
 
No one in your family loved you or thought you were important or special? 
 
 
 
or 
Your family didn’t look out for each other, feel close to each other, or support each other? 
 
  
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
CE1_05. Before you were 18 years old, did you often or very often feel that … 
 
 
You didn’t have enough to eat, had to wear dirty clothes, and had no one to protect you? 
 
 
 
or 
Your parents were too drunk or high to take care of you or take you to the doctor if you 
needed it? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
  
 
 
CE1_06. Before you were 18 years old, was a biological parent ever lost to you through divorce, 
abandonment, or other reason?   
 
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_07. Before you were 18 years old, was your mother or stepmother:   
 
 
Often or very often pushed, grabbed, slapped, or had something thrown at her? 
 
 
 
or 
Sometimes, often, or very often kicked, bitten, hit with a fist, or hit with something hard? 
 
 
 
or 
Ever repeatedly hit over at least a few minutes or threatened with a gun or knife? 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 41 of 48
 
CE1_08. Before you were 18 years old, did you live with anyone who was a problem drinker or 
alcoholic, or who used street drugs? 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
     
 
CE1_09. Before you were 18 years old, was a household member depressed or mentally ill, or did 
a household member attempt  suicide? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_10. Before you were 18 years old, did a household member go to prison? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deleted: SN1_01. How many close friends do 
you have? By close friends, we mean people that you 
feel at ease with, and that you can talk to about 
private matters.¶
¶
□ None  skip to Y2 ¶
¶
____ Number of close friends  ¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_01a.    How many of these close friends do 
you see at least once a month?   ¶
¶
____ Number of close friends (if none, write 
zero)¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_02. Thinking about your relatives, how many 
relatives do you feel at ease with, and feel that you 
can talk to about private matters? ¶
¶
□ None  skip to Y3¶
¶
____ Number of relatives ¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_02a.    How many of these relatives do you 
see at least once a month? ¶
¶
____ Number of relatives (if none, write 
zero)¶
¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
¶
¶
¶
SN1_03. About how often do you participate in 
groups or clubs, such as religious connected groups, 
self-help groups, charities, or a public service or 
community group.¶
¶
□ Never or almost never¶
□ A few times a year¶
□ Once or twice a month¶
□ Once a week¶
□ More than once a week¶
□ I do not know ¶
□ I prefer not to answer ¶
¶
¶
SN1_04. About how often do you go to religious 
meetings or services? ¶
¶
□ Never or almost never¶
□ A few times a year¶
□ Once or twice a month¶
□ Once a week¶
□ More than once a week¶
... [2]

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 42 of 48
Blood Pressure Medication Use 
 
BM1_01. Do you currently take medication for your blood pressure? 
□ Yes 
□ No (if responding “no”, please skip to the next page).  
 
 
 
 
Yes 
No 
BM1_02. Do you sometimes forget to take your blood pressure pills? 
 
□ 
□ 
BM1_03. People sometimes miss taking their medications for reasons 
other than forgetting. Thinking over the past two weeks, were there 
any days when you did not take your blood pressure medicine? 
 
□ 
□ 
BM1_04. Have you ever cut back or stopped taking your blood 
pressure medicine without telling your doctor because you felt worse 
when you took it? 
 
□ 
□ 
BM1_05. When you travel or leave home, do you sometimes forget to 
bring along your blood pressure medicine? 
 
□ 
□ 
BM1_06. Did you take all your blood pressure medicine yesterday? 
 
□ 
□ 
BM1_07. When you feel like your symptoms are under control, do you 
sometimes stop taking your blood pressure medicine? 
 
□ 
□ 
BM1_08. Taking blood pressure medicine every day is a real 
inconvenience for some people. Do you ever feel hassled about 
sticking to your treatment plan? 
 
□ 
□ 
 
BM1_09. How often do you have difficulty remembering to take all your blood pressure 
medicine?  
□ Never/rarely 
□ Once in a while 
□ Sometimes 
□ Usually 
□ All the time 
 
 
 
Comment [SF5]: New Section 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 43 of 48
More About You 
Below are some modifiable factors that likely influence blood pressure. These may not all apply 
to you, as you may already have excellent levels of these factors.  
 
Physical activity: 
The United States Office of Disease Prevention and Health Promotion 2008 Physical Activity 
Guidelines for Americans states that  “Most health benefits occur with at least 150 minutes (2 
hours and 30 minutes) a week of moderate intensity physical activity, such as brisk walking. 
Additional benefits occur with more physical activity. Both aerobic (endurance) and muscle-
strengthening (resistance) physical activity are beneficial.” 
 
RC1_01. How motivated are you to make changes to your physical activity, using a scale of one 
to ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_02. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your physical activity? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Diet: 
 
The Dietary Approaches to Stop Hypertension (DASH) diet eating plan is a diet rich in fruits, 
vegetables, low fat or nonfat dairy. It also includes mostly whole grains; lean meats, fish and 
poultry; nuts and beans. It is high fiber and low to moderate in fat. It is a plan that follows US 
guidelines for sodium content, along with vitamins and minerals. It can be considered to be an 
Americanized version of the Mediterranean diet. 
 
RC1_03. How motivated are you to make changes to your diet to be consistent with the DASH 
diet, using a scale of one to ten, where one = definitely not ready to change, and 10 = definitely 
ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_04. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your diet to be more consistent with the DASH diet? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Comment [SF6]: New Section – readiness to 
change 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 44 of 48
Salt Intake: 
 
The 2010 Dietary Guidelines for Americans recommend that everyone age 2 years and up 
should consume less than 2,300 milligrams (mg) of sodium each day. Some groups of people 
should further limit sodium intake to 1,500 mg per day, including: 
• 
Adults age 51 years or older. 
• 
All African Americans. 
• 
Anyone who has high blood pressure, diabetes, or chronic kidney disease. 
 
RC1_05. How motivated are you to make changes to your salt intake, using a scale of one to 
ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_06. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your salt intake? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Overweight/Obesity: 
 
Extensive scientific evidence shows that being overweight or obese increases risk of having high 
blood pressure.  
 
RC1_07. How motivated are you to make changes to your body weight, using a scale of one to 
ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_08. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your body weight? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 45 of 48
Stress, and Stress Response: 
 
Several studies showed that stress, and being slower at emotionally recovering from stressful 
events, increase risk of hypertension.  
 
RC1_09. How motivated are you to make changes to the amount of stress in your life, or your 
response to that stress, using a scale of one to ten, where one = definitely not ready to change, 
and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□
□
□
□
□
 
 
RC1_10. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in the amount of stress in your life, or your response to that stress? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Alcohol Consumption: 
 
Heavy and regular use of alcohol can increase blood pressure substantially. The American Heart 
Association recommends limiting alcohol consumption to no more than two drinks per day for 
men and one drink per day for women. 
 
RC1_11. How motivated are you to make changes to the amount of alcohol you consume, using 
a scale of one to ten, where one = definitely not ready to change, and 10 = definitely ready to 
change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6
7
8
9
10
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
RC1_12. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in the amount of alcohol you consume? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 46 of 48
Blood Pressure (Antihypertensive) Medication Use: 
 
Blood pressure medication has been shown in many studies to be very effective at lowering 
blood pressure.  
 
RC1_13. How motivated are you to make changes to your blood pressure medication use, using 
a scale of one to ten, where one = definitely not ready to change, and 10 = definitely ready to 
change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□
□
□
□
□
 
RC1_14. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes your blood pressure medication use? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 47 of 48
Family History of Hypertension  
 
FH1_01. Did your biological mother ever have hypertension? 
 
 
 
□ No 
 
 
□ Yes 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
FH1_02. Did your biological father ever have hypertension? 
 
 
 
□ No 
 
 
□ Yes 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
  
 
FH1_03. How many full brothers and sisters do you have (Please include any brothers or 
sisters who may have died, but do not include half or step brothers and sisters). 
 
 
 
□ I do not have any brothers or sisters  Skip to the page 
 
 
____ brothers,  ______ sisters 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
FH1_04. Of these brothers and sisters, how many have ever had hypertension? 
 
 
 
________ (if none, write 0) 
 
□ I do not know   
 
□ I prefer not to answer  
 
 
 
 
Comment [SF7]: New section 

MBHT Home Baseline Assessment, Version 1.4, December 21, 2015 
Page 48 of 48
Your Sleep 
 
The following question relates to your usual sleep habits during the past month only. Your 
answer should indicate the most accurate reply for the majority of days and nights in the past 
month. 
 
SL1_04. During the past month, how many hours of actual sleep did you get on average at 
night?  (This may be different than the number of hours you spent in bed.) 
 
 
 
AVERAGE HOURS OF SL1_EEP PER NIGHT ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
END SCRIPT 
Thank you for completing this survey!  
 
Please note that these responses will not be seen immediately. Resources are shown below if you 
feel that you would like to talk with someone immediately for assistance.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
National Sexual Assault Hotline: 1-800-656-4673 
 
Other options are to: 
• Call your doctor’s office 
• Call 911 for emergency services 
• Go to the nearest hospital emergency room.  
 
 
 
 
 
  
Comment [D8]: This section (Sleep) was moved 
to the end of the survey.  Several of the items were 
dropped to reduce participant burden. 
Deleted: For each of the remaining questions, 
check the one best response. Please answer all 
questions.¶
¶
During the past month, how often have you had 
trouble sleeping because you…………..¶
¶
SL1_05.  …..Could not get to sleep within 30 
minutes?¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer¶
¶
¶
SL1_06. …..Woke up in the middle of the night or 
early morning?¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
¶
SL1_07. …..Had to get up to use the bathroom?¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
¶
¶
SL1_08. …..Could not breathe comfortably?¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
... [3]
Deleted: SL1_16. During the past month, how 
often have you taken medicine to help you sleep 
(prescribed or "over the counter")?¶
¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
SL1_17.  During the past month, how often have 
you had trouble staying awake while driving,     
eating meals, or engaging in social activity?¶
¶
□ Not during the past month¶
□ Less than once a week ¶
□ Once or twice a week¶
□ Three or more times a week ¶
□ I do not know¶
□ I prefer not to answer ¶
¶
... [4]

Page 9: [1] Deleted   
Saadeh, Frances   
10/28/2015 10:57:00 AM 
How Often You Eat or Drink This Item 
 
Never 
or less 
than 1 
per 
month 
1-3 per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3    
per 
day 
4-5    
per 
day 
More 
than 5 
per 
day 
I do 
not 
know 
I prefer 
not to 
answer 
DT1_01. 
Skim/low fat 
milk  (8 oz. 
glass) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_02. 
Whole milk  
(8 oz. glass) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_03. Ice 
cream (1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_04. 
Yogurt (1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_05. 
Cottage or 
ricotta cheese  
(1/2 cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_06. 
Butter, added 
to food or 
bread (1 pat), 
exclude use 
in cooking 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_07. 
Fruit (not 
including 
fruit juice. A 
serving = 1 
piece, or 1/2 
grapefruit, or 
1/2 cup 
berries) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_08. 
100% fruit 
juice, not 
including 
fruit drinks 
(small glass) 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 

How Often You Eat or Drink This Item 
 
Never 
or less 
than 1 
per 
month 
1-3 per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3    
per 
day 
4-5    
per 
day 
More 
than 5 
per 
day 
I do 
not 
know 
I prefer 
not to 
answer 
DT1_09. 
Vegetables - 
raw and 
cooked (1/2 
cup), 
including 
mixed dishes 
such as 
soups, 
casseroles 
and lasagna. 
Do not 
include 
potatoes. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_10. 
Eggs (do not 
include egg 
beaters) (1) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_11. 
Chicken or 
turkey (4-6 
oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_12. 
Processed 
meat (1 piece 
sausage, 1 
slice salami, 
2 pieces 
bacon) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_13. Hot 
dog/ 
hamburger 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 
 
 
 

How Often You Eat or Drink This Item 
 
Never or 
less than 
1 per 
month 
1-3 
per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3   
per 
day 
4-5   
per 
day 
More 
than 
5 per 
day 
I do 
not 
know 
I 
prefer 
not to 
answer 
DT1_14. Beef, pork, 
or lamb as a sandwich 
or mixed dish, e.g. 
stew, casserole, 
lasagna, etc. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_15. Beef, pork, 
or lamb as a main 
dish, e.g. steak, roast, 
ham, etc.   (4-6 oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_16. Fish 
(including canned 
tuna) (3-5 oz.) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_17. Shellfish 
such as shrimp, 
lobster, scallops and 
clams as a main dish 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_18. White bread 
(including pita bread) 
(slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_19. Dark bread 
(including whole 
wheat and rye) (slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_20. Bakery items 
(cookies, brownies, 
doughnuts, cake) (1 
piece or slice) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_21. Nuts (small 
packet, 1 oz., 1 Tbs 
peanut butter) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_22. Pasta (e.g. 
spaghetti, and 
macaroni and cheese; 
1 cup cooked) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_23. Potatoes, 
baked, boiled or 
mashed (do not 
include French fries/ 
chips) (1 potato or 1 
cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
  
 
 

                                  How Often You Eat or Drink This Item 
 
Never or 
less than 
1 per 
month 
1-3 
per 
month 
1 per 
week 
2-4 
per 
week 
5-6 
per 
week 
1 
per 
day 
2-3   
per 
day 
4-5   
per 
day 
More 
than 
5 per 
day 
I do 
not 
know 
I 
prefer 
not to 
answer 
DT1_24. Regular 
soft drinks 
(including caffeine 
free, but NOT 
including diet 
colas) (consider the 
serving size as 1 
glass, bottle or can) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DT1_25. Coffee 
(regular or decaf) 
(1 cup) 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
Page 41: [2] Deleted   
Saadeh, Frances   
10/28/2015 11:57:00 AM 
SN1_01. How many close friends do you have? By close friends, we mean people that you feel at 
 
ease with, and that you can talk to about private matters. 
 
 
 
□ None  skip to Y2  
 
 
 
____ Number of close friends   
 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
 
SN1_01a.    How many of these close friends do you see at least once a month?    
 
 
 
 
 
 
____ Number of close friends (if none, write zero) 
 
 
 
 
 
□ I do not know  
 
 
 
 
□ I prefer not to answer  
 
 
SN1_02. Thinking about your relatives, how many relatives do you feel at ease with, and feel that 
 
you can talk to about private matters?  
 
 
 
□ None  skip to Y3 
 
 
 
____ Number of relatives  
 
 
 
□ I do not know  
 
 
□ I prefer not to answer  

 
 
 
 
SN1_02a.    How many of these relatives do you see at least once a month?  
 
 
 
 
 
____ Number of relatives (if none, write zero) 
 
 
 
 
 
 
 
□ I do not know  
 
 
 
 
□ I prefer not to answer  
 
 
 
 
 
SN1_03. About how often do you participate in groups or clubs, such as religious connected 
groups,  self-help groups, charities, or a public service or community group. 
 
 
 
□ Never or almost never 
 
 
□ A few times a year 
 
 
□ Once or twice a month 
 
 
□ Once a week 
 
 
□ More than once a week 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
SN1_04. About how often do you go to religious meetings or services?  
 
 
 
□ Never or almost never 
 
 
□ A few times a year 
 
 
□ Once or twice a month 
 
 
□ Once a week 
 
 
□ More than once a week 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
 
Page 48: [3] Deleted   
Eric Loucks   
11/2/2015 10:42:00 AM 
For each of the remaining questions, check the one best response. Please answer all questions. 
 
During the past month, how often have you had trouble sleeping because you………….. 
 
SL1_05.  …..Could not get to sleep within 30 minutes? 
 □ Not during the past month 

 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer 
 
 
SL1_06. …..Woke up in the middle of the night or early morning? 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_07. …..Had to get up to use the bathroom? 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
 
SL1_08. …..Could not breathe comfortably? 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_09. …..Coughed or snored loudly? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 

 □ I prefer not to answer  
 
 
SL1_10.   …..Felt too cold? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_11.   …..Felt too hot? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_12.   …..Had bad dreams? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 
 
SL1_13.   …..Had pain? 
 
 □ Not during the past month 
 □ Less than once a week  
 □ Once or twice a week 
 □ Three or more times a week  
 □ I do not know 
 □ I prefer not to answer  
 

 
SL1_14a. 
   Other reason(s), please describe: ______________________________________ 
 
SL1_14b. How often during the past month have you had trouble sleeping because of  
 
 
 
this? 
  
 
□ Not during the past month 
  
 
□ Less than once a week  
  
 
□ Once or twice a week 
  
 
□ Three or more times a week  
  
 
□ I do not know 
 
 
 
□ I prefer not to answer 
 
Page 48: [4] Deleted   
Eric Loucks   
11/2/2015 10:43:00 AM 
SL1_16. During the past month, how often have you taken medicine to help you sleep 
(prescribed  or "over the counter")? 
 
 
 
□ Not during the past month 
 
 
□ Less than once a week  
 
 
□ Once or twice a week 
 
 
□ Three or more times a week  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
SL1_17.  During the past month, how often have you had trouble staying awake while driving, 
 
     eating meals, or engaging in social activity? 
 
 
 
□ Not during the past month 
 
 
□ Less than once a week  
 
 
□ Once or twice a week 
 
 
□ Three or more times a week  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
SL1_18.  During the past month, how much of a problem has it been for you to keep up enough 
 
 enthusiasm to get things done? 
 
 
 
□ No problem at all 
 
 
□ Somewhat of a problem 
 
 
□ A very big problem 
 
 
□ I do not know 
 
 
□ I prefer not to answer  

 
 
SL1_19.  Do you have a bed partner or a room-mate in the same room ? 
 
 
 
□ No bed partner or roommate in the same room  skip to next survey section:  
 
□ Partner in same bed  
 
 
 
 
 
 
 
 
 
□ Room-mate in the same room  
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
If you have a roommate or bed partner, ask him/her how often in the past month you 
have had . . . . . . . . . . . . . . . 
  
 SL1_20.    …..Loud snoring 
 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 SL1_21.     ……Long pauses between breaths while asleep 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
  
 SL1_22.   …..Legs twitching or jerking while you sleep 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  

  
SL1_23.    …..Episodes of disorientation or confusion during sleep 
  
 
 
□ Not during the past month 
  
 
 
□ Less than once a week  
  
 
 
□ Once or twice a week 
  
 
 
□ Three or more times a week  
  
 
 
□ Unable to ask him/her 
  
 
 
□ he/she does not know 
  
 
 
□ he/she prefers not to answer  
 
 
 
SL1_24a.   ……Other restlessness while you sleep; please describe: 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
____________________________________________________ 
  
 
SL1_24b. 
□ Not during the past month 
  
 
□ Less than once a week  
  
 
□ Once or twice a week 
  
 
□ Three or more times a week  
  
 
□ Unable to ask him/her 
  
 
□ he/she does not know 
  
 
□ he/she prefers not to answer  
 
 

Brown University
Research Protections Office
Institutional Review Board
Modification Request
Date of Request:2126116 Investigator's Name and Title: Eric Loucks, PhD, Assistant Professor
Study Titte: Mindfulness-based Hyptertension Therapy Pilot Study (#l4l200ll7l)
originat rype of Review: ! Exempt 
! Expedited 
X puil Board
1) Provide a brief lay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form)
See attached summary
2) Provide a detailed description of the changes being requested (Use additional pages, if necessary):
We are requesting permission to allow study participants the option to participate in the
MBHT Intervention (i.e., 9-week MBHT course) via online video õonferencing tãol (e.g.,
Skype, Zoom, etc.) in situations when they are not able to attend class in-person.
3.) State the reason (iustification) for the requested modification. (Use additional pages, if
necessary):
We would like to be able to allow participants, who are not able to physically come to the
study site on a given day (a maximum of 2 classes), the option to particìpát. in t-he study
intervention via online video conferencing tool (e.g., Skyp e, Zoom,etc.)^. None of the video
footage would be recorded and participation via viàeo conferencing would be optional.
Video conferencing would only take place with video software thaiestablishes ùnique
connections, such as via Skype names, or Zoomconference call ID numbers. This disallows
anyone to join the call other than those who are specifically invited by the study staff. Study
participants who choose to decline this option would still be allowed to continue with the
broader study.
4') What is your assessment of how the changes will affect the overall risk/benefit ratio of the study
and the willingness of indivicluals to participate?
V/e do not anticipate this amendendment will greatly affect the overall risk/benefti ratio
of the *udy' If anything, it will allow participants additional flexibility in how they participate
and will potentially reduce the number of classes missed, thus allowing participants, who
otherwise might have missed classes, to get more out of the course.
5') Does the requested modification require new documents or changes to the approved consent
form or other documents?
! 
Consent/assent documents (attach revised version with changes highlighted)
! 
New/revised instruments (attach - if revised, highlight changes)

! New/revised advertising materials (attach - if revised, highlight changes)
Do you have a conflict of interest on this project according to Brown's policy? nyns XNO
If yES, has this conflict been previously disclosed to the IRB? 
nyns lUO
PI signature:
Date of IRB Review:
Determination:
Signature of IRB Chair or Designate
IRB

1. Provide a brief lay summary of the overall project. Include enough 
detail to allow the IRB to evaluate the requested change(s) within 
the context of the overall project.   
  
The World Health Organization reported that suboptimal blood pressure (BP) is responsible 
for more than half of cardiovascular disease mortality world-wide. Furthermore, greater than half 
of those with hypertension have uncontrolled BP. A 2009 Institute of Medicine report 
recommended prioritizing research to “Compare the effectiveness of mindfulness-based 
interventions (e.g. yoga, meditation, deep breathing training) and usual care in treating… 
cardiovascular risk factors.”  Evidence-based mindfulness interventions, including Mindfulness-
Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant 
effects, but evidence of heterogeneity in effect sizes. The methodologically highest quality 
studies had the smallest effect sizes (range 0-5 mmHg). Mindfulness-Based Stress Reduction 
(MBSR) has been customized to a number of disease processes, such as Mindfulness-Based 
Cognitive Therapy for patients with recurrent depression, and Mindfulness-Based Relapse 
Prevention for patients with substance use addictions. Effect sizes have been increased by 
customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive 
patients have never been investigated. Until methodologically rigorous studies to evaluate 
customized interventions for hypertension are performed, we will not know if the observed 
preliminary effects of general mindfulness interventions on blood pressure reduction could be 
much more effective with a tailored approach. Consequently, we propose to conduct a stage I 
behavioral therapy intervention study to evaluate whether MBSR customized to prehypertensive 
and hypertensive patients has the potential to provide clinically relevant reductions in BP. 
Consequently the specific aims are:  
  
Stage 1a: Therapy Development/Manual Writing  
1. To outline and evaluate key novel elements of mindfulness-based hypertension therapy 
(MBHT), customized from the evidence-based MBSR. We hypothesize that the most 
important novel element will be generation of mindfulness skills specifically applied to 
hypertension risk factors such as diet, physical activity, obesity, alcohol consumption 
and antihypertensive medication adherence. This aim will be achieved using (1) focus 
groups of participants undergoing the MBHT behavioral intervention, (2) discussion with 
experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness 
intervention instructors) prior to, and following pilot testing of MBHT in participants, and 
(3) clinical judgment of the investigators performing the intervention.   
2. To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, 
retention rates, recruitment rates, and adverse effects) and secondary outcomes 
(hypertension risk factors such as diet, physical activity, obesity, and antihypertensive 
medication adherence) in hypertension subgroups, specifically participants with (1) 
prehypertension, (2) controlled hypertension, and (3) uncontrolled hypertension. Initial 
decisions about the targeted sample based on hypertension status will be made.  
3. To develop an MBHT therapist manual and training program, including procedures for 
training, supervising, and evaluating therapists. Furthermore, acceptable therapist 
characteristics will be developed. The manual and training program will include themes 
such as specification of unique and common elements of MBHT vs. other interventions, 
description of interventions excluded from MBHT, and specification of key treatment 
parameters such as frequency and duration of treatment, session length, topics 
addressed, sequence of sessions, as well as therapist adherence and competency 

measures. The MBHT training will consist of a therapist manual, a formal didactic 
training seminar, and at least one closely supervised training session.  
  
Stage Ib: Pilot Trial  
4. To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, 
customized from the evidence-based MBSR, has promise to be an effective behavioral 
therapy for participants with hypertension and/or prehypertension. We will perform a 
randomized controlled pilot trial for MBHT vs. enhanced usual care control. We 
hypothesize that MBHT will have adequate recruitment rates (≥10% of 
prehypertensive/hypertensive participants invited from physicians’ offices), fairly low 
drop out rates (<15%), and medium effect sizes (e.g. 5-10 mmHg systolic BP) for 
reduction in blood pressure.   
  
These findings will provide publishable pilot data that will inform future randomized clinical 
trials that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and 
active control groups. If proven effective, MBHT could be offered as a complementary program 
in the prehypertensive/hypertensive patient population that contributes to over half of the 
cardiovascular disease mortality world-wide.   
  
 
 

Brown University
Research Protections Offi ce
Institutional Review Board
Modification Request
Date of Request:4125116 Investigator's Name and Title: Eric Loucks, PhD, Assistant Professor
Study Title: Mindfulness-based Hypertension Therapy Pilot Study (#1412001111)
Original Type of Review: I Exempt 
I Expedited 
X fuil Board
1) Provide a brief lay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form)
See attached summary
2) Provide a detailed description of the changes being requested (Use additionalpages, if necessary):
See attached summary
3.) State the reason (iustification) for the requested modification. (Use additional pages, if
necessary):
See attached summary
4.) What is your assessment oflhow the changes will afïþct the overall risk/benefït r¿rtio of the stucly
and the willingness of inrlivirluals to participate?
See attached summary
5.) Does the requested modification require new documents or changes to the approved consent
form or other documents?
! 
ConsenVassent documents (attach revised version with changes highlighted)
[l New/revised instruments (attach - if revised, highlight changes)
X Neilrevised advertising materials (attach - if revised, highlight changes)
Do you have a conflict of interest on this project according to Brown's policy? lynS XNO
If YES, has this conflict been previously disclosed to the IRB? 
nyrcS lNO
PI signature:

1. Provide a brief lay summary of the overall project. Include enough 
detail to allow the IRB to evaluate the requested change(s) within 
the context of the overall project.   
  
The World Health Organization reported that suboptimal blood pressure (BP) is responsible 
for more than half of cardiovascular disease mortality world-wide. Furthermore, greater than half 
of those with hypertension have uncontrolled BP. A 2009 Institute of Medicine report 
recommended prioritizing research to “Compare the effectiveness of mindfulness-based 
interventions (e.g. yoga, meditation, deep breathing training) and usual care in treating… 
cardiovascular risk factors.”  Evidence-based mindfulness interventions, including Mindfulness-
Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant 
effects, but evidence of heterogeneity in effect sizes. The methodologically highest quality 
studies had the smallest effect sizes (range 0-5 mmHg). Mindfulness-Based Stress Reduction 
(MBSR) has been customized to a number of disease processes, such as Mindfulness-Based 
Cognitive Therapy for patients with recurrent depression, and Mindfulness-Based Relapse 
Prevention for patients with substance use addictions. Effect sizes have been increased by 
customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive 
patients have never been investigated. Until methodologically rigorous studies to evaluate 
customized interventions for hypertension are performed, we will not know if the observed 
preliminary effects of general mindfulness interventions on blood pressure reduction could be 
much more effective with a tailored approach. Consequently, we propose to conduct a stage I 
behavioral therapy intervention study to evaluate whether MBSR customized to prehypertensive 
and hypertensive patients has the potential to provide clinically relevant reductions in BP. 
Consequently the specific aims are:  
  
Stage 1a: Therapy Development/Manual Writing  
1. To outline and evaluate key novel elements of mindfulness-based hypertension therapy 
(MBHT), customized from the evidence-based MBSR. We hypothesize that the most 
important novel element will be generation of mindfulness skills specifically applied to 
hypertension risk factors such as diet, physical activity, obesity, alcohol consumption 
and antihypertensive medication adherence. This aim will be achieved using (1) focus 
groups of participants undergoing the MBHT behavioral intervention, (2) discussion with 
experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness 
intervention instructors) prior to, and following pilot testing of MBHT in participants, and 
(3) clinical judgment of the investigators performing the intervention.   
2. To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, 
retention rates, recruitment rates, and adverse effects) and secondary outcomes 
(hypertension risk factors such as diet, physical activity, obesity, and antihypertensive 
medication adherence) in hypertension subgroups, specifically participants with (1) 
prehypertension, (2) controlled hypertension, and (3) uncontrolled hypertension. Initial 
decisions about the targeted sample based on hypertension status will be made.  
3. To develop an MBHT therapist manual and training program, including procedures for 
training, supervising, and evaluating therapists. Furthermore, acceptable therapist 
characteristics will be developed. The manual and training program will include themes 
such as specification of unique and common elements of MBHT vs. other interventions, 
description of interventions excluded from MBHT, and specification of key treatment 
parameters such as frequency and duration of treatment, session length, topics 
addressed, sequence of sessions, as well as therapist adherence and competency 

measures. The MBHT training will consist of a therapist manual, a formal didactic 
training seminar, and at least one closely supervised training session.  
  
Stage Ib: Pilot Trial  
4. To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, 
customized from the evidence-based MBSR, has promise to be an effective behavioral 
therapy for participants with hypertension and/or prehypertension. We will perform a 
randomized controlled pilot trial for MBHT vs. enhanced usual care control. We 
hypothesize that MBHT will have adequate recruitment rates (≥10% of 
prehypertensive/hypertensive participants invited from physicians’ offices), fairly low 
drop out rates (<15%), and medium effect sizes (e.g. 5-10 mmHg systolic BP) for 
reduction in blood pressure.   
  
These findings will provide publishable pilot data that will inform future randomized clinical 
trials that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and 
active control groups. If proven effective, MBHT could be offered as a complementary program 
in the prehypertensive/hypertensive patient population that contributes to over half of the 
cardiovascular disease mortality world-wide.   
  
 
  
 
 
 

2. Provide a detailed description of the changes being requested (Use 
additional pages, if necessary): 
 
We would like to update the IRB on the following changes made to the overall study protocol, 
recruitment materials, and participant assessments… 
 
 
Change in Study Name – We have changed the study name from: “The Mindfulness-based 
Hypertension Therapy Pilot Study (MBHT)” to “The Mindfulness-Based Blood Pressure Reduction 
Study (MB-BP)”.  The rationale behind this change is that the original study title was not 
completely accurate since the program is not exactly “therapy”, as much as it is a tailored 
intervention to see if participant’s blood pressure can be reduced over time.  The revision also 
reflects the fact that we are not only recruiting individuals with hypertension but those with 
prehypertension as well. 
 
 
 
Revised NCCIH Safety Monitoring Protocol – the formal Safety Monitoring Protocol submitted 
to the NCCIH (a division of the NIH) was revised back on November 26, 2015.  We have attached 
the updated version 1.3 here to be included as part of the study protocol (see Appendix 1).  
Under the NIH Safety Monitoring Protocol, we are required to check in with study participants 
regularly (at four week intervals) to assess if they have sustained any physical injuries.  Please 
see p.9-10 of Appendix 1 for complete details on this process.  We have copied and pasted the 
most relevant text below. 
 
Monitoring of Physical Injuries: All patients will be monitored by study staff at weekly 
intervals in person or by telephone and assessed every four weeks with questionnaires 
about physical injuries, specifically the following questions: 
 
1. Have you sustained any physical injuries during the past four weeks? 
 
If yes, 
(a) Please describe the injury. 
(b) Please describe what happened to cause the injury. 
(c) Did this injury include: 
i. Broken bone(s)? yes/no 
ii. Lacerations requiring stiches? yes/no 
iii. Concussion? yes/no 
 
If injuries include any of the above (i – iii), it will be reported to Data Safety 
Monitoring Committee member Dr. Hank Wu, MD, who is a practicing physician and 
researcher. He will advise on any follow-up needed. It will also be reported to the 
chair of the Data Safety Monitoring Board.  
 
 
 
Baseline and Follow up Assessments (split into two visits) –  Instead of having participants 
come into the office once for their baseline and follow up assessments, we would like to have 
them come in on two separate occasions at about one week apart.  The reason behind this 
request is two-fold. First, participants will be asked to wear a Fitbit device, which will monitor 
their physical activity and sleep. The device will be worn for one week and will need to be 
returned to the office at the end of the week in order for the data to be synced and uploaded. 

By having participants return to the office, it will ensure that the Fitbit tracker is returned and 
that the data are properly uploaded.  The second reason for the return visit will be to allow the 
participant time to meet with the course instructor. This one-on-one meeting is already part of 
the mindfulness intervention.  It is important to note that, apart from participant travel to and 
from the office, we are not adding any additional time to the length of the baseline and follow 
up assessments but rather the assessment content has been divided across two separate visits. 
If a participant indicates that he/she is unable to come into the office for the second visit, we 
can allow the participant the option of mailing his/her Fitbit tracker back to the office with a 
prepaid envelope. 
 
 
 
Change in Data Collection Mode for Daily Practice Forms and other Class questionnaires – we 
would like to change the mode of administration by which our mindfulness-course practice 
forms and questionnaires are able to be completed by participants. Currently, participants are 
asked to complete these forms on paper.  Moving forward we would like to allow participants 
the option to complete the course assignments online in Qualtrics. We would still allow 
participants the option to complete on paper if preferred. 
 
 
 
Revised Study Recruitment Materials and Protocol – we have made revisions to our study 
advertisement material and protocol.  Below are details regarding these changes: 
 
Revised Flyers and Advertisement Cards – we have revised our study advertisement card 
and flyer.  See Appendix 2 for revisions noted with track changes. Note that the content of 
both the card and the flyer are the same, but that the print format is different (Appendix 3 
contains a clean version of each). A summary of the changes as well as the justification for 
the revisions are below: 
 
Per feedback from a Graphic Designer at RISD, we have made the following 
modifications to our study advertisement materials: (1) Moved "Research Study" from 
title to explanatory paragraph to make more visually appealing. (2) Changed study 
phone number from PI's personal cell phone to a study cell phone paid for by the grant 
and indicated that texting as well as calling is permissible. (3) Modified the descriptive 
language used to describe the study so that it is easier to read and is more specific and 
accurate. 
 
Facebook Page and Advertisements – we have created a study Facebook page and would 
like to begin using Facebook to recruit for the study. See Appendix 4 for screenshots from 
the study page. Note that we will wait for IRB approval before making this page public. 
 
Twitter Page – we have created a study twitter page, on which we can tweet about 
upcoming events (e.g., mindfulness courses). See Appendix 5 for a screenshots of our 
twitter account page (that can be made public once IRB approval has been received).  
 
Craigslist Advertisement – see Appendix 6 for craigslist advertisement content. Note that 
the content is the same as that used for the advertisement cards. 
 
 

 
NEW Study Webpage – we have created two new MB-BP study webpages, which are found on 
the broader Mindfulness and Cardiovascular Health Lab websites.  The Mindfulness and 
Cardiovascular Health Lab is located at the Brown University School of Public Health’s Center for 
Population Health and Clinical Epidemiology and is directed by Dr. Eric Loucks.  There are two 
websites for the Mindfulness and Cardiovascular Health Lab.  One is hosted through Brown’s 
domain and the other through an external website platform known as Weebly.  The MB-BP 
study is featured on both websites.  See Appendix 7 for screenshots and content from each of 
the websites. Note that these websites will not be publically launched until IRB approval has 
been received. 
 
Website URL’s are below: 
Brown University Site: https://www.brown.edu/research/projects/blood-pressure-reduction/home 
Weebly webpage: http://mindfulnesscvlab.weebly.com/ 
 
 
Revisions to the in-class worksheets and assessments – the following revisions have been made to the 
mindfulness course worksheets / assignments: 
 
Weeks 4 and 5: Goal Related to Diet, Alcohol Consumption, Physical Activity, or Stress 
Reaction/Response (v.1.1, Appendix 8) – there were errors in the question variable names found in 
the tables on p.3-5. This was likely due to a cut and paste error. This has since been corrected. We 
have included a track changed version of Week 4 (Appendix 7).  Week 5 is the same exact questions, 
so we did not include that version here. We can send upon request. 
 
 
MB-BP Questionnaire Revisions - we have made changes to several of the individual assessments.  See 
below for details as well as Appendices 9-12 for revised assessments with track changes) 
 
Phone Screener: (v.1.5, See Appendix 9) 
 
Modified the language slightly to improve survey flow, ease of administration and to be more 
clear and concise about study involvement. 
 
For other revisions - see individual comments in attached screener document for detailed 
rationale on revisions 
 
In-Person Screening: (v.1.5, See Appendix 10) 
 
Added in the Blood Pressure Safety Protocol, which is also reported to the NCCIH as part of the 
Data Safety Monitoring Plan. 
 
For other revisions - see individual comments in attached in-person screener document for 
detailed rationale on revisions  
 
In-Person Baseline Assessment (v.1.5, See Appendix 11) 
 
Added in the Blood Pressure Safety Protocol, which is also reported to the NCCIH as part of the 
Data Safety Monitoring Plan. 
 
To reduce participant burden we have dropped several of the variables collected on the Food 
Frequency Questionnaire. See marked up FFQ found within Appendix 10 for details on variables 
dropped. 

 
We switched the order of administration for the ANT and SART. The SART is a better measure of 
attention, so it is important that it is completed first, in case the first measure has an effect on 
the outcome of the second measure completed. 
 
For other revisions - see individual comments in attached in-person baseline assessment for 
detailed rationale on revisions  
 
Home Baseline Assessment: (v.1.5, See Appendix 12) - The only revision to this assessment is the 
addition of a scale known as the “self-efficacy for managing chronic disease questionnaire”.  See the 
track changes document for details. 
 
Follow-Up Assessments – Follow-up assessments will take place at 10 weeks, 6 months, and 1 year post 
baseline.  The follow-up assessments will be identical to those administered at baseline (Home and In-
Person), with the exception that any variables that are not expected to change over time (e.g., race-
ethnicity), will be removed in order to reduce participant burden.  We have listed the question items 
below that will NOT be included in the follow up assessments. The only additional measure during 
follow-up assessments is recording the amount of formal and informal mindfulness practices that 
participants are doing (see Appendix 13).  
 
In-Person Assessment – The in-person assessment used at baseline will be the same assessment 
used for all of the follow-ups. 
 
 
Home Assessment – The variables found in the Home Baseline Questionnaire that will NOT be 
included in the follow up assessments are: 
 
PG1_01-03 
Personal goals 
BQ1_01-03 
Age, Race and Ethnicity 
BQ1_05-08 
Education, degree earned, technical/vocation schooling 
CS1_01-04 
Parents’ education 
CE1_01-10 
Childhood experiences 
FH1_01-04 
Family history of hypertension 
 
Measurement of Mindfulness Practices – see Appendix 13 for questions that will be asked during 
the follow up assessments in order to record the amount of formal and informal mindfulness 
practices that participants are doing: 
 
 
 
3. State the reason (justification) for the requested amendment:  
  
Please see justifications in Section 2 above.  
  
 
 
 

4. What is your assessment of how the changes will affect the overall 
risk/benefit ratio of the study and the willingness of individuals to 
participate?  
  
The changes we have made in this amendment affect the risk/benefit ratio in small ways, and if 
anything, we anticipate the revisions will decrease participant burden.  We modified the study 
name to be more concise about the purpose of the study.  We moved around some of the 
questions in an attempt to improve the overall survey flow and spread out the overall time/effort 
burden on participants.  And although some new question items have been added to the 
assessments, we have also removed some items. We estimate, that the overall assessment 
time has not changed. 
 
The revisions to the formalized Safety Monitoring protocol help reduce participant risk by 
predicting potential areas of concern and by outlining clear procedures with how to manage 
incidents that may come up. 
 
  
5. Does the requested amendment require new documents or changes 
to the approved consent form or other documents?  
  
Yes. Please see Appendices 1-13. 
 
 
 
Appendix 1 
NCCIH Safety Monitoring Protocol (v.1.3) 
 
Appendix 2 
Revised MB-BP Recruitment Card – with track changes 
 
Appendix 3 
Revised MB-BP Recruitment Card and Flyer – clean copy 
 
Appendix 4 
MB-BP Study Facebook page screenshots 
 
Appendix 5 
MB-BP Study Twitter account screenshots 
 
Appendix 6 
MB-BP Study Craigslist advertisement screenshots 
 
Appendix 7 
MB-BP Study webpage screenshots 
 
Appendix 8 
Week 4: Goal Related to Diet, Alcohol Consumption, Physical Activity, 
 
 
or Stress Reaction/Response (v.1.1) – with track changes 
 
Appendix 9 
Phone Screener (v.1.5) – with track changes 
 
Appendix 10 
In-person Screener (v.1.5) – with track changes 
 
Appendix 11 
In-Person Baseline Assessment (v.1.5) – with track changes 
 
Appendix 12 
Home Baseline Assessment (v.1.5) – with track changes 
Appendix 13 
Measurement of formal and informal mindfulness practice at time 
 
 of follow ups - NEW 
  
References 
1 Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication 
adherence. Med Care. 1986;24 (1):67-74. 
 

 
 
 
 
 
 
 
Appendix 1:  
Safety Monitoring Protocol 
 
(Formal protocol submitted to the NCCIH – revised on November 26, 2015) 
 
 

Version 1.3 November 26, 2015 
1 
PROTECTION OF HUMAN SUBJECTS 
 
MINDFULNESS-BASED HYPERTENSION THERAPY 
 
NIH Grant #: 1UH2AT009145-01 
 
1. Risks to Human Subjects 
1.1 
Human Subjects Involvement, Characteristics, and Design 
1.1.1 Involvement:  
Participants will be recruited in part through cardiology and family practices via established relationships 
with physicians in Rhode Island and Massachusetts, such as Cathleen Hood MD, Sam Dudley MD, Charles 
Eaton MD and Hank Wu MD, amongst others. Furthermore, advertisements will be posted throughout Rhode 
Island, and distributed via social media, inviting participants interested in lowering their blood pressure to enroll 
MBHT Intervention Description: This study proposes to customize MBSR to participants with 
prehypertension/hypertension creating an intervention called Mindfulness-Based Hypertension Therapy 
(MBHT). Specifically, MBHT is based on the standardized MBSR intervention described elsewhere,153-156 and 
will consist of nine 2.5-hour weekly group sessions and an 8-hour one-day session, initially led by Dr. Loucks 
until further instructors are certified in MBHT if initial findings suggest an effect. Dr. Loucks is an expert in 
cardiovascular physiology, cardiovascular epidemiology, and social epidemiology. He completed MBSR 
instructor training at UMass Medical School, and has almost 20 years of mindfulness meditation experience, 
including teaching and mentoring community members, as well as a recent publication record investigating 
associations of mindfulness with cardiovascular health.164,183,184 The unique areas of MBHT are expected to be 
education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused 
on awareness of diet, physical activity, medication adherence, alcohol consumption, stress, and social support 
for behavior change. A preliminary manual has been created based on the standardized MBSR manual 
developed at UMass Medical School (Appendix A), and will be further developed through the approaches 
described above, and sequentially revised based on participant feedback and preliminary findings.155,156 MBHT 
sessions contain instruction and practice in mindfulness meditation, and conversations about stress and 
coping. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. 
Homework consists of practicing skills for ≥45 min/day, 6 days/week.  
MBHT builds a foundation of mindfulness skills (e.g. meditation, self-awareness, etc.) through the MBSR 
curriculum. MBHT then directs attention towards hypertension risk factors. Early in the MBHT, the importance 
of hypertension for health and mortality is described, along with hypertension risk factors. Participants will have 
their blood pressure and hypertension risk factors assessed at baseline, and be provided with this information 
during the first in-person MBHT session. This phase aims to engage participants’ interest in hypertension risk 
factors, and increase motivation for behavior change. MBHT encourages participants to explore personal 
readiness for change in the different hypertension risk factors, and explore utilizing mindfulness practices to 
engage with those risk factors that they choose to. Each week, focus is provided on different hypertension risk 
factors. However, common themes exist across all hypertension risk factors including (1) awareness of 
thoughts, emotions and physical sensations particularly surrounding hypertension risk factors such as 
overconsumption of palatable foods, sedentary activities, alcohol consumption, medication adherence; (2) 
craving, particularly for hypertension risk factors such as overconsumption of palatable foods, sedentary 
activities, and alcohol consumption; (3) the impact of bringing mindfulness to every moment, particularly in 
relation to hypertension risk factors. For example, when consuming highly palatable food, bringing awareness 
to the emotions, thoughts and physical sensations prior to eating it, during eating it, along with the many 
minutes, if not hours, afterwards. Participants are trained to bring non-judgmental attention to the often short-
term pleasure of overconsumption of foods, sedentary activities, heavy alcohol consumption, or not taking 
medications, and bring non-judgmental attention to the longer term suffering associations with these activities. 
Through this process, participants are encouraged to reflect on if behavioral choices provide more benefit or 
harm to their well-being, and to choose the behaviors that bring benefit. (4) Self-care: as awareness of 
thoughts, emotions and physical sensations increases, and self-regulation will likely increases as a result of the 
meditation practices, the curriculum will emphasize to participants that it is common for people to start caring 
for themselves more. It is a way of better knowing ourselves, and through knowing ourselves in in each 

Version 1.3 November 26, 2015 
2 
moment, we often want to care for ourselves in each moment. This may mean taking medication that will help 
our health, or being more physical active, eating more healthily, or consuming more moderate amounts of 
alcohol. The intervention can be modified to change the dose of any of these 4 components, for example via 
(1) Increased use of specific meditations focused on health behaviors such as diet and physical activity. (2) 
Increased use of mediations focused on craving. Participants will be trained to notice craving arising, and 
fading away in relation to hypertension risk factors such as palatable high caloric foods, sedentary activities, 
and alcohol consumption. (3) Increased used of mindfulness practices related to long term experiences of 
health behaviors such as alcohol consumption, diet, physical activity and medication use on thoughts, 
emotions, physical sensations and well-being. (4) Self-care: Increased use of modules that show how 
mindfulness practice increased self-awareness and in doing so can increase people’s desire to care for 
themselves. The potential use of loving kindness meditation will be considered. 
MBSR Intervention Group: MBSR consists of eight 2.5-hour weekly group sessions, led by a certified 
instructor.153,154 These sessions contain instruction and practice in mindfulness meditation, as well as 
conversations of stress, coping, and homework assignments. Students learn a range of mindfulness skills 
including body scan exercises, sitting meditation, and yoga. Homework consists of practicing these skills for at 
least 45 minutes per day, 6 days per week, in addition to practicing mindfulness skills during group meetings. 
The program concludes with an 8-hour intensive mindfulness retreat with the instructor. During and after the 
program, students are encouraged to pay mindful, nonjudgmental attention to daily activities like walking, 
eating and talking. One goal is for participants to see that most sensations, emotions, and thoughts are 
transient events that do not need to be acted upon. Towards the end of the program, participants are provided 
materials and encouragement to find existing groups in their communities to continue their practice with, such 
as meditation and yoga centers. The MBSR intervention will be performed by certified MBSR instructors with at 
least 500 hours of MBSR teaching experience, detailed further in Section 4.1.4.2 of the Research Strategy. 
There are over 80 instructors in New England. Participants will be enrolled in MBSR courses taking place close 
to their home or workplace. Having participants take part in standard MBSR courses will improve 
generalizability of these findings compared to if only a small number of instructors were selected to teach 
MBSR to participants. MBSR instructor competency and treatment fidelity are further described below. 
MBHT and MBSR Competency and Treatment Fidelity: Treatment fidelity strategies will be performed in 
accordance with recommendations of the NIH Behavior Change consortium, specifically ensuring treatment 
fidelity in the following five areas: study design, training providers, delivery of treatment, receipt of treatment 
and enactment of treatment skills,240 as follows. Study design: The study will provide the same treatment dose 
for each participant enrolled in the MBSR and MBHT interventions, including fixed length and number of 
frequency of contact sessions for all MBSR and MBHT sessions. All session durations will be recorded, and 
evaluated monthly by research staff to ensure consistency. Any deviations from the planned duration will be 
recorded. All class sessions will be audiotaped. Dr. Willoughby Britton and her team will review treatment 
audiotapes for one of out four sessions, using classes and sessions selected at random. Dr. Britton and her 
team will conduct competency ratings on these tapes using validated adherence scales (MBCT Adherence 
Scale, where items 1-11 in the scale are for MBSR, MBHT and MBCT241), and provide detailed feedback to 
treatment providers. We will ensure equivalent dose across conditions, including meditation, yoga and stress 
reduction training, through tracking the audio recordings. Possible setbacks in implementation of treatment will 
be addressed, including having a large pool of MBSR and MBHT instructors in the event that specific 
instructors no longer teach classes. Instructor attrition will be tracked.  
Provider training: MBSR and MBHT will be performed by certified instructors. MBSR teacher certification is 
fairly extensive, and accreditation occurs through the University of Massachusetts Medical School Center for 
Mindfulness in Medicine, Health Care and Society, detailed elsewhere.242 Examples of criteria for becoming a 
certified MBSR teaching include (i) completion of an eight-week MBSR course as a participant, (ii) completion 
of several multi-day residential training courses in mindfulness based stress reduction practice and teaching, 
(iii) substantial experience in teaching MBSR, (iv) strong references letters from colleagues and participants 
who have taken your MBSR courses, (v) completion of several multi-day mindfulness meditation retreats, (vi) 
have a graduate degree in a field connected to MBSR (e.g. education, psychology, medicine) or demonstration 
of equivalent understanding through work experience in a related field. There are 89 registered MBSR 
programs in Massachusetts (60), RI (9) and CT (20) that offer year-round program including the Center for 
Mindfulness where MBSR originated. Eligible programs must be 8 weeks and the instructors must have 
completed the MBSR Instructor certification training to participate in the study. Delivery of treatment: We will 
assess participants’ perceptions of provider warmth and credibility using brief measures based on the validated 

Version 1.3 November 26, 2015 
3 
Working Alliance Inventory,243 and Empathy Scale244 at Weeks 4 and 8 of the intervention. Feedback will be 
provided to the interventionist, and measures of warmth and credibility will be adjusted for in sensitivity 
analyses, to evaluate if results differ when these measures are included vs. excluded. Receipt of treatment and 
enactment of treatment skills: These will be assessed using the Mindfulness Skill Acquisition Scale,245 which 
assesses: (i) the frequency of how often participants apply strategies in their lives taught during MBSR and 
MBHT classes, and (ii) frequency by which participants refrain from using harmful coping strategies, such as 
mental/behavioral disengagement, substance use (e.g. smoking) and overeating.245 Participants’ meditation 
diaries, described in Section 5.4, will assess regularity of meditation practice. 
Phone-Based Screening: For people who indicate interest in the study, this screening will take place by 
phone using trained research assistants to assess the exclusion criteria described above, with the exception of 
blood pressure which will be assessed in-person  
In-Person Screening: If participants remain eligible after the phone-based screening, they will attend an in-
person screening for blood pressure and medication assessment. If mean blood pressure shows 
hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking antihypertensive 
medication), participants will be invited to return for a second blood pressure reading. At that time, if the mean 
blood pressure across both assessment times is ≥120 mmHg systolic, ≥80 mmHg diastolic pressure, they will 
be invited to participate in the study.  
Baseline Assessments: 
(1) Demographics: age, race/ethnicity, socioeconomic status (education).  
(2) Family History of Hypertension (FH): Assesses biological parents’ history of having hypertension, based 
on questions from New England Family Study LEAP Project. 
(3) Childhood socioecononomic status: retrospective reporting of parents’ education, based on standardized 
questionnaires used in the Atherosclerosis Risk in Communities (ARIC) study.  
(4) Adverse Childhood Experiences: Measured using the standardized Adverse Childhood Experiences 
(ACE) questionnaire developed by Vincent Felitti et al.185,186 
(5) Depressive symptomatology: Assessed using Center for Epidemiologic Studies Depression Scale Revised 
(CESD-R). The CESD survey has been used extensively in the epidemiologic literature to assess 
depressive symptomatology.187 The scale was updated to the CESD-R by Van Dam et al., which allows 
diagnosable criteria similar to Diagnostic and Statistical Manual (DSM) of Mental Disorders.188 
(6) Anxiety: Assessed using the validated Beck Anxiety Inventory.189-195 
(7) Medication use: Assessed directly from participants’ medication bottles and self-report using standardized 
forms, including medication name, dose, frequency of use, and reason of use.  
(8) Antihypertensive medication adherence: Measured using (a) electronic medication bottle caps, and (b) the 
validated Morisky 8-item questionnaire.196 
(9) Systolic and diastolic blood pressure: Blood pressure will be measured using a calibrated Omron 
HEM907XL Intellisense automated BP monitor with established validity,197 following American Heart 
Association and Joint National Committee (JNC) guidelines.178,198 
(10) Anthropometry: height, weight and waist circumference directly assessed using standard epidemiologic 
methods.172  
(11) Physical activity: (a) MET minutes per week, assessed using actigraphy. We will use two accelerometers, 
one (the Actical) worn round the waist, and one (the Actiwatch-64) worn on the wrist (Philips Respironics, 
Andover, MA),173,174 that have become the gold standard for such assessment.175-177 (b) Rapid 
Assessment Physical Activity Scale. This scale was chosen because it is validated and responsive to 
behavioral changes including the types (e.g. yoga) introduced in MBHT and MBSR.199,200 
(12) Diet: assessed utilizing the validated Food Frequency that allows for calculation of hypertension-related 
dietary factors, including salt intake, alcohol consumption, total caloric consumption, fruit and vegetable 
consumption, and Dietary Approaches to Stop Hypertension (DASH) eating pattern score.180 
(13) Cigarette smoking: current smoking assessed using self-report standardized questions from the New 
England Family Study.  
(14) Sleep duration: Sleep duration is assessed using actigraphy devices described above for assessing 
physical activity. 
(15) Mindfulness: Assessed using the validated Mindfulness Attention Awareness Scale204,205 and Five Facet 
Mindfulness Questionnaire.205 
(16) Emotional eating: measured using the Three Factor Eating Questionnaire Revised 21-item (TFEQ-
R21).207,208 

Version 1.3 November 26, 2015 
4 
(17) Self-control: assessed using the validated Self-Control Scale short form.209,210  
(18) Self-compassion: Assessed using the validated Self-Compassion Scale (SCS).113  
(19) Perceived stress: Assessed using the validated 10-item Perceived Stress Scale.212,213 
(20) Emotion regulation: Measured using (a) the validated Difficulties in Emotion Regulation Scale,214 and (b) 
positive reappraisal using the validated Cognitive Emotion Regulation Scale.215-217 
(21) Interoception: Used the validated Multidimensional Assessment of Interoceptive Awareness (MAIA).218-220 
(22) Decentering: Assessed using the validated Experiences Questionnaire.221,222 
(23) Attention control: Assessed using (a) the Attention Network Test (ANT), which is a brief validated 
computerized battery measuring three independent behavioral components of attention: conflict resolution, 
spatial orienting, and alerting.223, and (b) the Sustained Attention to Response Task (SART). The SART is 
a validated computerized test of sustained attention, response inhibition (executive function) and self-
regulation.224-226 227-229  
(24) Craving: craving for hypertension risk factors, including palatable foods, alcohol, and sedentary activities 
will be assessed using the validated Craving Experiences Questionnaire. 230 
(25) Social integration: Measured using the validated 12-item Interpersonal Support Evaluation List (ISEL-12) 
measure of social support.231 
(26) Loneliness: Assessed using the validated R-UCLA Loneliness Scale.232  
(27) Readiness to change for hypertension risk factors: Assessed using questionnaire on readiness to change 
for hypertension risk factors including physical activity, DASH diet, salt intake, overweight/obesity, stress 
and stress response, antihypertensive medication use, based on the Transtheoretical Model for stages of 
change.233,234 
(28) Functional Magnetic Resonance Imaging (fMRI): In the UH3 phase only, if secondary data analyses 
during the UH2 phase indicate evidence of neuroimaging-based measures of self-regulation being 
important mechanisms, participants in the UH3 phase will undergo an MRI scanning session for 
approximately 30 minutes at baseline and 10 weeks follow-up. Scans will be acquired with a 3T scanner 
while the subject is in the resting state. Sample size will be 24 per group. Participants will undergo a 
separate consent form for fMRI imaging, so that they can be in the MBHT study without imaging if they 
prefer. 
 
Follow-Up Assessments at 10 Weeks and 6 Months Follow-Up: Questionnaires and assessments 
administered at 10 weeks and 6 months follow-up are identical to those administered at the first in-person 
screening assessment and at baseline, with the exception that questionnaires for which the answers should 
not change or be informative (age, race/ethnicity, education, adverse childhood experiences, family history of 
hypertension) are not given at follow-ups. In addition adverse events are monitored at both the 10 week and 6 
month follow-up period. We are also exploring performing a 1-year follow-up to enhance understanding of 
longer term target engagement. However due to the relatively brief period of time for the UH2 phase, the 6 
month follow-up time is the primary endpoint for decisions on target engagement. In addition adverse events 
are monitored at all follow-up assessments. 
Focus Groups: Focus group assessments of experts (including cardiologists, epidemiologists, mindfulness 
experts, mindfulness intervention instructors) will occur prior to, and following pilot testing of MBHT in 
participants. Focus groups of participants undergoing the MBHT behavioral intervention will take place 
following the final week of class. The goal of the focus groups will be to adapt MBHT to the unique needs of 
this population. Adaptions may include, for example, types of specific mindfulness exercises, sequence in 
which modules are introduced, relative emphasis on different types of modules (e.g. mindfulness practices 
customized to prehypertension/hypertension risk factors vs. general mindfulness practices), and class duration. 
Focus groups will be facilitated by Dr. Melissa Clark, who is an experienced focus group moderator, along with 
another team member present to assist and take notes. The groups will be held in comfortable and convenient 
meeting rooms at the Brown University School of Public Health.  
We will follow study procedures similar to those performed during previous epidemiologic studies by our 
group. In-person screenings will take place at the Brown University Center for Population Health and Clinical 
Epidemiology, described in Sections 2.7.1 and 2.7.2 at baseline, completion of the 8-week MBHT course and 
at 6-months follow-up. Major assessment variables are shown in Table 1. Qualitative interviews (focus groups) 
will evaluate participants’ experiences such as usefulness of specific modules, duration of sessions, time 
burden, and overall intervention effectiveness. Interviewer training includes high standards for selection of 
interviewers who are at ease with strangers, are culturally-sensitive and able to readily establish professional 

Version 1.3 November 26, 2015 
5 
rapport. Interviewers will be 
thoroughly trained in the 
administration of the structured 
interview, anthropometry, and 
blood pressure assessments. 
Routine quality control 
procedures will be in place 
regarding calibration of scales 
and blood pressure 
instruments. Clinical exams will 
be supervised by Dr. Loucks to 
at least monthly to evaluate 
accuracy of technique, 
particularly for anthropometry 
and blood pressure 
assessment. Re-training will be 
implemented if needed. Data 
will be entered and cleaned in 
an ongoing matter to facilitate 
quality control and preliminary 
analyses.  
1.1.2 Inclusion/exclusion 
criteria:  
Inclusion Criteria: 
Hypertension/prehypertension 
(≥120 mmHg systolic, ≥80 
mmHg diastolic pressure or 
taking antihypertensive 
medication). Able to speak, 
read, and write in English. All 
adults (≥18 years of age), 
genders and racial/ethnic 
groups are eligible to be 
included. 
Exclusion Criteria: Exclusion criteria follow standard guidelines and recommendations:3 (a) current regular 
meditation practice (>once/week); (b) serious medical illness precluding regular class attendance; (c) current 
substance abuse, suicidal ideation or eating disorder, (d) history of bipolar or psychotic disorders or self-
injurious behaviors. These participants are excluded because they may disrupt group participation, require 
additional or specialized treatment, or are already participating in practices similar to the intervention. 
1.1.3 Vulnerable populations:  
There are no participants in the study we are aware of who are considered part of a vulnerable population.  
1.1.4 Collaborating sites:  
There are no other collaborating sites that will assess participants during this study.  
1.1.5 Data management:  
The clinical data will be de-identified but linked. Private information such as name date of birth, next of kin, 
address for recontacting will be kept in a password protected, encrypted database on a different disk that the 
clinical data. Only the principal investigators for the purposes of patient safety or monitoring by the NIH, data 
safety monitoring boards or HIPPA compliance officer approved agents will be given access to identifiable 
personal information. 
1.1.6 Equipoise 
Clinical equipoise, defined as “no consensus within the expert clinical community about the comparative 
merits of the alternative [trial arms] to be tested”138 applies to this study, and it will be designed in a way that 
the findings should disrupt clinical equipoise. The study will be described to potential participants as a 
Variables Measured
Baseline 10 weeks 6 months
Demographics
x
Family history of hypertension
x
Childhood socioeconomic status
x
Adverse childhood experiences
x
Depressive symptomatology
x
x
x
Anxiety
x
x
x
Medication use
x
x
x
Antihypertensive medication adherence
x
x
x
Anthropometry
x
x
x
Physical activity
x
x
x
Diet
x
x
x
Cigarette smoking
x
x
x
Sleep duration
x
x
x
Mindfulness
x
x
x
Emotional eating
x
x
x
Self-control
x
x
x
Self-compassion
x
x
x
Perceived stress
x
x
x
Emotion regulation
x
x
x
Interoception
x
x
x
Decentering
x
x
x
Attention control
x
x
x
Craving for hypertension risk factors
x
x
x
Social integration
x
x
x
Loneliness
x
x
x
Readiness to change for hypertension risk factors
x
x
x
Asessment Times
Table 1. Variables measured and assessment times in the Mindfulness-Based 
Hypertension Therapy Study. 

Version 1.3 November 26, 2015 
6 
randomized controlled trial that will evaluate the impact of a stress reduction program on risk for cardiovascular 
disease. The statements in the study description and consent forms will show equipoise (i.e. “a state of 
genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each 
arm in a trial”138), where the state of the research does not know conclusively know whether the stress-
reduction program will have an effect on subclinical cardiovascular disease (hence we are performing the trial). 
For example, the consent form will describe that is not currently known whether the stress reduction 
intervention we are testing reduces cardiovascular disease risk.  Similarly, all study personnel including the PI 
will be instructed to demonstrate equipoise to the best of their ability, regardless of personal biases (in either 
direction – favoring treatment or control), so that any types of biases on treatment effects will not be 
communicated to study participants. Instruction will be provided for all study personnel on the importance of 
demonstrating equipoise. Further instruction will be provided on ways to distinguish appropriately among (1) 
validated knowledge accepted by the clinical community, (2) data on treatments that are promising but are not 
generally convincing, and (3) mere hunches, including how these principles apply to the current study.138   
1.2 
Sources of Materials   
1.2.1 Research material obtained from living individuals 
1.2.1.1 Outcomes 
 
Primary Outcomes 
Self-regulation will be assessed using targets identified in the UH2 phase. A list shown above in the 
Baseline Assessments section. Examples include emotional eating (measured using the Three Factor Eating 
Questionnaire),207,208 self-control (assessed using the validated Self-Control Scale short form.209,210), self-
compassion (Assessed using the validated Self-Compassion Scale (SCS).113 ), emotion regulation (measured 
using the validated Difficulties in Emotion Regulation Scale,214 and positive reappraisal using the validated 
Cognitive Emotion Regulation Scale.215-217), interoception (using the validated Multidimensional Assessment of 
Interoceptive Awareness218-220), decentering (assessed using the validated Experiences Questionnaire.221,222), 
attention control (assessed using the validated Attention Network Test,223, and the Sustained Attention to 
Response Task224-226 227-229 ), and craving for hypertension risk factors, including palatable foods, alcohol, and 
sedentary activities will be assessed using the validated Craving Experiences Questionnaire.230 
 
Secondary Outcome 
Prehypertension/Hypertension Medical Regimen Adherence Outcomes Assessment Methods: (1) 
Electronically-Measured Antihypertensive Medication Adherence: measured continuously using electronic 
medication bottle caps. (2) Body Mass Index: height and weight directly assessed using standard 
epidemiologic methods.172 (3) Physical activity: MET minutes per week, assessed using actigraphy. We will 
use two accelerometers, one (the Actical) worn round the waist, and one (the Actiwatch-64) worn on the wrist 
(Philips Respironics, Andover, MA),173,174 that have become the gold standard for such assessment.175-177 
Adherence to Joint National Commission-7 (JNC-7) guidelines is 30 min aerobic physical activity ≥4 days per 
week.178 (4) Diet: assessed utilizing Dietary Approaches to Stop Hypertension (DASH) eating pattern score,179 
measured via diet history food frequency questionnaire.180 Adherence to JNC-7 guidelines DASH eating 
pattern score (range 0-8).178,179 (5) Alcohol consumption: Amount and frequency of alcohol consumption, will 
be assessed via self-report utilizing standard questions from the behavioral Risk Factor Surveillance Survey.181 
JNC-7-stated cut-point of healthy alcohol intake is ≤ 2 drinks (e.g. 24 oz. beer, 10 oz. wine, or 3 oz. 80-proof 
whiskey) per day in men and ≤1 drink per day in women.178 Medical regimen adherence will be defined as 
adherence to JNC-7-recommended behavioral and medication treatment of hypertension.178 Specifically, 
analyses will assess changes in mean Z-scores of health behaviors or medication adherence in 6 domains, 
being (1) Physical activity assessed via MET scores. (2) Electronically-measured antihypertensive medication 
adherence measured continuously using electronic medication bottle caps, where medication adherence is 
calculated as the percent of days during which medication was taken as prescribed. For multi-day dosings, 
participants will receive points for the proportion of actual over expected dosings. (3) Body Mass Index (kg/m2), 
(4) Diet via Dietary Approaches to Stop Hypertension (DASH) eating pattern score179 (5) Alcohol consumption 
(number of drinks per day).  

Version 1.3 November 26, 2015 
7 
1.2.2 Who will have access to individually identifiable private information about human subjects.  
Only the principal investigators for the purposes of patient safety or monitoring by the NIH, data safety 
monitoring boards or HIPPA compliance officer approved agents will be given access to identifiable personal 
information. 
1.2.3 How the specimens, records, and/or data are collected, managed, and protected as well as 
whether material or data that include individually identifiable private information will be 
collected specifically for the proposed research project. 
Questionnaire data will typically be collected using Qualtrics, LLC (Provo, UT, USA) survey instruments, so 
that participants can complete questionnaires on their own time at home, using their computers or smart 
phones. Exceptions to this include the phone screening questionnaire, and the baseline and follow-up 
questions on depression and anxiety to allow for a safety protocol to be followed if there are high levels of 
depression, anxiety or suicidal ideation.  
Assessments of blood pressure, height, weight, waist circumferences and medication use are assessed in-
person by trained research assistants blinded to treatment allocation.  
Confidentiality of Patient Records: The clinical data will be de-identified but linked. Private information such 
as name, date of birth, and address for recontacting will be kept in a password protected, encrypted database 
on a different disk than the clinical data. Only the principal investigator for the purposes of patient safety or 
monitoring by the NIH, data safety monitoring boards or HIPPA compliance officer approved agents will be 
given access to identifiable personal information. 
Data management will be performed by downloading data at minimum every 2 weeks during data collection 
periods, and assessing data for missingness and errors. Data will be maintained in password-protected 
Microsoft Excel Spreadsheets, and then exported using .csv functions for analysis in SAS software.  
1.3 
Potential Risks and Minimization of Risk  
1.3.1 Expected Risks 
The following is a statement from NCCIH about the potential risks of meditation practice: “Meditation is 
considered to be safe for healthy people. There have been rare reports that meditation could cause or worsen 
symptoms in people who have certain psychiatric problems, but this question has not been fully researched. 
People with physical limitations may not be able to participate in certain meditative practices involving physical 
movement. Individuals with existing mental or physical health conditions should speak with their health care 
providers prior to starting a meditative practice and make their meditation instructor aware of their condition.”235  
Discomfort during meditation: Meditation-based interventions may results in discomfort with attention to 
unpleasant thoughts, feelings or body sensations. Some individuals may experience an initial increase in 
undesirable emotions with increased attention to them. In order to minimize risk, instructors encourage 
participants to be aware of their discomfort and to set their own limitations. Participants are encouraged to alter 
their postures, including standing, sitting in chairs, lying down, as needed in order to be comfortable. In 
addition, the curriculum of the training program is specifically geared towards addressing such discomfort.  
Psychological distress: Research subjects participating in this study may have feelings of loss of privacy 
from being contacted about participating in the study, and possible psychological distress caused by questions 
on the diagnostic interview that bring up painful memories or feelings. However, the resulting potential for injury 
to research subjects is judged to be minimal. We have already contacted and clinically evaluated thousands of 
participants from other studies such as the New England Family and Women’s Health Initiative using similar 
assessment procedures to this study, with good responses from the participants. With regard to psychological 
distress from taking part in the MBSR or MBHT intervention, given that screening questions will exclude 
participants with substantial mental illness, and given the NCCIH statement above that “Meditation is 
considered to be safe for healthy people.”235 we expect that risk of psychological distress will be low. The risk 
of increased psychological distress from meditation will be clearly outlined in the consent form and participants 
will be encouraged to consult with both the course instructor and study staff in the case of any increased 
distress. Dr. Ellen Flynn, a licensed psychiatrist, will be available to advise on any psychological events that 
occur, and provide referrals for treatment if needed.  
Loss of confidentiality: Likelihood: rare. Minimization: Confidentiality will be maintained by numerically 
coding all data, by disguising identifying information, and by keeping all data in locked file drawers. All 
information obtained from participants will be accessible only to research staff.  
Injury due to physical activities: It is possible that injuries could be sustained from (1) the gentle mindful 
movements (yoga), or (2) physical activities that participants engage in as a result of the intervention 

Version 1.3 November 26, 2015 
8 
encouraging exploration of physical activity as a way to reduce blood pressure. (1) Mindful movements: 
Participants receive a handout during the orientation showing the yoga poses that will be offered during the 
course. They are encouraged to explore limits in their body related to movement, but not to go beyond those 
limits Participants are asked to listen to what their body is telling them more closely than what the mindful 
movement instructor is telling them. Modifications of poses are available, including for those limited to chairs or 
wheelchairs. Participants are encouraged to bring the handout of poses to their health care providers if they 
have any physical limitations, so that the providers can advise on which poses to do, and which to avoid. (2) 
Physical activities: Participants are encouraged to explore physical activities that promote strength and 
conditioning as a way to reduce blood pressure. As with the mindful movements, they are encouraged to 
explore limits in their body related to movement, but not to go beyond those limits. Participants are asked to 
listen to what their body is telling them more closely than what the mindful movement instructor is telling them. 
Furthermore, they are encouraged to ask their healthcare provider about advised physical activities if they 
have any physical limitations.  
Risks associated with fMRI: This study will be conducted in a 3T MR scanner at UMass Medical School, 
which has been approved for research and clinical studies in children and adults by the FDA. Magnetic 
resonance (MR) technology does not use X-rays, it uses strong magnetic fields and radio waves. Subjects will 
be asked whether they have devices that can be affected by MRI, and if so, they will not be able to participate 
in this study. Significant risks also can arise if ferromagnetic materials are brought into the high magnetic field 
environment of the scanner and immediate vicinity, as they can become hazardous projectiles. These types of 
items are not permitted in the scanning area. The MR exams are painless, and except for the pulsating 
sounds, subjects will not be aware that MR scanning is taking place. With proper safety precautions in terms of 
the avoidance of metal objects, there are no known health risks associated with MRI. The safety of MRI is 
reflected in the fact that it is used in standard medical practice without the requirement for informed patient 
consent. Most people experience no ill effects from the magnetic field, but some report claustrophobia, 
dizziness, mild nausea, headaches, a metallic taste in their mouth, double vision, or a sensation of flashing 
lights. These symptoms are transient and resolve quickly after the subject exits the scanner. The technologist 
will be able to hear subjects at all times and subjects are free to end the procedure at any time. In rare cases, a 
very slight, uncomfortable tingling of the back due to the rapid switching of the magnetic field has been 
reported during certain types of scans. Subjects are asked to report this immediately so the scan can be 
changed to avoid this. Although these precautions will avoid all known risks associated with MR, this procedure 
may involve risks that are currently unknown. The scanner is noisy, but does not harm hearing. For comfort, 
subjects will be given earplugs to muffle the noise. 
Risk of adverse events during the study: It is possible that some patients will have an adverse event during 
the study, including increased stress or anxiety. Participants with major mental health conditions, such as 
bipolar depression, suicidal ideation, borderline personality disorder, post-traumatic stress disorder, and 
obsessive compulsive disorder, are ineligible for the study. We expect risk of adverse events to be very low. 
Impact statement: These risks are considered to be minimal and are addressed in the protocol and consent 
form. 
 
 
Adverse Events 
 
Mental Health Deterioration and Suicidality: Participants assigned to any treatment group may experience 
mental health or suicidal ideation. All patients will be monitored by study staff at weekly intervals in person or 
by telephone and assessed every four weeks with questionnaires about anxiety, depression and suicidal 
ideation, specifically the Beck Anxiety Inventory and the Center for Epidemiology Study Depression Scale 
Revised (CESD-R). Dr. Flynn is a licensed psychiatrist and has extensive experience evaluating research 
participants for clinical deterioration or suicidality.  
 
Beck Anxiety Inventory (BA): If participant scores ≥26 on the Beck Anxiety Inventory, while having the 
participant wait, immediately notify the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), 
to determine need for a psychiatric consultation. She has provided her cell phone #, and your phone # will be 
entered into her phone recognition software to indicate it is a call from the MBHT study. It is likely she will 
answer the phone. If Dr. Flynn cannot be reached, please leave a phone message for her with your contact 
information and provide her with the Beck Anxiety Inventory results on the message. If Dr. Flynn is not 

Version 1.3 November 26, 2015 
9 
immediately reachable, or following participant release after consulting with Dr. Flynn, immediately contact the 
PI, Dr. Eric Loucks (cell phone #401-369-0443).  
 
Depressive Symptomatology: The CESD-R will be administered during the in-person assessment visits, and 
scores will be reviewed immediately upon completion of the in-person assessments. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Participants are considered to meet criteria for major depressive episode if they have anhedonia or dysphoria 
nearly every day for the past two weeks, plus symptoms in an additional 4 DSM symptom groups noted as 
occurring nearly every day for the past two weeks. If participants meet criteria for major depressive episode, 
while having the participant wait, staff will immediately notify the collaborating psychiatrist, Dr. Ellen Flynn (cell 
phone # 401-258-9829), to determine need for a psychiatric consultation. She has provided her cell phone #, 
and the staff’s phone #’s will be entered into her phone recognition software to indicate it is a call from the 
MBHT study. It is likely she will answer the phone. If Dr. Flynn cannot be reached, staff will leave a phone 
message for her with their contact information and provide her with the Depressive Symptomatology results on 
the message. If Dr. Flynn is not immediately reachable, or following participant release after consulting with Dr. 
Flynn, staff will immediately contact the PI, Dr. Eric Loucks (cell phone #401-369-0443).  
 
 
If participants respond having any suicidal ideation (CES-D questions 14 or 15), staff will perform the following 
2 steps: 
 
1. Immediately call 911 and Dr. Ellen Flynn. Specifically, while the participant is in the waiting room, staff will 
call 911 immediately, and tell them about the situation. This will be followed by a call to Dr. Flynn. 
 
2. While speaking calmly with the participant, staff will let them know that he/she called 911 and Dr. Flynn, 
and why (i.e. because we are concerned about them). Staff can speak with participant to keep him/her in 
the waiting room if 911 has sent assistance, but the discussion should not be clinical in nature.  
 
The following information can be provided to study participants.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
Injury due to physical activities: It is possible that injuries could be sustained from (1) the gentle mindful 
movements (yoga), or (2) physical activities that participants engage in as a result of the intervention 
encouraging exploration of physical activity as a way to reduce blood pressure. 

Version 1.3 November 26, 2015 
10 
 
(1) Mindful movements: Participants receive a handout during the orientation showing the yoga poses that 
will be offered during the course. They are encouraged to explore limits in their body related to 
movement, but not to go beyond those limits Participants are asked to listen to what their body is telling 
them more closely than what the mindful movement instructor is telling them. Modifications of poses are 
available, including for those limited to chairs or wheelchairs. Participants are encouraged to bring the 
handout of poses to their health care providers if they have any physical limitations, so that the 
providers can advise on which poses to do, and which to avoid. 
(2) Physical activities: Participants are encouraged to explore physical activities that promote strength and 
conditioning as a way to reduce blood pressure. As with the mindful movements, they are encouraged 
to explore limits in their body related to movement, but not to go beyond those limits. Participants are 
asked to listen to what their body is telling them more closely than what the mindful movement 
instructor is telling them. Furthermore, they are encouraged to ask their healthcare provider about 
advised physical activities if they have any physical limitations.  
 
All patients will be monitored by study staff at weekly intervals in person or by telephone and assessed every 
four weeks with questionnaires about physical injuries, specifically the following questions: 
 
1. Have you sustained any physical injuries during the past four weeks?  
 
If yes,  
(a) please describe the injury 
(b) please describe what happened to cause the injury.  
(c) did this injury include  
i. 
Broken bone(s) yes/no 
ii. 
Lacerations requiring stiches yes/no 
iii. 
Concussion yes/no 
 
If injuries include any of the following, it will be reported to Data Safety Monitoring Committee member Dr. 
Hank Wu, MD, who is a practicing physician and researcher. He will advise on any follow-up needed. It will 
also be reported to the chair of the Data Safety Monitoring Board.  
 
a. Broken bone(s) 
b. Lacerations requiring stiches 
c. Concussion 
 
Non-Response to Treatment: The possibility that the treatment will not yield benefit is another possible risk and 
will be explained during informed consent procedures. Non-responders (identified as minimal change in 
medical regimen adherence from baseline assessment) will be provided with referrals to other treatment, if 
desired. 
 
1.4 
Safety Monitoring  
Oversight of internal monitoring of the participants’ safety will be conducted by the PIs, Dr. Eric Loucks and 
Dr. Willoughby Britton. Oversight of the external Data and Safety Monitoring Committee will be conducted by 
the chair (Dr. Edmondson). The Data and Safety Monitoring Committee will include experts in cardiology, 
psychology/psychiatry, epidemiology, and biostatistics.  
 
Entities Conducting Monitoring 
 
The Institutional Review Board (IRBs) at Brown University will review all research procedures, and will 
provide oversight. Internal monitoring will be done by the Brown University principal investigators (Dr. Loucks 
and Dr. Britton) and the Brown University IRB. The Data Safety Monitoring Committee will provide external 
monitoring, and will meet every six months by phone or in-person. They will be provided data every six months 
to evaluate potential effects of the RCT on major outcomes (e.g. medical regimen adherence). Any serious 
adverse effects will be immediately reported to the principal investigators (Loucks, Britton) and the committee 
chair.  

Version 1.3 November 26, 2015 
11 
 
What is Monitored 
 
Monitoring is done of all procedures to ensure that they conform to the approved protocol; of unforeseen 
circumstances that might arise and affect safety; of all reports of serious adverse events as defined in US 
Department of Health and Human Services regulations for the protection of human research subjects 45 CFR 
Part 46, and the FDA 312.32 (death, life-threatening experience, new or prolonged hospitalization, persistent 
or significant disability/incapacity); of other significant adverse events (adverse events that lead to drop out by 
participant or termination by the investigator); of unexpected adverse events resulting from the study; and of 
expected adverse events.  
 
Monitoring is done of all study inclusion and exclusion criteria. During this clinical trial, we will notify 
officials, as mandated by law, if a participant reports intentions to harm him/herself or others, or reports child 
abuse or abuse of an elder. Dr. Ellen Flynn, a licensed psychiatrist, will be available to advise on any 
psychological events that occur, and provide referrals for treatment if needed. 
 
Frequency of Monitoring 
 
All adverse events will be continuously monitored by the PI. Participants will be given contact information 
so that they can inform us of events that occur in between study visits. Dr. Loucks will conduct daily oversight 
of participant safety. He will meet weekly with staff to review participant progress and their experiences with 
the experimental procedures, including adverse events. Any adverse events that are observed and/or reported 
will be immediately reported to Dr. Loucks, Dr. Britton, and the Data Safety Monitoring Committee chair. The 
Investigators and Data Safety Monitoring Committee will be available to meet outside of the regularly 
scheduled meetings (scheduled semiannually), if necessary, due to concerns regarding a particular participant 
or any problems that may arise for participants. If necessary, they will make appropriate recommendations for 
changes in protocol, or terminate the study.  The Brown University IRB conducts the monitoring at the 
continuing reviews as scheduled, whenever modification requests are considered, and upon receiving reports 
of serious adverse events from the PI or anyone else.  
 
Reporting Plan 
Any serious adverse events that are observed and/or reported will be immediately reported to Dr. Loucks 
and the Data Safety Monitoring Committee Chair. Serious adverse events are then reported to the Brown 
University IRB and to NIH. Brown’s IRB requires fatalities related to the study be reported within 24 hours. All 
serious adverse events related to this study will be reported to the Brown University IRB immediately by 
telephone and by written report within 48 hours of our receipt of information regarding the event. All other 
adverse events related to the study will be reported at the continuing review. Serious adverse events will also 
be reported in writing to the NIH Project Officer within 48 hours. All serious adverse events related to the study 
will be reported annually in the Progress Report sent to the NIH Project Officer.  
Any actions taken by the IRB, other than acceptance of the adverse event report, will be reported to the 
NIH along with any changes or amendments to the protocol requested by the IRB in response to these reports. 
Proposed changes or amendments to the protocol in general must be requested first in writing to the Brown 
and IRB, which will then grant or deny permission to make the requested change or amendment in protocol. 
NIH will subsequently be informed of any substantive changes or amendments in approved protocol.  
 
2 
Adequacy of Protection Against Risks 
2.1 
Recruitment  and Informed Consent 
2.1.1 Recruitment:    
Participants will be recruited in part through cardiology and family practices via established relationships 
with physicians in Rhode Island and Massachusetts, such as Cathleen Hood MD, Sam Dudley MD, Charles 
Eaton MD and Hank Wu MD, amongst others. Furthermore, advertisements will be posted throughout Rhode 
Island, and distributed via social media, inviting participants interested in lowering their blood pressure to 
enroll. 
2.1.2 Informed Consent:  
All informed consent forms and protocols have been reviewed and approved by the Brown University 
IRB.  Each potential participant will be fully informed about the nature of the study, its risks and benefits, and 

Version 1.3 November 26, 2015 
12 
about his/her rights as a research subject.  The participant will sign and receive a copy of the document stating 
that he/she has given his/her informed consent to participate before interviewing is begun. In every instance, 
project personnel will verbally review the content of the consent form before participants sign.   
2.2 
Protections Against Risk 
Please refer to Section 1.3 above.  
3 
Potential Benefits of the Proposed Research to Human Subjects and Others 
There may be no direct benefits from participating in this study. The risks to participants are minimal. The 
potential benefits of participating in the proposed study include improved knowledge on stress reduction 
techniques and risk factors for cardiovascular disease.  Each participant will also be contributing to an 
important study which will answer questions on whether mindfulness-based stress reduction may influence 
health.   
4 
Importance of the Knowledge to be Gained 
There is great interest in understanding the impact of mindfulness-based interventions on risk for 
cardiovascular disease, however the vast majority of studies to date have had substantial methodological 
limitations, leading at 2007 government report on "Meditation Practices for Health: State of the Research" to 
conclude that "as a whole, firm conclusions on the effects of meditation practices in healthcare cannot be 
drawn based on the available evidence."36  This study proposes to fill a substantial gap in knowledge, and 
rigorously evaluate the effects of a mindfulness-based intervention on risk for hypertension and cardiovascular 
disease. Expected outcomes are to inform recommendations on whether mindfulness-based stress reduction 
has long-term impacts on subclinical cardiovascular disease and cardiovascular disease risk factors. Findings 
will further inform health care providers, communities, workplaces and individuals, who are currently grappling 
with whether to include mindfulness practices as part of approaches to reduce risk for cardiovascular disease. 
5 
Data and Safety Monitoring Plan 
 
Please see Section 1.4 above for Safety Monitoring details.  
 
Data Safety Monitoring Board: 
Oversight of internal monitoring of the participants’ safety will be conducted by the PIs, Dr. Eric Loucks and 
Dr. Willoughby Britton. Investigators on this application have extensive experience with clinical trials for 
mindfulness-based interventions and cardiovascular outcomes. Oversight of the external Data and Safety 
Monitoring Committee will be conducted by the chair, Dr. Donald Edmondson, PhD, is Assistant Professor of 
Behavioral Medicine at Columbia University Medical Center. He is a Psychologist, and has extensive research 
experience in evaluating effects of stress and psychsocial factors on cardiovascular disease outcomes.246-264 
The Data and Safety Monitoring committee will also include Dr. Wen-Chih (Hank) Wu and Dr. Tao Liu. Dr. Wu, 
MD, is Associate Professor of Medicine and Associate Professor of Epidemiology at Brown University. He is a 
practicing clinical cardiologist with research in preventive cardiology,265-272 and will be able to advise on clinical 
outcomes and any cardiovascular complications arising from the study, in addition to methodological concerns. 
Dr. Liu, PhD, is an Assistant Professor of Biostatistics at Brown University, experienced in clinical trials.273,274 
He will receive all preliminary analyses from the primary statistician, and will have access to all data from the 
study, to evaluate any evidence of serious adverse effects or other concerns.  
 
Entities Conducting Monitoring 
 
The Institutional Review Board (IRBs) at Brown University will review all research procedures, and will 
provide oversight. Internal monitoring will be done by the principal investigators (Dr. Loucks and Dr. Britton) 
and the Brown University IRB. The Data Safety Monitoring Committee will provide external monitoring, and will 
meet every six months by phone or in-person. During the randomized-controlled trial phase (phase 4), they will 
be provided data every six months to evaluate potential effects of the RCT on the primary outcome (i.e. 
medical regimen adherence). Any serious adverse effects will be immediately reported to the principal 
investigator (Loucks) and the committee chair (Edmondson).  
5.1 
Entities Conducting Monitoring 
 
The Institutional Review Board (IRBs) at Brown University will review all research procedures, and will 
provide oversight.  Internal monitoring will be done by the Brown University principal investigators (Dr. Loucks 

Version 1.3 November 26, 2015 
13 
and Dr. Britton) and the Brown University IRB. Dr. The Data Safety Monitoring Committee will provide external 
monitoring, and will meet every six months by phone or in-person. They will be provided data every six months 
to evaluate potential effects of the RCT on major outcomes (e.g. medical regimen adherence). Any serious 
adverse effects will be immediately reported to the principal investigators (Loucks, Britton) and the committee 
chair.  
5.2 
What is Monitored 
 
Monitoring is done of all procedures to ensure that they conform to the approved protocol; of unforeseen 
circumstances that might arise and affect safety; of all reports of serious adverse events as defined in US 
Department of Health and Human Services regulations for the protection of human research subjects 45 CFR 
Part 46, and the FDA 312.32 (death, life-threatening experience, new or prolonged hospitalization, persistent 
or significant disability/incapacity); of other significant adverse events (adverse events that lead to drop out by 
participant or termination by the investigator); of unexpected adverse events resulting from the study; and of 
expected adverse events.  
 
Monitoring is done of all study inclusion and exclusion criteria. During this clinical trial, we will notify 
officials, as mandated by law, if a participant reports intentions to harm him/herself or others, or reports child 
abuse or abuse of an elder.  Co-investigator Dr. Willoughby Britton is a clinical psychologist, who will be 
available on call in case of any psychological adverse events.  
5.3 
Frequency of Monitoring 
 
All adverse events will be continuously monitored by the PI.  Participants will be given contact information 
so that they can inform us of events that occur in between study visits.  Dr. Loucks will conduct daily oversight 
of participant safety.  He will meet weekly with staff to review participant progress and their experiences with 
the experimental procedures, including adverse events.  Any adverse events that are observed and/or reported 
will be immediately reported to Dr. Loucks, Dr. Britton, and the Data Safety Monitoring Committee chair.  The 
Investigators and Data Safety Monitoring Committee will be available to meet outside of the regularly 
scheduled meetings (scheduled semiannually), if necessary, due to concerns regarding a particular participant 
or any problems that may arise for participants.  If necessary, they will make appropriate recommendations for 
changes in protocol, or terminate the study.  The Brown University IRB conducts the monitoring at the 
continuing reviews as scheduled, whenever modification requests are considered, and upon receiving reports 
of serious adverse events from the PI or anyone else.  
5.4 
Reporting Plan 
All adverse events will be continuously monitored by the PI. Participants will be given contact information 
so that they can inform us of events that occur in between study visits. Dr. Loucks will conduct daily oversight 
of participant safety. He will meet weekly with staff to review participant progress and their experiences with 
the experimental procedures, including adverse events. Any adverse events that are observed and/or reported 
will be immediately reported to Dr. Loucks, Dr. Britton, and the Data Safety Monitoring Committee chair. The 
Investigators and Data Safety Monitoring Committee will be available to meet outside of the regularly 
scheduled meetings (scheduled semiannually), if necessary, due to concerns regarding a particular participant 
or any problems that may arise for participants. If necessary, they will make appropriate recommendations for 
changes in protocol, or terminate the study.  The Brown University IRB conducts the monitoring at the 
continuing reviews as scheduled, whenever modification requests are considered, and upon receiving reports 
of serious adverse events from the PI or anyone else.  
Any actions taken by the IRB, other than acceptance of the adverse event report, will be reported to the 
NIH along with any changes or amendments to the protocol requested by the IRB in response to these reports.  
Proposed changes or amendments to the protocol in general must be requested first in writing to the Brown 
and IRB, which will then grant or deny permission to make the requested change or amendment in protocol. 
NIH will subsequently be informed of any substantive changes or amendments in approved protocol.   
5.5 
Data Quality Assurance and Confidentiality 
Several procedures currently in practice in our laboratory will also be utilized for this study to guarantee the 
validity, integrity, accuracy, and completeness of the data.  It will be made clear to all participants that all 
information obtained during assessments is confidential.   
Procedures to guarantee the accuracy and completeness of the data during data collection, transmission, 
and analysis: The data manager (Saadeh) will review each file within 2 weeks of data collection for 

Version 1.3 November 26, 2015 
14 
completeness, accuracy, and validity of responses. Data files are accessible only to project personnel and are 
password protected.  Ms. Saadeh will review the distributions of all raw data to ensure that data are within 
range and to check missing data with the hard copy of the data. The project database is password protected 
and accessible only to the project’s data managers, the biostatistician, and the PI.   
Procedures to maintain confidentiality: Study staff will maintain strict confidentiality regarding all aspects of 
a subject’s participation in this study. Any individual information gathered in the course of the study will not be 
discussed with anyone who is not directly involved with this study. For each stage of the research, participant 
names and contact information will be maintained in a recruitment/enrollment database during the course of 
the study.  Once individuals enroll in the study, names will be linked to participant ID number in this database, 
which will be kept in a restricted access folder on a secure server.  This file will be assigned a code name 
unrelated to the name of the study.  Signed consent forms will be kept in a locked file cabinet, separate from 
any other project data.  Once data collection is completed, the corresponding recruitment/enrollment database 
will be deleted as it is unnecessary to maintain the link between participant identity and study data.  All 
information collected as part of this study will be accessible only to research staff who have completed 
mandatory training in the protection of human subjects.   
6 
ClinicalTrials.gov Requirements 
The RCT will be registered, and results reported, at Clinical Trials.gov in accordance with NIH 
recommendations. Registration in ClinicalTrials.gov will occur no later than 21 days after the first subject is 
enrolled. Reporting of results (including adverse events) will occur no later than 1 year after completion date.  

A P P E N DI C E S  
 
 
A . M B H T C urri c ul u m G ui d e 
B. C V s of D at a S af et y M o nit ori n g B o ar d M e m b er s 
	  
	  
	  
	  
	  
	  
	  

Curriculum Vitae 
Prepared 10.6.2014 
Personal Data 
Name:  
Donald Edmondson 
Birthdate:  
12.12.1979  
Birthplace:  
Wynne, AR 
Citizenship:  U.S. 
Education  
2013 
M.P.H., Effectiveness and Outcomes Research; Mailman School of Public Health, 
Columbia University, New York, New York 
2009 
Ph.D., Personality Psychology; University of Connecticut, Storrs, CT;  
Dissertation: Edmondson, D., et al. From shattered assumptions to weakened 
worldviews: Trauma symptoms signal anxiety buffer disruption. Journal of Loss 
and Trauma. 2011, 16, 358-85. (Crystal L. Park, Ph.D., Dissertation Chair). 
2007  
M.A., Clinical Psychology; University of Connecticut, Storrs, CT 
2001  
B.A., History; Union University, Jackson, TN. 
Postdoctoral Training 
2009-2010 
Postdoctoral Research Scientist, Center for Behavioral Cardiovascular Health,  
 
 
Columbia University Medical Center, New York, NY 
Hospital Appointment 
2010-2011 
Associate Research Scientist, Center for Behavioral Cardiovascular Health,  
 
 
Columbia University Medical Center, New York, NY 
Academic Appointment 
2011-present Assistant Professor of Medicine (Departments of Medicine and Psychiatry), 
Center for Behavioral Cardiovascular Health, Columbia University Medical 
Center, New York, NY 
Professional Organizations and Societies  
American Psychological Association  
American Psychosomatic Society 
Association for Psychological Science 
Society for Personality and Social Psychology 
Society of Behavioral Medicine 
 
Honors  
2014 
Neal E. Miller Young Investigator award, Academy for Behavioral Medicine 
Research 
2014 
Grant reviewer, Israel Science Foundation 
2013 
Invited to join Social Psychology, Personality, and Interpersonal Processes (SPIP) 
study section as a permanent member 
2011 
NIH Early Career Reviewer, Social Psychology, Personality, and Interpersonal 
Processes (SPIP) study section  
2011  
Columbia Summer Research Institute selection 
2010-present NIH Loan Repayment Grant recipient  
2007 & 2008 Highest Distinction in Undergraduate Instruction, University of Connecticut  
2006 
Sydney Jourard Award for best paper, Division 32 of the Am Psych Assoc 

2003  
Psi Chi (psychology honors society), University of Memphis  
1997-2001 
Scholars of Excellence Provost’s Scholar Award, Union University 
Current Grants and Contracts:  
Title of Project and Source 
 
 
 
 
Dates             
R01 HL117832 (Edmondson, PI) 
 
 
 
2013-2018 
 
NIH/NHLBI                                                                                           
Impact of Social-Interpersonal Factors in the ER on PTSD/Cardiac Outcomes 
 
Loan Repayment Grant (Edmondson)                                  2011-2014 
 
NIH/NHLBI                                                                                           
PTSD Due to Acute Coronary Syndromes 
Role: Awardee 
 
P01 HL088117 (Davidson, PI)                                        
2008-2013 
 
NIH/NHLBI                                                                                           
Depression, Biobehavioral Mechanisms & CHD/Mortality Outcomes 
Role: Co-Investigator (in-kind support) 
 
P01 HL47540 (J Schwartz, PI)                                       
1993-2014 
NIH/NHLBI                                                                                           
Psychosocial Factors and Cardiovascular Disease 
Role: Co-Investigator (in-kind support) 
 
ECRIP-HPR iSCRIPT Center    (Davidson, PI)                     2014-2016 
New York State Department of Health 
Innovative Strategies to deCrease Readmissions through Improving Patient & System sTress & 
behavior 
Role: Training Director 
Completed 
KM1 CA156709  (Begg, PI)  
 
 
 
2011-2013 
 
NIH/NCI 
 
 
 
 
 
Comparative Effectiveness Research Career Development Award 
Role: Funded trainee 
 
Seed Grant (Edmondson, PI)  
 
 
 
2007-2008 
 
American Psychological Association   
Religious Struggle, PTSD, and Terror Management 
 
Teaching Experience and Responsibilities 
 
Instructor 
2014 
Course Instructor, P8112 Systematic Review and Metaanalysis, Columbia 
University Mailman School of Public Health 
2013 
Statistics Lectures, Epidemiology and Clinical Epidemiology Course, College of 

Physicians and Surgeons, Columbia University (David Lederer and Steven Shea, 
Unit Directors) 
2008    
Structural Equation Modeling (with Tessa V. West), Yale University, graduate 
level 
2006-2009  
Theories of Personality, University of Connecticut, undergraduate; 
enrollment=100 
Abnormal Psychology, University of Connecticut, undergraduate; 
enrollment=100 
Precepting and Invited Lectures  
2012-2013 
Epidemiology and Clinical Epidemiology Course, College of Physicians and 
Surgeons, Columbia University (David Lederer and Steven Shea, Unit Directors) 
2012 
Meta-analysis; N9653 Advanced Research Methods, Columbia University School 
of Nursing (Arlene Smaldone and Patricia Stone, Unit Directors) enrollment=30       
Teaching Assistant 
2008 
Structural Equation Modeling (David Kenny, Instructor), University of 
Connecticut, graduate; enrollment= 45  
2006-2009 
Multivariate Statistics [Eric Lundquist (2 sections), Brian Connelly, Instructors],     
 
         University of Connecticut, graduate; enrollment= 85 
2004-2006 
General Psychology I: Introductory, University of Connecticut; enrollment= 100  
 
        
 Honors General Psychology II: Enhanced, University of Connecticut,  
 
   
 
        
 undergraduate, enrollment= 100 
Thesis/Dissertation Sponsorship 
Student Name   Level of Learner 
Date of Training 
Nature of Responsibility 
 
 
 
Laura Goorin  
Ph.D.  
        2010 
 
Dissertation Committee Member (TC) 
Aurelie Athan  
Ph.D.  
        2010 
 
Dissertation Committee Member (TC) 
Other Professional Activities  
University Committees 
Clinical/Epidemiological Research Task Force (Elizabeth Shane, leader) 
Mailman School of Public Health student research practicum supervisor 
2012- Safiya Richardson, M.D.: The influence of stress on cardiovascular events 
BEST Diversity Program mentor; Biostatistics 
2012- Introduce biostatistics to under-represented minority, economically disadvantaged, and 
disabled undergraduates, with special emphasis on cardiovascular and pulmonary research.    
Co-editor (with Karina Davidson) 
2012-Progress in Cardiovascular Diseases special issue: “Psychosocial factors and 
cardiovascular disease” 
Ad hoc reviewer:  
Ageing and Society 
 
 
 
 
Annals of Behavioral Medicine 
Anxiety, Stress, and Coping  
 
 
Biological Psychiatry 
Biological Psychology 
 
 
 
Circulation 
 
 
 
Cleveland Clinic Journal of Medicine  
 
General Hospital Psychiatry  
 
European Heart Journal 
 
 
 
Health Psychology 
 
 
International J for the Psych of Religion  
 
Journal of Applied Social Psychology 

Journal of Behavioral Medicine 
 
 
J of Personality and Social Psychology 
Journal of Psychosomatic Research  
 
J of the American College of Cardiology  
J of Traumatic Stress  
 
 
 
Metabolism 
Personality and Individual Differences  
 
Psychosomatic Medicine 
 
Trials  
 
 
 
 
 
World Journal of Biological Psychiatry 
Publications  
A. Original, Peer Reviewed Articles 
1. Wasson, L. T., Shaffer, J., Alcantara, C., Schwartz, J. E., & Edmondson, D. (2014). The 
association of posttraumatic stress disorder and quality of life during the first year after acute 
coronary syndrome. International Journal of Cardiology. Aug 13 [Epub ahead of print] 
2. Alcántara, C., Edmondson, D., Moise, N., Oyola, D., Hiti, D., & Kronish, I. M. (2014). 
Anxiety Sensitivity and Medication Nonadherence in Patients with Uncontrolled 
Hypertension. Journal of Psychosomatic Research, 77(4), 283-286. 
3. Davidson KW, Peacock J, Kronish IM, Edmondson D. (2014). Personalizing behavior 
change interventions through single-patient (N-of-1) randomized controlled trials. Social and 
Personality Psychology Compass, 8(8), 408-421. 
4. Edmondson D, Green P, Ye S, Halazun H, Davidson KW (2014). Psychological stress and 
30-day all-cause hospital readmission in acute coronary syndrome patients: An observational 
cohort study. PLoS ONE, 9(3): e91477. PMCID: PMC3951368 
5. Edmondson D, Kronish IM, Wasson LT, Giglio J, Davidson KW, Whang W. (2014). A test 
of the diathesis-stress model in the emergency department: Who develops PTSD after an 
acute coronary syndrome? Journal of Psychiatric Research, 53:8-13. PMCID: PMC4023688 
[Available on 2015/6/1]. 
6. Shaffer JA, Diaz K, Alcantara C, Edmondson D, Krupka DJ, Chaplin WF, Davidson KW. 
(2014). An inexpensive device for monitoring patients' weights via automated hovering. 
International Journal of Cardiology, 172(2): e263-4. PMCID: PMC3984000 [Available on 
2015/3/15] 
7. Shaffer JA, Edmondson D, Wasson LT, Falzon L, Homma K, Ezeokoli N, Li P, Davidson 
KW (2014). Vitamin D Supplementation for Depressive Symptoms: A Systematic Review 
and Meta-analysis of Randomized Controlled Trials. Psychosomatic Medicine, 2014, 76(3), 
190-196. PMCID: PMC4008710  [Available on 2015/4/1] 
8. Alcantara C, Peacock J, Hiti D, Davidson KW, Edmondson D. The association of short 
sleep after acute coronary syndrome with recurrent cardiac events and mortality. 
International Journal of Cardiology, 2014, 171(2):e11-2. PMCID: PMC3947905 [Available 
on 2015/2/1] 
9. Edmondson D. (2014). An enduring somatic threat model of posttraumatic stress disorder 
due to acute life-threatening medical events. Social and Personality Psychology Compass, 
8(3), 118-134. PMCID: PMC4048720 [Available on 2015/3/15] 
10. Kronish IM, Lin JJ, Cohen BE, Voils CI, Edmondson D.  (2014). Posttraumatic Stress 
Disorder increases risk for non-adherence to medications in patients with uncontrolled 
hypertension. JAMA Internal Medicine, 174(3), 468-470.  PMCID: PMC3999520 
11. Edmondson, D. & Cohen, B. (2013). Posttraumatic stress disorder and cardiovascular 
disease. Progress in Cardiovascular Diseases, 55, 548-56. PMCID: PMC3639489  

12. Burg, MM, Edmondson, D, Whang, W, Shaffer, JA, Kronish, IM, Alacántara, C, Schwartz, 
JE, Muntner, P, Shimbo, D., Davidson, KW. (2013). The ‘Perfect Storm’ that leads to acute 
coronary syndrome: Do psychosocial factors play a role? Progress in Cardiovascular 
Diseases, 55, 601-610. PMCID:PMC3652628  
13. Edmondson, D., Gamboa, C., Cohen, A., Hyre Anderson, A., Kutner, N., Kronish, I. M., 
Mills, M.A. & Muntner, P. (2013). Association of posttraumatic stress disorder and 
depression with all-cause and cardiovascular disease mortality and hospitalization among 
Hurricane Katrina survivors with end-stage renal disease. American Journal of Public 
Health,  2013;103:e130-137. PMCID: PMC3673270 
14. Edmondson, D., Horowitz, C. R., Goldfinger, J. Z., Fei, K., Kronish, I M. (2013). Concerns 
about medications mediate the association of posttraumatic stress disorder with adherence to 
medication in stroke survivors. British Journal of Health Psychology, 18:799-813. PMCID: 
PMC3760991 
15. Edmondson D, Kronish IM, Shaffer JA, Falzon L, Burg MM (2013). Posttraumatic stress 
disorder and risk for coronary heart disease: A meta-analytic review. American Heart 
Journal, 166, 806-814. PMCID:PMC3815706 [Available on 2014/11/1] 
16. Edmondson, D., Newman, J. D., Whang, W., & Davidson, K.W. (2013). Emotional triggers 
of acute myocardial infarction: Do they matter? European Heart Journal, 34, 300-6. 
PMCID:PMC3549526   
17. Edmondson D, Richardson S, Fausett JK, Falzon L, Howard VJ, Kronish I. Prevalence of 
posttraumatic stress disorder in stroke survivors: A meta-analytic review. PLoS ONE. 
2013;8:e66435. PMCID: PMC3686746 
18. Edmondson D, Shaffer JA, Chaplin WF, Burg MM, Stone AA, Schwartz JE. Trait anxiety 
and trait anger measured by ecological momentary assessment and their correspondence with 
traditional trait questionnaires. Journal of Research in Personality, 2013;47:843-852. 
PMCID: PMC3815708 
19. Edmondson, D., Shimbo, D., Ye, S., Wyer, P., & Davidson, K.W. (2013). The association of 
emergency department crowding during treatment for acute coronary syndrome with 
subsequent posttraumatic stress disorder symptoms. JAMA Internal Medicine, 2013;173:472-
475. PMCID: PMC3973030 
Editorial commentary: O’Malley PG. The environment of health care: Primum non 
nocere comment on “the association of emergency department crowding during treatment 
for acute coronary syndrome with subsequent posttraumatic stress disorder symptoms”. 
JAMA Internal Medicine, 2013;173:474-474. 
20. Goldfinger JZ, Edmondson D, Kronish IM, Fei K, Balakrishnan R, Tuhrim S, Horowitz CR 
(2013). Correlates of posttraumatic stress disorder in stroke survivors. Journal of Stroke and 
Cerebrovascular Diseases,  Oct 19 [Epub ahead of print]. PMCID: PMC3992186 [Available 
on 2015/4/19] 
21. Kronish IM,  Diefenbach M, Edmondson D, Phillips LA, Fei K, Horowitz CR (2013). Key 
barriers to medication adherence in survivors of strokes and transient ischemic attacks. 
Journal of General Internal Medicine, 28, 675-682. PMCID: PMC3631079   
22. Shaffer JA, Kronish IM, Burg M, Clemow L, Edmondson D (2013). Association of acute 
coronary syndrome-induced posttraumatic stress disorder symptoms with self-reported sleep. 

Annals of Behavioral Medicine, 46, 349-357. PMCID: PMC3800234  [Available on 
2014/11/30].  
23. Edmondson, D., Newman, J. D., Chang, M. J., Wyer, P., & Davidson, K.W. (2012). 
Depression is associated with longer emergency department length of stay in acute coronary 
syndrome patients. BMC Emergency Medicine, 12:14 (5 November 2012). PMCID: 
PMC3546889. 
24. Edmondson, D., Richardson, S., Falzon, L., Davidson, K.W., Mills, M.A., & Neria, Y. 
(2012). Posttraumatic stress disorder prevalence and risk of recurrence in acute coronary 
syndrome patients: A meta-analytic review. PLoS ONE. PMCID: PMCID: PMC3380054 
25. Edmondson D, Shaffer JA, Denton EG, Shimbo D and Clemow L (2012). Posttraumatic 
stress and myocardial infarction risk perceptions in hospitalized acute coronary syndrome 
patients. Frontiers in Psychology 3:144. doi: 10.3389/fpsyg.2012.00144. PMCID: 
PMC3350942 
26. Hale-Smith A, Park CL, Edmondson D. Measuring beliefs about suffering: Development of 
the views of suffering scale. Psychol Assess. 2012;24:855-866. PMCID: PMC3695743  
27. Kronish, I. M., Edmondson, D., Li, Y., Cohen, B. (2012). Posttraumatic stress disorder and 
medication adherence: Results from the Mind Your Heart study. Journal of Psychiatric 
Research, 43, 2192-7. PMCID: PMC3485414  
28. Kronish, I., Edmondson, D., Goldfinger, J., & Horowitz, C. (2012). Posttraumatic stress 
disorder and adherence to medications in survivors of strokes and transient ischemic attacks. 
Stroke, 43, 2192-7. PMC3404197  
29. Kronish IM, Rieckmann N, Burg MM, Edmondson D, Schwartz JE, Davidson KW. (2012). 
The Effect of Enhanced Depression Care on Adherence to Risk Reducing Behaviors after 
Acute Coronary Syndromes: Findings from the COPES Trial. American Heart Journal, 164, 
524-9. PMCID:PMC3549526   
30. Park, C.L., Edmondson, D., & Lee, J. (2012). Development of self-regulation abilities as 
predictors of psychological adjustment across the first year of college. Journal of Adult 
Development, 19, 40-49.  
31. Park, C.L., Mills, M. A., & Edmondson, D. (2012). PTSD as meaning violation: Testing a 
cognitive worldview perspective. Psychological Trauma: Theory, Research, Practice, Policy, 
4, 66-73. PMCID: PMC4029350 
32. Park, C. L., Sacco, S., & Edmondson, D. (2012). Expanding coping goodness of fit:  
Religious coping, health locus of control and depressed affect in heart failure patients. 
Anxiety, Stress, and Coping, 25, 137-53.   
33. Richardson, S., Shaffer, J.A., Falzon, L., Davidson, K.W., Krupka, D., & Edmondson, D. 
(2012). Meta-analysis of perceived stress and its association with incident coronary heart 
disease. American Journal of Cardiology, 110, 1711-16. PMC3511594  
34. Wortmann, J.H., Park, C.L., Swenson, E., & Edmondson, D. (2012). Spiritual struggle and 
adjustment to loss in college students: Moderation by denomination. International Journal 
for the Psychology of Religion, 22, 303-20.  
35. Edmondson, D., Chaudoir, S. C., Mills, M. A., Park, C. L., Holub, J., & Bartkowiak, J. M. 
(2011). From shattered assumptions to weakened worldviews: Trauma symptoms signal 
anxiety buffer disruption. Journal of Loss and Trauma, 16, 358-85. PMCID: PMC3783359 

36. Edmondson, D., Rieckmann, N., Shaffer, J. A., Schwartz, J. E., Burg, M. M., Davidson, K. 
W., Clemow, L., Shimbo, D., & Kronish, I. M. (2011). Posttraumatic stress due to an acute 
coronary syndrome increases risk of 42-month major adverse cardiac events and all-cause 
mortality.  Journal of Psychiatric Research, 45, 1621-26. PMCID: PMC3210372 
37. Ishikawa, J., Ishikawa, Y., Edmondson, D., Pickering, T. G., & Schwartz, J. E. (2011). Age 
and the difference in awake ambulatory blood pressure and clinic blood pressure: A meta-
analysis. Blood Pressure Monitoring, 16, 159-67. PMCID: PMC3839085 
38. Newman JD, Muntner P, Shimbo D, Davidson KW, Shaffer JA, & Edmondson D. (2011). 
Post-traumatic stress disorder (PTSD) symptoms predict delay to hospital in patients with 
acute coronary syndrome. PLoS One, 2011, 6, e27640. PMCID: PMC3214073 
39. Park, C. L., Wortmann, J.H., & Edmondson, D. (2011). Religious struggle as a predictor of 
subsequent mental and physical well-being in advanced heart failure patients. Journal of 
Behavioral Medicine, 34, 426-36. 
40. Shaffer, J. A., Edmondson, D., Chaplin, W. F., Schwartz, J. E., Iyer, P., Burg, M. M., 
Rieckmann, N., Shimbo, D., & Davidson, K. W. (2011). Directionality of the relationship 
between depression symptom dimensions and C-reactive protein among patients with acute 
coronary syndromes. Psychosomatic Medicine, 73, 370-77. PMCID: PMC3110525 
41. Wortmann,  J. H.,  Park, C. L., & Edmondson, D.  (2011). Trauma and PTSD symptoms: 
Does spiritual struggle mediate the link? Psychological Trauma: Theory, Research, Practice, 
Policy, 3, 442-52. PMCID: PMC3269830 
42. Edmondson, D., Mills, M. A., & Park, C. L. (2010). Factor structure of the Acute Stress 
Disorder Scale in Hurricane Katrina evacuees. Psychological Assessment, 22, 269-278. 
PMCID: PMC2883796 
43. Edmondson, D., & Park, C. L. (2009). Shifting foundations: Religious belief change and 
adjustment in college students. Mental Health, Religion, and Culture, 12, 289-302.  
44. Park, C. L., Edmondson, D., & Blank, T. O. (2009). Religious and non-religious pathways 
to stress-related growth in cancer survivors. Applied Psychology: Health and Well-Being, 1, 
321-335. 
45. Park, C. L., Edmondson, D., Blank, T. O., & Hale Smith, A. (2009). Religiousness/ 
spirituality and health behaviors in younger adult cancer survivors: Does faith promote a 
healthier lifestyle? Journal of Behavioral Medicine, 32, 582-591 
46. Penner, L. A., Dovidio, J. F., Edmondson, D., Albrecht, T. L., Dailey, R. K., & Markova, T. 
(2009). The experience of discrimination and Black-White health disparities in medical care. 
Journal of Black Psychology, 35, 180-203. PMCID: PMC3862356 
47. Sullivan, T. P., Cavanaugh, C. E., Buckner, J. D., & Edmondson, D. (2009). Testing 
posttraumatic stress as a mediator of physical, sexual, and psychological intimate partner 
violence and substance problems among women. Journal of Traumatic Stress, 22, 575-584. 
PMCID: PMC3012603 
48.  Yanez, B., Edmondson, D., Stanton, A. L., Park, C. L., Kwan, L., Ganz, P., & Blank, T. O. 
(2009). Facets of spirituality as predictors of adjustment to cancer: Relative contributions of 
having faith and finding meaning. Journal of Consulting and Clinical Psychology, 77, 730-
741. PMCID: PMC2825181 

49. Edmondson, D., Park, C. L., Chaudoir, S. R., & Wortmann, J. (2008). Death without God: 
Religious struggle, death concerns, and depression in the terminally ill. Psychological 
Science, 19, 628-632. 
50. Edmondson, D., Park, C. L., Blank, T. O., Fenster, J., & Mills, M. A. (2008). 
Deconstructing spiritual well-being: Existential well-being and HRQOL in cancer survivors. 
Psycho-Oncology, 17, 161-169. 
51. Park, C. L., Edmondson, D., Blank, T. O., & Fenster, J. R. (2008). Meaning making and 
psychological adjustment following cancer: The mediating roles of growth, life meaning, and 
restored just world beliefs. Journal of Consulting and Clinical Psychology, 76, 863-875.  
52. Park, C. L., Edmondson, D., Fenster, J. R., & Blank, T. O. (2008). Positive and negative 
health behavior changes in cancer survivors: A stress and coping perspective. Journal of 
Health Psychology, 13, 1198-1206. 
53. Mills, M. A., Edmondson, D., & Park, C. L. (2007). Trauma and stress response in Katrina’s 
evacuees. American Journal of Public Health, 97, S116-123. PMCID: PMC1854990 
B. Case Reports 
n/a 
C. Reviews, Chapters and Editorials 
1. Edmondson D, Davidson KW. Introduction to the special issue on psychosocial factors in 
cardiovascular disease. Prog Cardiovasc Dis. 2013; 55:509-510 
2. Park, C. L., Edmondson, D., & Hale Smith, A. Why religion? Meaning as the motivation. In 
K. I. Pargament (Ed.), APA Handbook of Psychology, Religion, and Spirituality. 
Washington, D.C., APA. 2013. 
3. Edmondson D, Hiti D, Kronish IM. Posttraumatic stress disorder and cardiovascular disease. 
In Cardiovascular Prevention: A Global Challenge, Donna K. Arnett, ed. In press. 
4. Park, C. L. & Edmondson, D. Religion as a source of meaning. In Mikulincer, M. & Shaver, 
P. (Eds.), Meaning, Mortality, and Choice: The Social Psychology of Existential Concerns. 
Washington, D.C., APA. 2012. 
5. Park, C. L., Edmondson, D., & Mills, M. A. Religious worldviews and stressful encounters: 
Reciprocal influence from a meaning making perspective. In T. W. Miller (Ed.), Handbook 
of stressful transitions across the lifespan. New York, Springer. 2009, 485-502. 
6. Edmondson, D. & Mills, M. A. Research in New Orleans: Through the eyes of the victims 
of Hurricane Katrina. The Society for the Psychological Study of Social Issues: The Rookie. 
2005, November. 
D. Patents 
n/a 
E. Abstracts  
1. Brondolo E, Wasson L, Alcantara C, Edmondson D. Posttraumatic stress disorder and 
smoking in year after an acute coronary syndrome event. Paper presented at American 
Psychosomatic Society, San Francisco, CA. March 2014. 
2. Kronish I, Lin J, Cohen B, Voils C, Olamiju B, Edmondson D. PTSD and medication 
nonadherence in patients with uncontrolled hypertension. Paper presented at American 
Psychosomatic Society, San Francisco, CA. March 2014. 
3. Edmondson D, Green P, Ye S, Halazun H, Davidson KW (2013). Psychological Stress And 

30-day Readmission In Acute Coronary Syndrome Patients. Poster presented at the American 
Heart Association Scientific Sessions, Dallas. 
4. Edmondson D, Richardson S, Fausett JK, Falzon L, Howard, VJ, Kronish, IK. (2013). 
Prevalence of PTSD in Stroke Survivors: A Meta-analytic Review. Poster presented at the 
American Heart Association Epidemiology and Prevention Scientific Sessions, New Orleans.  
5. Edmondson D, Kronish, IK, Shaffer JA, Falzon L, Burg MM. (2013). Posttraumatic Stress 
Disorder and Risk for Coronary Heart Disease: A Meta-analytic Review of Prospective 
Studies Poster presented at the American Heart Association Epidemiology and Prevention 
Scientific Sessions, New Orleans.  
6. Halazun H, Kronish I, Edmondson D, Davidson KW, Ye S (2013). The Impact of Patient 
Comorbidity on Risk of 30-day Readmission Following Hospitalization for Acute Coronary 
Syndromes. Poster presented at the American Heart Association Scientific Sessions, Dallas. 
7. Happy, S., Morales, R., & Edmondson, D. (2013). Lifetime history of PTSD predicts 
nonadherence to medications after acute coronary syndrome. Poster presented at the 25th 
Annual Association for Psychological Science Convention, May 23-26, 2013. 
8. Goldfinger JZ, Fei K, Balakrishnan R, Diefenbach MA, Edmondson D, Kronish IM, Tuhrim 
S, Horowitz CR. (2012, February). Prevalence and Correlates of PTSD After Stroke. Poster 
presented at the AHA/ASA International Stroke Conference, New Orleans, LA. 
9. Edmondson, D., Newman, J., Chang, M., Wyer, P., & Davidson, K.W. (2012, April). Patients 
with suspected NSTEMI or unstable angina who are depressed wait longer in emergency 
departments than non-depressed patients. Poster presented at the 33rd Annual Meeting & 
Scientific Sessions of the Society of Behavioral Medicine, New Orleans. 
10. Edmondson, D., Richardson, S., Falzon, L., Davidson, K. D., Mary Alice Mills, Ph.D., & 
Neria, Y. (2012, March). Acute coronary syndrome-induced posttraumatic stress disorder: A 
meta-analytic review of prevalence, association with clinical outcomes, and intervention 
effects. Poster presented at the Annual Meeting of the American Psychosomatic Society, 
Athens, Greece. 
11. Edmondson, D., Ye, S., Schulman, J., & Davidson, K. D. (2012, March). Cost-effectiveness 
of enhanced depression treatment in acute coronary syndrome patients. Paper presented at the 
Annual Meeting of the American Psychosomatic Society, Athens, Greece. 
12. Edmondson, D., Parsons, F., Shaffer, J. A., & Davidson, K. D. (2012, March). Wait, who 
are we missing? Demographic predictors of refusal to participate in a randomized controlled 
trial of depression treatment. Poster presented at the Annual Meeting of the American 
Psychosomatic Society, Athens, Greece. 
13. Edmondson, D., Shaffer, J. A., Denton, E., Shimbo, D., & Clemow, L. P. (2011, March).  
PTSD and Recurrence Risk Perceptions in Acute Coronary Syndrome Patients. Paper 
presented at the Annual Meeting of the American Psychosomatic Society, San Antonio, TX. 
14. Perez, S. A. (student), Duer-Hefel, J. T., Davidson, K. W., & Edmondson, D. (2011, 
November). Posttraumatic stress disorder symptoms and poor sleep quality in acute coronary 
syndrome patients. Paper presented at the American Heart Association Scientific Sessions, 
Orlando, FL. 
15. Moran, M. D. (student), Duer-Hefel, J. T., Davidson, K. W., & Edmondson, D. (2011, 
November). Female patients with suspected NSTEMI or unstable angina wait longer in 
emergency department than male patients. Paper presented at the American Heart 
Association Scientific Sessions, Orlando, FL. 
16. Shaffer, J. A., Edmondson, D., Chaplin, W., Schwartz, J. E., & Stone A. A. (2010, March). 

Anxiety and anger in daily life: Contributions of the person and situation in momentary 
assessments of elicited states. Poster presented at the annual meeting of the American 
Psychosomatic Society, Portland. 
17. Edmondson, D., Ishikawa, J., Yurgel, T., Burg, M. M., & Schwartz, J. E. (2010, March). 
Comparison of blood pressure assessment methods using CFA. Poster presented at the annual 
meeting of the American Psychosomatic Society, Portland. 
18. Park, C. L. & Edmondson, D. (2010, May). Advances in the measurement of meaning 
making and meanings made. In C. L. Park (Chair), Innovations in meaning making research: 
Conceptual and methodological advances.  Symposium conducted at the annual Association 
for Psychological Science Convention, Boston, MA. 
19. Edmondson, D. & Schwartz, J. E. (2010, May). Potentially Traumatic Events Increase 
Resting Heart Rate in Civilians Assessed with ABPM. Poster presented at the annual meeting 
of the Association for Psychological Science, Boston. 
20. Shaffer, J. A., Edmondson, D., Chaplin, W. F., Schwartz, J. E., Burg, M. M., Reickmann, 
N., & Davidson, K. W. (2010, August). Somatic and Cognitive Symptoms of Depression 
Predict Changes in C-Reactive Protein (CRP) in Patients with Acute Coronary Syndrome 
(ACS). Poster presented at the annual International Congress of Behavioral Medicine, 
Washington, D.C. 
21. Edmondson, D., Kronish, I., Harlapur, M., Shaffer, J. A., Davidson, K. W., Schwartz, J. E., 
Burg, M. M., Iyer, P., Shimbo, D., Clemow, L., & Rieckmann, N. (2010, November).  
 
Posttraumatic Stress Disorder (PTSD) Symptoms Predict Worse Long-term  
Cardiovascular Prognosis in Post-Acute Coronary Syndrome (ACS) Patients. Paper presented 
at the American Heart Association Scientific Sessions, Chicago, IL.  
22. Edmondson, D., Chaudoir, S. C., Bartkowiak, J., & Bestrom, P. (2009, February). Terror 
management and PTSD: Shattered assumptions or damaged worldview? Poster presented at 
the annual Society for Personality and Social Psychology Convention, Tampa, FL. 
23. Park, C. L., Edmondson, D., & Blank, T. O. (2009, April). Religious and non-religious 
pathways to stress-related growth in younger adult cancer survivors. Paper presented at the 
29th annual meeting of the Society of Behavioral Medicine, Montreal. 
24. Mills, M. A., Park, C. L., & Edmondson, D. (2009, November). Shattered assumptions? A 
prospective study: The impact of trauma on global beliefs. Paper presented at the 
International Society for Traumatic Stress Studies, Atlanta. 
25. Ishikawa, J., Ishikawa, Y., Edmondson, D., Schwartz, J. E., & Pickering, T. G. (2009, 
November). Age and the difference in awake ambulatory blood pressure and clinic blood 
pressure: A meta-analysis. Paper presented at the American Heart Association Scientific 
Sessions, Orlando. 
26. Edmondson, D., Chaudoir, S. C., Holub, J., & Park, C. L. (2008, August). Weakened, but 
not shattered: Evidence of worldview dysfunction in PTSD. In D. Edmondson (Chair), The 
causes and psychological consequences of cultural worldview breach. Symposium conducted 
at the annual American Psychological Association Convention, Boston, MA. 
27. Edmondson, D., Holub, J., Chaudoir, S. C., Gavitt, C., Bestrom, P., & Park, C. L. (2008, 
March). Religious struggle as adaptive meaning making in the service of terror management. 
In C. L. Park (Chair), Religious meaning systems in action: Stress appraisals, terror 
management, and restoration of global religious beliefs. Symposium conducted at the Annual 
Mid-Year Research Conference on Religion and Spirituality, Columbia, MD.  

28. Sullivan, T. P., Cavanaugh, C. E., Buckner, J. D., & Edmondson, D. (2008, July). Intimate 
partner violence (IPV) and drug and alcohol use problems among community women: The 
roles of physical, sexual, and psychological IPV and PTSD. Paper presented at the 
International Family Violence and Child Victimization Research Conference, Portsmouth, 
New Hampshire. 
29. Wortmann, J.H., Park, C.L., Edmondson, D., & Swenson, E.  (2008, August).  
Denominational Differences in Religious Comfort and Struggle and Adjustment After Loss.  
Paper presented at the annual Convention of the American Psychological Association, 
Boston. 
30. Edmondson, D., Park, C. L., Blank, T. O., & Smith, Hale Smith, A. (2008, August). 
Religion/Spirituality and Health Behaviors in Younger Adult Cancer Survivors. Poster 
presented at the annual American Psychological Association Convention, Boston, MA. 
31. Edmondson, D., Park, C. L., & Blank, T. O. (2007, March). Change in existential well-being 
influences HRQOL in cancer survivors. Paper presented at the 28th annual meeting of the 
Society of Behavioral Medicine, Washington, DC. 
32. Edmondson, D. (2007, March). Religious meaning influences the cognitive response to 
cancer, and vice versa. In M. Koltko-Rivera (Discussant), Trauma and spirituality: The 
recursive nature of spiritual meaning and meaning making. Symposium conducted at the 
annual Mid-Year Research Conference on Religion and Spirituality, Columbia, MD.  
33. Edmondson, D., Park, C. L., Blank, T. O., & Fenster, J. R. (2007, August). The process and 
products of meaning making in cancer survivorship. Poster presented at the annual American 
Psychological Association Convention, San Francisco.  
34. Mills, M. A., Park, C. L., & Edmondson, D. (2007, November). The immediate aftermath: 
Stress, coping, and distress in Hurricane Katrina's evacuees. Paper presented at the 23rd 
annual meeting of the International Society for Traumatic Stress Studies, Baltimore, MD. 
35. Fenster, J., Park, C. L., Edmondson, D., & Blank, T. O.  (2007, November). Relationship 
Between Previous Life Trauma, Resolution of Trauma, and Adjustment in Young Cancer 
Survivors. Poster presented at the International Society for Traumatic Stress Studies, 
Baltimore, MD. 
36. Edmondson, D., Park, C. L., & Mills, M. A. (2006, March). A terror management model of 
religious engagement in older adults. In C. L. Park (Chair), Religion and death-related 
phenomena. Symposium conducted at the annual Mid-Year Research Conference on 
Religion and Spirituality, Columbia, MD.  
37. Edmondson, D., & Mills, M. A. (2006, March). The role of religious coping in the cognitive 
processing of trauma. Paper presented at the annual Mid-Year Research Conference on 
Religion and Spirituality, Columbia, MD.  
38. Edmondson, D., Park, C.L., Blank, T. O., Mills, M. A., & Fenster, J. (2006, March). 
Existential well-being and health related quality of life in cancer survivors.  Paper presented 
at the 27th annual meeting of the Society of Behavioral Medicine, San Francisco. 
39. Park, C. L., Blank, T. O., Fenster, J. R., & Edmondson, D. (2006, July). Spirituality, 
Meaning, and Well-being in Young to Middle Aged Cancer Survivors.  Paper presented in 
Symposium, Meaning, Spirituality and Approaches to Decrease Distress (D. Pyritz, Chair) at 
the UICC World Cancer Congress. Washington, DC. 
40. Park, C. L., Blank, T. O., Fenster, J. R., & Edmondson, D. (2006, July). Meaning Making 
Processes and Adjustment to Cancer Survivorship.  Poster presented at the UICC World 
Cancer Congress, Washington, DC. 

41. Edmondson, D., Wortmann, J., Ayotte, K., & Park, C. L. (2006, August). Model of religious 
struggle and depression in CHF (congestive heart failure) patients. Poster presented at the 
annual American Psychological Association Convention, New Orleans, LA. 
42. Edmondson, D. (2006, August). Cancer survivorship as mortality salience: Terror 
management and wellbeing. Paper presented at the annual American Psychological 
Association Convention, New Orleans, LA. 
43. Edmondson, D., & Park, C. L. (2005, April). Terror management perspectives on religion 
and adjustment to cancer. Paper presented in Symposium, Religion and Death-Related 
Adjustment (C. L. Park, Chair), at the Annual Midwinter Meeting of Division 36 
(Psychology of Religion), American Psychological Association, Baltimore. 
44. Edmondson, D., Parizeau, L., & Park, C. L. (2005, April). Religious and spiritual 
dimensions as determinants of health behaviors in college students. Paper presented at the 
annual Mid-Year Research Conference on Religion and Spirituality, Columbia, MD.  
45. Edmondson, D., & Park, C. L. (2005, August). Religious belief change in college students. 
Paper presented at the American Psychological Association Convention, Washington, DC. 
Invited Presentations 
1. 
Edmondson, D. (2013, February). PTSD and Cardiovascular Disease. Invited 
presentation to New York University Department of Psychiatry. 
2. 
Edmondson, D. (2011, April). Religion and Meaning. Presented at the Fourth Annual 
Herzliya Symposium on Social and Personality Psychology, Interdisciplinary Center, 
Herzliya, Israel. 
3. 
Edmondson, D. (2010, April). PTSD after acute coronary syndrome as an independent 
risk factor for MACE/ACM recurrence. Presented at Division of General Medicine Spring 
Conference, Columbia University Medical Center, NY.  
4. 
Edmondson, D. (2006, March). Meaning and mortality in health research. Presented at 
the University of Connecticut Center for Health Intervention and Prevention, “Sex, Drugs, and 
Health Behaviors II”, Storrs, CT. 
5. 
Edmondson, D., & Mills, M.A. (2006, March). Acute Stress Disorder in Katrina’s 
evacuees: Prevalence and predictors. Presented at the University of Connecticut Economics 
Department Graduate Student Seminar series, Storrs, CT. 
 
F. Media 
2013 
 
For: Edmondson, D., Shimbo, D., Ye, S., Wyer, P., & Davidson, K.W. (2013). The association 
of emergency department crowding during treatment for acute coronary syndrome with 
subsequent posttraumatic stress disorder symptoms. JAMA Intern Med. 2013;173:472-475. 
NIHMS453931 
 
1. Chicago Tribune 
Overcrowded ERs, PTSD signs tied in heart patients 
Being treated for a heart attack in a crowded emergency department may be linked to 
developing symptoms of a stress disorder, according to a new study. 

 
For: Edmondson D, Richardson S, Fausett JK, Falzon L, Howard VJ, Kronish I. Prevalence of 
posttraumatic stress disorder in stroke survivors: A meta-analytic review. PLoS ONE. 
2013;8:e66435 
 
1. CBS THIS MORNING 
PTSD can be triggered by serious medical events 
June 29, 2013 
Post-Traumatic Stress Disorder - PTSD - is often associated with military combat veterans, but a 
new study found that it can also be triggered by serious health events. Donald Edmondson and 
Dr. Ian Kronish, the co-authors of the study, talk to the "CBS This Morning: Saturday" co-hosts 
about their findings. 
 
2. WALL STREET JOURNAL LIVE 
PTSD: Not Just for Soldiers Anymore 
July 24, 2013 
A new study finds that one in four stroke patients are developing post traumatic stress disorder 
within a year of the stroke. And the odds of a psychological recovery are worse for younger 
patients. Sumathi Reddy and the study's lead author Dr. Donald Edmondson have details.  
 
3. Also: CNN; USA Today; LA Times; WCBS; Medscape; HHS Healthbeat 
 
2012 
 
For Edmondson, D., Richardson, S., Falzon, L., Davidson, K.W., Mills, M.A., & Neria, Y. 
(2012). Posttraumatic stress disorder prevalence and risk of recurrence in acute coronary 
syndrome patients: A meta-analytic review. PLoS ONE. PMCID: PMC3380054 
 
1. JAMA 
Voelker R. Study: Acute coronary events linked with PTSD: JAMA. 2012 Jul 11;308(2):121. 
 
2. American Psychiatric Association 
 
Sinclair L. PTSD Often Overlooked in Treating Cardiac Patients. Psychiatric News. 2012;Sect. 
22-5. 
 
3. NEW YORK TIMES  
Heart Attack Survivors May Develop P.T.S.D. By Tara Parker-Pope; June 20, 2012 
 
4. TIME 
Heart Attacks Can Trigger Post-Traumatic Stress By Amanda Macmillan; June 21, 2012 
 

5. ABC NEWS/ World News with Diane Sawyer 
Heart Attacks and PTSD: A Vicious Cycle By Dr. Jenniffier Mahand; June 20, 2012  
 
6. FOX NEWS 
PTSD prevalent among heart attack patients, study finds By Alex Crees; June 21, 2012 
  
7. CNN  
PTSD strikes one in eight heart attack patients 
 
8. US News and World Report 
Doheny, K. (2012), PTSD symptoms common after heart attack: Study. U.S.News & World 
Report. 
 
9. PBS NewsHour for June 21, 2012 
 
2011 
 
For: Edmondson, D., Rieckmann, N., Shaffer, J. A., Schwartz, J. E., Burg, M. M., Davidson, K. 
W., Clemow, L., Shimbo, D., & Kronish, I. M. (2011). Posttraumatic stress due to an acute 
coronary syndrome increases risk of 42-month major adverse cardiac events and all-cause 
mortality.  Journal of Psychiatric Research, 45, 1621-26. PMCID: PMC3210372 
 
1. Journal Watch Psychiatry 
PTSD Affects Medical Outcomes After Acute Coronary Syndromes (2011, September 19). 
Journal Watch Psychiatry. http://psychiatry.jwatch.org. 
Internal Medicine News 
 
2. Internal Medicine News 
PTSD Linked to Risk for Coronary Disease, Death (2010, December 10). Internal Medicine 
News. http://www.internalmedicinenews.com/news/mental-health/single-article/ptsd-linked-
to-risk-for-coronary-disease-death/60996e5568.html. 
 
2009 
 
1. UConn Magazine 
Surviving the Ph.D. Process (2009, Fall/Winter). UConn Magazine 
http://uconnmagazine.uconn.edu/fwin2009/feature2.html. 

 
1
Revised 5/1/2015 
 
 
 
 
 
 
 
                       
CURRICULUM VITAE 
WEN-CHIH HANK WU, M.D., M.P.H. 
 
 
Business address:   
 
 
830 Chalkstone Ave, Providence, RI 02908 
 
Business Tel:  
 
 
 
(401) 273-7100 ext. 2426 
 
Business Fax:  
 
 
 
(401) 457-3311 
 
E-mail:  
 
 
 
 
Wen-chih.wu@va.gov 
Wen-Chih_Wu@brown.edu 
 
Education: 
 
B.S., M.D.  
 
 
 
 
University of Costa Rica School of Medicine 
                                                       
   
San Jose, Costa Rica, 1989-1995 
Full-tuition Honor Scholarship 1990-1995 
 
 
 
 
 
 
Honor Graduation 1995 
 
M.P.H.  
 
 
 
 
Brown University, June 2010 
M.A. 
 
 
 
 
 
Brown University, July 2010 (ad eundem gradum) 
 
Postgraduate Training: 
 
1996-1997                         
     
 
Internship, Primary Care Internal Medicine 
University of Connecticut School of Medicine 
Farmington, CT 
 
1997-1999 
 
 
 
 
Residency, Primary Care Internal Medicine 
University of Connecticut School of Medicine 
Farmington, CT 
                                                                                                                      
1999-2002 
           
 
 
Fellowship, Cardiovascular Diseases 
  
 
 
 
 
 
Brown University Medical School  
 
 
 
 
 
 
Providence, RI 
 
2008 
 
 
 
Level 2 Training, Cardiac Computed Tomography  
 
 
 
 
Angiography; The Christ Hospital, Cincinnati, Ohio 
 
 
Postgraduate Honors and Awards 
 
1999  
 
        
 
 
Medical Resident of the Year 
   
 
 
University of Connecticut School of Medicine 
 
2001-2003 
 
 
 
 
Dean’s Teaching Excellence Awards 
 
 
 
 
 
 
Brown Medical School 
 
2002 – 2005  
 
 
 
Teacher of the Year Award 

 
2
Cardiology Fellowship, Brown Medical School 
 
2010  
 
 
 
 
Beckwith Family Award for Outstanding Teaching  
 
 
 
 
 
 
Dept. of Medicine, Alpert Medical School, Brown Univ. 
 
Professional Licensure and Board Certification     
 
1999-2011 
 
 
 
 
Connecticut Medical License  
 
1999-  
 
 
 
 
ABIM- Internal Medicine 
 
2001-  
 
 
 
 
Rhode Island medical license  
 
2002-  
 
 
 
 
ABIM - Cardiology 
 
Academic Appointments 
 
 
2002 - 2010        
 
 
 
Assistant Professor of Medicine (Cardiology) 
                                    
Brown University Alpert Medical School 
 
2010 –  
Associate Professor of Medicine (Research),  
Brown University Alpert Medical School 
 
2012 -  
 
 
Associate Professor of Epidemiology,  
Brown University School of Public Health 
 
Hospital Appointments 
 
July, 2002- 
 
 
 
 
Staff Cardiologist 
Providence VA Medical Center 
 
July 2004 - 2014 
 
 
 
Medical Director, Cardiovascular Risk Reduction Clinic,  
 
 
 
 
 
 
Providence VA Medical Center 
 
July 2008 – July 2010  
 
 
Medical Director, Heart Failure Clinic,  
Providence VA Medical Center 
 
July 2011 – September 2014  
 
Medical Director, Intravenous Diuretic Clinic,  
Providence VA Medical Center 
 
July 2012 – current 
Medical Director Shared-medical-appointment Clinics in 
Heart Failure, Providence VA Medical Center 
 
March 2013 – current 
Chief of Cardiology (Acting), Providence VA Medical 
Center 
 
October 2014 - 
Director of the Cardiovascular Wellness and Prevention 
Center at Miriam, Newport, and Rhode Island Hospitals 
 
Other Appointments 
 

 
3
1995-1996 
          
   
 
General Practitioner  
                        
Orotina / San Mateo Division, 
                                                             
Ministry of Health of Costa Rica 
 
2007- 
Faculty, NHLBI R25HL088992-01, Short-Term 
Training Program to Increase Diversity in 
Health-Related Research 
 
2008-2013  
Faculty, NHLBI T32HL094300-01, Brown 
CardioPulmonary Research Training Program 
 
2009- 
Faculty, T35HL094308-01, Alpert Medical School 
Summer Research Program (AMSSRP) in 
Molecular Pathobiology and Health 
Services/Outcomes research in cardiopulmonary 
diseases 
 
2012- 
Core investigator, Providence VAMC Center of 
Innovation (COIN) for Long Term Support and 
Services 
 
2012-2015 
Core investigator, CHF QUERI, Palo Alto, CA 
 
2012-2015 
Core investigator, DM QUERI, Ann Arbor, MI 
 
 
Editorial Positions 
 
2008-2013 
Section Editor, Ferri's Clinical Advisor, Ferri, FF 
[ed], Elsevier, St. Louis. 
 
April 2014 - present 
 
 
 
Academic Editor, PLoS One 
 
April 2015 – present 
Editorial Board: Alzheimer's & Dementia: 
Diagnosis, Assessment & Disease Monitoring 
(DADM)  - a journal of the Alzheimer's Association 
 
Ad Hoc Reviewer for JAMA 
 
Ad Hoc Reviewer for Chest 
 
Ad Hoc Reviewer for American Journal of Medicine 
 
Ad Hoc Reviewer for Cardiovascular Reviews and Reports 
 
Ad Hoc Reviewer for Journal of the American Society of Echocardiography 
 
Ad Hoc Reviewer for American Journal of Cardiology 
 
Ad Hoc Reviewer for International Journal of Impotence Research 
 

 
4
Ad Hoc Reviewer for Journal of Sexual Medicine 
 
Ad Hoc Reviewer for Diabetes Care 
 
 
Study Section/Review Group 
 
2008  Ad Hoc Reviewer for VA Cooperative Studies Program  
2009 - 2010 NIH Special Emphasis Panel/Scientific Review Group 2009/10 ZRG1 HDM-P(58) R 
2010 - present VA HSR&D Scientific Merit Review HSR1 Group 
2010 – 2013 VA VISN 1 Career Development Award Program (V1CDA)  
2011 – 2014 VA QUERI Rapid Response Projects review board  
2012/08 Special Emphasis Panel/Scientific Review Group  HQ2 R (CREATE review board) 
2013 – 2015 VA Quality Enhancement Research Initiative (QUERI) Service Directed Project (SDP) 
Proposal Review Section  
Hospital Committees 
 
2003-present  
 
 
 
IRB Committee 
 
2005-2010 
 
 
 
 
Chair, Radiation Safety Committee 
 
2006- 2010 
 
 
 
 
Member, VA Advanced Clinic Access Committee 
 
2006- 2010 
 
 
 
 
Member, VA (VISN-1) Laboratory Utilization Council 
 
2010-present  
 
 
 
Member, Radiation Safety Committee 
 
2012-present  
 
 
 
Member, Education Leadership Committee 
 
University Committees 
 
2004 - 2007  
 
 
 
Medical Faculty Executive Committee, Brown Univ.  
 
Membership in Societies 
 
1996-          
 
 
 
 
Member, American College of Physicians 
 
1999-     
 
 
 
 
Member, American College of Cardiology 
 
1999-     
   
 
 
 
Member, American Heart Association 
 
2003-  
 
 
 
 
Interdisciplinary Working Group on Quality of Care & 
Outcomes Research, AHA 
 
2005- 
 
Fellow, American College of Cardiology 

 
5
 
2007- 
Member, Minority Members Committee, American Heart 
Association 
 
2008- 
Member, American Society of Preventive Cardiology 
 
2008- 
Member, Society of Cardiovascular Computed 
Tomography 
 
2008- 
Fellow, American Heart Association 
 
Original Peer Reviewed Publications      
 
1. 
Wu WC, Rathore SS, Wang Y, Radford MJ, Krumholz HM.  Effectiveness of blood transfusion in 
elderly patients with acute myocardial infarction.  N Eng J Med 2001; 345(17): 1230-6. 
 
2. 
Shahi C, Rathore SS, Wang Y, Thakur R, Wu WC, Lewis JM, Petrillo MK, Radford MJ, 
Krumholz HM.  Quality of care among elderly patients hospitalized with unstable Angina.  
Am Heart J 2001;142(2):263-70. 
 
3. 
Wu WC, Tilkemeier PL.  Significance of right ventricular visualization on stress sestamibi in a 
patient with dyspnea after atrial-septal-defect repair.  J Nucl Cardiol 2002:9(2):236-7. 
 
4. 
Sebastian CC, Wu WC, Shafer M, Choudhary G, Patel PM. Pneumopericardium and 
pneumothorax after permanent pacemaker implantation. PACE 2005; 28:1–3. 
 
5. 
Wu WC, Sharma SC, Choudhary G, Coulter L, Coccio E, Eaton CB. Flow Mediated Vasodilation 
Predicts the Presence and Extent of Coronary Disease Assessed by Stress Thallium Imaging. J 
Nucl Cardiol 2005; 12(5):538-44. 
 
6. 
Taveira TH, Wu WC, Martin OJ, Schleinitz MD, Friedmann P, Sharma SC. Pharmacist-led cardiac 
risk reduction model. Prev Cardiol 2006; 9(4):202-8. 
 
7. 
Martin OJ, Wu WC, Taveira TH, Eaton CB, Sharma SC. Multidisciplinary Group Behavioral 
and Pharmacologic Intervention for Cardiac Risk Reduction in Diabetes-a Pilot Study. 
Diabetes Educator 2007; 33(1):118-27.  
 
8. 
Wu WC, Schiffter TL, Henderson WG, Eaton CB, Poses RM, Uttley G, Sharma SC, 
Vezeridis M, Khuri SF, Friedmann PD. Levels of Preoperative Hematocrit Predict 
Postoperative Cardiovascular and Fatal Outcomes in Elderly Patients Undergoing Major 
Non-Cardiac Surgery.  J.A.M.A. 2007; 297(22): 2481-8.*(selected publication submitted) 
 
9. 
Pirraglia PA, Taveira TH, Cohen LB, Wu WC. The moderating effect of depression diagnosis 
on the effectiveness of a multi-factorial cardiovascular risk reduction clinic. Preventing 
Chronic Disease 2008; 5(4): A127 pp1-7 
 
10. 
Khatana SAM, Taveira TH, Miner M, Eaton CB, Wu WC. Does Cardiovascular Risk 
Reduction Alleviate Erectile Dysfunction in Men with Type 2 Diabetes Mellitus? Int J Impot 
Res. 2008; 20(5): 501-6. 
 

 
6
11. 
Taveira TH, Pirraglia PA, Cohen LB, Wu WC. Efficacy of a Pharmacist-led Cardiovascular 
Risk Reduction Clinic for Diabetic Patients with and without Mental Health Conditions. Prev 
Cardiol 2008; 11(4):195-200. 
 
12. 
Khatana SA, Taveira TH, Choudhary G, Eaton CB, Wu WC. Change in Hemoglobin A1C 
and C-Reactive Protein Levels in Patients with Diabetes Mellitus. J Cardiometab Synd 
2009;4:1-5. 
 
13. 
Pirraglia PA, Taveira TH, Cohen LB, Dooley A, Wu WC. Maintenance of Cardiovascular 
Risk Goals in Veterans with Diabetes after Discharge from a Cardiovascular Risk Reduction 
Clinic. Prev Cardiol 2009;12(1):3-8. 
 
14. 
Taveira TH, Friedmann PD, Cohen LB, Dooley AG, Khatana SAM, Pirraglia PA, Wu WC.  
Pharmacist-led Group Medical Appointment Model in Type 2 Diabetes. Diabetes Educator 
2009; Dec 4 [Epub ahead of print], doi:10.1177/0145721709352383. 
  
15. 
Choudhary G, Shin V, Punjani S, Ritter N, Sharma SC, Wu WC. The Role of Calcium Score 
and CT Angiography in the medical management of patients with normal myocardial 
perfusion imaging. J Nuc Cardiol 2009; Nov 21[Epub ahead of print]. doi:10.1007/s12350-
009-9158-x. 
 
16. 
Chen CK, Tseng VL, Wu WC, Greenberg PB. A Survey of the Current Role of Manual 
Extracapsular Cataract Extraction. Journal of Cataract and Refractive Surgery 2010; 
36(4):692-3. 
 
17. 
Wu WC, Smith TS, Henderson WG, Eaton CB, Poses RM, Uttley G, Mor V, Sharma SC, 
Vezeridis M, Khuri SF, Friedmann PD. Operative Blood Loss, Blood Transfusion and 30-day 
Mortality in Older Patients after Major Noncardiac Surgery. Annals of Surgery 2010 
252(1):11-7. 
 
 
18. 
Chen CK, Tseng VL, Wu WC, Scott IU, Greenberg PB.  A Survey on the Use of General 
Anesthesia for Cataract Surgery. Graefes Arch Clin Exp Ophthalmol. 2010;248(7):1051-2. 
 
19. 
Jankowich MD, Taveira TH, Wu WC. Decreased lung function is associated with increased 
arterial stiffness as measured by peripheral pulse pressure: data from NHANES III.  Am J 
Hypertension 2010 23(6):614-9. 
 
20. 
Cohen LB, Taveira TH, Wu WC, Pirraglia PA. Maintenance of risk factor control in patients 
with diabetes after discharge from a cardiovascular risk reduction clinic in patients with and 
without mental health conditions. Annals of Pharmacotherapy 2010; [Epub ahead of print], 
DOI 10.1345/aph.1P034. 
 
21. 
Greenberg PB, Tseng VL, Wu WC, Liu J, Jiang L, Chen CK, Scott IU, Friedmann PD. 
Prevalence and Predictors of Ocular Complications Associated with Cataract Surgery in 
United States Veterans. Ophthalmology 2010 Oct 28. [Epub ahead of print]. 
 
22. 
Greenberg PB, Liu J, Wu WC, Jiang L, Tseng VL, Scott IU, Friedmann PD. Predictors of 
Mortality Within 90 Days of Cataract Surgery. Ophthalmology 2010 117(10):1894-9. 
 

 
7
23. 
Khatana SAM, Taveira TH, Dooley AG, Wu WC. The Association between C-Reactive 
Protein Levels and Insulin Therapy in Obese vs. Non-Obese Veterans with Type 2 Diabetes 
Mellitus. J Clin Hypertens 2010;12(6):462-8. 
 
24. 
Chen CK, Tseng VL, Wu WC, Scott IU, Greenberg PB. A Survey of the Management of 
Antithrombotic Therapy in Cataract Surgery Patients. J Cataract Refract Surg. 
2010;36(7):1239-40. 
 
25. 
Choudhary G, Atalay MK, Ritter N, Shin V, Grand D, Pearson C, Kirchner RM, Wu WC. 
Interobserver Reliability In The Assessment Of Coronary Stenoses By Multi- 
Detector Computed Tomography. J Comput Assist Tomogr 2011;35: 126-134. 
 
26. 
Tseng VL, Greenberg PB, Wu WC, Jiang L, Li E, Kang JM, Scott IU, Friedmann PD.  
Cataract Surgery Complications in Nonagenarians. Ophthalmology. 2011 Mar 7. [Epub 
ahead of print] 
 
27.      Punjani S, Wu WC, Cohen S, Sharma SC, Choudhary G. Echocardiographic indices of 
diastolic function relate to functional capacity and quality of life in ambulatory men with atrial 
fibrillation. Journal of the American Society of Echocardiography 2011;24(5): 533-540. 
 
28.     Greenberg PB, Tseng VL, Jiang L, Wu WC. Cataract Surgery in the very ill. J Cataract 
Refract Surg 2011, 37(5):970-1. 
 
29.      Wu WC, Waring ME, Lessard D, Yarzebski J, Gore J, Goldberg RJ. 6-Month Mortality and 
Cardiac Catheterization in Non-ST Elevation Myocardial Infarction Patients with Anemia. 
Coronary Artery Disease 2011, 22:317–323. 
 
30.     Khatana SAM, Kane J, Taveira TH, Bauer MS, Wu WC. Monitoring and Prevalence Rates of 
Metabolic Syndrome in Veterans with Major Mental Illness. PLOS One 2011, 6(4): e19298. 
 
31.    Jankowich M, Choudhary G, Taveira TH, Wu WC. Age-, Race-, and Gender-Specific 
Prevalence of Diabetes among Smokers. Diabetes Research and Clinical Practice 2011, 
doi:10.1016/j.diabres.2011.05.029 (Epub ahead of print). 
 
32.      Taveira TH, Dooley AG, Cohen LB, Khatana SAM, Wu WC. Pharmacist-led Group Medical 
Appointments for the Management of Type 2 Diabetes with Co-Morbid Depression in Older 
Adults. Annals of Pharmacotherapy 2011; DOI: 10.1345/aph.1Q212 (Epub ahead of print). 
 
33.  
Cohen LB, Taveira TH, Khatana SAM, Dooley AG, Pirraglia PA, Wu WC.  Pharmacist-led 
Shared Medical Appointments for Multiple Cardiovascular Risk Reduction in Patients with 
Type 2 Diabetes. Diabetes Educator 2011; 37(6): 785-95. DOI 10.1177/0145721711423980 
 
34.     Malandrino N, Wu WC, Taveira TH, Whitlatch H, Smith RJ. Association between Red Blood 
Cell Distribution Width and Macrovascular and Microvascular Complications in Diabetes. 
Diabetologia 2011; 55(1):226-35. 
 
35.  
Wu WC, Trivedi A, Friedmann PD, Henderson WG, Smith TS, Poses RM, Uttley G, Vezeridis 
M, Eaton CB, Mor V. Association between Hospital Intraoperative Blood Transfusion 
Practices for Surgical Blood Loss and Hospital Surgical Mortality Rates. Ann Surg. 2012 Feb 
24. [Epub ahead of print] 

 
8
 
36. 
Pirraglia PA, Rowland E, Wu WC, Taveira TH, Cohen LB, Friedmann PD, O’Toole TP. The 
benefits of a primary care clinic co-located and integrated in the mental health setting for 
veterans with serious mental illness. Preventing Chronic Disease 2012;9:E51. [Epub Feb 2] 
 
37.     Li E, Greenberg PB, Tseng V, Caffrey AR, Wu WC, Friedmann PD, LaPlante KL. In vitro 
coagulation effects of ophthalmic doses of bevacizumab. Journal of Ocular Pharmacology 
2012, Feb 3. [Epub ahead of print]. 
 
38. 
Kapoor M, Schleinitz MD, Gemignani A, Wu WC. Outcomes of Patients with Chronic Heart 
Failure and Iron Deficiency Treated with Intravenous Iron: A Meta-analysis. Cardiovasc 
Hematol Disord Drug Targets. 2012 Sep 27. [Epub ahead of print] 
 
39. 
Patel N, Taveira TH, Choudhary C, Wu WC. C-peptide Levels Predict Cardiovascular 
Mortality In Nondiabetic Adults. J Am Heart Assoc. 2012;1:e003152 
 
40. 
Cohen S, Gaddam S, Gemignani A, Wu WC, Sharma S, Choudhary G. Right Ventricular 
Function Relates To Functional Capacity In Men With Atrial Fibrillation And Preserved Left 
Ventricular Ejection Fraction. Echocardiography 2013;0:1-9. 
 
41.     Kim J, Gaddam S, Wu WC, Behera V, Sharma S, Choudhary G. Stratified Reporting of High 
Sensitivity Troponin I Assay is Associated with Suboptimal Management of Patients with 
Acute Coronary Syndrome and Intermediate Troponin Elevation. Journal of Clinical 
Laboratory Analysis 2013 Sep;27(5):402-6. doi: 10.1002/jcla.21618. PubMed PMID: 
24038227. 
 
42.  
Sathya B, Davis R, Taveira T, Whitlatch H, Wu WC. Intensity of Peri-operative Glycemic 
Control and Postoperative Outcomes in Patients with Diabetes: A Meta-analysis. Diabetes 
Research and Clinical Practice 102 (2013), pp. 8-15. DOI information: 
10.1016/j.diabres.2013.05.003 
 
43.     Chatterjee S, Kim J, Dahhan A, Choudhary G, Sharma S, Wu WC. Use of High-Sensitivity 
Troponin Assays Predicts Mortality in Patients with Normal Conventional Troponin Assays on 
Admission - Insights from a Meta-Analysis. Clinical Cardiology 2013. doi: 10.1002/clc.22196. 
[Epub ahead of print] PubMed PMID:24037966. 
 
44. 
Khatana SAM, Jiang L, Wu WC. A comprehensive analysis of multidisciplinary management 
of dyslipidemia in a large health care system. Journal of Evaluation in Clinical Practice 2013. 
doi:10.1111/jep.12082. [Epub ahead of print] PubMed PMID: 24118549. 
 
45.     Sardar P; Chatterjee S; Wu WC; Lichstein E; Ghosh J; Aikat S; Mukherjee D. New Oral 
Anticoagulants are not Superior to Warfarin in Secondary Prevention of Stroke or Transient 
Ischemic Attacks, but Lower Risk of Intracranial Bleeding: Insights From a Meta- Analysis 
and Indirect Treatment Comparisons. PLoS ONE 2013; 8(10): e77694. 
doi:10.1371/journal.pone.0077694. 
 
46.     Taveira TH; Wu WC; Tschibelu E; Borsook D; Simonson D; Yamamoto R; Langleben DD; 
Swift R; Elman I. Naltrexone decreases body fat mass in olanzapine-treated schizophrenic or 
schizoaffective patients: a randomized double-blind placebo-controlled study. Journal of 
Psychopharmacology 2013. Nov 11. [Epub ahead of print]  PMID: 24218048 
 

 
9
47.     Choudhary G, Jankowich M, Wu WC. Prevalence And Clinical Characteristics Associated 
With Pulmonary Hypertension In African-Americans. PLoS One. 2013;8(12):e84264. doi: 
10.1371/journal.pone.0084264. PMID: 24358351. 
 
48.     Kirsh S, Wu WC, Edelman D, Aron DC. Research versus Quality Improvement: Distinct or a 
Distinction without a Difference? The Joint Commission Journal on Quality and Patient Safety 
2014; 40(8): 365-75. 
 
49. 
Taveira TH, Wu WC. Interventions to maintain cardiac risk control after discharge from a 
           cardiovascular risk reduction clinic: A randomized controlled trial. Diabetes Res Clin Pract 
(2014), http://dx.doi.org/10.1016/j.diabres.2014.05.013  PMID: 24969964 
 
51. 
Choudhary G, Jankowich M, Wu WC. Elevated Pulmonary Artery Systolic Pressure Predicts 
Heart Failure Admissions in African Americans: Jackson Heart Study. Circ Heart Fail. 2014 
Jun 5. pii: CIRCHEARTFAILURE.114.001366. [Epub ahead of print]. PMID: 24902739 
 
52.     Wu WC, Jiang L, Friedmann PD, Trivedi A. Association Between Process Quality Measures 
for Heart Failure and Mortality Among U.S. Veterans. Am Heart J 2014; 168(5): 713–720.e3. 
 
53. 
Greenberg PB, Chen AJ, Wu WC. Sudden vision loss and cardiovascular risk factors in 
African Americans: the Jackson Heart Study. Ophthalmic Epidemiol. 2015; 22(2):116-22. doi: 
10.3109/09286586.2015.1012273. PubMed PMID: 25777311. 
 
54.  
Jones LG, Sin M-K, Hage FG, Kheirbek RE, Morgan CJ, Zile MR, Wu WC, Deedwania P, 
Fonarow GC, Aronow WS, Prabhu SD, Fletcher RD, Ahmed A, Allman RM. Characteristics 
and Outcomes of Patients with Advanced Chronic Systolic Heart Failure Receiving Care at 
the Veterans Affairs vs. Other Hospitals: Insights from the BEST Trial. Circ Heart Fail. 2015; 
DOI: 10.1161/CIRCHEARTFAILURE.114.001300. 
 
55. 
Chan KHK, Chacko SA, Song Y, Cho M, Eaton CB, Wu WC, Liu S. Genetic Variations in 
Magnesium-Related Ion Channels May Affect Diabetes Risk among African American and 
Hispanic American Women J. Nutr. 2015 jn.114.203489; published online January 7, 2015. 
 
56.     Steiner J, Wu WC, Jankowich M, Maron BA, Sharma S, Choudhary G. Echocardiographic 
Predictors of Mortality in Patients with Pulmonary Hypertension and Cardiopulmonary 
Comorbidities. PLoS ONE 03/2015; 10(3):e0119277. DOI:10.1371/journal.pone.0119277 
 
57.     Lin X, Zhang X, Guo J, Roberts CK, McKenzie S, Wu WC, Liu S, Song Y. Effects of Exercise 
Training on Cardiorespiratory Fitness and Biomarkers of Cardio-metabolic Health: A 
Systematic Review and Meta-analysis of Randomized Controlled Trials. J Am Heart Assoc. 
2015 (4:e002014 doi: 10.1161/JAHA.115.002014)  
 
58.     Salmoirago-Blotcher E, Wayne P, Bock BC, Dunsiger S, Wu WC, Stabile L, Yeh G. Design 
and methods of the Gentle Cardiac Rehabilitation Study - A behavioral study of tai chi 
exercise for patients not attending cardiac rehabilitation. Contemporary clinical trials 06/2015; 
DOI:10.1016/j.cct.2015.06.020 
 
59.     Chen A, Trivedi AN, Jiang L, Vezeridis M, Henderson WG, Wu WC. Hospital Blood 
Transfusion Patterns During Major Noncardiac Surgery and Surgical Mortality. Medicine  
     2015; 94(32):e1342. doi: 10.1097/MD.0000000000001342. 
 

 
10
60. 
Wellenius G, Kingsley S, Eliot M, Whitsel E, Wang Y, Coull B, Hou L, Margolis H, Margolis K, 
Mu L, Wu WC, Johnson K, Allison M, Manson J, Eaton C. Residential proximity to major 
roadways and incident hypertension in post-menopausal women. Environmental Research 
2015; 142:522–528. 
 
61. 
Santos CY, Lim YY, Wu WC, Polynice S, Maruff P, Snyder PJ. Resting-State Cardiac 
Workload is Related to Both Increased Neocortical Aggregation of β-Amyloid Protein and 
Relative Impairments in Spatial Working Memory in Pre-Clinical Alzheimer’s Disease. Journal 
of Alzheimer's Disease 2015 (in press) 
 
62.  
Lacy ME, Wellenius GA, Carnethon MR, Loucks EB, Carson AP, Luo X, Kiefe CI, Gjelsvik A, 
Gunderson EP, Eaton CB, Wu WC. Racial differences in the performance of existing risk 
prediction models for incident type 2 diabetes: The CARDIA study. Diabetes Care 2015 (in 
press). 
 
63. 
Dev S, Lacy ME, Masoudi FA, Wu WC. Temporal Trends and Hospital Variation in 
Mineralocorticoid Receptor Antagonist Use in Veterans Discharged with Heart Failure. J Am 
Heart Assoc 2015 (in press) 
 
Other Peer Reviewed Publications      
 
1. Sadaniantz A, Wu WC.  Survival of renal transplant patients after first myocardial infarction: a look 
to the past and promises for the future.  Am J Kidney Dis 2000;36:211-3.  
 
2. Rathore SS, Wu WC, Krumholz HM.  Transfusion in elderly patients with myocardial infarction. 
Correspondence: authors reply to editor. N Eng J Med 2002;346(10):780-1. 
 
3. Wu WC, Ireland LA*, Sadaniantz A. Evaluation of aortic valve disorders using stress 
echocardiography. Echocardiography 2004;21:451-8. 
 
4. Sadaniantz A, Katz A, Wu WC.  Miscellaneous use of stress echocardiography in patients with 
chronic pulmonary disease or congenital heart defect.  Echocardiography 2004;21:477-84. 
 
5.  Wu WC, Aziz GF*, Sadaniantz A.  Evaluation of aortic valve disorders using stress 
echocardiography. Echocardiography 2004;21:459-66. 
 
6. Wu WC, Bhavsar JH*, Sadaniantz A.  An overview of stress echocardiography in the study of 
patients with dilated and hypertropic cardiomyopathy.  Echocardiography 2004;21:467-75.  
 
7. Wu WC, Gordon PG. Invasive management of patients with ST elevation MI with >12 hour delay in 
presentation, the question remains unanswered. Chest 2004;126:2-4.  
 
8. Mehta SB*, Wu WC. Management of coronary heart disease – stable angina, acute coronary 
syndrome, myocardial infarction. Primary Care Clinics of North America 2005; 32(4):1057-81. 
 
9. Patel PM*, Wu WC. The electrocardiogram in the primary care office. Primary Care Clinics of North 
America 2005; 32(4):901-30.  
 
10. Wu WC, Schiffter TL, Henderson WG.  Preoperative Hematocrit Levels and Outcomes After 
Noncardiac Surgery J.A.M.A. 2007; 298(13): 1513-4. 
 

 
11
11. Karnik RS*, Wu WC. Self assessment in Cardiology. Common Tachyarrhythmias: Review 
Questions. Hospital Physician 2007; 43(11): 33-6. 
 
12. Regnante R*, Wu WC. Self-Assessment in Cardiology. Management of Chest Pain in the 
Emergency Department: Review Questions. Hospital Physician 2008; 44(11): 13-16. 
 
13. Wu, WC. Does Blood Transfusion Increase Mortality Risk in Acute Myocardial Infarction? Am J 
Cardiol 2008; 102(8):1116-7 (Editorial letter). 
 
14. Leitner J*, Wu WC. Self-Assessment in Cardiology. Management of Aortic Valve Disease: Review 
Questions. Hospital Physician; November/December 2009: 33-7. 
 
15. Greenberg PB, Tseng VL, Wu WC, Margo CE. Creating a Feedback Loop to Improve Cataract 
Surgery Outcomes. J Cataract Refract Surg 2011, Oct 22nd. [Epub ahead of print]. 
 
 
*Fellow/Resident/Trainee 
 
Books and Chapters 
 
1. Salas I, Chan K, Wu WC.  Pain relief in cancer patients.  San Jose: Editorial Universidad de  
Costa Rica 1996. 79 pp. (Spanish). 
 
2.  Aziz GA*, Wu WC.  Hypertension.  In: Primary Care for Women. 2nd ed. Leppert PC, 
Peippert  JF [ed], Lippincott, Williams, & Wilkins: Philadelphia, 2004. 
 
3.   Mehta, SB*, Wu, WC. Atrial myxoma. In: Ferri's Clinical Advisor, Ferri, FF [ed], Elsevier, St. 
Louis, 2007 (p.100). 
 
4.   Mikaelian B*, and Wu, WC. Carotid sinus syndrome. In: Ferri's Clinical Advisor, Ferri, FF 
[ed], Elsevier, St. Louis, 2007 (p. 158). 
 
5.   Wu, WC. Tricuspid Regurgitation. In: Ferri's Clinical Advisor, Ferri, FF [ed], Elsevier, St. 
Louis, 2006 (p. 860-861). 
 
6.   Afshar M*, and Wu, WC Tricuspid Stenosis. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2007 (p. 913). 
 
7. Cho Y*, and Wu, WC. Ventricular Septal Defect. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2007 (pgs. 955-956). 
 
8.  Patel PM* and Wu, WC. Aneurysm, abdominal aorta. In: Ferri's Clinical Advisor, Ferri, FF 
[ed], Elsevier, St. Louis, 2006 (p. 59-60). 
 
9.  Patel PM* and Wu, WC. Cardiac tamponade. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2006 (p. 155). 
 
10. Patel PM* and Wu, WC. Cor pulmonale. In: Ferri's Clinical Advisor, Ferri, FF [ed], Elsevier, 
St. Louis, 2006 (p. 219-220). 
 

 
12
11. Mehta S*, and Wu, WC. Tetralogy of Fallot. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2007 (pgs. 880-881). 
 
12. Cho Y*, Wu, WC. Peripheral Vascular Disease. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2007 (pgs. 674-675). 
 
13. Wu, WC. Temporomandibular Joint Syndrome. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2009 (pg. 916). 
 
14.  Gemignani, AS*; Ferri, FF; Wu, WC. Cardiomyopathy, hypertrophic. In: Ferri's Clinical 
Advisor, Ferri, FF [ed], Elsevier, St. Louis, 2011 (pg. 204-205). 
 
15.  Gemignani, AS*; Ferri, FF; Wu, WC. Cardiomyopathy, dilated. In: Ferri's Clinical Advisor, 
Ferri, FF [ed], Elsevier, St. Louis, 2011 (pg. 202-203). 
 
16.  Gemignani, AS*; Ferri, FF; Wu, WC. Cardiomyopathy, restrictive. In: Ferri's Clinical 
Advisor, Ferri, FF [ed], Elsevier, St. Louis, 2011 (pg. 206-207). 
 
17.  Gemignani, AS*; Ferri, FF; Wu, WC. Mitral regurgitation. In: Ferri's Clinical Advisor, Ferri, 
FF [ed], Elsevier, St. Louis, 2011 (pg. 685-686). 
 
18. Pacheco, R*; Ferri, FF; Wu, WC. Mitral stenosis. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 687-688). 
 
19. Gemignani, AS*; Ferri, FF; Wu, WC. Mitral valve prolapse. In: Ferri's Clinical Advisor, Ferri, 
FF [ed], Elsevier, St. Louis, 2011 (pg. 689). 
 
20. Cohen S*; Ferri, FF; Wu, WC. Pericarditis. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 815-816). 
 
21. Punjani, S*; Ferri, FF; Wu, WC. Hyperosmolar hyperglycemic syndrome. In: Ferri's Clinical 
Advisor, Ferri, FF [ed], Elsevier, St. Louis, 2011 (pg. 542). 
 
22. Punjani, S*; Ferri, FF; Wu, WC. Diabetes mellitus. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 327-332). 
 
23. Punjani, S*; Ferri, FF; Wu, WC. Diabetic ketoacidosis. In: Ferri's Clinical Advisor, Ferri, FF 
[ed], Elsevier, St. Louis, 2011 (pg. 333-335). 
 
24. Punjani, S*; Wu, WC. Obesity. In: Ferri's Clinical Advisor, Ferri, FF [ed], Elsevier, St. Louis, 
2011 (pg. 748-751). 
 
25. Punjani, S*; Ferri, FF; Wu, WC. Hypertension. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 548-551). 
 
26. Brancato, S*; Ferri, FF; Wu, WC. Heart block, second degree. In: Ferri's Clinical Advisor, 
Ferri, FF [ed], Elsevier, St. Louis, 2011 (pg. 472). 
 
27. Brancato, S*; Ferri, FF; Wu, WC. Multifocal atrial tachycardia. In: Ferri's Clinical Advisor, 
Ferri, FF [ed], Elsevier, St. Louis, 2011 (pg. 696). 
 

 
13
28. Wu, WC; Ferri, FF. Aortic regurgitation. In: Ferri's Clinical Advisor, Ferri, FF [ed], Elsevier, 
St. Louis, 2011 (pg. 92). 
 
29. Earl, T*; Ferri, FF; Wu, WC. Heart block, complete. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 470-471). 
 
30. Brancato, S*; Ferri, FF; Wu, WC. Paroxysmal Supraventricular Tachycardia. In: Ferri's 
Clinical Advisor, Ferri, FF [ed], Elsevier, St. Louis, 2011 (pg. 800). 
 
31. Brancato, S*; Ferri, FF; Wu, WC. Sick sinus syndrome. In: Ferri's Clinical Advisor, Ferri, FF 
[ed], Elsevier, St. Louis, 2011 (pg. 1011). 
 
32. Cohen, S*; Ferri, FF; Wu, WC. Atrial septal defect. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 128-129). 
 
33. Earl, T*; Ferri, FF; Wu, WC. Atrial flutter. In: Ferri's Clinical Advisor, Ferri, FF [ed], Elsevier, 
St. Louis, 2011 (pg. 125-126). 
 
34. Earl, T*; Ferri, FF; Wu, WC. Atrial fibrillation. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 122-124). 
 
35. Cohen, S*; Ferri, FF; Wu, WC. Kawasaki disease. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 598-600). 
 
36. Pacheco, R*; Ferri, FF; Wu, WC. Radiation exposure. In: Ferri's Clinical Advisor, Ferri, FF 
[ed], Elsevier, St. Louis, 2011 (pg. 926-928). 
 
37. Earl, T*; Ferri, FF; Wu, WC. Long QT syndrome. In: Ferri's Clinical Advisor, Ferri, FF [ed], 
Elsevier, St. Louis, 2011 (pg. 628-629). 
 
38. Earl, T*; Ferri, FF; Wu, WC. Wolff-Parkinson-White. In: Ferri's Clinical Advisor, Ferri, FF 
[ed], Elsevier, St. Louis, 2011 (pg. 1192-1193). 
 
39. Sayeed, SM*; Ferri, FF; Wu, WC. Congestive heart failure. In: Ferri's Clinical Advisor, Ferri, 
FF [ed], Elsevier, St. Louis, 2011 (pg. 273-275). 
40. Silverstein, JR; Ferri, FF; Wu, WC. Atrial Fibrillation. In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 120-121). 
 
41. Silverstein, JR; Ferri, FF; Wu, WC. Atrial Flutter.  In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 122-123). 
 
42. Pacheco, R; Ferri, FF; Wu, WC. Atrial Myxoma.  In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 124). 
 
43. Cohen, S; Abdulbaki, A; Ferri, FF; Wu, WC. Atrial Septal Defect, In Ferri's Clinical Advisor , 
FF [ed], Elsevier, St. Louis, 2012 (pg. 125-126). 
 
44. Lee, P; Wu, WC. Brugada Syndrome, In Ferri's Clinical Advisor , FF [ed], Elsevier, St. Louis, 
2012 (pg. 176-177). 
 

 
14
45. Lee, P; Wu, WC. Cardiomyopathy, Stress-Induced, In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 197) 
 
46. Brancato, S; Wu, WC. Carotid Symdrome.  In Ferri's Clinical Advisor , FF [ed], Elsevier, St. 
Louis, 2012 (pg. 198). 
 
47. Gemignani, A; Ferri, FF; Wu, WC. Diabetes Mellitus, In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 301-306). 
 
48. Gemignani, A; Ferri, FF; Wu, WC. Diabetic Ketoacidosis, In Ferri's Clinical Advisor , FF 
[ed], Elsevier, St. Louis, 2012 (pg. 307-308). 
 
49. Earl, TJ; Ferri, FF; Wu, WC. Heart Block, Complete, In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 436). 
 
50. Silverstein, JR; Ferri, FF; Wu, WC. Heart-Block, Second Degree, In Ferri's Clinical Advisor 
, FF [ed], Elsevier, St. Louis, 2012 (pg. 437). 
 
51. Kapoor, M; Ferri, FF; Wu, WC. Heart Failure,  In Ferri's Clinical Advisor, FF [ed], Elsevier, 
St. Louis, 2012 (pg. 438-441). 
 
52. Gemignani, A; Ferri, FF; Wu, WC. Hyperosmolar, In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 510). 
 
53. Gemignani, A; Ferri, FF; Wu, WC. Hypertension, In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 516-518) 
 
54. Abdulbaki, A; Wu, WC. Kawasaki Disease, In Ferri's Clinical Advisor , FF [ed], Elsevier, St. 
Louis, 2012 (pg. 564-566). 
 
55. Silverstein, JR; Ferri, FF; Wu, WC. Long QT Syndrome, In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 596-597). 
 
56. Wu, WC; Ferri, FF.  Myocardial Infarction, In Ferri's Clinical Advisor, FF [ed], Elsevier, St. 
Louis, 2012 (pg. 675-678). 
57. Gemignani, A; Ferri, FF; Wu, WC. Obesity, In Ferri's Clinical Advisor , FF [ed], Elsevier, St. 
Louis, 2012 (pg. 705-707) 
 
58. Truesdell, A; Ferri, FF; Wu, WC. Sick Sinus Symdrome, In Ferri's Clinical Advisor , FF [ed], 
Elsevier, St. Louis, 2012 (pg. 936). 
 
59. Cohen, S; Wu, WC.. Tetralogy of Fallot, In Ferri's Clinical Advisor , FF [ed], Elsevier, St. 
Louis, 2012 (pg. 1003-1004). 
 
60. Cohen, S; Abdulbaki, A; Wu, WC. Ventricular Septal Defect, In Ferri's Clinical Advisor , FF 
[ed], Elsevier, St. Louis, 2012 (pg. 1077-1079). 
 
61. Silverstein, JR; Ferri, FF; Wu, WC. Wolff-Parkinson-White Syndrome, In Ferri's Clinical 
Advisor , FF [ed], Elsevier, St. Louis, 2012 (pg. 1104-1005). 
 
*Fellow/Resident/Trainee 

 
15
 
Abstracts 
 
1. Lai T, Ma L, Wu WC, Knibbs D, Waters D, Chen C.  Recovery of myocyte hypertrophy and 
slippage associated with the left ventricular remodeling of myocardial hybernation.  J Am Coll Cardiol 
1998;31:15A. 
 
2. Lai T, Ma L, Linfert D, Wu WC, Olatidoye A, Gillam L, Waters D, Tsongalis G, Chen C.  
Reperfusion prevents apoptosis in hybernating myocardium.  J Am Coll Cardiol 1998;31:394A.   
 
3. Shahi C, Wang Y, Wu WC, Wang Y, Chen YT, Lewis JM, Krumholz HM, Radford MJ.   
Variability in quality of care for elderly patients admitted with unstable angina in Connecticut.   
J Am Coll Cardiol 1999; 33:337A. 
 
4. Shahi C, Wang Y, Wu WC, Wang Y, Chen YT, Radford MJ, Krumholz HM.  Prognostic 
significance of abnormal creatine kinase MB fraction with normal total creatine kinase in patients with 
acute coronary ischemic syndrome.  J Am Coll Cardiol 1999; 33:394A. 
 
5. Wright RM, Wu WC, Hamdan N, Fan A, Erickson A.  Case report of carotid sinus  
hypersensitivity in a patient with head and neck cancer.  2000 Rhode Island Chapter of American 
College of Physicians Annual Meeting. 
 
6. Wu WC, Cannistra AJ, Leavitt JI.  Transient Brugada pattern in EKG mimicking anteroseptal  
myocardial infarction.  2002 Rhode Island Chapter of American College of Physicians Annual  
Meeting.  
 
7. Taveira TH, Martin OJ, Petropoulos PN, Patel P, Sharma SC, Wu WC.  Effectiveness of  
interdisciplinary cardiovascular risk reduction clinic for patients with coronary disease or  
diabetes.  Circulation 2003; 107(19):e131,P4. 
 
8. Martin OJ, Wu WC, Schleinitz MD, Taveira TH, Anderson ML, Patel PM, Donofrio G, 
Sharma S. Effectiveness of pharmacist-coordinated care to reduce cardiovascular risk factors in 
patients with diabetes mellitus. Circulation 2004; 109(7):e71,P203. 
 
9.   Uttley G., Wu WC, Freeman N, Sharma SC, Vezeridis M. The relationship of 
preoperative hematocrit levels with post-operative 30-day mortality in older veterans undergoing 
surgery.  National Surgical Quality Improvement Program Meeting 2004. 
 
10.  Wu WC, Martin OJ, Taveira TH, Schleinitz MD, Mor V, Sharma SC. Durability of 
 
guideline     
adherence in coronary disease and diabetic patients after discharge from a  
cardiovascular risk reduction clinic. Circulation 2004; 109(20):e285, P41. 
 
11. Patel PM, Wu WC, Cheng J, Martin OJ, Taveira TH, Sharma SC. Pattern of  care of 
 
 outpatients with coronary artery disease in a VA hospital. Circulation 
2004;109(20):e231, P184. 
 
12. Misra B, Gopalakrishnan G, Martin O, Wu WC, Taveira T, Anderson M, Sharma SC. 
Cardiovascular risk reduction programs for patients with diabetes. Circulation 2005;111(14): 
e209, P80. 
 

 
16
13. Wu WC, Schifftner TL, Henderson WG, Eaton CB, Poses RM, Uttley G, Sharma SC, 
Vezeridis M, Khuri SF, Friedmann PD. Levels of Preoperative Hematocrit Predict Postoperative 
Cardiovascular and Fatal Outcomes in Elderly Patients Undergoing Major Non-Cardiac Surgery. 
VA HSR&D 2007 National Meeting Abstract. Washington, D.C., Feb 2007. 
 
14. Pirraglia PA, Taveira TH, Cohen LB, Wu W. Depression diagnosis impact on the 
effectiveness of a multidisciplinary diabetes and cardiovascular risk reduction clinic.  Journal of 
General Internal Medicine, 22(Supplement 1):17, 2007. 
 
15. Taveira TH, Pirraglia PA, Cohen LB, Wu WC. Pharmacist-led Cardiac Risk Reduction 
Clinic Reduces Framingham Risk Score in Patients with Diabetes and Mental Illness. American 
Psychosomatic Society 65th Annual Scientific Meeting. Budapest, Hungary March 10, 2007. 
Psychosomatic Medicine 2007;69 (Supplement  1:1585) A-81. 
 
16. Taveira TH, Cohen LB, Pirraglia PA, Friedmann PD, Wu WC. Pharmacist-led Group 
Medical Visits for Cardiovascular Risk Reduction in Diabetes. VA National HSRD 2008. National 
Meeting Abstract, Baltimore, MD, Feb 2008. 
 
17. Khatana S, Taveira TH, Choudhary G, Eaton CB, Wu WC. Change In Hemoglobin A1c 
And C-reactive Protein Levels In Patients With Diabetes Mellitus American Heart Association 
48th Cardiovascular Disease Epidemiology and Prevention and Nutrition, Physical Activity and 
Metabolism Conference.  Colorado Springs, Colorado, March 11 –15, 2008. 
 
18. Taveira TH, Cohen LB, Pirraglia PA, Friedmann PD, Wu WC. Pharmacist-led Group 
Medical Visits for Cardiovascular Risk Reduction in Diabetes. American Heart Association 48th 
Cardiovascular Disease Epidemiology and Prevention and Nutrition, Physical Activity and 
Metabolism Conference.  Colorado Springs, Colorado, March 11 –15, 2008. 
 
19. Cohen LB, Taveira TH, Wu WC, Pirraglia P. The Impact of Mental Health Conditions on 
Maintenance of Risk Factor Control in Diabetic Patients After Discharge from a Cardiovascular 
Risk Reduction Clinic. Academy Health 25th Annual Research Meeting. Marriott Wardman Park, 
Washington, DC. June 8-10, 2008. 
 
20. Wu WC, Smith TS, Henderson WG, Eaton CB, Poses RM, Uttley G, Sharma SC, 
Vezeridis M, Khuri SF, Friedmann PD. Preoperative Hematocrit Is Not Predictive of CNS Events 
in Elderly Patients After Major Non-Cardiac Surgery. VA National QUERI Meeting 2008, 
Phoenix, AZ. 
 
21. Wu WC, Lessard D, Goldberg RJ. Underuse of, and Mortality Associated With, Cardiac 
Catheterization in Patients with Acute Myocardial Infarction According to Anemia Status. VA 
National HSR&D meeting. Baltimore Marriott Waterfront, Baltimore, MD. Feb 10-12, 2009. 
 
22. Prachanronarong K, Khatana SAM, Taveira TH, Cohen LB, Dooley AG, Pirraglia PA, 
Friedmann PD, Wu WC.  Pharmacist-led Group Medical Visits for Multiple Cardiovascular Risk 
Reduction in Patients with Type 2 Diabetes. VA National HSR&D meeting. Baltimore Marriott 
Waterfront, Baltimore, MD. Feb 10-12, 2009. 
 
23. Wu WC, Jiang L, Pirraglia P, O'Toole T, Friedmann P. Multidisciplinary Service 
Utilization and Cholesterol Guideline Implementation for Patients with Coronary Disease or 
Diabetes. AHA American Heart Association 49th Cardiovascular Disease Epidemiology and 

 
17
Prevention and Nutrition, Physical Activity and Metabolism Conference.  Circulation 2009; 119: 
e353, P322. 
 
      24. Taveira TH, Cohen LB, Dooley AG, Pirraglia PA, Friedmann PD, Wu WC. Pharmacist-
Led Group Medical Visits for Diabetes in Patients with Comorbid Depression. AHA Joint 
Conference - Cardiovascular Disease Epidemiology and Prevention and Nutrition, Physical 
Activity, and Metabolism. Circulation 2009; 119: e359.  
 
     25. Wu WC, Parker D, Taveira TH, Choudhary G, Eaton C. Prevalence of Diabetes Among 
Adult Smokers: Need for Early Screening? AHA National Meeting 2009; Orlando, FLA. 
 
     26.  Wu WC, Lessard D, Yarzebski J, Gore J, Goldberg RJ. Anemia and Invasive 
Management Utilization in Acute Non-ST Elevation Myocardial Infarction. AHA National Meeting 
2009; Orlando, FLA. 
 
     27.  Chen CK; Tseng VL; Wu WC; Greenberg PB. Current Role of Manual Extracapsular 
Cataract Extraction in Veterans Health Administration. American Society of Cataract and 
Refractive Surgery (ASCRS) 2010; Boston, MA. 
 
     28. Tseng VL; Greenberg PB; Wu WC; Jiang L; Scott IU; Friedmann PD. Cataract Surgery 
Complications in Nonagenarians. Joint Meeting of the American Academy of Ophthalmology 
and the Middle East Africa Council of Ophthalmology, October 16-19 2010; Chicago, IL.  
 
     29. Trivedi AN, Jiang L, Friedmann PD, Wu WC. Adherence to Quality Measures and 
Mortality among Veterans with Congestive Heart Failure. 2011 VA National HSRD meeting, 
Washington DC, February 2011. 
 
     30. Taveira TH, Dooley AG, Cohen LB, Khatana SAM, Wu WC. Effectiveness of  Different 
Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged 
from  a Cardiovascular Risk Reduction Clinic. AHA CVD Epidemiology and Prevention Scientific 
sessions 2011, March 14-16, San Diego, CA. 
 
      31. Khatana SAM, Kane, J, Taveira TH, Bauer MS, Wu WC. Monitoring and prevalence 
rates of metabolic syndrome in veterans with major mental illness. AHA CVD Epidemiology and 
Prevention Scientific sessions 2011, March 14-16, San Diego, CA. 
 
32. Patel N, Taveira TH, Choudhary C, Wu WC. C-peptide Levels Predict Cardiovascular 
And Diabetes Related Mortality In Nondiabetic Adults, American Heart Association Scientific 
Sessions 2011, Orlando, FLA; November 15th, 2011. 
 
33.  Gemignani A, Kapoor M, Cohen S, Sharma SC, Choudhary G, Wu WC. Preoperative 
Renin-Angiotensin System Inhibitor Use is Associated with Worse Clinical Outcomes Following 
Cardiovascular Surgery: Results of a Meta-Analysis. American Heart Association Scientific 
Sessions 2011, Orlando, FLA; November 15th, 2011. 
 
34. Jankowich M, Choudhary G, Klinger J, Wu WC. Relationship Between Lung Function 
And Albuminuria: Data From The Third National Health And Nutrition Examination Survey 
(NHANES III). 2012 ATS International Conference in San Francisco, California.  
 
35. Grebla RC; Wellenius GA; Eaton CB; Gatsonis C, Wu WC. Beta-Blocker Monotherapy is 
Inferior to Treatment with Angiotensin-Converting-Enzyme Inhibitor/Angiotensin-Receptor 

 
18
Blocker or Combined Therapy after Hospital Discharge among Patients with Acute 
Decompensated Heart Failure with Reduced Ejection Fraction. Circ Cardiovasc Qual Outcomes. 
2012; 5: A99.  
 
36. Lacy ME, Wellenius G, Eaton CB, Loucks EB, Correa A, Gjelsvik A, Wu WC. Examining 
the Gender-specific Effect of Adding Hemoglobin A1c to Existing Diabetes Risk Prediction 
Models: the Jackson Heart Study. American Diabetes Association 74th Scientific Sessions. San 
Francisco, CA: June 13-17, 2014. 
 
37. Dev S, Lacy ME, Masoudi F, Wu WC. Patient Characteristics Associated with 
Appropriate Use of Aldosterone Antagonists in a National Cohort of Veterans Hospitalized with 
Heart Failure.  Circ Cardiovasc Qual Outcomes. 2014;7:A158 
 
 
Invited Presentations 
 
Local 
 
1. Outpatient Management of Chronic Stable Angina.  RI Chapter of American College of 
Cardiology’s Symposium: “Second Annual Cardiology for the Primary Care Provider”, 
September 24, 2003; Warwick, RI  
 
2. “BNP and the management of CHF.” Medical Grand Rounds, Roger Williams Hospital, 
Boston University School of Medicine. March, 2005; Providence, RI. 
 
3. “NOVEL RISK FACTORS OF CARDIOVASCULAR DISEASE”, Cardiovascular Disease and 
Cancer Behavioral Medicine Seminar Series. The Miriam Hospital and Brown 
University. October 9, 2007; Providence, RI. 
 
4. “Pathophysiology of Cardiovascular Diseases”, RI Dept. of Health Cardiovascular disease 
educator certification course; October 7th, 2009, Warwick Sheraton Hotel, RI. 
 
5. “Anemia and Transfusions in the ICU”, Pulmonary Research Seminar, October 19th, 2009, 
Rhode Island Hospital.  
 
6. “Outpatient management of CHF exacerbation”, Primary Care Retreat, September 29th, 
2010, White’s of Westport, Westport, MA.  
 
7. “Group Medical Visits in Diabetes”, Center for Primary Care and Prevention Grand Rounds, 
March 15th, 2011; Memorial Hospital of Rhode Island. 
 
8. “Group Medical Visits in Diabetes”, Medical Grand Rounds -General Internal Medicine 
Update, March 22, 2011; Rhode Island Hospital. 
 
9. “Obesity, Insulin Resistance, Diabetes and Cardiovascular Disease”, Alpert 
Medical School of Brown University. Adult and Pediatric Endocrine Grand Rounds,  
October 17, 2012; Rhode Island Hospital.  
 
10. Obesity, Insulin Resistance, Diabetes and Cardiovascular Disease, Alpert 
Medical School of Brown University. Cardiology Grand Rounds, May 9th, 2014; Rhode 
Island Hospital. 

 
19
 
11. Magnesium Intake or Supplementation and Heart failure, Center for Primary Care and 
Prevention, Brown University. Grand Rounds, September 10th, 2014; Memorial Hospital of 
Rhode Island.  
 
12. Cardiac Rehabilitation, Weight Control and Diabetes Research Center, Miriam hospital, 
September 29th, 2015, CARDIOVASCULAR BEHAVIORAL MEDICINE lecture series. 
 
Regional 
 
“Preoperative Risk Stratification for non-cardiac surgery”, Cardiology Grand Rounds. Rhode 
Island Hospital and Lifespan. November 2nd, 2007. 
 
“Radiation Exposure in Cardiac Imaging”, at INVESTIGATION, INSTITUTIONAL COMMITTEES 
& INNOVATION Conference of the Massachusetts Medical Society, Waltham, MA. September 
25, 2008 
 
“Dyslipidemia in the Elderly, is it too late to help?”, at 2009 Senior Symposium by the 
Connecticut Chapter of the American Society of Consultant Pharmacists, Ledyard, CT. 
 
“Anemia and Transfusions in the ICU”, at 2009 Update in Critical Care “Where are we now, and 
where are we going?” by Rhode Island Hospital, Providence, RI. 
 
“Anemia and Acute Myocardial Infarction”, Quality Scholars Conference. Louis Stokes 
Cleveland Dept. of Veterans Affairs Medical Center. May 21st, 2009. 
 
“Pharmacist-Led Group Medical Appointments for Cardiac Risk Reduction  
in Diabetes”, Medicine / Primary Care Noon Conference. Louis Stokes Cleveland Dept. of 
Veterans Affairs Medical Center. May 21st, 2009. 
 
“Pharmacist-Led Group Medical Appointments for Cardiac Risk Reduction  
in Diabetes”, Medicine / Primary Care Noon Conference. Louis Stokes Cleveland Dept. of 
Veterans Affairs Medical Center. May 21st, 2009. 
 
“NOVEL RISK FACTORS OF CARDIOVASCULAR DISEASE”, Medicine Grand Rounds, 
Honolulu VA Medical Center, February 24, 2010; Honolulu, HI. 
 
“Interobserver Reliability in the Assessment of Coronary Stenoses by Multi-Detector Computed 
Tomography” West Roxbury VA Medical Center, October 22, 2010. 
 
“Practical Approach to Group Visits or SMAs”, VISN 7 (VHA) Shared Medical Appointments 
(SMA) Mini-Collaborative, October 25-26, 2011 in Duluth, GA. 
 
“Status of SMA Implementation”, VISN 7 (VHA) Shared Medical Appointments (SMA) Mini-
Collaborative, April 24-25, 2012 in Duluth, GA. 
 
Obesity, Insulin Resistance, Diabetes and Cardiovascular Disease. 44th Annual Samuel D. 
Plotkin Cardiovascular Symposium - April 28th, 2015, The Heart & Vascular Program at 
Baystate Medical Center, Springfield, MA. 
 

 
20
National 
 
1. Wu WC.  Blood Transfusion Use in AMI.  Society of Critical Care Medicine 33rd Critical Care 
Congress: “Transfusion Medicine Today – Blood Banking”, February 23, 2004; Orlando, Florida. 
 
2. Wu WC, Kirsh S, Edelman D. Workshop in “Inter-professional Diabetes Care: Research and 
Operational Issues of Group Appointments”, 2008 VA HSR&D QUERI National Meeting, 
December 10-12, 2008; Phoenix, AZ. 
 
3. Wu WC, Pascuzzi K, Taveira TH.  “The Art & Science of Shared Medical Appointments:  
Lessons Learned”, VA Employee Education System, May 31, 2011; National webcast. 
 
4. Wu WC. “C-peptide Levels Predict Cardiovascular And Diabetes Related Mortality In 
Nondiabetic Adults”, American Heart Association Scientific Sessions 2011, Orlando, FLA; 
November 15th, 2011. 
 
5. Wu WC. “Adherence to Quality Measures and Mortality among Veterans with Congestive 
Heart Failure” CHF QUERI; March 14th, 2012; National webcast. 
 
6. Wu, WC. “Group Medical Visits: System Redesign Practice to Enhance Patient Centered-
Care” Specialty and Surgical Collaborative learning session; VA Employee Education System, 
September 21, 2012, National webcast 
 
7. Wu WC. “Implementation of Transition of Care Model in CHF to Reduce Rehospitalization 
Rates” CHF QUERI; November 28th, 2012; National webcast. 
 
8. Wu WC. “Group Visits” Specialty and Surgical Collaborative Practice Day (Learning Session 
#3), VA Employee Education System, January 9, 2014; VA National webcast 
 
International  
 
1. Wu WC. “Reducing hospitalization and improving outcomes in heart failure” Dept. of 
Emergency Medicine; National Taiwan University Hospital, August 18th, 2014. 
 
 
Grants 
 
2003-2005 
Scios, Inc. 
 
 
“The use of nesiritide for treatment of acute  
decompensated congestive heart failure  
complicated by acute renal insufficiency”  
Wu, PI $20,000 Direct costs (no grant number) 
 
2003- 2005     Merck, Inc.                 
“Effectiveness of different strategies in maintaining 
                                                             
target of cardiovascular risk factors in patients  
discharged from cardiovascular risk reduction 
clinic” 
Wu, PI $35,000 Direct costs (no grant number) 
 
2004-2006     CVT-5131                              “A Phase III, Randomized, Double-Blind Study  
 
 
 
 
 
 
of Intravenous CVT-3146 vs. Adenoscan® in  
 
 
 
 
 
 
Patients Undergoing Stress Myocardial  

 
21
 
 
 
 
 
 
Perfusion Imaging":  
Wu, site PI $20,000 Direct (no grant number) 
 
2005                RI Foundation 
Multidisciplinary Behavioral and Pharmacological                            
Intervention for Cardiac Risk Reduction in 
Diabetes.                                                                                 
Wu, PI Initiator   $9,952 Direct costs (no grant 
number) 
2005-2007       VA HSR&D               
IIR- 04-313 "Variability in Surgical Blood  
 
 
 
 
 
 
transfusion Practices and Cardiovascular  
 
 
 
 
 
 
Outcome"; W. Wu, PI   $ 171,850 Direct costs 
 
2006-2007       ACCP  
 
 
“Pharmacist-led Group Intervention for Diabetes  
 
 
 
 
 
 
and Psychiatric Illness”: Role: Mentor, Co-I 
 
 
 
 
 
 
Taveira: trainee PI, $20,000 (no grant number) 
 
2006-2008        ASHP 
 
 
“Pharmacist-led Telehealth Disease  
 
 
 
 
 
 
Management in Patients with Diabetes and  
 
 
 
 
 
 
Depression”: Role: Mentor, Co-I; Cohen, PI  
 
 
 
 
 
 
trainee), $25,000 (no grant number) 
 
2006-2008        Auxilium, Inc. 
“Effect of Testosterone on flow-mediated 
vasodilation, small artery elasticity index, insulin 
resistance, and erectile dysfunction in men with 
hypogonadism”: Wu, Co-investigator (PI = 
Miner), $20,000 Direct. (no grant number) 
 
2006-2008       Daugherty                   
“Multi-Targeted Cardiac Risk Intervention in Type 2  
                        Foundation                             Diabetes”, Wu, PI:  $50,000 Direct costs  
(no grant number) 
 
2007-2009 
VA HSRD 
 
 
VISN-1 Patient Safety Center of Inquiry,  
 
“Clinical Trial of a Home Safety Intervention for 
Alzheimer's Disease” (NRH 05-056 PI: Horvath), 
“PROVIDENCE VAMC CHF Clinic” substudy, Wu, 
co-I: $45,000 Direct costs  
 
2008-2012       VA HSR&D  
IAB – 06-269 "Group Intervention for DM Guideline 
Implementation”, Wu, PI: $ 900,000 Direct costs 
 
2009-2011       VA HSR&D  
Supplement to IAB-06-269: Implementation of 
Honolulu VAMC in group intervention for DM and 
feasibility of video-conferencing diabetes group 
intervention in American Samoa, Wu, PI: $169,990. 
 
2010-2011       VA QUERI - HSR&D 
RRP 09-172 “Variations in Quality of Care and 
Outcomes for Veterans with Heart Failure”, Wu, PI: 
$100,000 direct 
 
2010-2013       Dept. Med, Brown Univ. 
Chairman’s developmental research grant program 

 
22
“Role of systemic vascular dysfunction in exercise 
tolerance rehabilitation in COPD” (Jankowich, PI, 
mentee): $50,000.  Role: Co-I, Mentor. 
 
2011                VA HSR&D 
Supplement to IAB-06-269: Assessment of Patient 
Satisfaction in Group Intervention for DM, Wu, PI: 
$41,500 
 
2011-2012       VA QUERI - HSR&D 
RRP 10-229 “Medical Center Implementation of 
PCMH in Acute CHF to Reduce Rehospitalization 
Rates”, Wu, PI: $100,000 direct 
 
2012-2014      AHA Founder Affiliate 
12CRP9840018 “Behavioral activation therapy for 
both depression and diabetes vs. diabetes alone 
delivered via group visits. Role: co-PI, mentor 
(Taveira, PI mentee); $75,000 
 
2012-2013     RI Foundation 
#20113648 “Effect of cardiovascular risk reduction 
on systemic vascular function in diabetics with 
COPD.” Role: co-I, mentor (Jankowich, PI mentee); 
$13,790. 
 
2012-2013    VA CHF QUERI 
Heart Failure Shared-Medical-Appointment to 
provide early (<7 days) post-heart failure discharge 
follow-up. Role: PI; $24,800. 
 
2013-2014    VA DM QUERI 
RRP 12-452 “Video-Conference Shared Medical 
Appointments to Improve Rural Diabetes Care.” 
Role: PI, $100,000 
 
2013-2014    VA CHF QUERI 
Pre-Implementation Study of Spironolactone 
Appropriateness and Safety Monitoring. Role: co-PI 
(Dev, PI); $100,000. 
 
2013 – 2015 VA HSRD DM QUERI SDP      1 I01 HX000869-01A1 “Implementation Study of the 
Peer-to-Peer Program for Patients with Diabetes”. 
Role: co-I & site PI (PI: Heisler) $335,000.    
 
2013 – 2016 VA HSR&D  
IIR 12-346 “Patient-experienced Integrated Care for 
Veterans with Multiple Chronic Conditions” 
Role: Co-I (PI: Meterko, M) 
$1,048,073     
 
2014 – 2016 R34 AT 007569  
Development of A Tai-Chi Program To Overcome 
Barriers To Cardiac Rehabilitation 
 
Role: Co-I (PI: Salmoirago-Blotcher) 
 
4/2013 – 4/2015 VA V1CDA2012-19 
Process Quality and Outcomes in Cataract Surgery 
Role: Mentor (Mentee: Paul Greenberg, MD – study 
PI) $245,000 (salary support).     
 

 
23
6/2015 – 5/2017 1 F31 DK105791-01A1 
The effect of sickle cell trait status on diabetes 
prediction in African Americans 
 
Role: Sponsor (Mentee: Mary E. Lacy, PhD 
Candidate) 
 
2015-2016 5R01CA155381-04 
Quit for Health study: Role: Co-I  
(PI: D Williams – Brown University, Subcontract 
710-9852 TMH: S Dunsiger)  
 
09/01/11-05/31/16  5 R01HL109116-04       “Efficacy of Exercise Videogames for Physical 
Activity Adoption and Maintenance”  
  
(B. Bock, PI)   $367,976    
Role: Co-Investigator    0.6 Calendar       
 
08/01/15 – 07/31/19 VA HSR&D  
 
“Group Medical Visits in Heart Failure for Post- 
IIR 14-293-2  
 
 
 
Hospitalization Follow-Up”  $275,000 per yr    
 
 
 
 
 
 
Role: PI      3 CM         
 
University Teaching Roles 
 
July, 2002 - 2009                       
 
Section co-leader: BI/0281 - Pathophysiology course 
 
 
 
 
 
Brown Medical School 
 
July, 2003 - 2009 
 
 
 
Lecturer Bio 281 – “Pharmacologic management of CHF” 
 
 
 
 
 
The Warren Alpert Medical School of Brown University 
 
July 2003 - 
 
 
VA Site director, Fellowship Program in Cardiovascular  
 
 
 
Diseases at Brown University 
 
July 2003 - 2008  
 
 
 
Lecturer “EKG course” for Medical Students, Providence  
 
 
 
 
VA Medical Center, Alpert Medical School of Brown  
 
 
 
 
University 
 
April 2008 
Leader, Epidemiology for Medical students, small group 
sessions, Dept. of Community Health, Brown University 
 
August 2008- 
 
 
Program Director, Fellowship Program in Preventive  
 
 
 
Cardiology at Brown University 
 
2010-2012 
 
 
Member, Doctoral Thesis Committee, Dept. of  
 
 
 
Epidemiology, Brown University 
 
2012- 
 
 
Research Mentor: Doctoral Student, Dept. of  
 
 
 
Epidemiology, School of Public Health, Brown University 
 
 
Hospital Teaching Roles 
 
July, 2002- 
 
 
 
 
Consult Service Attending in Cardiology and clinic  
 
 
 
 
 
preceptor, Brown Fellowship in Cardiovascular diseases 
 

 
24
July, 2002- 
 
 
 
 
Medical student inpatient preceptor, 
                                                             
Alpert Medical School, Brown University 
 
July 2003 – present   
 
 
Lecturer, EKG  course Internal Medicine Residency  
Program – Brown University 
 
July 2005 – present   
 
 
Lecturer, Preoperative cardiac evaluation,  
Brown Fellowship in Cardiovascular diseases  
 
July 2008 – present   
 
 
Lecturer, Syncope and CV pharmacology for Internal  
 
 
 
 
Medicine Residency Program – Brown University 
 
 

March 2015 
T. LIU, PhD
                                                                                                                                                                            
Curriculum Vitae
Tao Liu,  Ph.D.
Assistant Professor of Biostatistics (Research)
Brown University School of Public Health 
Department of Biostatistics
Tel: (401) 863-6480
                                                                                            
Center for Statistical Sciences (CSS)
Fax: (401) 863-9182
                                                                           
Center for AIDS Research (CFAR)
Email: tliu@stat.brown.edu
                                                                     
Alcohol Research Center on HIV (ARCH)
Campus Addr: Box GS121-7
                                                         
American College of Radiology Imaging Network (ACRIN)
Brown University
                                                 
The AMPATH Biostatistics and Data Program (AMPATH)
Providence, RI 201912, US
                                   
PROFESSIONAL APPOINTMENTS 
A.    Current Academic Positions
Assistant Professor of Biostatistics (Research)
Department of Biostatistics, Brown University School of Public Health.
Associate Director of the ARCH Data and Biostatistics Core
Brown Alcohol Research Center on HIV (ARCH).
Faculty Member
Brown Center for Statistical Sciences (CSS).
The Lifespan/Tuft/Brown Center for AIDS Research (CFAR).
The American College of Radiology Imaging Network (ACRIN).
Brown Alcohol Research Center on HIV (ARCH).
Afﬁliated Faculty Member 
The AMPATH Biostatistics and Data Program (AMPATH), Kenya-USA. 
B.    Former Academic Appointments
Assistant Professor of Community Health (Research)  (Sep. 2008 – Sep. 2012)
Biostatistics Division, Department of Community Health, the Alpert Medical School of 
Brown University. 
Acting Co-Director of the CFAR Outcomes & Biostatistics Core  (Jan. – Jun. 2010)
The Lifespan/Tuft University/Brown Center for AIDS Research (CFAR). 
Postdoctoral Research Associate  (Oct. 2006 – Aug. 2008)
Biostatistics Division, Department of Community Health, the Alpert Medical School of 
Brown University.
Graduate Teaching Assistant  (Sep. 2003 – Oct. 2006)
Department of Biostatistics, Center for Clinical Epidemiology and Biostatistics (CCEB), 
the University of Pennsylvania.
Graduate Research Assistant / Consultant  (May 2004 – May 2005)
Department of Biostatistics, Center for Clinical Epidemiology and Biostatistics (CCEB), 
the University of Pennsylvania.
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
Research Assistant / Graduate Instructor  (Aug. 2001 – Jun. 2003)
Department of Statistics, Iowa State University.
Graduate Research Assistant  (Aug. 1999 – Aug. 2001)
Department of Civil Engineering, Iowa State University.
Undergraduate Research Assistant  (Aug. 1998 – May 1999)
Department of Environmental Science and Engineering, State Key Center of Environ-
mental Stimulation and Pollution Control, Tsinghua University, Beijing, China. 
C.   Other Appointments 
 
Research Fellow & Consultant  (Jan. 2005 – Sep. 2006)
Research Statistics Unit, GlaxoSmithKline (GSK) Corp., Collegeville, PA
Summer Intern  (Summer, 2003)
Department of Biostatistics, Amgen Incorporation, Thousand Oaks, CA
EDUCATION
2006
Ph.D. Biostatistics
The University of Pennsylvania, PA, US
     
  
                                     
PhD Dissertation: Measuring sensitivity to nonignorable censoring in nonparametric 
and semiparametric survival modeling.
2002 
M.S. 
Statistics
Iowa State University, IA, US
     
   
                                         
Thesis: Improved Conﬁdence Interval Estimation for Parameters in Nonlinear Models
2002 
M.S. 
Civil Engineering 
Iowa State University, IA, US
     
   
                            
Thesis: Ammonia Inhibition in Thermophilic Anaerobic Process
             
1999 
B.E.
Environmental Engineering
Tsinghua University, Beijing, China
     
    
           
                      
PUBLICATIONS 
A. Book Chapter
1.
Fedorov, V.V. and Liu, T.* (2007). “Enrichment Design.” Encyclopedia of Clinical Trials. 
John Wiley & Son Press.  (*Authorship in alphabetical order)
B. Journals Articles (Peer-reviewed)
1.
Liu, T. and Hogan, J. (2015). “Inference about ATE from observational studies with contin-
uous outcome and unmeasured confounding.” Under revision for Statistics in Medicine.
2.
Kahler, C., Liu, T., Cioe, P., Bryant, V., Pinkston, M., Kojic, E., Onen, N., Baker, J., Ham-
mer, J., Brook, J. and Patel, P. (2015). “Direct and Indirect Effects of Heavy Alcohol Use on 
HIV and non-HIV Outcomes in a Longitudinal Study of HIV Patients Receiving ART.” Un-
der review in Journal of AIDS. 
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
3.
Liu, T., Bazerman, L., Pinkston, M., Nunn, A., Rana, A. and Beckwith, C. (2015). “Co-oc-
curring HIV risk behaviors among males entering jail.” Invited revision for Journal of AIDS 
& Clinical Research. 
4.
Merchant RC, Baird JR, Liu T, and Nirenberg TD (2015). “Short-term efﬁcacy of a brief 
intervention to reduce drug misuse and increase drug treatment utilization among adult 
emergency department patients.” Academic Emergency Medicine (Accepted).
5.
Stillman, A.E., Gatsonis, C., Lima, J.A.C., Black, W.C., Cormack, J., Gareen, I., Hoffmann, 
U., Liu, T., Mavromatic, K., Schnall, M.D., Udelson, J.E., Wood, P. (2015). “Rationale and 
Design of the RESCUE (Randomized Evaluation of Patients with Stable Angina Compar-
ing Utilization of Noninvasive Examinations) Trial.” Under review in the American Heart 
Journal. 
6.
Merchant RC, DeLong AK, Liu T, Baird JB (2015). “The impact of time elapsed participat-
ing in a study on a brief intervention aimed to increase uptake of rapid HIV and Hepatitis C 
screening among drug misusing adult Emergency Department patients.” AIDS and Behav-
ior. (in press). 
7.
Bernardino VL, Baird JR, Liu T, and Merchant RC (2015). “Comparison of substance use 
prevalence among Rhode Island and The Miriam Hospital Emergency Department pa-
tients to state and national general population prevalence estimates.” Rhode Island Med-
ical Journal. (In press). 
8.
Beaudoin F; Baird JR; Liu T; Merchant RC (2015). “Gender differences in substance use 
among adult emergency department patients: prevalence, severity, and need for interven-
tion.” Academic Emergency Medicine. (In press). 
9.
Shao W, Guan W*, Clark MA, Liu T, Santelices, C, Cortes, DE, and Merchant, RC (2015) 
“Does a video improve knowledge of HIV/AIDS and HIV testing among a global internet 
audience?” International Journal of STD & AIDS. (*student advised; Accepted). 
10. Shao W, Guan W*, Clark MA, Liu T, Santelices C, Cortes DE, and Merchant RC (2015). 
“Variations in recruitment yield, costs, and speed and participant diversity across internet 
platforms in a global study of English- or Spanish-speaking Internet users.”. Digital Culture 
& Education, 7(1), 40-86. (*student advised)
11. Merchant R.C., Clark, M.A., Santelices, C.A., Liu, T., and Cortes, D. (2015). “Effectiveness 
of an HIV/AIDS and HIV testing informational video for Spanish-speaking Latinos in 
healthcare and non-healthcare settings”. AIDS and Behavior. 19(3): 523—535. [PMID: 
25179540].
12. Rana, A.I., Liu, T., Gillani, F.S., Reece, R., Kojic, E.M., Zlotnick, C., and Wilson, I.B. (2014) 
“Multiple gaps in care common among newly diagnosed HIV patients.” AIDS Care. 27(6): 
679—687. [PMCID: PMC25634492] [PMCID: PMC4366312].
13. Tai, M.*, Liu, T., and Merchant, R.C. (2014). “HIV/AIDS-related hospitalizations in the 
United States short-stay hospitals, 1982-2010.” Journal of the International Association of 
Providers of AIDS Care. (*Advised student). (in press).
14. Merchant, R.C., Baird, J.R., Liu, T., and Taylor, L.E. (2014). “HCV among the Miriam Hos-
pital and Rhode Island Hospital adult emergency department patients.” Rhode Island Med-
ical Journal, 97(4): 35—39. [PMID: 24983020]. 
15. Merchant, R., Baird, J., Liu, T., Taylor, L, Montague, B., and Nirenberg, T. (2014)  “Brief 
intervention to increase emergency department uptake of combined rapid HIV and hepati-
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
tis C screening among a drug misusing population.” Academic Emergency Medicine. 
21:752—767. [PMID: 25125271] [PMCID: PMC4135533]
16. Federov, V. and Liu, T.* (2014). "Randomized discontinuation trials with binary outcomes." 
The Journal of Statistical Theory and Practice, 8:30—45. (*Authorship in alphabetical or-
der)
17. Liu, T., Hogan J.W., Wang, L., Zhang, S. and Kantor, R. (2013). "Optimal Allocation of 
Gold Standard Testing under Constrained Availability: Application to Assessment of HIV 
Treatment Failure." Journal of the American Statistical Association (JASA), 108 (504): 
1173—1188. [PMCID: PMC3963362].
18. Trillo, A., Merchant, R., Baird, J., Ladd, G., Liu, T., and Nirenberg, T. (2013). “Interrelation-
ship of alcohol misuse, HIV sexual risk and HIV screening uptake among emergency de-
partment patients.” BMC Emergency Medicine, 13:9-22. [PMID: 23721108] [PMCID: PM-
C3686630]
19. Xu, H.*, Short, S.E., and Liu, T. (2013). “Dynamic relations between fast-food restaurant 
and body weight status: A longitudinal and multilevel analysis of Chinese adults.” Journal 
of Epidemiology & Community Health, 67:271-279. [PMID: 22923769]. (*Advised student; 
Recipient of the 2009 Brown Global Health Scholarship). 
20. Liu, T. and Heitjan, D.F. (2012). "Sensitivity of the discrete-time Kaplan-Meier estimate to 
non-ignorable censoring: Application in a clinical trial". Statistics in Medicine, 31: 
2998-3010. [PMID: 22806989]. 
21. Trillo, A., Merchant, R.C., Baird, J.R., Liu, T., and Nirenberg, T.D. (2012). “Sex differences 
in alcohol misuse and estimated blood alcohol concentrations among emergency depart-
ment patients: Implications for brief interventions.” Academic Emergency Medicine, 19(8):
924-33. [PMID: 22849748] [PMCID: PMC3424395]. 
22. Wei, F., Zhou, J., Wei, X., Zhang, J., Fleming, B.C., Terek, R., Pei, M., Chen, Q., Liu, T., 
and Wei, L. (2012). “Activation of Indian Hedgehog promotes chondrocyte hypertrophy 
and upregulation of MMP-13 in human osteoarthritic cartilage.” Osteoarthritis and Carti-
lage, 20(7):755-63. [PMID: 22469853] [PMCID: PMC3374008]. 
23. Anderson, A., Cindy, F., Liu, T., Swarts, A., Siminya, M. and Cu-Uvin, S. (2012). “Effect of 
trichomoniasis therapy on genital HIV viral burden among African women.” Sexually 
Transmitted Diseases. 39(8):638-642. [PMID: 22797689] [PMCID: PMC3398383]. 
24. Loucks, E.B., Gilman, S.E., Rogers, M., Liu, T., Kawachi, I., Martins, L., Kubzansky, L., 
Buka, S.L. (2012). “Education and coronary heart disease risk associations may be affect-
ed by early life common prior causes: A propensity matching analysis.” Annals of Epidemi-
ology, 22(4):221-232. [PMID: 22463841] [PMCID: PMC3327475]. 
25. Merchant, R.C., Waxman, M.J., Maher, J.G., Clark, M.A., Celada, M.T., Liu, T., Simmons, 
E.M., Beckwith, C.G. and Mayer, K.H. (2012). “Patient and clinician ethical perspectives on 
the 2006 Centers for Disease Control and Prevention HIV testing methods.” Public Health 
Reports, 127(3):318- 329. [PMID: 22547863] [PMCID: PMC3314076]. 
26. Rosen (Asnis)*, L.M., Liu, T. and Merchant, R.C. (2012). “Efﬁciency of ICD-9 billing code 
searches to identify blood or body ﬂuid exposure emergency department visits through a 
state-wide multi-center database.” Infection Control and Hospital Epidemiology. 33(6): 
581-588. [PMID: 22561713 ] (*Advised student)
27. Saffarini, C.M., Heger, N.E., Yamasaki, H., Liu, T., Hall, S.J., and Boekelheide, K. (2012). 
“Induction and persistence of abnormal testicular cells following gestational exposure to di-
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
(n-butyl) phthalate in p53-null mice.” The Journal of Andrology, 33(3):505-13. [PMID: 
21868749]. 
28. Mabeya, H., Khozaim, K., Liu, T., Orango, O., Chumba, D., Pisharodi, L., and Cu-Uvin, S. 
(2011). “Comparison of conventional cervical cytology versus visual inspection with acetic 
acid (VIA) among HIV-infected women in western Kenya.” Journal of Lower Genital Tract 
Disease. 16(2): 92. [PMID: 22126834] [PMCID: PMC3289722]. 
29. Merchant, R.C., DePalo D.M., Liu, T., Rich J.D., and Stein M.D. (2010). “Developing a 
system to predict laboratory-conﬁrmed chlamydial and/or gonococcal urethritis in adult 
male emergency department patients.” Postgraduate Medicine. 22(1): 52–60. [PMID: 
20107289] [PMCID: PMC3021915]. 
30. Beckwith, C.G., Liu, T., Bazerman, L.B., DeLong, A.K., Desjardins, S.F., Poshkus, M., 
Flanigan, T.P. (2010). “HIV risk behavior pre- and post-HIV testing in jail: A pilot study.” 
Journal of Acquired Immune Deﬁciency Syndromes, 53(4): 485–90. [PMID: 20035232] 
[PMCID: PMC2837107]. 
31. Merchant R.C., Lau T.S., Liu, T., Mayer K.H., and Becker B.M. (2009). “Adult sexual as-
sault evaluations at Rhode Island emergency departments, 1995-2001.” Journal of Urban 
Health, 86(1): 43–53. [PMID: 18797994] [PMCID: PMC2629515]. 
32. Phelan, S., Liu, T., Gorin, A., Lowe, M., Hogan, J., Fava, J., Wing, R. (2009). “What distin-
guishes long-term weight loss maintainers from the treatment-seeking obese? Analysis of 
environmental, behavioral, and psychosocial variables in diverse patient populations.” An-
nals of Behavioral Medicine, 38: 94–104. [PMID: 19847584] 
33. Moreira C., Venkatesh, K.K., DeLong A.K., Liu, T., Kurpewski J., Ingersoll J., Caliendo 
A.M., Cu-Uvin S. (2009). “Effect of treatment of asymptomatic bacterial vaginosis on HIV-1 
shedding in the genital tract among women on antiretroviral therapy: Pilot study.” Clinical 
Infectious Diseases, 49: 991–992. [PMID: 19694541] [PMCID: PMC2730467].
34. Hogan, J.W. and Liu, T. (2008). “Mediation analysis for intervention trial: Objectives, mod-
els and inference.” Health Services and Outcomes Research Method, 8: 77-79. 
35. Anderson B.L., Wang C.C., Liu, T., DeLong A.K., Kojic E.M., Kurpewski J., Ingersoll J., 
Mayer K., Caliendo A., and Cu-Uvin S. (2008). “Genital tract leukocytes and shedding of 
genital HIV-1 RNA.” Clinical Infectious Diseases, 47(9): 1216–1221. [PMID: 18808359] 
[PMCID: PMC2714169]. 
36. Merchant, R.C., Chee, K.J., Liu, T., Mayer, K.H., and Becker, B.M. (2008). “Incidence of 
visits for health care worker blood and body ﬂuid exposures and HIV post-exposure pro-
phylaxis provision at Rhode Island Emergency Departments.” Journal of AIDS, 47: 358–
368. [PMID: 18176321] [PMCID: PMC3180865]. 
37. Sung, S. and Liu, T. (2003). “Ammonia inhibition on thermophilic methanogens.” Chemos-
phere, 53(1):43-52. [PMID: 12892665].
38. Liu, T. and Sung, S. (2002). “Ammonia inhibition on thermophilic aceticlastic 
methanogens.” Water Science and Technology, 45(10):113–120. [PMID: 12188530].
39. Liu, T. and Sung, S. (2001). “Effect of ammonia inhibition in thermophilic anaerobic 
process.” Proceedings of the Water Environment Federation, 2001(1): 1292-1306.
C. Non-Refereed Articles
 
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
38. Liu, T., DeLong, A., and Blossom, B. (2009) “Challenge to IDSA recommendations for late 
neurologic Lyme disease treatment and post Lyme syndrome: A statistical review of NIH-
funded treatment studies.” The International Lyme And Associated Diseases Society 
(IDSA) Lyme Panel Review Hearing (http://www.ilads.org/lyme_disease/written_testimony/ 
12%20Liu%20DeLong%20Blossom%20-%20Statistical%20Review.pdf)
39. Liu, T. (2006). “Measuring sensitivity to nonignorable censoring in nonparametric and 
semiparametric survival modeling.” Doctoral Dissertation. The University of Pennsylvania. 
(http://repository.upenn.edu/dissertations/AAI3246193/)
40. Fedorov, V. V. and Liu, T.* (2005). “Randomized discontinuation trials: design and efﬁcien-
cy.” GlaxoSmithKline Biomedical Data Science Technical Report, 3. (*Authorship in Alpha-
betical order). 
41. Liu, T. (2001). “Ammonia inhibition in thermophilic anaerobic process.” Master thesis, Iowa 
State Univ. (http://books.google.com/books?id=_XZfNwAACAAJ)
D. Manuscript in Progress
 
42. Merchant, R.C., Liu, T., and Baird, J. (2015) “Comparison of Priorities for Addressing Adult 
Emergency Department Patient Substance Misuse based on Simpliﬁed Screening Strate-
gies versus Formal Substance Misuse Evaluations.” Under revision. 
43. Liu T, Huang R, Hogan J, and Kantor R. (2015) “Improved Viral Load Monitoring Capacity 
with Rank-Based Algorithms for Pooled Assays”. Under revision. 
44. Merchant R.C., Liu, T., and Baird, J.R. (2015) “Priorities for substance misuse interven-
tions among adult emergency department patients based on prevalence, recency of use, 
frequency and severity of use misuse screening strategies.” Under preparation.
45. Liu T, Hogan J, Xu Y, DeLong Am and Kantor R. (2015) “Covariate-Assisted Pooled Nu-
cleic Acid Testing to Identify Antiretroviral Treatment Failure During HIV Infection”. Under 
revision.
46. Omenge, O., Liu, T., Christoffersen-Deb A., Itsura, P., Mabeya, H., Washington, S., and 
Cu-Uvin, S. (2015) “A comparison of Visual Inspection with Acetic Acid (VIA), Pap smear 
and HPV typing for follow-up after VIA/Cryotherapy in HIV-infected women.” [working title] 
Under preparation.  
47. Jones, M.M, Liu, T. and Shenassa, E. (2015). “Differential secular trends in BMI in relation 
to region of childhood residence: A 25 year follow-up of a nationally representative 
sample”. Under preparation. 
 
E. Abstracts / Conference Presentations
 
48. Liu T. and Hogan J. (2015). “Coherence, Relevance, Transparency: The three require-
ments for sensitivity analysis in clinical trials.” The Fourth ISBS/DIA Joint Symposium on 
Biopharmaceutical Statistics, June 29-July 1, Beijing, China. 
49. Merchant RC, Liu T, Clark M, Rosenberger J, Bauermeister J and Mayer K (2015). “How 
do young adult social media-using black, Hispanic and white MSM differ in their interest in 
using ﬁngerstick rapid HIV self-testing? Implications for encouraging testing among hard to 
reach populations.” The 2015 International AIDS Society Meeting (late breaker). Vancou-
ver, Canada. July 20-22. (Submitted)
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
50. Kuo I, Kurth A, Liu T, Trezza C, Bazerman L, Castonguay B, Olsen H, Patrick R, Abbott S, 
Cates A, Peterson J, Beckwith C. (2015) “Gender Disparities Among HIV-Positive Individu-
als Involved in the Criminal Justice System: The CARE+ Corrections Study in Washington, 
DC”. The 2015 National HIV Prevention Conference. Atlanta, GA, December 6-9, 2015. 
(Submitted).
51. Merchant RC, Liu T, Melissa C, Bauermeister, J, Mayer K. (2015). “Incongruence between 
self-perceived HIV risk and reported sexual risk among social media-using Black, Hispanic 
and white MSM.” The 2015 National HIV Prevention Conference. Atlanta, GA, December 
6-9, 2015. (Submitted).
52. Merchant RC, Liu T, Melissa C, Bauermeister, J, Mayer K. (2015). “Low PrEP utilization 
among among social media-using young adult Black, Hispanic and white MSM at higher 
risk for HIV acquisition.” The 2015 National HIV Prevention Conference. Atlanta, GA, De-
cember 6-9, 2015. (Submitted).
53. (Invited presentation) Liu T (2015) “Coherence, Relevance, Transparency: The three re-
quirements for sensitivity analysis in clinical trials” The 4th International Symposium on 
Biopharmaceutical Statistics, Beijing, China, June 29 - July 1, 2015. 
54. Merchant RC, DeLong AK, Liu T and Baird JR (2015) “Does a brief intervention among 
drug misusing adult emergency department patients increase uptake of rapid HIV/HCV 
screening?”  The 2015 National Summit on HCV and HIV Diagnosis, Prevention and Ac-
cess to Care, June 4-6, Arlington VA. (Submitted). 
55. Kuo I, Kurth A, Cates A, Trezza C, Bazerman L, Castonguay B, Olsen H, Patrick R, Liu T, 
Peterson J, Abbott S, Beckwith C (2015). “HIV Risk and Clinical Characteristics Among 
HIV-Positive Individuals Involved in the Criminal Justice System: The CARE+ Corrections 
Trial in Washington, DC” The 2015 International AIDS Society Meeting. Vancouver, Cana-
da. July 20-22. (Accepted).
56. Merchant RC, Baird JR, Liu T, and Nirenberg TD. “Does A Brief Intervention For Adult 
Emergency Department Patients Decrease Drug Misuse And Increase Drug Treatment 
Services Utilization?” [abstract] 2015 Society for Academic Emergency Medicine Annual 
Meeting, San Diego, CA, May 12-15, 2015. (Accepted). 
57. Merchant RC, Shao W, Guan W*, Clark MA, Liu T, Santelices C and Cortes DE (2015). 
“Variations in recruitment yield, costs, and speed and participant diversity across internet 
or social media platforms in a global study of HIV/AIDS and HIV testing knowledge”. The 
2015 International AIDS Society Meeting. Vancouver, Canada. July 20-22. (Accepted). 
58. Merchant, R.C., Baird, J.R., Liu T, and Nirenberge, T.D. (2015). “Short-term efﬁcacy of a 
brief intervention to reduce drug misuse and increase drug treatment utilization among 
adult emergency department patients”. The 2015 Society for Academic Emergency Medi-
cine (SAEM) Meeting. San Diego, CA. May 12-16, 2015. (Accepted).  
59. Guan W*, Liu T, Baird JR, and Merchant RC (2015) “Evaluation of a Brief Intervention to 
Reduce Negative Consequences of Drug Misuse among Adult Emergency Department 
Patients.” Brown Public Health Research Day (Poster Presentation). April 16 2015, Brown 
University, Providence, RI. (*Advised student)
60. Stillman, AE, Gatsonis, CG, Lima, J, Cormack, J, Gareen, I., Hoffmann, U, Liu T., Mavro-
matis, K., Schnall, M., Udelson, J., Woodward, P., and RESCUE Investigators ACRIN. 
(2015). “Randomized Evaluation of Patients with Stable Angina Comparing Utilization of 
!7

March 2015 
T. LIU, PhD
                                                                                                                                                                            
Noninvasive Examinations (RESCUE) Trial.” The 64th Annual Scientiﬁc Session & Expo of 
American College of Cardiology (ACC). San Diego, CA. March 14-16, 2015. 
61. (Invited lecture) Liu T (2015) “Design of non-inferiority and equivalence clinical trials with 
time-to-event outcomes: The RESCUE study.” North Sichuan Medical College School of 
Public Health, March 3-4, Sichuan, China.
62. Liu, T., Hogan, J.W., Huang, R.*, Kantor, R. (2015) “Improved viral load monitoring capaci-
ty with rank-based algorithms for pooled assays”. The 2015 Conference on Retroviruses 
and Opportunistic Infections (CROI). Seattle, WA. Feb 23-26, 2015. (*advised student). 
63. (Invited Poster Presentation) Liu T, Hogan JW, and Kantor R (2014). “Optimal Allocation 
of Viral Load Testing Under Resource Constraints”. The 2014 CFAR National Meeting. 
Providence, RI. November 5-6, 2014. 
64. Merchant, R.C., Baird, J.R., Liu, T., Beaudoin, F., and Nirenberg, T. (2014). “Severity of 
substance misuse and need for substance misuse interventions among adult emergency 
department patients.” [abstract 189] American College of Emergency Physicians Scientiﬁc 
Assembly. Chicago, IL, October 27. (Peer reviewed). 
65. Shao, W., Merchant, R., Clark, M., Liu, T., Guan, W., Santelices, C, Cortes, D. (2014). 
“Does a Video Improve HIV/AIDS and HIV Testing Knowledge Among a Global Sample of 
Internet and Social Media Users?” [abstract 35819] National Conference on Health Com-
munication, Marketing, and Media. Atlanta, GA, August 20. (Peer reviewed).
66. (Invited Presentation) Liu, T., Hogan, J.W., and Kantor, R. (2014). “Optimizing Diagnosis 
of HIV Treatment Failure with Selective Use of Gold Standard Test.” The 2014 New Eng-
land Statistics Symposium. Harvard University School of Public Health, Boston, MA. April 
25-26. 
67. Shao, W., Merchant, R., Clark, M., Liu, T., Guan, W., Santelices, C, Cortes, D. (2014). 
“How Do Internet and Social Media Sites Compare in Achieving Optimal Completion Rates 
and Costs for an Internet-Based Research Study?” The 2014 CDC National Conference 
on Health Communication, Marketing, and Media. (August 19-21). (Peer reviewed).
68. Omenge, E., Liu, T., Itsura, P., Mabeya, H., Christofferson-deb, A., Washington, S., and 
Cu-Uvin, S. (2014)  “Visual inspection with acetic acid is good for follow-up after cryother-
apy in HIV-infected women.”  The 2014 Conference on Retroviruses and Opportunistic In-
fections. March 3-6, 2014, Boston, MA. (Peer reviewed).
69. Merchant RC, Baird JR, Liu T., Taylor L, Montague B, and Nirenberg T. (2014). “Does a 
Brief Intervention Increase HIV/HCV Screening among Drug-using Emergency Depart-
ment Patients?” [abstract #743] 2014 Society for Academic Emergency Medicine Annual 
Meeting, Dallas, TX, May 14, 2014. (Peer reviewed).
70. Liu, T., Hogan, J.W., Wang, L., Zhang, S. and Kantor, R. (2014) “Optimizing diagnostic 
accuracy of HIV treatment failure in resource-limited settings with selective use of of viral 
load testing.” The 17th International Workshop on HIV Observational Databases. Cavtat, 
Croatia. March 2014. (Reference #17-185). (Peer reviewed).
71. Jones, M.M, Liu, T., and Shenassa, E.D. (2013) “Differential secular trends in BMI in rela-
tion to region of childhood residence: A 25 years follow-up of a nationally representative 
sample.” (Poster, Session 4362). The American Public Health Association (APHA) 141st 
Annual Meeting. Nov 2-6, 2013, Boston, MA. (Peer reviewed).  
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
72. Thakore, R.*, Pinkson, M., and Liu, T. (2013). “The effect of cocaine Use on the diet and 
metabolic status of HIV-infected individuals.” Brown Public Health Research Day (Poster 
Presentation). April 18, Brown University, Providence, RI. (*Advised student). 
73. Tai, M.*, Liu, T., and Merchant, R.C. (2013). “HIV/AIDS-related hospitalization rates in US 
short-stay hospitals, 1982-2010.” Brown Public Health Research Day (Poster Presenta-
tion). April 18, Brown University, Providence, RI. (*Advised student)
74. Omenge, E., Itsura, P., Liu, T., Mabeya, H., Christoffersen-Deb, A., Washington, S., and 
Cu-Uvin, S. (2013). “Six Months Follow-up of HIV-infected Women After Visual Inspection 
with Acetic Acid (VIA) and Immediate Cryotherapy in Western, Kenya.” The 2013 Confer-
ence on Retroviruses and Opportunistic Infections (CROI). March 3-6, 2013; Poster. 
(Peer-reviewed).
75. Merchant RC, Clark MA, Liu, T., Santelices C, and Cortes D. (2012). “Can a video substi-
tute for an in-person discussion in delivering HIV pre-test information to Spanish-speaking 
Latinos and better serve those with lower health literacy?” [Paper #31945] 2012 National 
Conference on Health Communication, Marketing, and Media. Atlanta, GA, August 7-9, 
2012. (Peer-reviewed).
76. Merchant R.C., Clark M.A., Liu, T., Santelices C., and Cortes D. (2012) “Can a video sub-
stitute for an in-person discussion in delivering HIV pre-test information to Spanish-speak-
ing Latinos?” The 2012 National Summit on HIV and Viral Hepatitis Diagnosis, Prevention 
and Access To Care. Poster #116. Washington DC. November 26-28, 2012. (Peer-re-
viewed).  
77. Tai, M.*, Liu, T., and Merchant, R.C. (2013). “HIV/AIDS-related hospitalization rates in US 
short-stay hospitals, 1982-2010.” The 2012 National Summit on HIV and Viral Hepatitis 
Diagnosis, Prevention and Access To Care. Abstract #80. Washington DC. November 
26-28, 2012. (Peer-reviewed). 
78. Kuo I., Kurth A., Bazerman L., Peterson J., Cates A., Azikiwe N., Wong J., Liu, T., and 
Beckwith C. (2012). “CARE+ Corrections—Innovative use of technology in jails to support 
linkage and adherence to HIV care.” The 2nd International Treatment as Prevention Work-
shop 2012, April, Vancouver, BC, Canada. 
79. (Invited Presentation) Liu, T., Hogan, J.W., Zhang, S., Kantor, R. (2012). “Using auxiliary 
biomarkers to improve pooling strategies for HIV viral load testing.” The 2012 International 
Biometrics Society (IBS) ENAR Meeting, May, Washington DC. 
80. (Invited Presentation) Liu, T. (2011). “Optimizing diagnosis of HIV viral failure with selec-
tive use of gold standard testing in resource limited settings.” CFAR Research-in-Progress 
Lectureship Series, November 18, 2011. The Mariam Hospital, Providence, RI. 
81. (Invited Presentation) Liu, T. (2011). “Instrumental variable method and principal stratiﬁca-
tion: An application to a CFAR study.” ACRIN Working Group Meeting, Brown University, 
Oct 18, 2011, Providence, RI. 
82. Baird J.R., Merchant R.C., Nirenberg T.D., Liu, T., and Ladd G.T. (2011). “Increasing the 
uptake of testing for chlamydia and gonorrhea among young female Emergency Depart-
ment patients.” [Abstract: 244972] 139th American Public Health Association Annual Meet-
ing, Nov 1, Washington, DC. (Peer-reviewed).  
83. Trillo A., Merchant R.C., Baird J.R., Liu, T., and Nirenberg, T.D. (2011). “Gender differ-
ences in alcohol misuse and estimated blood alcohol levels among emergency department 
patients: implications for brief interventions.” [Abstract: 16] 8th Annual International Net-
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
work on Brief Interventions for Alcohol & Other Drugs (INEBRIA) Conference, Sept 22, 
Boston, MA. (Peer-reviewed).
84. Merchant R.C., Baird J.R., Nirenberg T.D., Liu, T., and Ladd G.T. (2011). “Does self-report 
of alcohol misuse and sexual risk-taking behavior motivate patients to be tested for HIV? 
“[Abstract: 1399] CDC 2011 National HIV Prevention Conference, Aug 14-17, Atlanta, GA. 
(Peer-reviewed).
85. Merchant R.C., Baird J.R., Nirenberg T.D., Liu, T., and Ladd G.T. (2011). “Increasing HIV 
sexual risk-taking as a function of alcohol misuse among emergency department patients.” 
[Abstract: 1408] CDC 2011 National HIV Prevention Conference, Aug 14-17, Atlanta, GA. 
(Peer-reviewed).
86. (Invited Presentation) Liu, T. (2011). “Optimizing diagnosis of HIV treatment failure with 
selective use of gold standard test.” ACRIN Working Group Meeting, Brown University, 
July 27, 2011, Providence, RI.
87. (Invited Presentation) Liu, T. (2011). “Comparison of positive predictive values in matched 
pairs clinical trials.” Invited Lectureship Series of the 60th Anniversary of North Sichuan 
Medical College. June 7, 2011. Nanchong, Sichuan, China. 
88. Hogan, J., Liu, T., Kantor, R., Wang, L., and Zhang, S. (2011). “Optimizing diagnosis of 
HIV viral failure with selective use of gold standard testing in resource limited settings.” 
Workshop on Statistical Methods in HIV research. April 14-15, 2011, Montreal Canada. (By 
Invitation).  
89. Liu, T., Hogan, J. and Kantor, R. (2011). “Optimal use of selective viral load testing for HIV 
treatment monitoring in resource limited settings.” The 2011 International Biometrics Soci-
ety (IBS) ENAR Meeting. March, Miami, FL. 
90. Anderson, A., Firnhaber C., Liu, T., Swarts, A., Siminya, M. and Cu-Uvin, S. (2011). “ ” The 
International Conference on Retroviruses and Opportunistic Infections. Feb 27-Mar 2, Bos-
ton, MA. (Peer-reviewed).
91. Anderson, B., Firnhaber, C., Swarts, A., Siminya, M., Liu, T., and Cu-Uvin, S (2010). “Self-
Collected Vaginal Swabs for Trichomoniasis Testing in HIV-infected Women in South 
Africa.” The 34th Annual Scientiﬁc Meeting of Infectious Diseases Society for Obstetrics 
and Gynecology (IDSOG). Aug. 5-7. Santa Fe, NM. (Peer-reviewed).
92. Guzman H., Merchant, R.C., Baird, J.R., Nirenberg, T.D., Liu, T., Ladd, G.T. (2010) “How 
does hazardous and heavy episodic alcohol drinking relate to HIV sexual risk among 
emergency department patients?” Annals of Emergency Medicine, 56 (3), S22-S22. [PII: 
S0196-0644(10)00690-6; doi:10.1016].
93. Guzman, H., Merchant, R.C., Baird, J.R., Nirenberg, T.D., Liu, T., and Ladd, G.T. (2010). 
“How does hazardous and heavy episodic alcohol drinking relate to HIV sexual risk among 
emergency department patients?” 2010 American College of Emergency Physicians Sci-
entiﬁc Assembly Research Forum, Las Vegas, NV. (Peer-reviewed).
94. Xu, H*, and Liu, T. (2010). “Community Context and Obesity among Chinese Adults: A 
Longitudinal and Multilevel Analysis.” Population Association of America 2010 Annual 
Meeting, Dallas, TX. (Peer-reviewed) (*Advised student).
95. Mabeya, H., Khozaim, K., Liu, T., Orango, O., Chumba, D., Pisharodi, L., and Cu-Uvin, S. 
(2010). “Comparison of Conventional Pap Smear and Visual Inspection with Acetic Acid 
(VIA) in HIV Infected Women in Western Kenya.” The International Conference on Retro-
viruses and Opportunistic Infections (CROI) 2010, San Francisco, CA. (Peer-reviewed).
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
96. Liu, T., DeLong, A., and Blossom, B. (2009). “Challenge to IDSA recommendations for late 
neurologic Lyme disease treatment and post Lyme syndrome.” The 2009 International 
Lyme and Associated Diseases Society (ILADS) Conference, Washington DC. 2010. (By 
invitation). 
97. Merchant R.C., Waxman M.J., Clark M.A., Maher J.C., Celada M.T., Beckwith C.G., Liu, 
T., Simmons E.A., and Mayer K.H. (2009). “Do patients and clinicians have ethical con-
cerns about the 2006 CDC HIV testing recommendations?” The 2009 CDC National HIV 
Prevention Conference, Atlanta, GA. (Peer-reviewed).
98. Waxman M.J., Merchant R.C., Clark M.A., Maher J.G., Celada M.T., Beckwith C.G., Liu, 
T., Simmons E.A., and Mayer K.H. (2009). “Will the 2006 CDC HIV testing recommenda-
tions reduce stigma and increase HIV testing?” The 2009 CDC National HIV Prevention 
Conference, Atlanta, GA. (Peer-reviewed). 
99. Nijhawan A., McManus J., Liu T., DeLong A.K., Chapman S., Rapoza K., Kurpewski J., 
Caliendo A. and Cu-Uvin S. (2009). “The effect of Acyclovir on CD4 count and CD4 per-
cent slope in HIV-1/HSV-2 co-infected women taking highly active antiretroviral therapy 
(HAART).” The 47th IDSA Annual Meeting; Oct. 29-Nov. 1, 2009, Philadelphia, PA. 
100. McManus J., Nijhawan A., Liu T., DeLong A., Chapman S., Rapoza K., Kurpewski J., 
Caliendo A. and Cu-Uvin S. (2009). “The effect of Acyclovir on the prevalence of bacterial 
vaginosis on HIV-1/HSV-2 co-infected women taking highly active antiretroviral therapy 
(HAART).”  47th IDSA Annual Meeting; Oct. 29-Nov. 1, 2009, Philadelphia, PA.
101. Waxman, M.J., Merchant, R., Maher, J., Clark, M., Simmons, E., Celada, T., Beckwith, 
C., Liu, T. (2009). “Who prefers CDC-recommended streamlined methods for HIV 
testing?” The 2009 Society for Academic Emergency Medicine (SAEM) Annual Meeting, 
New Orleans, LA. (Peer-reviewed).
102. Beckwith, C.G., Liu, T., Bazerman, L.B., DeLong, A.K., Pinkston, M., Nunn, A., and 
Flanigan, T.P. (2009). “Identiﬁcation of multiple HIV risk factors among jail detainees.” The 
2009 CDC National HIV Prevention Conference, Atlanta, GA. (Peer-reviewed).
103. Waxman, M.J., Merchant, R.C., Maher, J.G., Clark, M.A., Simmons, E.A., Celada, M.T., 
Beck- with, C.G., Liu, T., Mayer, K.H. (2008). “Do clinicians prefer the 2006 or 2001 CDC 
HIV testing recommendations?” The 2008 Forum for Collaborative HIV Research. Poster # 
151. (Peer-reviewed).
104. Waxman, M.J., Clark, M.A., Maher, J.C., Simmons, E.A., Celada, M.T., Beckwith, C.G., 
Liu, T., and Mayer, K.H. (2008). “Do patients and clinicians have ethical concerns about 
the 2006 CDC HIV testing recommendations?” The CDC National HIV Prevention Confer-
ence. (Peer-reviewed).
105. Beckwith, C., Liu, T., Bazerman, L., DeLong, A.K., Desjardins, S., and Flanigan, T. 
(2008). “HIV risk behavior pre- and post-HIV testing and counseling in jail.” The 2008 In-
fectious Diseases Society of America (IDSA) Annual Meeting, Washington DC. (Peer-re-
viewed).
106. Phelan, S., Gorin, A., Liu, T., Hogan, J.W., Lowe, M., Fava, F., and Wing, R. (2008). 
“What distinguishes long-term weight loss maintainers from the treatment-seeking obese? 
Analysis of environmental, behavioral, and psychosocial variables.” The 2008 Annual Sci-
entiﬁc Meeting of the North American Association for the Study of Obesity (NAASO), 
Phoenix, AZ. (Peer-reviewed).
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
107. Moreira C., Delong A.K., Liu, T., Kurpewski J., Ingersoll J., Caliendo A., and Cu-Uvin 
S.C. (2008). “HIV-infected women on highly active antiretroviral therapy with asymptomatic 
bacterial vaginosis have low rates of genital tract HIV-1 RNA shedding.” The 17th In-
ternational AIDS Conference (IAS), Mexico. (Peer-reviewed).
108. Merchant R.C., DePalo D.M., Liu, T., Rich J.D., and Stein M.D. (2008). “Predictors of a 
chlamydia and/or gonorrhea infection among adult male emergency department patients.” 
The 2008 National Sexually Transmitted Diseases (STD) Prevention Conference, Chicago, 
IL. (Peer-reviewed).
109. Anderson B.L., Liu, T., DeLong A.K., Ingersoll J., Wang C.C., Kurpewski J., Caliendo A., 
and Cu-Uvin S.C. (2007). “Genital tract shedding of HIV-1 RNA and lower genital tract in-
fections may be linked by inﬂammation.” The 45th Annual Meeting of the Infectious Dis-
eases Society of America (IDSA), San Diego, CA. 2008 (Peer-reviewed).
110. Wang C.C., Liu T., Anderson B.L., DeLong A.K., Chapman S., Kurpewski J., Ingersoll J., 
Caliendo A.M., Cu-Uvin S.C. (2008) “Association between genital tract HIV-1 RNA shed-
ding and mucosal inﬂammation among women on effective ART with undetectable plasma 
viral load.” Poster presentation. The 15th  Annual Conference on Retroviruses and Oppor-
tunistic Infections (CROI), February, 2008, Boston, MA.
111. Anderson B.L., DeLong A.K., Liu, T., Wang C.C., Kurpewski J., and Cu-Uvin S.C. (2007). 
“Association between genital tract white blood cells and viral shedding among HIV-infected 
women in the absence of genital infections.” The 34th Annual Scientiﬁc Meeting of Infec-
tious Diseases Society for Obstetrics and Gynecology (IDSOG), Boston, MA. (Peer-re-
viewed).
112. Liu, T., Hogan, J.W., and DeLong, A.K. (2008). “Bounds of ATE and unmeasured con-
founding bias in observational studies with continuous outcome.” The 2008 International 
Biometric Society (IBS) ENAR meeting, Arlington, VA. 
113. Liu, T. and Heitjan, D.F. (2007). “Sensitivity of Cox regression to nonignorable censoring.” 
The 2007 American Statistical Association (ASA) Joint Statistical meeting, Salt Lake City, 
UT. 
114. (Invited Presentation) Liu, T. and Heitjan, D.F. (2006). “Sensitivity and Kaplan-Meier es-
timate to nonignorable censoring.” Dana-Farber Cancer Institute (Harvard University), De-
partment of Biostatistics and Computation Biology, Cambridge, MA.  
115. (Invited Presentation) Liu, T. and Heitjan, D.F. (2006). “Sensitivity and Kaplan-Meier es-
timate to nonignorable censoring.” Brown University, Center for Statistical Sciences, De-
partment of Community Health, Providence, RI.
116. Liu, T. and Heitjan, D.F. (2006). “Sensitivity and Kaplan-Meier estimate to nonignorable 
censoring.” The 2006 American Statistical Association (ASA) Joint Statistical Meeting, 
Seattle, WA. 
117. Liu, T. and Gao, L. (2006). “Relationship assessment between PK and PD.” The 2006 
International Biometric Society (IBS) ENAR Meeting, Tampa, FL. 
118. (Invited Presentation; Distinguished Student Paper Award) Liu, T. and Heitjan, D.F. 
(2006). “Sensitivity and Kaplan-Meier estimate to nonignorable censoring.” The 2006 In-
ternational Biometric Society (IBS) ENAR Meeting, Tampa, FL.
119. Liu, T. and Fedorov, V.V. (2006). “Randomized discontinuation trials.” The 2006 In-
ternational Biometric Society (IBS) ENAR Meeting, Tampa, FL. 
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
RESEARCH GRANTS 
A. Active Grants
 
1.
Facilitating HIV Testing Among Young Adult MSM Through Social Networking
My Role: 
Brown CSS sub-Award PI
Funding Agency:  
NIH/Rhode Island Hospital subcontract
PI: 
Merchant
Type:  
R21
Period: 
4/15/2014-3-31/2016
Cost:  
$91,042
This project assesses acceptance of a new rapid HIV self-test, as compared to current HIV 
testing approaches, as well as usage of a MSM social-networking website to facilitate HIV 
testing and dissemination. The entire study will be internet-based, in regards to recruit-
ment, enrollment, follow-up, and acquisition of HIV tests, which is appropriate given the 
high level of familiarity, use and comfort with the internet among young adult MSM.
2.
Optimal HIV Treatment Monitoring Strategies under Resource Constraints
My Role:  
Co-Investigator 
Funding Agency:  
NIH
PI:
Hogan, Kantor
Type:  
R01
Period: 
12/1/2014-11/31/2019
Cost:  
$2,882,699 (Project total)
We propose to develop the statistical framework, theory and methods required to discover 
optimal diagnostic algorithms for monitoring treatment failure with limited or no VL avail-
ability; to use cohort data from both the US and Kenya to derive, calibrate and cross-vali-
date the algorithms; to use extant blood samples from patients in a PEPFAR-funded HIV 
care program to design and cross-validate a new diagnostic algorithm that includes im-
plementation of pooled assays; and to develop usable software that will enable programs 
to design their own protocols based on the characteristics of their patient population and 
local capacity for viral load testing.
3. Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients
My Role: 
Co-Investigator 
Funding Agency: 
NIH
PI: 
Merchant
Type: 
RO1
Period: 
7/23/2014-4/30/2019
Cost: 
pending
This project aims to address HIV/AIDS and HIV testing literacy deﬁcits among emergency 
department patients. The video from the prior R21 study will be tested for efﬁcacy as com-
pared to a pictorial brochure in a multi-site, randomized, controlled, longitudinal study. 
4.
AMPATH-Oncology Institute: HPV and Cervical Cancer in Kenyan Women with HIV/AIDS 
My Role: 
Co-investigator and Lead Statistician
Funding Agency: 
NCI 
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
Brown PI: 
Lehrer, Darron, Omenge 
Type: 
U54
Period: 
9/19/2014-8/31/2019
Cost: 
$728,206 (Project total)
This project aims to assess the results of cryotherapy and LEEP among VIA positive HIV- 
and HIV+ women in western Kenya. Modiﬁable risk factors that lead to treatment failure 
and HPV types (persistence and alterations) also will be assessed. 
5. “See and LEEP” Training for Kenyan Non-gynecologists
My Role: 
Brown sub-Award PI
Funding Agency: 
CFAR/PepFAR Supplement 
PI: 
CuUvin
Type: 
P30
Period: 
4/4/2014-3/31/2015
Cost: 
$364,969 (Project total)
This project proposes to evaluate the feasibility of training Kenyan nurses to perform cer-
vical cancer screening and LEEP treatment for HIV+ women in Western Kenya and to as-
sess its safety. Findings of the study will provide important information to improve health 
outcomes among HIV-infected women needing treatment for cervical neoplasia.  
6.
Alcohol and HIV: Biobehavioral Interactions and Intervention 
My Role:  
Investigator
Funding Agency:  
NIAAA
PI: 
Monti
Type:  
P01 AA019072
Period:  
09/30/10-08/31/15 (renewal pending)
Cost:  
$148,924
The goals of this alcohol research center are to study the effects of alcohol use on HIV 
disease progression and the effects of interventions to reduce alcohol use in HIV-infected 
populations. The center also fosters multidisciplinary collaborations and training in re-
search on alcohol and HIV and dissemination of research ﬁndings to clinicians treating ad-
dictions and HIV.
7. CARE Corrections: A technology-based HIV and HCV tool 
My Role: 
Brown sub-Award Principal Investigator
Funding Agency:  
NIDA/The Miriam Hospital subcontract
PI:
Beckwith
Type: 
R01DA030747-01
Period:  
07/01/10-06/30/15 
Cost:  
$18,806
It involves providing biostatistical expertise and collaboration in a project related to a new 
intervention to reduce substance abuse and hence reduce risks of HIV and HCV infec-
tions. 
8. A Stage 2 Cognitive-Behavioral Trial: Reduce Alcohol First in Kenya Intervention
My Role:  
Co-Investigator 
Funding Agency: 
NIAAA/Brown
PI: 
Papas
Type:  
R01 AA020805-01
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
Period:  
09/15/11 – 08/31/16
Cost:  
$429, 932
The major objectives of this stage 2 randomized clinical trial are to determine whether a 
para-professionally led group cognitive-behavioral therapy intervention is effective in re-
ducing alcohol use among 336 HIV-infected Kenyan outpatients who report hazardous or 
binge drinking when compared against a group health education intervention
9. Evaluating the impact of patient-centric home health quality reports
My Role:  
Co-Investigator 
Funding Agency:  
Healthcentric Advisors/AHRQ
Brown PI: 
Clark
Type:  
R21 HS021879-01
Period:  
09/30/12-08/31/15
Cost:  
$69,111 
The speciﬁc aims are to: (1) determine how home health consumers (patients and care-
givers) use the current reporting content and format, and what changes they recommend 
to increase its frequency of use and decision-making utility; (2)  determine how hospital 
discharge planners use the current reporting content and format, and what changes do 
they recommend to increase its frequency of use and decision-making utility; (3) evaluate 
whether or not home health consumers and hospital discharge planners who view a re-
vised, consumer-centric, web-based public report understand the information and how to 
use it; and (4) evaluate the extent to which home health consumers offered a new con-
sumer-centric report prior to hospital discharge use the information to inform their home 
health choices, and how their use, satisfaction and outcomes compare to consumers of-
fered the old format.
10. Center for AIDS Research (CFAR) Biostatistics Core
My Role:  
Investigator
Funding Agency:  
NIH/The Miriam Hospital contract
Brown PI: 
Hogan
Type:  
P30 A1 42853
Period:  
09/01/12 - 06/30/16
Cost:  
$100,966
The primary goal involves providing biostatistical expertise for the design and analysis of 
individual projects within CFAR; the core will also be responsible for implementation of 
data analyses and will participate in the preparation of reports and manuscripts. 
B. Grant Submitted (Disposition Pending) 
 
11. Mindfulness RCT for CVD Risk
My Role: 
Statistician 
Funding Agency: 
NIH
PI: 
E. Loucks
Type: 
RO1 GRANT11597822
Cost: 
$535,497 (Project Total)
Period: 
9/1/2014 - 8/31/2019
The research objective is to conduct a methodologically rigorous randomized controlled 
trial that will provide information on whether mindfulness-based stress reduction has sus-
!15

March 2015 
T. LIU, PhD
                                                                                                                                                                            
tained one-year impacts on CVD risk factors, with systolic blood pressure and smoking as 
the primary outcomes.
12. Computerized Intervention to Improve HIV Medication Adherence
My Role: 
Brown sub-Award PI
Funding Agency: 
NIMH
PI: 
Ramsey
Type: 
RO1
This project aims to promote HIV medication adherence using an innovative computerized 
intervention. A revised computerized medication adherence intervention (MAI) will be test-
ed for effectiveness as compared to a general health control intervention (GHC) in a ran-
domized, controlled, longitudinal study. 
13. The inﬂuence of fetal growth on infant growth and obesity among Samoans
My Role: 
Investigator 
Funding Agency: 
NIMHD 
PI: 
McGarvey
Type: 
RO1
The research objective is to document the relationships between maternal obesity and 
related pregnancy conditions to fetal growth and directly relate temporal patterns of fetal 
growth to childhood obesity.
14. Behavioral Intervention to Prevent Child Overweight and Obesity in American Samoa
My Role: 
Investigator
Funding Agency: 
NIMHD
PI:
McGarvey
Type: 
R01
Cost: 
$1,250,000 (Project total)
The research objective is to conduct a randomized trial of family-based lifestyle interven-
tion with conditional incentives on parents in order to prevent excessive weight gain 
among American Samoan children 7-12 years of age. 
C. Completed Grants
15. Brief Intervention for Drug Misuse in the Emergency Department (BIDMED) 
My Role:  
Brown Principal Investigator
Funding Agency:  
NIDA/Rhode Island Hospital subcontract
PI:
Merchant
Type:  
R01 DA026066
Period:  
03/15/09-02/28/14
Cost:  
$27,705 
The primary goal involves providing biostatistical expertise and collaboration in a project 
related to a new intervention to reduce drug misuse in the Emergency Department.
16. Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Noninva-
sive Examinations (RESCUE)
My Role:  
Protocol Statistician 
Funding Agency:  
AHRQ
Brown PI: 
Gatsonis 
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March 2015 
T. LIU, PhD
                                                                                                                                                                            
Type:  
R01 HS019403 
Period:  
09/30/10-09/29/14
Cost:  
$401,721
This research project involves organizing and operating the Biostatistics Center and the 
Outcomes and Economics Core Laboratory components of the RESCUE trial - a random-
ized, multi-center study designed to compare CCTA and SPECT for patients with symp-
toms of stable angina. 
17. Cervical Cancer See and Treat: How Best to Follow-Up
My Role:  
Co-Investigator 
Funding Agency:  
NIAID/The Miriam Hospital subcontract
PI: 
Cu-UVin
Type:  
P30 A142853
Period:  
07/01/11 – 06/30/13
Cost:  
$51,488 
This proposal involves providing biostatistical expertise and collaboration in a project re-
lated to comparing three methods, visual inspection with acetic acid (VIA), pap smear and 
HPV typing, for diagnosing cervical neoplasia/cancer. 
18. Methods to Optimize Use of Limited Resources for Monitoring Treatment of HIV/AIDS in 
the Developing World
My Role:  
Principal Investigator
Funding Agency:  
Center for AIDS Research
PI: 
Liu
Type:  
5P30 AI042853-12
Period:  
1/01/10-12/31/11
Cost: 
$40,000
This project involves developing a clinical algorithm that will make optimal use of viral load 
assays when they are available on a limited basis.
19. Increasing Viral Testing in the Emergency Department (InVITED)
My Role:  
Brown sub-Award Principal Investigator 
Funding Agency:  
NIDA/Rhode Island Hospital subcontract
PI: 
Merchant
Type:  
R21 DA028645
Period:  
3/04/10 – 2/28/2012
Cost:  
$15,000
This project involves providing biostatistical expertise and collaboration in a project 
related to a new intervention to reduce substance abuse. 
20. Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos
My Role:  
Investigator
Funding Agency:  
DHHS/ Rhode Island Hospital subcontract
PI: 
Merchant
Type:  
R21 NR011997
Period:  
03/04/11-02/29/13
Cost:  
$18,806
This research project involves comparing the effects of video delivery of HIV testing infor-
mation for Spanish-Speaking Latinos.
!17

March 2015 
T. LIU, PhD
                                                                                                                                                                            
21. New Approaches to Mediation Analysis using Causal Inference Methods
My Role:  
Co-Investigator 
Funding Agency:  
NIAAA (stimulus)
PI: 
Hogan
Type:  
1RC1AA019186-01
Period:  
10/01/09-09/30/11
Cost:  
$327,201 (Project total)
The proposed research will develop statistical approaches for discovering pathways and 
mechanisms of behavioral interventions targeted at alcohol abuse. Knowledge of mecha-
nistic pathways allows deeper understanding of how and why certain interventions work, 
and opens the door to customizing interventions based on person-speciﬁc characteristics.
22. Shaping Long-Term Care in America 
My Role:     
Statistician 
Funding Agency:  
NIH/NIA
PI: 
Mor
Type:  
P01 AG027296
Cost:  
$1,390,110 (Project total)
Period:
  
09/01/08-06/30/10
The overall objectives of the program project are to (1) Build a long term care data and 
policy repository and analysis infrastructure as the basis for currently proposed and future 
examining the nations long term care” system;” (2) Implement a survey of states policies 
and a national sample of nursing homes, integrating them with secondary data to serve 
the proposed research projects within an overall administrative structure; (3) integrate 
economic and organizational theory to develop measures and to propose testable hypoth-
esis in the proposed projects focusing on provides responses to market and policy 
changes; and (4) systematically catalogue and broadly disseminate to numerous audi-
ences project ﬁndings.
23. Analyzing Complex Longitudinal Data in Behavior Sciences 
My Role: 
Lead Statistician
Funding Agency: 
NIH
Brown PI: 
Hogan
Type: 
RO1 HL079457
Cost: 
$249,500 (Project total)
Period: 
Aug., 1, 04 --- July, 31, 08 
This project will develop innovative approaches to the analysis of longitudinal data speciﬁ-
cally for behavioral medicine trials. The ﬁrst two components of the project will develop 
latent class and latent variable models for classifying patterns of behavior change in smok-
ing cessation and weight change. The third aim of the study addresses the issue of infor-
mative missing data, presenting a unifying and coherent framework for pattern-mixture 
modeling and associated sensitivity analyses. All of the methods will be developed on and 
applied to data from recently completed or ongoing trials in behavioral medicine, particu-
larly in smoking cessation and weight change.
24. Secondhand Tobacco Smoke Exposure, Maternal Stress, and Adverse Birth Outcomes 
My Role: 
Lead Statistician 
Funding Agency: 
Flight Attendants Medical Research Institute
!18

March 2015 
T. LIU, PhD
                                                                                                                                                                            
PI: 
Shenassa
Type: 
FAMRI 032069       
Cost: 
$623,239 (Project total)
Period: 
Sept. 1, 08 --- Dec. 31, 08 
This is a study to elucidate mechanisms explaining the heightened susceptibility to ad-
verse health effects of secondhand tobacco smoke exposure observed among people of 
low SES by examining the exacerbating role of stress as measured by Allostatic Load.
ACADEMIC SERVICES
A. Department and University Services 
 
 
1.
Search Committee for Assistant or Associate Professor, Teaching Scholar. 2015.
2.
Biostatistics PhD Student Admission Committee. 2011— 2013, 2014 — 15.
3.
The 2014 Atlantic Causal Inference Conference (ACIC) Organizing Committee. 2014. 
4.
Best Thesis Award Committee. 2013 — 2014
5.
Biostatistics Master Student Admission Committee. 2014.  
6.
Biostatistics Curriculum Committee. 2012 — 2014.
7.
The 2014 Scholarship for Overseas Chinese Students Evaluation Committee 2014.
8.
Search Committee for Research Assistant Professor of Biostatistics. 2013.
9.
Biostatistics PhD Qualifying Exam Committee. 2008 — 11, 2012 — 13
10. Biostatistics Graduate Program Committee. 2011 — 2013.
11. Epidemiology MPH Qualifying Exam Committee. 2010 — 2011.
B. Editorial Services
 
Journal Reviewer
Journal of the American Statistical Association (JASA); Annals of Applied Statistics; Annals 
of Epidemiology; Biometrics; Biostatistics; Statistics in Medicine; Statistical Science; Sta-
tistics and Probability Letters; Statistical Modelling; Journal of Computational and Graphi-
cal Statistics (JCGS); Health Services and Outcomes Research Methodology (HSOR); 
The American Journal of Epidemiology (AJE); BMC Infectious Diseases; Emerging 
Themes in Epidemiology; Epidemiology; Clinical Infectious Diseases (CID); International 
Journal of Epidemiology & Infection; Journal of AIDS & Clinical Research; Journal of Clini-
cal Epidemiology (JCE). 
Book Reviewer
1.
Chapman & Hall/CRC Press. 
Journal Editorial Board
!19

March 2015 
T. LIU, PhD
                                                                                                                                                                            
1.
2010 – Present
Journal of Clinical Research & Bioethics (JCRB). 
     
2.
2012 – Present
International Journal of Clinical Therapeutics and Diagnosis. 
     
3.
2013 – Present
Annals of Biometrics & Biostatistics (ABB). 
     
4.
2010 – Present
International Journal of Epidemiology & Infection
     
C. Grant Reviewer
 
1.
2015
Ad-Hoc reviewer for Beijing Natural Science Foundation & Shanyuan 
                    
Joint Research Projects: Infectious Diseases and Epidemiology. 
2.
2014 
Ad-Hoc reviewer for the National Science Foundation (NSF): Panel of 
                   
Methodology, Measurement, and Statistics. 
2.
2013
Scientiﬁc expert reviewer for the French National Research Agency 
                    
(ANR): Basic Research on Networks of Trials. 
D. Other Academic Services
 
1.
2015
Judge of the Best Student Poster Awards, Brown Public Health Re
                    
-
search Day, April 16th 2015.  
2.
2011-2012
Chair of the 2011-12 Starr Lectureship Series on “Comparative Effective 
           
Research and Causal Inference”. Brown University.
3.
2011-2012
Chair of the Biostatistics Seminar Series. Department of Biostatistics, 
           
Center for Statistical Sciences, Brown University. 
4.
August 2009.
Chair of “Biometrics Section” (No.570). The American Statistical 
       
Association Joint Statistical Meeting (JSM). Washington D.C. 
HONORS & AWARDS
1.
2010  
The Lifespan/Tuft/Brown CFAR Developmental Award.
                   
2.
2006  
The Biometric Society ENAR Distinguished Student Paper Award. 
                   
3.
2004  
Jonathan Raz Award for the Best Doctoral Qualifying Exam.
                   
4.
1999-2002   
Iowa State University Graduate Scholarship. 
        
5.
1994-1998 
Tsinghua University Undergraduate Scholarships.
          
6.
1994  
Outstanding Freshmen Award at Tsinghua University.
                   
7.
1993
Second Prize, National Physics Olympiad (High School).
                     
TEACHING
A. Brown University (Instructor):
 
1.
Spring 2012 
PHP 2511  Applied Regression Analysis. (student enrollment: 18).
        
  
2.
Fall 2009 
PHP 2510 
Principles of Biostatistics and Data Analysis. (27).
            
   
3.
Spring 2008 
PHP 2603
Analysis of Longitudinal Data (with Prof. Hogan). (15).
        
    
!20

March 2015 
T. LIU, PhD
                                                                                                                                                                            
4.
Fall 2008 
PHP 2601 
Linear and Generalized Linear Models. (11).
            
   
B. University of Pennsylvania (Graduate Teaching Assistant/Instructor):
 
5.
Spring 2006 
BSTA 771  Applied Bayesian Analysis. (7).
        
  
6.
Fall 2005 
BSTA 630  Statistical Methods and Data Analysis. (26).
            
  
7.
Spring 2004 
EPI 520 
Introductory Biostatistics. (32).
        
      
C. Iowa State University (Graduate Instructor):
 
8.
Summer. 2002 
STAT 402 
Statistical Methods for Research Workers. (43).
 
     
    
G. Invited/Guess Lectures
1.
Fall 2013 
“Clinical Trials Methodology”  
             
Brown University, School of Public Health
                           
2.
Summer 2012 
“Causality 101 Workshop: Recent Mediation Analysis Methods”  
     
Brown University, School of Public Health
                           
3.
Fall 2010 
“Design of Clinical Trials with Survival Outcomes”  
             
Brown University, School of Public Health 
                           
4.
Fall 2010
“Statistical Methods in Biology” 
              
Brown University, Department of Molecular Biology 
                           
4.
Fall 2009 
“Statistical Methods in Biology” 
             
Brown University, Department of Molecular Biology 
                           
ADVISING/CONSULTING 
A. Thesis Advisor/Reader
 
     
1.
Ran Wei, 
Sc.M. (Biostatistics)
2016 (Expected). 
  
                     
            
Thesis: To be decided.  
My role: Thesis Advisor.
1.
Wentao Guan, 
Sc.M. (Biostatistics)
2015.
  
             
            
Thesis: Evaluation of a Brief Intervention to Reduce Negative Consequences of Drug Mis-
use among Adult Emergency Department Patients.  
My role: Thesis Advisor.
2.
Jay Jia Xu, 
B.S. (Statistics)
2015.
  
                  
                   
Thesis: A Comparison of INLA and JAGS When Applied To Multiple Imputation with the 
Penalized Spline of Propensity Prediction Method 
My role: Thesis reader.
3.
Renxia Huang, 
Sc.M. (Biostatistics)
2014. 
  
            
            
Thesis: Combining Routine Clinical Markers and Pooled Viral Load Strategy to Monitor 
     
  
   
Antiretroviral Treatment Failure in Resource Poor Settings.
 
     
                                                   
!21

March 2015 
T. LIU, PhD
                                                                                                                                                                            
My role: Thesis Advisor.  
     
Winner of the 2014 Best Thesis Award of Public Health
     
4.
Andrea Austin, 
Ph.D. (Biostatistics) 
2013. 
  
             
           
Thesis: Methods for prediction and inference on social networks with extensions to 
  
bimolecular pathways.  
My role: Committee member. 
5.
Miao Tai,
Sc.M. (Biostatistics) 
2013
  
                      
           
Thesis: HIV/AIDS-related hospitalizations in United States short-stay hospitals, 
  
1982-2010  
My role: Thesis Advisor.
6. Rachel Thakore, 
B.S. (Community Health)    2013 
 
          
Honors Thesis: The effect of cocaine use on the diet and metabolic status of HIV-infected 
     
 
individuals.
     
My role: Committee member
7. Xuan Deng, 
Sc.M. (Biostatistics) 
2013
 
                 
           
Thesis: Mediation effects of behavioral and psychological factors in maintaining weight 
loss.  
My role: Committee member.
8. Edwin Sang, 
Sc.M. (Biostatistics)
2013
 
                
            
Thesis: Causal effect of HIV serostatus disclosure on mortality and loss to follow-up after 
HAART initiation using propensity score.
My role: Committee member 
Winner of the 2013 Best Master Thesis Award of Public Health
9. Ann Mwangi, 
Ph.D. (Biostatistics) 
2011
 
               
           
Thesis: Addressing selection bias in observational event history data, with application to 
HIV in Western Kenya.
My role: Committee member.
10. Jing Zhang, 
Ph.D. (Biostatistics)
2011
                 
            
Thesis: Causal Inference for Mediation Effects.  
My role: Committee member.
11. Raymond Ng, 
Sc.M. (Biostatistics)
2011
              
            
Thesis: Analysis of repeated FDG-PET scans in the National Oncology PET Registry 
(NOPR).  
My role: Committee member.
12. Patricia S. Fox, 
Sc.M. (Biostatistics)
2009
           
            
Thesis: Transition within states of lung function: A multinomial logistic approach using two-
year follow-up data from bacteriologically cured tuberculosis patients.
My role: Committee member.
13. Lisa tai (Asnis), 
Sc.M. (Biostatistics) 
2009
           
           
Thesis: Evaluating the utilization and efﬁciency of ICD-9 codes to identify visits for blood or 
body ﬂuid exposures in 11 Rhode Island emergency departments.
My role: Thesis advisor. 
C. Graduate Academic Advisor
!22

March 2015 
T. LIU, PhD
                                                                                                                                                                            
1.
Ran Wei, 
Sc.M. (Biostatistics)
2016 (expected)
                     
            
2.
Jin Shi,
Sc.M. (Biostatistics)
2016 (expected)
                        
            
3.
Wuntao Guan
M.S. (Biostatistics)
2015
               
              
4.
Lisa Wang, 
M.S. (Biostatistics) 
2013
                  
             
5.
Nuo Xu, 
M.A. (Biostatistics)
2012
                      
              
6.
Junchao Shangguan, 
M.A. (Biostatistics)
2011
   
              
7.
Dong-Hyun Ahn, 
M.A. (Biostatistics)
2010
          
              
D. Other Teaching and Advising Roles
 
1.
C Yuan, Brown master student (Biostatistics). 2013 Summer Intern at Press Ganey. My 
role: Curriculum Practical Training Advisor. 
2.
J Shangguan, Brown master student (Biostatistics). 2010 Summer Intern at Fidelity Co. My 
role: Curriculum Practical Training Advisor.
3.
Alina Kung, Brown undergraduate student (International Relationships). Awardee of In-
ternational Scholars Program Scholarship 2010. “Evaluating the Effectiveness of American 
Healthcare NGOs in China.” My role: Research Advisor.
4.
Hongwei Xu, Brown PhD student (Sociology). Awardee of Brown University Global Health 
Scholarship 2009. “A Longitudinal Study of the Coexistence of Underweight and Over-
weight Persons within Household in China: 1997-2006.” My role: Research Advisor.
E. Junior Faculty Mentoring and Medical Consulting
 
1.
Ed Wing, M.D. and Rena Wing, Ph.D. (2014). CFAR Developmental Grant: "An Internet-
based Behavioral Weight Programs for HIV+ patients". My role: Consultant.  
2.
Elizabeth M. Goldberg, M.D. (2014). UEMF Research Development Grant: “Is Emergency 
Department Hypertension Predictive of Future Hypertension?” My role: Mentor.
3.
Gary Wessel, Ph.D. (MCBB) (2013). CFAR Developmental Grant: “Metagenomic Analysis 
of the Gut Microbiome in the HIV Infected Patients: Prospects for Therapy.” My role: Men-
tor. 
4.
Francesca Beaudoin, M.D. (2013). NIDA Emergency Medicine Foundation. “Prescription 
opioid use and misuse in older emergency department patients.” My role: Mentor.
5.
Francesca Beaudoin, M.D. (2013). NIH RO3: “Chronic Opioid Use, Pain Sensitivity and 
Acute Pain in the Emergency Department.” My role: Consultant.
6.
Elkanah Omenge Orango, M.D. (2013). CFAR Supplement: “Cryotherapy and HIV Genital 
Shedding.” My role: Mentor. 
7.
Nick Zaller, Ph.D. (2013). CFAR Supplement: “HIV treatment cascade among HIV+ person 
in community corrections (tentative title).” My role: Consultant. 
8.
Elkanah Orango, MD. (2013). International CFAR Developmental Award: “Outcome of ex-
cisional treatment for cervical neoplasia in HIV infected and uninfected women in Western 
Kenya.” My role: Consultant.
!23

March 2015 
T. LIU, PhD
                                                                                                                                                                            
9.
Kevin Dushay, M.D. (2012). CFAR Developmental Grant: “The prevalence of obstructive 
airway disease and the burden of chronic respiratory symptoms in HIV subjects enrolled in 
care in Kenya.” My role: Consultant.
10. Rana Aadia, M.D. (2012). K-23 Award: “Improving Retention in Care Among Postpartum 
HIV-infected Women in Mississippi.” My role: Mentor.
11. Willoughby Britton, Ph.D. (2012). K-Award (NCCAM): “Dismantling Mindfulness: Contribu-
tions of Attention vs. Acceptance.” My role: Consultant.
12. Becky Genberg, PhD. (2012). K-Award: “Linkage to care following home-based counseling 
and testing for HIV in western Kenya.” My role: Consultant.
13. Michelle Mellion, MD. (2011). CFAR Developmental Award: “The effect of alcohol on CSF 
cytokine concentrations in patients with HIV and its association with neuro-cognitive dis-
turbances.” My role: Consultant.
14. Philips Chan, MD. (2011). K-Award: “Molecular Epidemiology of HIV Transmission Net-
works”. My role: Consultant.
15. Adrian Garder, MD. (2011). CFAR Developmental Award: “Implementation of GeneXpert® 
for evaluation of HIV positive TB suspects previously treated for TB in Western Kenya.” My 
role: Consultant.
16. Ammy Nunn, PhD. (2010). K-Award: “Exploring Patterns of Sexual Concurrency Among 
Urban African Americans.” My role: Consultant.
17. Rosemarie Martin, PhD (2010). Developmental Award: “Contingency Management for 
Drug Use in HIV+ Adults after Prison or Jail Release”. My role: Consultant.
18. Philips Chan, MD. (2010). Burroughs Wellness Grant: “Association of human leukocyte 
antigen and the development of antiretroviral drug resistance in HIV-1 infection”. My role: 
Consultant
19. Erna Kojic, MD (2009). K-Award: “HPV and related diseases in HIV infected women”. My 
role: Consultant.
20. Michael Waxman, MD (Assistant Professor of Emergency Medicine) (2007). The Brown 
Department of Emergency Medicine Junior Faculty Research Award. My role: Consultant.
21. Brenna Anderson, MD (Assistant Professor of Obstetrics & Gynecology) (2007). Develop-
mental Award: “Effect of trichomoniasis therapy on genital HIV viral burden among African 
women”. My role: Consultant.
SOFTWARES
1.
R-package: TVLT (Targeted testing under cost constraints); alpha-version. 
PROFESSIONAL SOCIETIES
1.
The American Association for the Advancement of Science (AAAS). 
2.
International Biometric Society
3.
American Statistics Association (ASA).
4.
The Tau Beta Pi Honor Society.
!24

March 2015 
T. LIU, PhD
                                                                                                                                                                            
HOBBIES
Soccer; beekeeping; carpentry; organic gardening. 
  
!25

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 2: 
Revised MB-BP Recruitment Card 
with track changes 
 
 

RESEARCH STUDY: 
MINDFULNESS-BASED 
INTERVENTION 
FOR BLOOD PRESSURE REDUCTION 
 
 
Free to qualified participants 
 
For more information on our research study, or to see if you 
qualify, call contact the Brown University Mindfulness & 
Cardiovascular Health Lab at 401-369-0443400-4768 (call or 
text), or email: mindfulness@brown.edu. 
 
Brown University 
School of Public Health 

 
This is a 9-week program that includes 
mindfulness meditation, mindful movements, 
education about hypertension, and support for 
reducing hypertension risk factors. The study 
is testing whether this intervention lowers 
blood pressure. The program course consists 
of nine weekly sessions that are 2.5 hours, 
and as well as an all-day weekend retreat. 
People who have a current regulation regular 
meditation practice (i.e. meditate more than 
once per week) are not eligible. 
  
Research participation includes interviews, 
questionnaires and health measurements, 
such as of blood pressure, height, and weight, 
and waist circumference,, completed both 
before and after the meditation program. 
 
 
Contact: For more information, or to see if you 
qualify, call contact the Brown University 
Mindfulness & Cardiovascular Health Lab 
at  401-369-0443401-400-4768 (call or text) or 
email at mindfulness@brown.edu. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 3: 
Revised MB-BP Recruitment 
Card and Flyer - clean copies 
 
 

MINDFULNESS-BASED 
INTERVENTION 
FOR BLOOD PRESSURE REDUCTION 
 
 
 
 
Free to qualified participants 
 
For more information on our research study, or to see if 
you qualify, contact the Brown University Mindfulness & 
Cardiovascular Health Lab at 401-400-4768 (call or text), 
or email: mindfulness@brown.edu. 
 
Brown University 
School of Public Health 

 
This is a 9-week program that includes free 
training in mindfulness meditation, mindful 
movements, education about hypertension, 
and support for reducing hypertension risk 
factors. The study is testing whether this 
intervention lowers blood pressure. The 
course consists of nine weekly sessions that 
are 2.5 hours, as well as an all-day weekend 
retreat. People who have a current regular 
meditation practice (i.e. meditate more than 
once per week) are not eligible. 
  
Research participation includes interviews, 
questionnaires and health measurements, 
such as blood pressure, height, and weight, 
completed both before and after the 
meditation program. 
 
 
Contact: For more information, or to see if 
you qualify, contact the Brown University 
Mindfulness & Cardiovascular Health Lab at  
401-400-4768 (call or text) or email at 
mindfulness@brown.edu. 

MINDFULNESS-BASED INTERVENTION 
FOR BLOOD PRESSURE REDUCTION 
 
  
Free to qualified participants 
 
This is a 9-week program that includes free training in mindfulness meditation, mindful 
movements, education about hypertension, and support for reducing hypertension risk 
factors. The research study is testing whether this intervention lowers blood pressure. 
The course consists of nine weekly sessions that are 2.5 hours, as well as an all-day 
weekend retreat. People who have a current regular meditation practice (i.e. meditate 
more than once per week) are not eligible. 
  
Research participation includes interviews, questionnaires and health measurements, 
such as blood pressure, height, and weight, completed both before and after the 
meditation program. 
 
Contact: For more information, or to see if you qualify, contact the Brown University 
Mindfulness & Cardiovascular Health Lab at: 401-400-4768 (call or text) or 
email: mindfulness@brown.edu. 
Brown University  
School of Public Health 
 
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  
Mindfulness Blood Pressure Study 
Call/Text: 401-400-4768 
Email: mindfulness@brown.edu  

 
 
 
 
 
 
 
 
 
Appendix 4: 
MB-BP Study Facebook 
Page Screenshots 
 
 

 
 
 
 
 
 
 
Appendix 5: 
MB-BP Study Twitter 
Account Screenshots  
 
 

Mindfulness-Based Blood Pressure Reduction Study – Twitter Account 
Below is a screenshot from the MB-BP Twitter Page 
 
 
Note: that the current privacy setting is set so that no one can see the MB-BP tweets. This setting will remain in effect until IRB 
approval has been received. 
 
 

 
 
 
 
 
 
 
 
Appendix 6: 
MB-BP Study Craigslist 
Advertisement Screenshots  
 
 

Mindfulness-Based Blood Pressure Reduction Study – Craigslist Advertisement  
Screenshots of the MB-BP Craigslist Advertisement is shown below. 
 
 
 
 

 
 
 
 
 
 
 
 
Appendix 7: 
MB-BP Study webpage 
screenshots  
 
 

Mindfulness-Based Blood Pressure Reduction Study Webpage – Brown University  
Screenshots of the MB-BP study webpage are shown below. 
 
 
HOME PAGE: 
 
 
 

SUB-PAGES: 
 
 
 
 
 

CONTACT US PAGE: 
 
 

Mindfulness-Based Blood Pressure Reduction Study Webpage 
The MB-BP study webpage is found within the Mindfulness and Cardiovascular Health Lab Website.  The 
Mindfulness CV and Health Lab main page is shown below. Note that there is MB-BP content within the 
General Update section. This section can be used to draw attention to study enrollment phases. 
 
 
 
 
 
 

Mindfulness-Based Blood Pressure Reduction Study Webpage 
The MB-BP study webpage is shown below.  
 
 
 
 

MB-BP Webpage settings are shown below: 
 
 
 

 
 
 
 
 
 
 
 
 
 
Appendix 8: 
Week 4:  Goal Related to Diet, Alcohol Consumption, Physical 
Activity, or Stress Reaction/Response -  
with Track Changes (v.1.1) 
 
 
 

Goal Daily Record Form – MB-BP Week 4, Version 1.1, April 25, 2016 
Page 1 of 5 
Deleted: August 31, 2015
Participant ID#________ 
 
Week 4: Goal Related to Diet, Alcohol Consumption, Physical Activity, 
or Stress Reaction/Response 
 
 
W4_GO_1. What is your goal related to diet, alcohol consumption, physical activity, or stress 
reaction/response for the week?  
 
 
 
W4_GO_2. On a scale of 1-10, where 10 is high, how MOTIVATED are you to achieve this goal?  
 
 
 
 
W4_GO_3. On a scale of 1-10, how CONFIDENT are you that you will achieve the goal?  
 
 
 
 
 
W4_GO_4. What could you do that would bring your motivation or confidence a little higher?  
 
 
 
 
 
 
 
W4_GO_5. What might make it difficult to achieve the goal this week, and if that happens, what will 
you do?  
 
 
 
 
 
 
 
W4_GO_6. What is a way to measure this goal that resonates with you? 
 
 
 
 
 

Goal Daily Record Form – MB-BP Week 4, Version 1.1, April 25, 2016 
Page 2 of 5 
Deleted: August 31, 2015
Day/Date 
Event related 
to goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were there 
before, during and after 
this event? 
How did it 
contribute, or not, 
to achieving the 
goal?  
What thoughts 
are in your mind 
now as you write 
about this event? 
Mon 
Date: 
W4_GO_D1_1. 
 
 
 
W4_GO_D1_2a. 
Before: 
 
 
 
W4_GO_D1_2b. 
During: 
 
 
 
 
W4_GO_D1_2c. 
After: 
 
 
 
 
W4_GO_D1_3a. 
Before: 
 
 
 
W4_GO_D1_3b. 
During: 
 
 
 
 
W4_GO_D1_3c. 
After: 
 
 
 
 
W4_GO_D1_4. 
 
W4_GO_D1_5. 
 
 
 
Deleted: W4_GO_7. Goal for This Week 
Related to Diet, Alcohol Consumption, 
Physical Activity or Stress 
Reaction/Response: 
__________________________________
__________________________________
_________________¶
__________________________________
__________________________________
_________________¶
__________________________________
__________________________________
_________________¶
¶
W4_GO_8. How Goal Will Be Measured:¶
__________________________________
__________________________________
_________________¶
__________________________________
__________________________________
_________________¶
__________________________________
__________________________________
_________________¶
¶
¶
¶
Comment [SF1]: W4_GO_7 and 
W4_GO_8 were removed b/c of 
redundancy 

Goal Daily Record Form – MB-BP Week 4, Version 1.1, April 25, 2016 
Page 3 of 5 
Deleted: August 31, 2015
 
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Tues 
Date: 
W4_GO_D2_1. 
 
W4_GO_D2_2a. 
Before: 
 
 
 
W4_GO_D2_2b. 
During: 
 
 
 
 
W4_GO_D2_2c. 
After: 
 
 
 
W4_GO_D2_3a. 
Before: 
 
 
 
W4_GO_D2_3b. 
During: 
 
 
 
 
W4_GO_D2_3c. 
After: 
 
 
W4_GO_D2_4. 
 
W4_GO_D2_5. 
 
Wed 
Date: 
W4_GO_D3_1. 
 
W4_GO_D3_2a. 
Before: 
 
 
 
W4_GO_D3_2b. 
During: 
 
 
 
 
W4_GO_D3_2c. 
After: 
 
 
 
W4_GO_D3_3a. 
Before: 
 
 
 
W4_GO_D3_3b. 
During: 
 
 
 
 
W4_GO_D3_3c. 
After: 
 
 
W4_GO_D3_4. 
 
W4_GO_D3_5. 
 
Comment [SF2]: Corrected the cut and 
paste error on variables shown below 
Deleted: W4_GO_D2_1.¶
Deleted: 2a
Deleted: 2
Deleted: 2
Deleted: 3a
Deleted: Before:¶
¶
¶
¶
W4_GO_D2_3b.¶
During:¶
¶
¶
¶
W4_GO_D2_3c.¶
After:¶
Deleted: 4
Deleted: W4_GO_D3_1.¶
¶
...
Deleted: W4_GO_D3_2a.¶
Before:¶
...
Deleted: W4_GO_D3_3a.¶
Before:¶
¶
¶
¶
W4_GO_D3_3b.¶
During:¶
¶
¶
¶
¶
W4_GO_D3_3c.¶
After:¶
...
Deleted: W4_GO_D3_4.¶

Goal Daily Record Form – MB-BP Week 4, Version 1.1, April 25, 2016 
Page 4 of 5 
Deleted: August 31, 2015
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Thurs 
Date: 
W4_GO_D4_1. 
 
W4_GO_D4_2a. 
Before: 
 
 
 
W4_GO_D4_2b. 
During: 
 
 
 
 
W4_GO_D4_2c. 
After: 
 
 
 
W4_GO_D4_3a. 
Before: 
 
 
 
W4_GO_D4_3b. 
During: 
 
 
 
 
W4_GO_D4_3c. 
After: 
 
 
W4_GO_D4_4. 
 
W4_GO_D4_5. 
 
Fri 
Date: 
W4_GO_D5_1. 
 
W4_GO_D5_2a. 
Before: 
 
 
 
W4_GO_D5_2b. 
During: 
 
 
 
 
W4_GO_D5_2c. 
After: 
 
 
 
W4_GO_D5_3a. 
Before: 
 
 
 
W4_GO_D5_3b. 
During: 
 
 
 
 
W4_GO_D5_3c. 
After: 
 
 
W4_GO_D5_4. 
 
W4_GO_D5_5. 
 
Deleted: W4_GO_D4_1.¶
¶
¶
Deleted: W4_GO_D4_2a.¶
Before:¶
¶
¶
¶
W4_GO_D4_2b.¶
During:¶
¶
...
Deleted: W4_GO_D4_3a.¶
Before:¶
¶
¶
¶
W4_GO_D4_3b.¶
During:¶
¶
¶
¶
¶
W4_GO_D4_3c.¶
After:¶
¶
¶
Deleted: W4_GO_D4_4.¶
Deleted: W4_GO_D5_1.¶
¶
¶
Deleted: W4_GO_D5_2a.¶
Before:¶
¶
¶
...
Deleted: W4_GO_D5_3a.¶
Before:¶
¶
¶
...
Deleted: W4_GO_D5_4.¶

Goal Daily Record Form – MB-BP Week 4, Version 1.1, April 25, 2016 
Page 5 of 5 
Deleted: August 31, 2015
Day/Date 
Event related to 
goal 
How did your body 
feel, in detail, before, 
during and after this 
experience? 
What moods, feelings, 
and thoughts were 
there before, during 
and after this event? 
How did it contribute, 
or not, to achieving 
the goal?  
What thoughts are 
in your mind now 
as you write about 
this event? 
Sat 
Date: 
W4_GO_D6_1. 
 
W4_GO_D6_2a. 
Before: 
 
 
 
W4_GO_D6_2b. 
During: 
 
 
 
 
W4_GO_D6_2c. 
After: 
 
 
 
W4_GO_D6_3a. 
Before: 
 
 
 
W4_GO_D6_3b. 
During: 
 
 
 
 
W4_GO_D6_3c. 
After: 
 
 
W4_GO_D6_4. 
 
W4_GO_D6_5. 
 
Sun 
Date: 
W4_GO_D7_1. 
 
W4_GO_D7_2a. 
Before: 
 
 
 
W4_GO_D7_2b. 
During: 
 
 
 
 
W4_GO_D7_2c. 
After: 
 
 
 
W4_GO_D7_3a. 
Before: 
 
 
 
W4_GO_D7_3b. 
During: 
 
 
 
 
W4_GO_D7_3c. 
After: 
 
 
W4_GO_D7_4. 
 
W4_GO_D7_5. 
 
 
Deleted: W4_GO_D6_1.¶
¶
¶
Deleted: W4_GO_D6_2a.¶
Before:¶
¶
¶
¶
W4_GO_D6_2b.¶
During:¶
¶
¶
...
Deleted: W4_GO_D6_3a.¶
Before:¶
¶
¶
¶
W4_GO_D6_3b.¶
During:¶
¶
¶
¶
W4_GO_D6_3c.¶
After:¶
¶
¶
Deleted: W4_GO_D6_4.¶
Deleted: W4_GO_D7_1.¶
¶
¶
Deleted: W4_GO_D7_2a.¶
Before:¶
¶
¶
...
Deleted: W4_GO_D7_3a.¶
Before:¶
¶
¶
...
Deleted: W4_GO_D7_4.¶

 
 
 
 
 
 
 
 
 
Appendix 9: 
Revised Phone Screener  
with Track Changes 
 
(v.1.5– April 14, 2016) 
 
 
 
 
 
 
 
 
 
 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 1 of 9 
Deleted: MBHT 
 
 
 
 
 
 
 
PHONE-DELIVERED SCREENING 
QUESTIONNAIRE  
 
 
 
 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 2 of 9 
Deleted: MBHT 
PHONE SCREENING QUESTIONNAIRE - PART 1 of 2 
 
The script is shown below in bold italics.  
 
PID. Participant ID: ___________ 
 
SQ01. Staff ID: ______________ 
 
SQ02. Today’s Date (MMDDYY): ________________ 
 
SQ03. Current Time (24 hour time, e.g. 14:45): ________ 
 
Please now call the participant.  
 
SQ04. Was the participant reached?   YES   NO 
 
Hello, my name is ____________. I am calling from the Brown University School of Public 
Health because (name of participant) expressed interest in participating in our 
mindfulness blood pressure study. Is he/she available to talk at this time? 
 
I would like to do a 10-15 minute phone interview with you to determine if you are a good 
match for this particular study.  
 
SQ05. Is now a good time to speak? 
 
[If yes, proceed to SQ05 script below] 
 
If no… When would be a good time to talk? 
 
SQ06. Day to call back (DDMMYY) ____________ 
 
SQ07. Time to call back ______ AM/PM 
OK, great. I’m going to give you a quick overview of the study first and can then move on 
to the screener to see if you may qualify. Feel free to interrupt me at any point if you have 
a question. Okay? 
STUDY OVERVIEW: In this study, we are looking to see if mindfulness practices improve 
blood pressure, and if education about hypertension risk factors may also improve blood 
pressure. If eligible, we will provide you with training in meditation, mindful movements, 
and the roles of things like diet, physical activity and medication in reducing blood 
pressure. 
You will be taught by a very experienced teacher who is an expert in these fields. The 
course is free and will take place over a 9-week period, where you come to a class once 
each week for 2.5 hours each time. There is also a one-day weekend retreat that will be 
7.5 hours long. [Go over days / times of course and retreat ] 
As part of the project, we will also ask you to participate in health assessments before 
and after the study. Health assessments include measures such as blood pressure, 
Deleted: How about I
Deleted: answer any questions you 
may have to see if it is a good fit for 
you. We will then go through a 
screening questionnaire to see if you 
qualify for the study. Does this sound 
OK?
Deleted: on a Saturday 
Deleted: 8 
Comment [SF1]: Retreat is 7.5hrs long 
and can be on a Saturday or a Sunday. 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 3 of 9 
Deleted: MBHT 
height and weight, and questionnaires about your health and experiences.  At the end of 
the study, you will be given $100 USD to express our gratitude. Do you have any 
questions about the study? [Answer questions] 
SQ08. Does this study sound like something you would be interested in doing? Yes  No 
[If yes, proceed to next statement below. If no, politely thank the participant for considering 
being in this study, and end the call].  
Great. There are a few things that I would like to go over before we start the interview. 
First, some of the questions that I will ask now to figure out if you are eligible to be in 
this study will be of personal nature, including asking about your mental health and life’s 
experiences.  
 
SQ09. Are you in a private place to talk? 
 
[If yes, proceed to text below. If no, reschedule meeting using variables SQ06 and SQ07 above].  
 
 Because this interview is of a personal nature, it is important that you understand that 
everything you say will be kept strictly confidential.  No one outside of our project will 
ever be able to see your answers, and we will not keep your name in the same place as 
any of your answers. If you are not eligible after the phone screen, we will destroy your 
information.  If you like, though, we can keep your information on file for future studies. 
 
Ok, to begin, I am going to start by recording your name and contact information. 
 
SQ10. Participant’s First Name:  ____________________________________ 
 
SQ11. Participant’s Last Name:______________________________________ 
 
Participant’s Address (in case we need to send any study materials to you): 
SQ12a. Street address: _____________ 
SQ12b. City: ____________________ 
SQ12c: State: ________ 
SQ12d: Zip Code: ________________ 
 
SQ13a. Participant’s Phone number #1 (in case we need to contact you by phone) 
____________________________________  Type of Phone: work / home / cell / other 
 
SQ13b. Participant’s Phone number #2 
____________________________________  Type of Phone: work / home / cell / other 
 
 
SQ14. Participant’s email address (or mailing address if no email):______________________ 
 
SQ15. Notes from interviewer related to participants’ contact information (if any): 
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________ 
 
Deleted: make clear
Deleted: First of all, s
Comment [SF2]: Type of phone was 
added so that communication with 
participants can be more informed. 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 4 of 9 
Deleted: MBHT 
PHONE SCREENING QUESTIONNAIRE - PART 2 of 2 
 
PID. Participant ID #: ______________ 
 
SQ.recruit  
How did you find out about the study? Select one. 
 
From a friend / family member / coworker ...................................... [   ] 
From a former or current participant ............................................... [   ] 
From PCP or other health care provider ........................................ [   ] 
Facebook ........................................................................................ [   ] 
Twitter.............................................................................................. [   ] 
Craigslist ......................................................................................... [   ] 
Saw an orange flier / card (note location __________) ................. [   ] 
Other (please describe ___________________________) .......... [   ] 
 
 
INCLUSION CRITERIA: All answers in 3rd column must be YES. If an answer is NO, 
immediately proceed to question SQ40. 
 
 
 
Comments 
SQ26. 
 
What is your age? [Is age at least 18 
years?] 
 
 
 
 
YES 
NO 
 
 
SQ27. 
Can you read and write in English? 
YES 
NO 
 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40.  
 
 
 
Comments 
I will now start to ask some questions about your mental health. 
 
SQ28. 
Has anyone ever told you that you have bipolar 
disorder or manic depression?  
YES 
NO  
 
SQ29. 
Has anyone ever used the word “Borderline” to 
describe you? 
YES 
NO  
 
SQ30a. 
 
 
 
SQ30b. 
Have you ever had a hallucination or seen things 
that other people can’t see, or hear things other 
people can’t hear?  
 
Have you ever been diagnosed with 
schizophrenia or psychosis? 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
SQ31_1 
SQ31_2 
SQ31_3 
SQ31_4 
SQ31_5 
SQ31_6 
SQ31_7 
SQ31_8 
Have you ever taken any of the following 
medications that I am about to read to you?  
Lithium                               
Seroquel (quetiapine) 
Abilify (aripiprazole)           
Zyprexa (olanzapine) 
Clozaril (clozapine)           
Haldol/Haloperidol 
Geodon (ziprasidone)         
Risperdal (risperidone) 
 
 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
YES 
NO   DK 
 
Comment [SF3]: For internal tracking to 
know how best to recruit 
Comment [SF4]: Use of Facebook, 
Twitter, and Craigslist are subject to IRB 
approval 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 5 of 9 
Deleted: MBHT 
SQ32a 
 
SQ32b 
 
 
SQ32c 
 
 
 
 
SQ32d 
 
 
Have you ever had a suicide attempt?  
 
[If yes, ask…] Have you considered killing 
yourself during the past month?  
 
[If yes, ask…] Are you currently suicidal? 
 
[If yes, keep participant on the phone, and follow 
suicide safety plan below] 
 
[If no, ask…] Are you getting any help for that? If 
not, then provide list of resources from Safety 
Plan including Gateway, Anchor and The 
Providence Center] Not urgent, but inform Dr. 
Flynn about what was discussed.  
YES 
NO 
 
YES 
NO 
 
 
 
YES 
NO 
 
 
 
 
YES 
NO 
 
 
 
 
EXCLUSION CRITERIA: All answers in 3rd column must be NO with the exception of SQ32a and 
SQ33a. If an answer (other than SQ32a and SQ33a) is YES, then immediately proceed to 
question SQ40. 
SQ33a 
 
SQ33b 
 
SQ33c 
Would you say you have a trauma history?  
[If yes…]  
In the past month, have you had any 
problems with dissociation (memory loss)?  
In the past month, have you had any 
flashbacks (i.e. sudden and disturbing vivid 
memory) about the trauma?  
YES 
NO 
 
YES 
NO 
 
YES 
NO 
 
 
 
SQ34a 
 
 
 
 
SQ34b 
In the past month, have you had any 
problems with obsessions or compulsions, 
such as washing your hands or checking the 
oven over and over again?  
[If yes…] Has anyone diagnosed you with 
obsessive compulsive disorder? 
YES      NO 
 
 
 
 
YES 
NO 
 
SQ35 
In the past month, have you had a panic 
attack (i.e. sweating, heart palpitations, 
nausea, trouble breathing, fear of 
dying/choking/going crazy)?  
YES 
NO 
 
SQ36 
Have you had any problems with alcoholism 
or drug use in the past year? 
YES 
NO 
 
SQ37 
In the past year, have you had an eating 
disorder, such as starving, binge eating, or 
vomiting?  
YES 
NO 
 
SQ38a 
 
 
 
SQ38b 
 
 
Do you currently have a mindfulness practice, 
such as meditation or yoga? 
 
If Yes –  
Please tell me more about your mindfulness 
practice, including how often you practice per 
week.  
YES 
NO 
 
 
Fill in 
response in 
comments 
section to 
 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 6 of 9 
Deleted: MBHT 
 
 
SQ38c 
 
 
Do you currently practice meditation more 
than once per week? (yoga does not count as 
meditation in this context) 
the right  
 
 
YES 
NO 
 
SQ39 
This class will take place at Brown University 
in-person. Do you have any medical or 
mobility issues that would affect you being 
able to attend class? 
YES 
NO 
 
SQ40 
Participant qualifies for next step of study (next 
step is 1st blood pressure screening) 
YES 
NO 
 
If YES go 
to SQ41.  
 
If NO, go to 
SQ42.  
 
 
SQ41a. Thank you for taking the time to answer these questions. You qualify for the next 
stage of screening, which is to take your blood pressure at our office. If you’re still 
interested, we’d like to schedule a time to have you come in to complete the in-person 
screener.  It will only take 30 minutes or less and will involve taking your blood pressure 
3-5 times, as well as measuring your height and weight.  Is there a day or time that works 
best for you?  [Schedule the In-Person Screening visit now] 
 
SQ41b. As I mentioned earlier, there is a mindfulness intervention that is part of this 
study.  If you are eligible based on the In-Person screening, you will then be invited to 
take part in a 9 week Mindfulness Course.  We will be scheduling the mindfulness 
intervention at a time that works best with most of the participants. What days and times 
of the week typically work best with your schedule? Please keep in mind that the 
sessions are 2.5 hours long, and take place once per week for 9 weeks.  
 
[Record participant’s availability for Intervention and then proceed with the script] 
 
Thank you for your time and interest in this study. We look forward to meeting you in 
person on [DATE / TIME]. Do you have any questions before we end this call?  
 
 
 IF INELIGIBLE: 
SQ42a. Thank you for taking the time to answer these questions. According to the 
survey, you do not qualify for the study at this time. There may be other studies you 
quality for.  
 
SQ42b. Would you like me to keep your information to pass on to these studies?  YES /  
NO 
 
SQ42c. [If yes…] OK, thank you. We will keep this information for future studies you 
may qualify for. Thank you for taking the time to talk with me today. Can I answer any 
questions before hanging up? 
 
Comment [SF5]: These measures were 
moved to the In-Person screener from the 
In-Person Baseline. 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 7 of 9 
Deleted: MBHT 
SQ42d. [If no…] OK, our copy of this information will be destroyed. Thank you for 
taking the time to talk with me today. Can I answer any questions before hanging up? 
 
 
 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 8 of 9 
Deleted: MBHT 
SAFETY PLAN 
 
Enter details below on paper during screening (These variables should are also be entered in 
the survey via questions SQ10-SQ13). Destroy this paper after screening is complete.  
 
Participant’s First Name:  ____________________________________ 
 
Participant’s Last Name:______________________________________ 
 
Participant’s Address: 
 
Street address: _____________ 
 
City: ____________________ 
 
State: ________ 
 
Zip Code: ________________ 
 
Participant’s Phone number #1: ____________________________________ 
 
Participant’s Phone number #2____________________________________ 
 
During the phone-based screening, if participants respond yes to “Are you currently suicidal?”, 
the interviewer should perform the following 2 steps: 
 
1. Immediately have 911 and Dr. Ellen Flynn called by a colleague who has been 
informed beforehand that this is a possibility.  
 
Specifically, while keeping the participant on the phone, show the text below in the box 
to a colleague.  
 
I have a study participant on the phone who is currently suicidal. Please call 911 
immediately, and tell them: 
 
“I am calling on behalf of [my name] who is performing a research study at Brown 
University. He has a participant on the phone who says they are currently suicidal.” 
Please provide the participants’ contact information to the 911 operator (i.e. name, 
address, phone #, email address) as requested. This information is shown above.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know what you are doing. 
Specifically, let them know we are calling our study’s psychiatrist Dr. Flynn and 911, 
and why you are doing that (i.e. because we are concerned about you). You can speak 
with participant to keep him/her on the phone, but the discussion should not be 
clinical in nature.   
 

MB-BP Phone Screener, Version 1.5, April 14, 2016      
                Page 9 of 9 
Deleted: MBHT 
Examples of questions that could be asked in order to keep them on the phone: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
• 
Tell me more about why you are interesting in being part of this study.  
• 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants if they state they have had 
considered killing themselves in the past month. If they are currently suicidal, the main priority is 
to keep them on the phone while 911 and Dr. Flynn are being contacted.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 

 
 
 
 
 
 
 
 
Appendix 10: 
Revised In-Person Screener  
with Track Changes 
 
(v.1.5– April 14, 2016) 
 
 
 
 

MB-BP In-Person Screening, Version 1.5, April 14, 2016      
                Page 1 of 3 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
 
 
 
 
 
IN-PERSON SCREENING  
ASSESSMENT FORM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MB-BP In-Person Screening, Version 1.5, April 14, 2016      
                Page 2 of 3 
Deleted: MBHT 
Deleted: December 21, 2015
PID. Participant ID # __________ 
BA01. Staff ID # __________ 
BA02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
BA04. Were the 2nd and 3rd systolic blood pressure readings within 20 mmHg of each other? 
□ Yes 
□ No (repeat measurements)  
 
BA05. Were the 2nd and 3rd diastolic blood pressure readings within 10 mmHg of each other? 
□ Yes 
□ No (repeat measurements) 
 
BA06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  _________ mmHg 
BA06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
 
Blood Pressure Safety Protocol – The out-of-range blood pressure values are as follows: systolic blood 
pressure >200 mmHg or <90 mmHg; diastolic blood pressure >110 mmHg.  
 
In absence of symptoms (chest pain, shortness of breath, dizziness, headache), for a SBP>200 or DBP>110 
or both, we will strongly encourage participants to see their doctor right away or to go to urgent care. If there 
are symptoms, we will immediately call 911. 
 
In absence of symptoms (chest pain, shortness of breath, dizziness, passing out), for a SBP<90, we will 
strongly encourage participants to see their doctor right away or to go to urgent care. If there are symptoms, 
we will immediately call 911. 
 
 
BA07. Blood pressure cuff size used:  □ S     □ Reg    □  L        □ XL 
 
BA08. Arm that cuff was placed on: 
 □ L      □  R 
 
 
Deleted: 2_
Comment [SF1]: Variable numbering was 
off. Should be “BA##” not “BA02_##”. 
Changed for all. 
Comment [SF2]: This is part of our Safety 
Monitoring Plan, which is also reported to the 
NCCIH 

MB-BP In-Person Screening, Version 1.5, April 14, 2016      
                Page 3 of 3 
Deleted: MBHT 
Deleted: December 21, 2015
ELIGIBILITY OUTCOME - based on the average of the 2nd and 3rd BP (repeat) readings, note 
the participant’s eligibility below and read the corresponding script: 
 
Not Eligible: mean systolic BP < 120mmHg AND mean diastolic BP < 80mmHg 
 
Unfortunately, at this time you are not eligible for the study. If participant is 
interested, we can keep his/her contact information on file for future studies.  
END ASSESSMENT. 
 
Eligible:  mean systolic BP ≥ 120mmHg OR mean diastolic BP ≥ 80mmHg 
 
Congratulations, you are eligible for the study! At this time we would like to take 
your height and weight, ask a few follow up questions and go over the next 
steps of the study.   Note that if the participant does not wish to continue, thank the 
participant for his/her time and then END THE ASSESSMENT. Otherwise, continue 
below. 
 
 
BA09. Height: 
______ . __ cm (one decimal place) 
 
 
 
BA10. Weight: 
______ . __ lbs (one decimal place) 
 
 
 
 
 
BA11. What is your date of birth?  _____ / _____/ _____  [mm/dd/yyyy] 
 
 
BA12. How old are you?: ______ years 
 
 
BA13. Is participant male or female? 
□ Male 
□ Female  
□ Unknown 
 
 
BA14. Do you currently take any prescription medications to reduce blood pressure? 
□ Yes – go over eCAP protocol; equipment will be given to participant at baseline 
□ No  
 
 
Go over the next phase of the study, including discussing the Fitbits and eCAPs (if 
applicable).  Before participant leaves, schedule the in-person baseline assessment (must be 
within 1-3 weeks of the scheduled intervention) or have the Project Coordinator follow up to 
schedule. 
 
END ASSESSMENT 
 
 
Comment [SF3]: Scripts were added for 
ease of administration. The actual eligibility 
criteria has NOT been changed. 
Comment [SF4]: Height and weight were 
moved here from the In-Person Baseline 
assessment. These variables are needed in 
order to set up the Fitbit equipment, which is 
given to participant at baseline. 
Comment [SF5]: This information is needed 
to set up the Fitbit and eCAP equipment. This 
was moved here from the In-Person Baseline 
so that the equipment could be set up prior to 
the baseline assessment rather than during 
the assessment in order to save the 
participant time at baseline. 

 
 
 
 
 
 
 
 
Appendix 11: 
Revised In-Person Baseline Assessment  
with Track Changes 
 
(v.1.5– April 22, 2016) 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 1 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
 
 
 
 
 
IN-PERSON BASELINE  
QUESTIONNAIRE AND ASSESSMENT FORMS 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 2 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
PID. Participant ID # __________ 
BA01. Staff ID # __________ 
BA02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
 
BA04. Were the 2nd and 3rd systolic blood pressure readings within 20 mmHg of each other? 
□ Yes 
□ No (repeat measurements)  
 
BA05. Were the 2nd and 3rd diastolic blood pressure readings within 10 mmHg of each other? 
□ Yes 
□ No (repeat measurements) 
 
BA06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
 
Blood Pressure Safety Protocol – The out-of-range blood pressure values are as follows: systolic blood 
pressure >200 mmHg or <90 mmHg; diastolic blood pressure >110 mmHg.  
 
In absence of symptoms (chest pain, shortness of breath, dizziness, headache), for a SBP>200 or DBP>110 
or both, we will strongly encourage participants to see their doctor right away or to go to urgent care. If there 
are symptoms, we will immediately call 911. 
 
In absence of symptoms (chest pain, shortness of breath, dizziness, passing out), for a SBP<90, we will 
strongly encourage participants to see their doctor right away or to go to urgent care. If there are symptoms, 
we will immediately call 911. 
 
BA07. Blood pressure cuff size used: 
 □ S     □ Reg    □  L        □ XL 
 
BA08. Arm that cuff was placed on: 
  □ L      □  R 
 
BA10. Weight: 
______ . __ lb (one decimal place) 
 
 
 
 
 
 
 
Comment [SF1]: This is part of our Safety 
Monitoring Plan, which is also reported to the 
NCCIH 
Deleted: BA09. Height: ______ . __ cm 
(one decimal place)
Comment [SF2]: Height was moved to the 
In-Person Screener. 
Deleted: kg
Comment [SF3]: Weight is measured in 
pounds not kilograms on our study scale. 
Deleted: Waist Circumference:   
Comment [SF4]: Waist Circumference was 
dropped as a measure due to too much 
variability in measurement and to reduce 
participant burden. 
Deleted: ¶
BA11a. Measurement 1 ______ . __ cm 
(one decimal place)¶
BA11b. Measurement 2 ______ . __ cm 
(one decimal place)¶
¶
BA12. Is the difference between 
Measurement 1 and Measurement 2 
greater than 1.0cm? ¶
□ Yes (repeat measurements 3&4) ¶
□ No¶
¶
BA13a. Measurement 3 ______ . __ cm   ¶
BA13b. Measurement 4 ______ . __ cm¶

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 3 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
Medications (ME) 
 
 
ME01. Do you take any prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME02a. What is the name of the first prescription medication or over-the-counter drug that you take? 
 
 Label product name: 
______________________________________________________________________ 
 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
ME02b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME02c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 4 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME02d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME02f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME02g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME02h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME02i. Interviewer comments: 
_______________________________________________________________________ 
 
 
ME02j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
Deleted: ME02e. Total dosage per day. 
(Record strength of how it is actually 
taken, not how it is prescribed.)
Comment [SF5]: Total dosage per day 
(ME.2-10.e) was dropped to reduce 
participant burden since this variable can be 
calculated. 
Deleted: 
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)
¶
Section Break (Continuous)

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 5 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME03a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME03b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
ME03d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.) 
 
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 
Deleted: ME03c. How frequently do you 
take it?¶
<#>
Section Break (Continuous)
<#>_________ times per day ¶
<#>_________ times per week¶
<#>_________ times per month¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)
¶

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 6 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME03e.  Total dosage per day. (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME3f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME03g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
 
 
ME03h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME03i. Interviewer comments:  
__________________________________________________________________ 
 
 
ME03j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME04a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 
 Label product name: 
_____________________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 7 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME04b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME04c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME04d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME04f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
 
 
Deleted: ME04e.  Total dosage per day. 
(Record strength of how it is actually 
taken, not how it is prescribed.)
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)
¶

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 8 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME04g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME04h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME04i. Interviewer comments: 
 
________________________________________________________________________ 
 
ME04j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
section 
 Yes 
 Don’t know 
 Prefer not to answer
 
ME05a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME05b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 9 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME05c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME05d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME05f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME05g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME05h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME05i. Interviewer comments: 
________________________________________________________________________ 
 
 
ME05j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of end of 
medications questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
Deleted: ¶
Section Break (Continuous)
ME05e.  Total dosage per day. (Record 
strength of how it is actually taken, not 
how it is prescribed.)
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 10 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME06a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
__________________________________________________________________ 
 
 
 Label generic name: 
___________________________________________________________________ 
 Don’t know 
 
 
 Prefer not to answer 
 
ME06b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
ME06c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
ME06d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 11 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
 
ME06f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME06g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME06h. What is the medication used for? 
 
_______________________________________________________________________ 
 
 
ME06i. Interviewer comments: 
________________________________________________________________________ 
 
 
 
ME06i. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
ME07a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
_____________________________________________________________ 
 
 
 Label generic name: 
______________________________________________________________ 
  Don’t know  
 
 Prefer not to answer 
 
 
 
 
Deleted: ME06e.  Total dosage per day. 
(Record strength of how it is actually 
taken, not how it is prescribed.)
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 12 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME07b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME07c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME07d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 
ME07f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
 
 
Deleted: ME07e.  Total dosage per day. 
(Record strength of how it is actually 
taken, not how it is prescribed.)
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 13 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME07g For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME07h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME07i. Interviewer comments: 
____________________________________________________________________ 
 
ME07j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
ME08a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 Label product name: 
 
______________________________________________________________________ 
 
 Label generic name: 
 
______________________________________________________________________ 
 
 Don’t know  
 
 Prefer not to answer 
 
ME08b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 14 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME08c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME08d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME08f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
ME08g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME08h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME08i. Interviewer comments: 
___________________________________________________________________ 
 
 
ME08j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer
 
 
 
Deleted: ¶
ME08e.  Total dosage per day. (Record 
strength of how it is actually taken, not 
how it is prescribed.)
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 15 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME09a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
____________________________________________________________ 
 
 
 Label generic name: 
 
____________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
ME09b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME09c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
 
 
 
 
ME09d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 16 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
ME09f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME09g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME09h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME09i. Interviewer comments: 
___________________________________________________________________ 
 
ME09j. Do you take any other prescription medications or over-the-counter drugs? 
 No  skip to end of medications 
questions 
 Yes 
 Don’t know 
 Prefer not to answer 
 
ME10a. What is the name of the next prescription medication or over-the-counter drug that you take? 
 
 
 
 Label product name: 
______________________________________________________________________ 
  Label generic name: 
______________________________________________________________________ 
  Don’t know  
 Prefer not to answer 
 
 
 
 
Deleted: ME09e.  Total dosage per day. 
(Record strength of how it is actually 
taken, not how it is prescribed.)
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 17 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME10b. What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-disintegrating tablet 
 Liquid solution or suspension (drink, 
syrup) 
 Powder 
 
Topical 
 Liquid, cream, gel, or ointment 
 Ear drops (otic) 
 Eye drops (ophthalmic) 
 Skin patch (transdermal) 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, pessary) 
 
Other: 
 Don’t know 
 Prefer not to answer 
ME10c. How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
ME10d. What is the strength? (Record strength of how it is actually taken, not how it is prescribed.)
 _________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: 
_____________ 
 Don’t know 
 Prefer not to answer 
 
 
 
ME10f. Do you take it regularly or only as needed? 
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer
Deleted: ME10e.  Total dosage per day. 
(Record strength of how it is actually 
taken, not how it is prescribed.)
Section Break (Continuous)
<#>_________ %¶
<#>_________ mg¶
<#>_________ mcg¶
<#>_________ grams¶
<#>_________ I.U.¶
<#>_________ Other unit: 
_____________¶
<#>Don’t know¶
<#>Prefer not to answer¶
Section Break (Continuous)

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 18 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
ME10g. For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME10h. What is the medication used for? 
 
_______________________________________________________________________ 
 
ME10i. Interviewer comments: 
_______________________________________________________________ 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 19 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
FOOD FREQUENCY QUESTIONNAIRE:  
 
RA Script to be read to participants: At this time, we are going to have you complete a 
few forms on your own.  The first is a Food Frequency Questionnaire that will ask you 
about the types of foods and drinks that you consume.  It should take around 20 minutes 
to complete.  Please let me know if you have any questions. 
 
Comment [SF6]: To reduce participant 
burden we have dropped several of the 
variables collected on the Food Frequency 
Questionnaire. See attached document with 
mark up for FFQ variables that were dropped. 

r I 
a 
I 
DAao erinted ir U.S A
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- 1. Do you currently take multi-vitamins? (Please report other individual vitamins in question 2.)
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For each food listed, fill in the circle indicating how often on
average you have used the amount specified during the
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Yams or sweet potatoes (1/2 cupl
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Chicken or turkey, with skin 14-6 ozl
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ozl
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MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 20 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
Questions for Participants to Answer on Their Own In-Person on Paper: 
For each statement, please place a mark in the column that best describes how you 
have been feeling. 
 
Not at all 
or less 
than 1 day 
last week 
1 or 2 
days 
last 
week 
3 to 4 
days 
last 
week 
5 to 7 
days 
last 
week 
Nearly 
every day 
for two 
weeks 
I do not 
know 
I prefer 
not to 
answer 
DS_1. My appetite was poor. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_2. I could not shake off 
the blues. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_3. I had trouble keeping 
my mind on what I was doing. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_4. I felt depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_5. My sleep was restless. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_6. I felt sad. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_7. I could not get going. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_8. Nothing made me 
happy. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
C_9. I felt like a bad person. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_10. I lost interest in my 
usual activities. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_11. I slept much more 
than usual. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_12. I felt like I was moving 
too slowly. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_13. I felt fidgety. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_14. I wished I were dead. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_15. I wanted to hurt 
myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_16. I was tired all the 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_17. I did not like myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_18. I lost a lot of weight 
without trying to. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_19. I had a lot of trouble 
getting to sleep. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
DS_20. I could not focus on 
the important things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 21 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
Below is a list of common symptoms of anxiety. Please carefully read each item in the 
list. Indicate how much you have been bothered by that symptom during the past 
month, including today, by marking the box in the corresponding space in the column 
next to each symptom.  
 
 
 
 
 
 
 
 
 
Not At All 
Mildly – it 
didn’t 
bother me 
much 
Moderately – it 
wasn’t pleasant 
at all times 
Severely – 
it bothered 
me a lot 
I do not 
know 
I prefer 
not to 
answer 
BE_1. Numbness or tingling 
□ 
□ 
□ 
□ 
□ 
□ 
BE_2. Feeling hot 
□ 
□ 
□ 
□ 
□ 
□ 
BE _3. Wobbliness in legs 
□ 
□ 
□ 
□ 
□ 
□ 
BE _4. Unable to relax 
□ 
□ 
□ 
□ 
□ 
□ 
BE _5. Fear of worst happening 
□ 
□ 
□ 
□ 
□ 
□ 
BE _6. Dizzy or lightheaded 
□ 
□ 
□ 
□ 
□ 
□ 
BE _7. Heart pounding/racing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _8. Unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _9. Terrified or afraid 
□ 
□ 
□ 
□ 
□ 
□ 
BE _10. Nervous 
□ 
□ 
□ 
□ 
□ 
□ 
BE _11. Feeling of choking 
□ 
□ 
□ 
□ 
□ 
□ 
BE _12. Hands trembling 
□ 
□ 
□ 
□ 
□ 
□ 
BE _13. Shaky/unsteady 
□ 
□ 
□ 
□ 
□ 
□ 
BE _14. Fear of losing control 
□ 
□ 
□ 
□ 
□ 
□ 
BE _15. Difficulty in breathing 
□ 
□ 
□ 
□ 
□ 
□ 
BE _16. Fear of dying 
□ 
□ 
□ 
□ 
□ 
□ 
BE _17. Scared 
□ 
□ 
□ 
□ 
□ 
□ 
BE _18. Indigestion 
□ 
□ 
□ 
□ 
□ 
□ 
BE _19. Faint/lightheaded  
□ 
□ 
□ 
□ 
□ 
□ 
BE _20. Face flushed 
□ 
□ 
□ 
□ 
□ 
□ 
BE _21. Hot/cold sweats 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 22 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
After questionnaires are complete, participants will be asked to perform the following two 
computer-based tests: 
Sustained Attention to Response Task (15 minutes) 
 
The Sustained Attention to Response Task (SART) is a computerized test of sustained 
attention, response inhibition (executive function) and self-regulation. Subjects are instructed to 
press a key in response to rapidly displayed integers (1-9) and withhold response to a 
designated "no-go" integer. SART errors consist of summed commission errors (button press on 
no-go trial) and omission errors (button not pressed on "go" integers). SART performance is 
associated with prefrontal cortex functioning, has been found to increase with mindfulness 
training and is correlated with scores on mindfulness questionnaires (specifically, the Mindful 
Attention Awareness Scale).  
 
Attention Control: Attention Network Test (20 minutes) 
 
Attention Network Test (ANT) is a brief computerized battery measuring three independent 
behavioral components of attention: Conflict resolution (ability to overcome distracting stimuli), 
spatial Orienting (the benefit of valid spatial pre-cues), and Alerting (the benefit of temporal pre-
cues). Efficiency of orienting is examined by changes in RT that accompany cues indicating 
where the target will occur. The efficiency of the executive conflict resolution network is 
examined by requiring the subject to respond by pressing two keys indicating the direction (left 
or right) of a central arrow surrounded by congruent, incongruent or neutral flankers. Moderate 
to high reliabilities are found for all networks. 
 
ANT data to be entered by RA prior to ANT: 
PPT Age: ______ 
PPT Sex: Male / Female 
Category: Normal 
Diagonal of “subject info” window: 10” 
Press “distance between eyes and screen” button to calculate.  Should be 23.2. 
 
ANT data to be entered by RA after ANT: 
PPT Age: ______ 
Alerting effect (ms): ______ 
Orienting effect (ms): ______ 
Conflict effect (ms): ______ 
Mean RT for correct trials (ms): ______ 
Mean accuracy (%):______ 
 
 
 
 
Moved (insertion)  [1]
Comment [SF7]: We switched the order of 
administration for the ANT and SART. The 
SART is a better measure of attention, so it is 
important that it is completed first, in case the 
first measure has an effect on the outcome of 
the second measure completed. 
Moved up [1]: Sustained Attention to 
Response Task (15 minutes)¶
¶
The Sustained Attention to Response 
Task (SART) is a computerized test of 
sustained attention, response inhibition 
(executive function) and self-regulation. 
Subjects are instructed to press a key in 
response to rapidly displayed integers (1-
9) and withhold response to a designated 
"no-go" integer. SART errors consist of 
summed commission errors (button press 
on no-go trial) and omission errors (button 
not pressed on "go" integers). SART 
performance is associated with prefrontal 
cortex functioning, has been found to 
increase with mindfulness training and is 
correlated with scores on mindfulness 
questionnaires (specifically, the Mindful 
Attention Awareness Scale). ¶
¶

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 23 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
SAFETY PLAN 
After the participant has completed the Beck Anxiety Inventory questionnaire and the Centers 
for Epidemiologic Studies Depressive Symptomatology questionnaire, ask the participant to wait 
for a few minutes while you check that all forms and assessments are completed. While the 
participant is waiting in a different room, check the scores according to the criteria below. If any 
scores trigger the safety plan, move forward with steps below as written.  
Beck Anxiety Inventory (BA)  
 
If participant scores ≥26 on the Beck Anxiety Inventory, while having the participant wait, 
immediately notify the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to 
determine need for a psychiatric consultation. She has provided her cell phone #, and your 
phone # will be entered into her phone recognition software to indicate it is a call from the MBHT 
study. It is likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a 
phone message for her with your contact information and provide her with the Beck Anxiety 
Inventory results on the message. If Dr. Flynn is not immediately reachable, or following 
participant release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks 
(cell phone #401-369-0443).  
Depressive Symptomatology (DS) 
 
The CESD-R will be administered during the in-person assessment visits, and scores will be 
reviewed immediately upon completion of the in-person assessments. 
1. Sadness (dysphoria): Question numbers 2,4, 6 
2. Loss of Interest (anhedonia): Question numbers 8, 10 
3. Appetite: Question numbers 1, 18 
4. Sleep: Question numbers 5, 11, 19 
5. Thinking / concentration: Question numbers 3, 20 
6. Guilt (worthlessness): Question numbers 9, 17 
7. Tired (fatigue): Question numbers 7, 16 
8. Movement (agitation): Question numbers 12, 13 
9. Suicidal ideation: Question numbers 14, 15 
Participants are considered to meet criteria for major depressive episode if they have anhedonia 
or dysphoria nearly every day for the past two weeks, plus symptoms in an additional 4 DSM 
symptom groups noted as occurring nearly every day for the past two weeks. If participants 
meet criteria for major depressive episode, while having the participant wait, immediately notify 
the collaborating psychiatrist, Dr. Ellen Flynn (cell phone # 401-258-9829), to determine need 
for a psychiatric consultation.  She has provided her cell phone #, and your phone # will be 
entered into her phone recognition software to indicate it is a call from the MBHT study. It is 
likely she will answer the phone. If Dr. Flynn cannot be reached, please leave a phone message 
for her with your contact information and provide her with the Depressive Symptomatology 
results on the message. If Dr. Flynn is not immediately reachable, or following participant 
release after consulting with Dr. Flynn, immediately contact the PI, Dr. Eric Loucks (cell phone 
#401-369-0443).  
 
 

MB-BP  In-Person Baseline Assessment 
Version 1.5, April 22, 2016  
 
            Page 24 of 24 
 
Deleted: MBHT 
Deleted: December 21, 2015
If participants respond having any suicidal ideation (DS questions 14 or 15), perform the 
following 2 steps: 
 
1. Immediately call 911 and Dr. Ellen Flynn.  
 
Specifically, while the participant is in the waiting room, call 911 immediately, and tell 
them: 
 
“My name is _____. I am working on a research study at Brown University. I have a study 
participant in the waiting room who has shared that he/she is currently suicidal.” Please 
provide the participants’ name to the 911 operator, as requested.  
 
Finally, after calling 911, please call Dr. Ellen Flynn, who is the psychiatrist supporting 
this study. Her cell phone # is 401-258-9829. Please provide her with the same 
information as was done during the 911 call.  
 
2. While speaking calmly with the participant, let them know that you have called 911 
and Dr. Flynn, and why (i.e. because we are concerned about you). You can speak 
with participant to keep him/her in the waiting room if 911 has sent assistance, but 
the discussion should not be clinical in nature.   
 
Examples of questions that could be asked in order to keep them in the waiting room: 
• 
“Tell me what is going on.” 
• 
“What’s happening right now?” 
• 
Tell me more about why you are interesting in being part of this study.  
• 
What are you hoping to get out of this study? 
 
The following information can be provided to study participants.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
 
Other options are to: 
• 
Call your doctor’s office 
• 
Call 911 for emergency services 
• 
Go to the nearest hospital emergency room.  
 
Local Non-Urgent Free or Inexpensive Mental Health Services: 
Gateway Healthcare: 401-729-8701 
Anchor Counseling Center: 401-475-9979 
The Providence Center: 401-276-4020 
 
 

 
 
 
 
 
 
 
 
Appendix 12: 
Revised Home Baseline Assessment  
with Track Changes 
 
(v.1.5– April 22, 2016) 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 1 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
 
 
 
 
HOME BASELINE ASSESSMENT 
 
 
 
 
QUESTIONNAIRES ANSWERED BY PARTICIPANTS 
AT BASELINE (VIA ONLINE OR PAPER FORM) 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 2 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Questionnaire Table of Contents 
Introductory Questions .................................................................................................................. 3 
Background Questions ................................................................................................................... 5 
Physical Activity ............................................................................................................................. 8 
Eating Practices ............................................................................................................................ 10 
Alcohol Consumption ................................................................................................................... 13 
Smoking ......................................................................................................................................... 14 
About You ..................................................................................................................................... 15 
Parent’s Education ....................................................................................................................... 37 
Your Childhood Experiences ...................................................................................................... 39 
Chronic Illness .............................................................................................................................. 42 
Blood Pressure Medication Use .................................................................................................. 43 
More About You ........................................................................................................................... 44 
Family History of Hypertension.................................................................................................. 48 
Your Sleep ..................................................................................................................................... 49 
END SCRIPT ................................................................................................................................ 49 
Deleted: Introductory Questions 3¶
Background Questions 5¶
Physical Activity 8¶
Eating Practices 10¶
Alcohol Consumption 13¶
Smoking 14¶
About You 15¶
Parent’s Education 37¶
Your Childhood Experiences 39¶
Blood Pressure Medication Use 42¶
More About You 43¶
Family History of Hypertension 47¶
Your Sleep 48¶
END SCRIPT 48¶

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 3 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Introduction 
We appreciate you taking the time to participate in this research study. These questionnaires will 
ask a series of questions on various aspects of your health, health behaviours, family, and other 
life circumstances. It should take approximately one hour. Please keep in mind that you can 
refuse to answer any questions that you are not comfortable with.  
 
Introductory Questions 
 
IQ1_01. Please enter the 4-digit ID number you were given.   ___   ___   ___  ___.  
 
 
 
IQ1_02. What is your main reason for participating in this study? 
 
 
 
 
 
IQ1_03. What do you care about most? 
 
 
 
 
 
IQ1_04. What gives you the most pleasure in your life? 
 
 
 
 
 
IQ1_05. What are your greatest worries? 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 4 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Please list three personal goals you have for taking this mindfulness program: 
 
PG1_01.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_02.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PG1_03.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 5 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Background Questions 
 
BQ1_01. 
How many years old are you? 
 
 
 
 
BQ1_02. 
Are you Latino or Hispanic?  
 
 
 
□ No  skip to B3 
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
  
B1_02a.    Which of the following represents your family's country of origin? (check 
 
  
 
 
    all that apply) 
 
 
 
 
 
 
□ Cuba 
 
 
 
 
□ Mexico 
 
 
 
 
□ Puerto Rico 
 
 
 
 
□ Spain 
                         □ South America 
 
 
 
 
□ Columbia 
 
□ Dominican Republic 
 
□ Other Central American 
 
□ Other: _______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 
BQ1_03. 
If you were asked to put yourself into only one of these groups, in which one would 
you  place yourself? (select one only): 
 
 
 
□ Asian 
 
 
□ Pacific Islander 
 
 
□ African American/Black 
 
 
□ Caucasian/White 
 
□ Native American 
□ Other : ________________________ 
□ I do not know 
□ I prefer not to answer
BQ1_04. 
Which of the following best describes your current work situation? (select one only) 
 
 
 
□ Working full-time 
 
 
□ Working part-time  
 
 
□ Retired 
 
 
□ Unemployed:  
 
 
Looking for work 
□ Unemployed: Not currently    
      
looking for work 
 
 
□ Unemployed due to disability 
□ Keeping house or raising children  
    
full-time 
 
□ Military 
 
□ Full-time student 
 
□ Other:_______________________ 
 
□ I do not know 
 
□ I prefer not to answer 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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BQ1_05.    What is the highest grade or level of regular school you have completed? 
 
 
 
□ Elementary School 
 
 
□ Junior High  
 
 
□ High School 
 
 
□ College 
 
 
□ Graduate School  
 
 
□ I do not know 
 
 
□ I prefer not to answer 
     
 
BQ1_06.    What is the highest degree you earned? (select one only) 
 
 
 
□ Elementary school 
□ Some high school, but no GED 
□ GED 
□ High school 
□ Associate degree (Junior College) 
□ Bachelor’s degree 
□ Master’s degree 
□ Doctorate (PhD, EdD, etc) 
□ Professional (MD, JD, DDS, DVM, etc.) 
□ Other: _____________________________ 
□ I do not know 
□ I prefer not to answer 
 
 
 
BQ1_07.    Did you ever attend any other school like a technical, vocational, or trade school? 
 
 
 
□ No 
 
 
 
□ Yes 
 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
BQ1_08.    In total, about how many full-time years of education have you had, including 1st 
grade and all years of school after 1st grade? 
 
 
 
________ years 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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BQ1_09a.    Do you currently live alone? 
 
 
 
□ No 
 
 
 
□ Yes  skip to next section 
 
 
□ I do not know  
 
 
□ I prefer not to answer 
 
 
 
 
BQ1_09b. 
How many people currently live in your household, including   
 
 
             yourself? 
 
 
 
 
 
_________  
      
 
 
 
 
 
 
 
 
 
 
 
BQ1_09c.    Of these people, how many are under 18? 
 
 
 
 
 
 
 _________  
 
 
 
 
 
 
 
BQ1_09d. 
  Of the adults in your household (including yourself), how many bring  
 
 
 
      
 income into the household?   
 
 
 
 
 
 
_________  
 
 
 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 8 of 49 
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Physical Activity 
 
Physical activities are activities where you move and increase your heart rate above its resting 
rate, whether you do them for pleasure, work, or transportation. The following questions ask 
about the amount and intensity of physical activity you usually do. The intensity of the activity is 
related to the amount of energy you use doing these activities. 
 
Examples of physical activity intensity levels: 
 
Light activities 
 
Your heart beats slightly faster than normal 
You can talk and sing 
 
 
 
 
 
 
 
 
 
Moderate activities 
 
Your heart beats faster than normal 
You can talk but not sing 
 
 
 
 
 
 
 
 
 
 
Vigorous activities 
 
Your heart rate increases a lot 
You can’t talk, or your talking is broken 
up by large breaths 
 
 
 
 
 
 
 
 
Light exercise   
 
Light stretching  
 
Light vacuuming  
or yard work 
Brisk walking     Aerobics class      Strength training    Swim gently 
Aerobics classes 
 Jogging, Running,   
Singles tennis, 
or Power Walking  
 
Racquetball, Pickle ball 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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How physically active are you? 
 
 
YES 
NO 
I do not 
know 
I prefer 
not to 
answer 
PA1_01. I rarely or never do any physical 
activities. 
□ 
□ 
□ 
□ 
PA1_02. I do some light and/or moderate 
physical activities, but not every week. 
□ 
□ 
□ 
□ 
PA1_03. I do some light physical activity every 
week. 
□ 
□ 
□ 
□ 
PA1_04. I do moderate physical activity every 
week but less than 5 days per week or less than 
30 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_05. I do vigorous physical activities every 
week, but less than 3 days per week or less than 
20 minutes on those days. 
□ 
□ 
□ 
□ 
PA1_06. I do 30 minutes or more per day of 
moderate physical activities 5 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_07. I do 20 minutes or more per day of 
vigorous physical activities 3 or more days per 
week. 
□ 
□ 
□ 
□ 
PA1_08. I do activities to increase muscle 
strength, such as lifting weights or calisthenics, 
once a week or more. 
□ 
□ 
□ 
□ 
PA1_09. I do activities to improve flexibility, 
such as stretching or yoga, once a week or more. 
□ 
□ 
□ 
□ 
 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Eating Practices 
 
 
Definitely 
True 
Mostly 
True 
Mostly 
False 
Definitely 
False 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_01. I deliberately take small 
helpings to control my weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_02. I start to eat when I feel 
anxious. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_03. Sometimes when I start 
eating, I just can’t seem to stop. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_04. When I feel sad, I often eat 
too much. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_05. I don’t eat some foods 
because they make me fat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_06. Being with someone who is 
eating, often makes me want to also 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_07. When I feel tense or 
‘‘wound up’’, I often feel I need to 
eat. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_08. I often get so hungry that 
my stomach feels like a bottomless 
pit. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_09. I’m always so hungry that 
it’s hard for me to stop eating before 
finishing all of the food on my plate. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_10. When I feel lonely, I 
console myself by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_11. I consciously hold back on 
how much I eat at meals to keep 
from gaining weight. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_12. When I smell a sizzling 
steak or see a juicy piece of meat, I 
find it very difficult to keep from 
eating even if I’ve just finished a 
meal. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_13. I’m always hungry enough 
to eat at any time. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_14. If I feel nervous, I try to 
calm down by eating. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_15. When I see something that 
looks very delicious, I often get so 
hungry that I have to eat right away. 
□ 
□ 
□ 
□ 
□ 
□ 
EE1_16. When I feel depressed, I 
want to eat. 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Almost 
Never 
Seldom 
Usually 
Almost 
Always 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_17. How often do you avoid 
‘stocking up’’ on tempting foods? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Unlikely 
A little 
likely 
Somewhat 
likely 
Very 
likely 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_18. How likely are you to 
make an effort to eat less than you 
want? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Never 
Rarely Sometimes 
At least 
once a 
week 
I Do Not 
Know 
I Prefer 
Not to 
Answer 
EE1_19. Do you go on eating 
binges even though you’re not 
hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Only at 
mealtimes 
Sometimes 
between 
meals 
Often 
between 
meals 
Almost 
always 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_20. How often do you 
feel hungry? 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
EE1_21. On a scale from 1 to 8, where 1 means 
no restraint in eating and 8 means total restraint, 
what number would you give yourself? Mark the 
number that best applies to you: 
□ □ □ □ □ □ □ □ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 12 of 49 
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Table Salt Use: 
 
TS1_01 
Please report your average total use, during the past year, of “salt added at the table”.  
Would you say… 
 
Never ...................................................................... □ 
Less than once per month ....................................... □ 
1-3 shakes per month .............................................. □ 
1 shake per week .................................................... □ 
2-4 shakes per week ............................................... □ 
5-6 shakes per week ............................................... □ 
1 shake per day ....................................................... □ 
2-3 shakes per day .................................................. □ 
4-5 shakes per day .................................................. □ 
6+ shakes per day ................................................... □ 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 13 of 49 
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Alcohol Consumption  
 
A drink of alcohol is defined as 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine 
cooler, 1 cocktail, or 1 shot of liquor. 
 
AC1_01. During the past 30 days, how many days per week or per month did you have at least 1 
drink of any alcoholic beverage? [if none, skip to next section] 
 
_______________ 
 
 
AC1_02. On the days when you drank, about how many drinks did you drink on average?  
 
______________ 
 
 
AC1_03. Men: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 5 or more drinks on an occasion? 
 
Women: Considering all types of alcoholic beverages, how many times during the past 30 
days did you have 4 or more drinks on an occasion? 
 
_________________ 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 14 of 49 
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Smoking  
 
SM1_01. 
Have you smoked at least 100 cigarettes in your entire life? 
 
 Yes 
 No 
 I Do Not Know 
 Prefer not to answer 
 
 
SM1_02.  
Did you ever become a daily smoker (that is, smoke every day or nearly every day 
for two months or longer)? 
 
 Yes 
 No  skip to next section 
 I Do Not Know 
 Prefer not to answer 
 
SM1_03.  
How old were you when you last smoked daily? 
 
  
Age ______ (in years) 
 
 
 I Do Not Know 
 Prefer not to answer  
 Still smoking daily 
 
 
 
SM1_04. 
Do you smoke cigarettes now? 
 
 Yes 
 No  skip to next section 
 I Do Not Know 
 Prefer not to answer 
 
 
 SM1_04a.    How many cigarettes per day do you smoke? (One pack equals 20   
 
   
 
 cigarettes) 
 
  
 
 
Number of cigarettes ________  
 
 
 
 
 
 
 
 
 I Do Not Know 
 
 
 
 
 Prefer not to answer 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 15 of 49 
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About You 
 
Please bring to mind a type of very tasty food that may contribute to hypertension through high 
salt intake or through eating too many calories (e.g., sweet sugary dessert, salty snack foods, etc.).   
 
Think about the LAST WEEK you MOST WANTED this type of food.  For each item, select a 
number (0 to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine its taste? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
6. …imagine its smell? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …imagine what it would feel like in 
your mouth or throat? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
9. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
10. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
11. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 16 of 49 
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Please bring to mind any times in the LAST WEEK when you had a desire to do sedentary 
activities (e.g., read a book, watch a movie, be on the computer, etc.) instead of physical activities 
(e.g., walking, gardening, exercise). 
 
Think about the LAST WEEK you MOST WANTED to do a sedentary activity.  For each item, 
select a number (0 to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
6. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Please bring to mind any times in the LAST WEEK when you had a desire to drink alcohol, such 
as wine, beer or spirits.   
 
Think about the LAST WEEK you MOST WANTED alcohol.  For each item, select a number (0 
to 10) to indicate your rating. 
 
At that time… 
Not at All 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
10 
1. …how much did you want it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
2. …how much did you need it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
3. …how strong was the urge to have it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time, how vividly did you… 
 
 
 
 
 
 
 
 
 
 
 
4. …picture it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
5. …imagine its taste? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
6. …imagine its smell? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
7. …imagine what it would feel like in 
your mouth or throat? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
8. …imagine how your body would feel? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
At that time… 
 
 
 
 
 
 
 
 
 
 
 
9. …how hard were you trying not to 
think about it? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
10. …how intrusive were the thoughts? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
11. …how hard was it to think about 
anything else? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 17 of 49 
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Using the scale provided, please indicate how much each of the following statements reflects how 
you typically are.  
 
 
Not 
at all 
A 
little 
Somewhat 
Fair 
Amount 
Very 
much 
I do 
not 
know 
I 
prefer 
not to 
answer 
SC1_01. I am good at resisting 
temptation. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_02. I have a hard time 
breaking bad habits. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_03. I am lazy. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_04. I say inappropriate 
things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_05. I do certain things that 
are bad for me, if they are fun.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_06. I refuse things that are 
bad for me. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_07. I wish I had more self-
discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_08. People would say that 
I have iron self-discipline. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_09. Pleasure and fun 
sometimes keep me from 
getting work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_10. I have trouble 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_11. I am able to work 
effectively toward long-term 
goals. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_12. Sometimes I can’t stop 
myself from doing something, 
even if I know it is wrong. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
SC1_13. I often act without 
thinking through all the 
alternatives.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 18 of 49 
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Please read each statement carefully before answering. To the left of each item, indicate how 
often you behave in the stated manner, using the following scale: 
 
 
Almost 
never 
Not very 
often 
Sometimes Frequently 
Almost 
always 
I Do 
Not 
Know 
Prefer not 
to answer 
CO1_O1. When I fail at 
something important to me, 
I become consumed by 
feelings of inadequacy. 
 
 
 
 
 
 
 
CO1_02. I try to be 
understanding and patient 
towards those aspects of 
my personality I don’t like. 
 
 
 
 
 
 
 
CO1_O3. When something 
painful happens I try to 
take a balanced view of the 
situation. 
 
 
 
 
 
 
 
CO1_O4. When I’m 
feeling down, I tend to feel 
like most other people are 
probably happier than I am. 
 
 
 
 
 
 
 
CO1_O5. I try to see my 
failings as part of the 
human condition. 
 
 
 
 
 
 
 
CO1_O6. When I’m going 
through a very hard time, I 
give myself the caring and 
tenderness I need. 
 
 
 
 
 
 
 
CO1_O7. When something 
upsets me I try to keep my 
emotions in balance. 
 
 
 
 
 
 
 
CO1_O8. When I fail at 
something that’s important 
to me, I tend to feel alone 
in my failure 
 
 
 
 
 
 
 
CO1_O9. When I’m 
feeling down I tend to 
obsess and fixate on 
everything that’s wrong. 
 
 
 
 
 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Almost 
never 
Not very 
often 
Sometimes Frequently 
Almost 
always 
I Do 
Not 
Know 
Prefer not 
to answer 
CO1_10. When I feel 
inadequate in some way, I 
try to remind myself that 
feelings of inadequacy are 
shared by most people. 
 
 
 
 
 
 
 
CO1_11. I’m disapproving 
and judgmental about my 
own flaws and 
inadequacies. 
 
 
 
 
 
 
 
CO1_12. I’m intolerant and 
impatient towards those 
aspects of my personality I 
don’t like. 
 
 
 
 
 
 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 20 of 49 
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The questions in this scale ask you about your feelings and thoughts during the last month. In 
each case, you will be asked to indicate by circling how often you felt or thought a certain way.  
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do not 
know 
I prefer 
not to 
answer 
PS1_01. In the last month, how 
often have you been upset 
because of something that 
happened unexpectedly?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_02. In the last month, how 
often have you felt that you 
were unable to control the 
important things in your life?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_03. In the last month, how 
often have you felt nervous and 
“stressed”? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_04. In the last month, how 
often have you felt confident 
about your ability to handle 
your personal problems?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_05. In the last month, how 
often have you felt that things 
were going your way? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_06. In the last month, how 
often have you found that you 
could not cope with all the 
things that you had to do?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_07. In the last month, how 
often have you been able to 
control irritations in your life? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_08. In the last month, how 
often have you felt that you 
were on top of things? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_09. In the last month, how 
often have you been angered 
because of things that were 
outside of your control? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
PS1_10. In the last month, how 
often have you felt difficulties 
were piling up so high that you 
could not overcome them?  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 21 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Please indicate how often the following statements apply to you by checking the box that 
best describes your experience.  
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_01.  I am clear 
about my feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_02.  I pay 
attention to how I 
feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_03.  I 
experience my 
emotions as 
overwhelming and 
out of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_04.  I have no 
idea how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_05.  I have 
difficulty making 
sense out of my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_06.  I am 
attentive to my 
feelings. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_07.  I know 
exactly how I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_08.  I care 
about what I am 
feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_09.  I am 
confused about how 
I feel. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_10.  When I’m 
upset, I acknowledge 
my emotions. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_11.  When I’m 
upset, I become 
angry with myself 
for feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_12.  When I’m 
upset, I become 
embarrassed for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 22 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
 
 
Almost 
Never  
(0-10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_13.  When I’m 
upset, I have 
difficulty getting 
work done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_14. When I’m 
upset, I become out 
of control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_15.  When I’m 
upset, I believe that I 
will remain that way 
for a long time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_16.  When I’m 
upset, I believe that I 
will end up feeling 
very depressed. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_17.  When I’m 
upset, I believe that 
my feelings are valid 
and important. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_18.  When I’m 
upset, I have 
difficulty focusing 
on other things. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_19.  When I’m 
upset, I feel out of 
control. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_20.  When I’m 
upset, I can still get 
things done. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_21.  When I’m 
upset, I feel ashamed 
at myself for feeling 
that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_22.  When I’m 
upset, I know that I 
can find a way to 
eventually feel 
better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 23 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
 
 
Almost 
Never  
(0-
10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_23.  When I’m 
upset, I feel like I am 
weak. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_24.  When I’m 
upset, I feel like I can 
remain in control of my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_25. When I’m 
upset, I feel guilty for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_26. 
When 
I’m 
upset, I have difficulty 
concentrating. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_27.  When I’m 
upset, I have difficulty 
controlling my 
behaviours. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_28.  When I’m 
upset, I believe there is 
nothing I can do to 
make myself feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_29.  When I’m 
upset, I become 
irritated at myself for 
feeling that way. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_30.  When I’m 
upset, I start to feel 
very bad about myself. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_31.  When I’m 
upset, I believe that 
wallowing in it is all I 
can do. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_32.  When I’m 
upset, I lose control 
over my behaviour. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 24 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
 
 
Almost 
Never  
(0-
10%) 
Sometimes 
(11-35%) 
About Half 
The Time 
(36-65%) 
Most of 
the Time 
(66-90%) 
Almost 
Always 
(91-100%) 
I Do 
Not 
Know 
I Prefer 
Not to 
Answer 
ER1_33.  When I’m 
upset, I have difficulty 
thinking about anything 
else. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_34.  When I’m 
upset I take time to 
figure out what I’m 
really feeling. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_35.  When I’m 
upset, it takes me a long 
time to feel better. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
ER1_36.  When I’m 
upset, my emotions feel 
overwhelming. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 25 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
This scale is made up of a list of statements each of which may or may not be true about you. For 
each statement, select “definitely true” if you are sure it is true about you and “probably true” if 
you think it is true but are not absolutely certain. Similarly, you should select “definitely false” if 
you are sure the statement is false and “probably false” if you think it is false but are not 
absolutely certain. 
 
 
 
 
 
Definitely 
False 
Probably 
False 
Probably 
True 
Definitely 
True 
I do not 
know 
I prefer not 
to answer 
IS1_01  If I wanted to go on a trip 
for a day (for example, to the 
country or mountains), I would have 
a hard time finding someone to go 
with me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_02  I feel that there is no one I 
can share my most private worries 
and fears with. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_03   If I were sick, I could easily 
find someone to help me with my 
daily chores. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_04   There is someone I can turn 
to for advice about handling 
problems with my family. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_05   If I decide one afternoon 
that I would like to go to a movie 
that evening, I could easily find 
someone to go with me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_06   When I need suggestions 
on how to deal with a personal 
problem, I know someone I can turn 
to. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_07   I don’t often get invited to 
do things with others. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_08   If I had to go out of town 
for a few weeks, it would be difficult 
to find someone who would look 
after my house or apartment (the 
plants, pets, garden, etc.). 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_09   If I wanted to have lunch 
with someone, I could easily find 
someone to join me. 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 26 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
 
 
Definitely 
False 
Probably 
False 
Probably 
True 
Definitely 
True 
I do not 
know 
I prefer not 
to answer 
IS1_10   If I was stranded 10 miles 
from home, there is someone I could 
call who could come and get me. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_11   If a family crisis arose, it 
would be difficult to find someone 
who could give me good advice 
about how to handle it. 
□ 
□ 
□ 
□ 
□ 
□ 
IS1_12   If I needed some help in 
moving to a new house or apartment, 
I would have a hard time finding 
someone to help me. 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 27 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Please indicate how often each of the statements below is descriptive of you. 
 
Statement 
Never 
Rarely 
Sometimes 
Often 
I Do 
Not 
Know 
Prefer 
not to 
answer 
LS1_01. I feel in tune with the people 
around me 
□ 
□ 
□ 
□ 
□ 
s 
LS1_02. I lack companionship 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_03. There is no one I can turn to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_04. I do not feel alone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_05. I feel part of a group of 
friends 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_06. I have a lot in common with 
the people around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_07. I am no longer close to 
anyone 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_08. My interests and ideas are 
not shared by those around me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_09. I am an outgoing person 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_10. There are people I feel close 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_11. I feel left out 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_12. My social relationships are 
superficial 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_13. No one really knows me 
well 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_14. I feel isolated from others 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_15. I can find companionship 
when I want it 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_16. There are people who really 
understand me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_17. I am unhappy being so 
withdrawn 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_18. People are around me but 
not with me 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_19. There are people I can talk 
to 
□ 
□ 
□ 
□ 
□ 
□ 
LS1_20. There are people I can turn 
to 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 28 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Below you will find a list of statements. Please indicate how often each statement applies to you 
generally in daily life.  
 
 
0- 
Never 
1 
2 
3 
4 
5 - Always 
IA1_01. When I am tense I notice where the tension is 
located in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_02. I notice when I am uncomfortable in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_03. I notice where in my body I am comfortable.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_04. I notice changes in my breathing, such as 
whether it slows down or speeds up.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_05. I do not notice (I ignore) physical tension or 
discomfort  
until they become more severe.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_06. I distract myself from sensations of 
discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_07. When I feel pain or discomfort, I try to power 
through it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_08. When I feel physical pain, I become upset.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_09. I start to worry that something is wrong if I 
feel any discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_10. I can notice an unpleasant body sensation 
without worrying about it.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_11. I can pay attention to my breath without being 
distracted by things happening around me.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_12. I can maintain awareness of my inner bodily 
sensations even when there is a lot going on around me.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_13. When I am in conversation with someone, I 
can pay attention to my posture.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_14. I can return awareness to my body if I am 
distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_15. I can refocus my attention from thinking to 
sensing my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_16. I can maintain awareness of my whole body 
even when a part of me is in pain or discomfort.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_17. I am able to consciously focus on my body as 
a whole.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_18. I notice how my body changes when I am 
angry.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_19. When something is wrong in my life I can feel 
it in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_20. I notice that my body feels different after a 
peaceful experience.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_21. I notice that my breathing becomes free and 
easy when I feel comfortable.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_22. I notice how my body changes when I feel 
happy / joyful.  
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 29 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
 
 
0- Never 
1 
2 
3 
4 
5 - Always 
IA1_23. When I feel overwhelmed I can find a calm 
place inside.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_24. When I bring awareness to my body I feel a 
sense of calm.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_25. I can use my breath to reduce tension.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_26. When I am caught up in thoughts, I can 
calm my mind by focusing on my body/breathing.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_27. I listen for information from my body about 
my emotional state.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_28. When I am upset, I take time to explore how 
my body feels.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_29. I listen to my body to inform me about what 
to do.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_30. I am at home in my body.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_31. I feel my body is a safe place.  
□ 
□ 
□ 
□ 
□ 
□ 
IA1_32. I trust my body sensations.  
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 30 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
We are interested in your recent experiences. Below is a list of things that people sometimes 
experience. Next to each item are five choices: “never”, “rarely”, “sometimes”, “often”, and 
“all the time”. Please choose one of these to indicate how much you currently have experiences 
similar to those described. 
 
Please do not spend too long on each item–it is your first response that we are interested in. 
Please be sure to answer every item. 
 
 
Never 
Rarely 
Sometimes 
Often 
All the time 
RD1_01. I think about what will happen in 
the future. 
□ 
□ 
□ 
□ 
□ 
RD1_02. I remind myself that thoughts 
aren’t facts. 
□ 
□ 
□ 
□ 
□ 
RD1_03. I am better able to accept myself 
as I am. 
□ 
□ 
□ 
□ 
□ 
RD1_04. I notice all sorts of little things 
and details in the world around me. 
□ 
□ 
□ 
□ 
□ 
RD1_05. I am kinder to myself when things 
go wrong. 
□ 
□ 
□ 
□ 
□ 
RD1_06. I can slow my thinking at times of 
stress. 
□ 
□ 
□ 
□ 
□ 
RD1_07. I wonder what kind of person I 
really am. 
□ 
□ 
□ 
□ 
□ 
RD1_08. I am not so easily carried away 
by my thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_09. I notice that I don’t take 
difficulties so personally. 
□ 
□ 
□ 
□ 
□ 
RD1_10. I can separate myself from my 
thoughts and feelings. 
□ 
□ 
□ 
□ 
□ 
RD1_11. I analyze why things turn out the 
way they do. 
□ 
□ 
□ 
□ 
□ 
RD1_12. I can take time to respond to 
difficulties. 
□ 
□ 
□ 
□ 
□ 
RD1_13. I think over and over again about 
what others have said to me. 
□ 
□ 
□ 
□ 
□ 
RD1_14. I can treat myself kindly. 
□ 
□ 
□ 
□ 
□ 
RD1_15. I can observe unpleasant feelings 
without being drawn into them. 
□ 
□ 
□ 
□ 
□ 
RD1_16. I have the sense that I am fully 
aware of what is going on around me and 
inside me. 
□ 
□ 
□ 
□ 
□ 
RD1_17. I can actually see that I am not 
my thoughts. 
□ 
□ 
□ 
□ 
□ 
RD1_18. I am consciously aware of a 
sense of my body as a whole. 
□ 
□ 
□ 
□ 
□ 
RD1_19. I think about the ways in which I 
am different from other people. 
□ 
□ 
□ 
□ 
□ 
RD1_20. I view things from a wider 
perspective. 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 31 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
How do you cope with events?  Everyone gets confronted with negative or unpleasant 
events now and then and everyone responds to them in his or her own way. By the following 
questions you are asked to indicate what you generally think, when you experience negative or 
unpleasant events. 
 
 
(Almost) 
Never 
Some-
times 
Regularly 
Often 
(Almost) 
Always 
CR1_01. I think that I have to 
accept that this has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_02. I often think about how I 
feel about what I have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_03. I think I can learn 
something from the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_04. I feel that I am the one 
who is responsible for what has 
happened. 
□ 
□ 
□ 
□ 
□ 
CR1_05. I think that I have to 
accept the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_06. I am preoccupied with 
what I think and feel about what I 
have experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_07. I think of pleasant things 
that have nothing to do with it. 
□ 
□ 
□ 
□ 
□ 
CR1_08. I think that I can become 
a stronger person as a result of 
what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_09. I keep thinking about how 
terrible it is what I have 
experienced. 
□ 
□ 
□ 
□ 
□ 
CR1_10. I feel that others are 
responsible for what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_11. I think of something nice 
instead of what has happened. 
□ 
□ 
□ 
□ 
□ 
CR1_12. I think about how to 
change the situation. 
□ 
□ 
□ 
□ 
□ 
CR1_13. I think that it hasn’t been 
too bad compared to other things. 
□ 
□ 
□ 
□ 
□ 
CR1_14. I think that basically the 
cause must lie within myself. 
□ 
□ 
□ 
□ 
□ 
CR1_15. I think about a plan of 
what I can do best. 
□ 
□ 
□ 
□ 
□ 
CR1_16. I tell myself that there are 
worse things in life. 
□ 
□ 
□ 
□ 
□ 
CR1_17. I continually think how 
horrible the situation has been. 
□ 
□ 
□ 
□ 
□ 
CR1_18. I feel that basically the 
cause lies with others. 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 32 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Instructions: Below is a collection of statements about your everyday experience. Using the scale 
below, please indicate how frequently or infrequently you currently have each experience. Please 
answer according to what really reflects your experience rather than what you think your 
experience should be. Please treat each item separately from every other item.  
 
Please indicate the degree to which you agree with each of the following items using the scale 
below. Simply check your response to each item 
 
 
  
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
MA1_01. I could be 
experiencing some 
emotion and not be 
conscious of it until 
some time later.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_02. I break or 
spill things because 
of carelessness, not 
paying attention, or 
thinking of 
something else.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_03. I find it 
difficult to stay 
focused on what’s 
happening in the 
present. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_04. I tend to 
walk quickly to get 
where I’m going 
without paying 
attention to what I 
experience along the 
way.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_05. I tend not 
to notice feelings of 
physical tension or 
discomfort until they 
really grab my 
attention.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_06. I forget a 
person’s name almost 
as soon as I’ve been 
told it for the first 
time. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 33 of 49 
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Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
I do 
not 
know 
I prefer 
not to 
answer 
MA1_07. It seems I 
am “running on 
automatic” without 
much awareness of 
what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_08. I rush 
through activities 
without being really 
attentive to them.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_09. I get so 
focused on the goal I 
want to achieve that I 
lose touch with what 
I am doing right now 
to get there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_10. I do jobs or 
tasks automatically, 
without being aware 
of what I’m doing.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_11. I find 
myself listening to 
someone with one 
ear, doing something 
else at the same time.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_12. I drive 
places on “automatic 
pilot” and then 
wonder why I went 
there.   
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_13. I find 
myself preoccupied 
with the future or the 
past.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_14. I find 
myself doing things 
without paying 
attention. 
 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_15. I snack 
without being aware 
that I’m eating.    
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 34 of 49 
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Please rate each of the following statements using the scale provided. Write the number in the 
blank that best describes your own opinion of what is generally true for you.  
 
 
 
Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_01. When I’m walking, I 
deliberately notice the sensations of 
my body moving.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_02. I’m good at finding words to 
describe my feelings.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_03. I criticize myself for having 
irrational or inappropriate emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_04. I perceive my feelings and 
emotions without having to react to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_05. When I do things, my mind 
wanders off and I’m easily distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_06. When I take a shower or 
bath, I stay alert to the sensations of 
water on my body.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_07. I can easily put my beliefs, 
opinions, and expectations into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_08. I don’t pay attention to what 
I’m doing because I’m daydreaming, 
worrying, or otherwise distracted.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_09. I watch my feelings without 
getting lost in them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_10. I tell myself I shouldn’t be 
feeling the way I’m feeling.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_11. I notice how foods and 
drinks affect my thoughts, bodily 
sensations, and emotions.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_12. It’s hard for me to find the 
words to describe what I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_13. I am easily distracted. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_14. I believe some of my 
thoughts are abnormal or bad and I 
shouldn’t think that way.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_15. I pay attention to sensations, 
such as the wind in my hair or sun on 
my face.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_16. I have trouble thinking 
of the right words to express how 
I feel about things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_17. I make judgments about 
whether my thoughts are good or 
bad.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_18. I find it difficult to stay 
focused on what’s happening in 
the present.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_19. When I have distressing 
thoughts or images, I “step back” 
and am aware of the thought or 
image without getting taken over 
by it.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_20. I pay attention to 
sounds, such as clocks ticking, 
birds chirping, or cars passing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_21. In difficult situations, I 
can pause without immediately 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_22. When I have a sensation 
in my body, it’s difficult for me 
to describe it because I can’t find 
the right words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_23. It seems I am “running 
on automatic” without much 
aware- ness of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_24. When I have distressing 
thoughts or images, I feel calm 
soon after.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_25. I tell myself that I 
shouldn’t be thinking the way 
I’m thinking.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_26. I notice the smells and 
aromas of things.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_27. Even when I’m feeling 
terribly upset, I can find a way to 
put it into words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_28. I rush through activities 
without being really attentive to 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Never 
Almost 
Never 
Sometimes 
Fairly 
Often 
Often 
I do 
not 
know 
I prefer 
not to 
answer 
FF1_29. When I have distressing 
thoughts or images, I am able 
just to notice them without 
reacting.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_30. I think some of my 
emotions are bad or 
inappropriate and I shouldn’t feel 
them.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_31. I notice visual elements 
in art or nature, such as colors, 
shapes, textures, or patterns of 
light and shadow.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_32. My natural tendency is 
to put my experiences into 
words.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_33. When I have distressing 
thoughts or images, I just notice 
them and let them go.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_34. I do jobs or tasks 
automatically without being 
aware of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_35. When I have distressing 
thoughts or images, I judge 
myself as good or bad depending 
what the thought or image is 
about.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_36. I pay attention to how 
my emotions affect my thoughts 
and behavior.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_37. I can usually describe 
how I feel at the moment in 
consider- able detail.  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_38. I find myself doing 
things without paying attention. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
FF1_39. I disapprove of myself 
when I have irrational ideas. 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Parent’s Education 
 
CS1_01. Please check the box beside the highest grade or degree that your BIOLOGICAL 
MOTHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
CS1_02. Please check the box beside the highest grade or degree that your BIOLOGICAL 
FATHER completed. 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Now please think of the two most important adults in your home between the time you were born 
and age 18 years. Please check the category below that best described their level of education 
during this time period. 
 
CS1_03. First adult’s highest level of education: 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
CS1_04. Second adult’s highest level of education 
 
Never went to school 
□ 
Grades 1 to 3 
□ 
Grades 4 to 8 
□ 
Grades 9 to 11 
□ 
Grade 12 
□ 
GED 
□ 
One or more years of Vocational or 
Professional School after High School 
□ 
One or more years of College 
□ 
One or more years of Graduate or 
Professional School after College 
□ 
I Do Not Know 
□ 
I prefer not to answer 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Your Childhood Experiences 
 
The following questions ask about some difficult experiences that you might have had as a child. 
These questions may be emotionally difficult to answer. Just as a reminder, you do not need 
answer any questions that you would prefer not to. Your answers to these questions, as with all 
questions, will remain confidential.  
 
CE1_01. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Swear at you, insult you, put you down, or humiliate you? 
 
 
 
or 
Act in a way that made you afraid that you might be physically hurt? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_02. Before you were 18 years old, did a parent or other adult in the household often or very 
often… 
 
Push, grab, slap, or throw something at you? 
 
 
 
or 
Ever hit you so hard that you had marks or were injured?  
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
CE1_03.  
Before you were 18 years old, did an adult or person at least 5 years older than you 
ever… 
 
 
Touch or fondle you or have you touch their body in a sexual way? 
 
 
 
or 
Attempt or actually have oral, anal, or vaginal intercourse with you? 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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CE1_04. Before you were 18 years old, did you often or very often feel that … 
 
 
No one in your family loved you or thought you were important or special? 
 
 
 
or 
Your family didn’t look out for each other, feel close to each other, or support each other? 
 
  
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
CE1_05. Before you were 18 years old, did you often or very often feel that … 
 
 
You didn’t have enough to eat, had to wear dirty clothes, and had no one to protect you? 
 
 
 
or 
Your parents were too drunk or high to take care of you or take you to the doctor if you 
needed it? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
  
 
 
CE1_06. Before you were 18 years old, was a biological parent ever lost to you through divorce, 
abandonment, or other reason?   
 
 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_07. Before you were 18 years old, was your mother or stepmother:   
 
 
Often or very often pushed, grabbed, slapped, or had something thrown at her? 
 
 
 
or 
Sometimes, often, or very often kicked, bitten, hit with a fist, or hit with something hard? 
 
 
 
or 
Ever repeatedly hit over at least a few minutes or threatened with a gun or knife? 
 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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CE1_08. Before you were 18 years old, did you live with anyone who was a problem drinker or 
alcoholic, or who used street drugs? 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
     
 
CE1_09. Before you were 18 years old, was a household member depressed or mentally ill, or did 
a household member attempt  suicide? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
CE1_10. Before you were 18 years old, did a household member go to prison? 
 
 
 
□ No  
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Chronic Illness 
 
CD1_01. Do you have a chronic illness, health problem or disease? 
□ Yes 
□ No (if responding “no”, please skip to the next section).  
 
CD1_02. Please select the illness from the list below that has the greatest effect on your life or 
feels like the most important for you to be able to manage. You may have more than one, but the 
purpose of this question is to identify what you might view as your PRIMARY chronic 
illness/problem/disease. 
 
 
 
 
 
 
 
 
 
 
We would like to know how confident you are in doing certain activities related to the chronic illness or 
disease you selected above. For each of the following questions, please choose the number that 
corresponds to your confidence that you can do the tasks regularly at the present time. Please keep the 
chronic illness or disease in mind as you answer the following questions. 
 
How confident are you that…. 
Not at All 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Totally 
Confident 
10 
CD1_03a    …you can keep the fatigue caused 
by your disease from interfering with the things 
you want to do? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
CD1_03b    …you can keep the physical 
discomfort or pain of your disease from 
interfering with the things you want to do? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
CD1_03c   …you can keep the emotional 
distress caused by your disease from interfering 
with the things you want to do? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
CD1_03d   …you can keep any other symptoms 
or health problems you have from interfering 
with the things you want to do? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
CD1_03e   …you can do the different tasks and 
activities needed to manage your health 
condition so as to reduce you need to see a 
doctor? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
CD1_03f   …you can do things other than just 
taking medication to reduce how much your 
illness affects your everyday life? 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Comment [SF1]: This is a new scale. It was 
added so that our study findings can be analyzed 
and compared to the other concurrent studies. 
Formatted: Font: 11 pt

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Blood Pressure Medication Use 
 
BM1_01. Do you currently take medication for your blood pressure? 
□ Yes 
□ No (if responding “no”, please skip to the next page).  
 
 
 
 
Yes 
No 
BM1_02. Do you sometimes forget to take your blood pressure pills? 
 
□ 
□ 
BM1_03. People sometimes miss taking their medications for reasons 
other than forgetting. Thinking over the past two weeks, were there 
any days when you did not take your blood pressure medicine? 
 
□ 
□ 
BM1_04. Have you ever cut back or stopped taking your blood 
pressure medicine without telling your doctor because you felt worse 
when you took it? 
 
□ 
□ 
BM1_05. When you travel or leave home, do you sometimes forget to 
bring along your blood pressure medicine? 
 
□ 
□ 
BM1_06. Did you take all your blood pressure medicine yesterday? 
 
□ 
□ 
BM1_07. When you feel like your symptoms are under control, do you 
sometimes stop taking your blood pressure medicine? 
 
□ 
□ 
BM1_08. Taking blood pressure medicine every day is a real 
inconvenience for some people. Do you ever feel hassled about 
sticking to your treatment plan? 
 
□ 
□ 
 
BM1_09. How often do you have difficulty remembering to take all your blood pressure 
medicine?  
□ Never/rarely 
□ Once in a while 
□ Sometimes 
□ Usually 
□ All the time 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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More About You 
Below are some modifiable factors that likely influence blood pressure. These may not all apply 
to you, as you may already have excellent levels of these factors.  
 
Physical activity: 
The United States Office of Disease Prevention and Health Promotion 2008 Physical Activity 
Guidelines for Americans states that  “Most health benefits occur with at least 150 minutes (2 
hours and 30 minutes) a week of moderate intensity physical activity, such as brisk walking. 
Additional benefits occur with more physical activity. Both aerobic (endurance) and muscle-
strengthening (resistance) physical activity are beneficial.” 
 
RC1_01. How motivated are you to make changes to your physical activity, using a scale of one 
to ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_02. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your physical activity? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Diet: 
 
The Dietary Approaches to Stop Hypertension (DASH) diet eating plan is a diet rich in fruits, 
vegetables, low fat or nonfat dairy. It also includes mostly whole grains; lean meats, fish and 
poultry; nuts and beans. It is high fiber and low to moderate in fat. It is a plan that follows US 
guidelines for sodium content, along with vitamins and minerals. It can be considered to be an 
Americanized version of the Mediterranean diet. 
 
RC1_03. How motivated are you to make changes to your diet to be consistent with the DASH 
diet, using a scale of one to ten, where one = definitely not ready to change, and 10 = definitely 
ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_04. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your diet to be more consistent with the DASH diet? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
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Salt Intake: 
 
The 2010 Dietary Guidelines for Americans recommend that everyone age 2 years and up 
should consume less than 2,300 milligrams (mg) of sodium each day. Some groups of people 
should further limit sodium intake to 1,500 mg per day, including: 
• 
Adults age 51 years or older. 
• 
All African Americans. 
• 
Anyone who has high blood pressure, diabetes, or chronic kidney disease. 
 
RC1_05. How motivated are you to make changes to your salt intake, using a scale of one to 
ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_06. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your salt intake? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
Overweight/Obesity: 
 
Extensive scientific evidence shows that being overweight or obese increases risk of having high 
blood pressure.  
 
RC1_07. How motivated are you to make changes to your body weight, using a scale of one to 
ten, where one = definitely not ready to change, and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_08. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in your body weight? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 46 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Stress, and Stress Response: 
 
Several studies showed that stress, and being slower at emotionally recovering from stressful 
events, increase risk of hypertension.  
 
RC1_09. How motivated are you to make changes to the amount of stress in your life, or your 
response to that stress, using a scale of one to ten, where one = definitely not ready to change, 
and 10 = definitely ready to change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
RC1_10. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in the amount of stress in your life, or your response to that stress? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
Alcohol Consumption: 
 
Heavy and regular use of alcohol can increase blood pressure substantially. The American Heart 
Association recommends limiting alcohol consumption to no more than two drinks per day for 
men and one drink per day for women. 
 
RC1_11. How motivated are you to make changes to the amount of alcohol you consume, using 
a scale of one to ten, where one = definitely not ready to change, and 10 = definitely ready to 
change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
RC1_12. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes in the amount of alcohol you consume? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 47 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Blood Pressure (Antihypertensive) Medication Use: 
 
Blood pressure medication has been shown in many studies to be very effective at lowering 
blood pressure.  
 
RC1_13. How motivated are you to make changes to your blood pressure medication use, using 
a scale of one to ten, where one = definitely not ready to change, and 10 = definitely ready to 
change? 
 
Little intention of 
changing 
Mixed feelings towards taking 
action 
Motivated to take 
action 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
RC1_14. On a scale of 1-10, with 10 being 100% confident, how confident are you that you can 
make changes your blood pressure medication use? 
 
Not confident 
Moderately confident 
Confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 48 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Family History of Hypertension  
 
FH1_01. Did your biological mother ever have hypertension? 
 
 
 
□ No 
 
 
□ Yes 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
FH1_02. Did your biological father ever have hypertension? 
 
 
 
□ No 
 
 
□ Yes 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
  
 
FH1_03. How many full brothers and sisters do you have (Please include any brothers or 
sisters who may have died, but do not include half or step brothers and sisters). 
 
 
 
□ I do not have any brothers or sisters  Skip to the page 
 
 
____ brothers,  ______ sisters 
 
 
□ I do not know  
 
 
□ I prefer not to answer  
 
 
FH1_04. Of these brothers and sisters, how many have ever had hypertension? 
 
 
 
________ (if none, write 0) 
 
□ I do not know   
 
□ I prefer not to answer  
 
 
 
 

MB-BP Home Baseline Assessment, Version 1.5, April 22,2016 
Page 49 of 49 
Deleted: MBHT 
Deleted: December 21, 2015
Your Sleep 
 
The following question relates to your usual sleep habits during the past month only. Your 
answer should indicate the most accurate reply for the majority of days and nights in the past 
month. 
 
SL1_04. During the past month, how many hours of actual sleep did you get on average at 
night?  (This may be different than the number of hours you spent in bed.) 
 
 
 
AVERAGE HOURS OF SL1_EEP PER NIGHT ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 
 
END SCRIPT 
Thank you for completing this survey!  
 
Please note that these responses will not be seen immediately. Resources are shown below if you 
feel that you would like to talk with someone immediately for assistance.  
 
National Suicide Prevention Lifeline: 1-800-273-8255 
National Sexual Assault Hotline: 1-800-656-4673 
 
Other options are to: 
• Call your doctor’s office 
• Call 911 for emergency services 
• Go to the nearest hospital emergency room.  
 
 
 
 
 
  

 
 
 
 
 
 
 
 
Appendix 13: 
Measurement of Formal and Informal Mindfulness 
Practice Post-intervention - NEW 

MB-BP Mindfulness Practice – post-Intervention, Version 1.0, April 26, 2016      
                Page 1 of 2 
MB-BP Study: Measurement of Mindfulness Practice post-Intervention 
(To be administered at each Follow-up assessment) 
 
 
MP1_01 
 10wk follow up:  Since the date of the last mindfulness class, have you 
practiced mindfulness, either formally or informally, in any way? 
 
 6mo / 1yr follow ups:  Think about the last six months. During that time, 
have you practiced mindfulness, either formally or informally, in any way? 
 
No ...................................................................... 0 (Skip to MP1_04) 
Yes .................................................................... 1 
 
 
On average, how minutes PER WEEK do you engage in 
the following types of mindfulness activities? 
Average # 
Minutes 
per week 
Less 
than 
weekly 
Don’t 
Know 
Prefer not 
to answer 
MP1_02a   Body Scan ........................................................................... 
 
____ 
666 
777 
888 
MP1_02b   Yoga .................................................................................... 
 
____ 
666 
777 
888 
MP1_02c   Awareness of breath meditation .......................................... 
 
____ 
666 
777 
888 
MP1_02d   Sitting Meditation ................................................................. 
 
____ 
666 
777 
888 
MP1_02e   Walking Meditation .............................................................. 
 
____ 
666 
777 
888 
MP1_02f   Loving-kindness Meditation .................................................. 
 
____ 
666 
777 
888 
MP1_02g   Mountain Meditation ............................................................ 
 
____ 
666 
777 
888 
MP1_02h   Visual Meditation ................................................................. 
 
____ 
666 
777 
888 
MP1_02i   Eating Meditation .................................................................. 
 
____ 
666 
777 
888 
MP1_02j   Meditation moving through regions, such as breath, 
  physical sensations, sound, thoughts, and open awareness .............. 
 
____ 
666 
777 
888 
MP1_02k   Goal-related activity (e.g., physical activity, diet change, 
etc.).  Please describe____________________________ ................... 
 
 
 
 
____ 
666 
777 
888 
MP1_02l   Other mindful activities: 
    Other 1 describe: _______________ ................................................ 
    Other 2 describe: _______________ ................................................ 
    Other 3 describe: _______________ ................................................ 
 
 
____ 
666 
777 
888 
 

MB-BP Mindfulness Practice – post-Intervention, Version 1.0, April 26, 2016      
                Page 2 of 2 
MP1_03.a-l  If > 0 min per day, skip.  All others, ask:  Which of the following 
statements, BEST describes your current attitude towards [insert 
mindfulness activity from table above]? 
 
I do not plan on practicing this activity ........................................ 1 
I see value in this activity but do not practice it regularly ............ 2 
Something else: Describe_____________________ ................. 3 
Don’t Know ................................................................................ 7 
Prefer not to answer ................................................................... 8 
 
MP1_04 
 If NO Mindfulness Practice, Ask:  Which of the following statements, 
BEST describes your current attitude towards mindfulness? 
 
I do not plan on practicing mindfulness ...................................... 1 
I see value in mindfulness but do not practice it regularly ........... 2 
Other (please describe ____________________________) ...... 3 
Don’t Know ................................................................................ 7 
Prefer not to answer ................................................................... 8 
 
 
MP1_05 
Which of the following, if any, have you participated in [since completing 
the course / the last six months]? 
 
None, I have not practiced mindfulness .................... 00 
 
 
Check ALL that apply 
 
MB-BP Study Booster Sessions ............................... [   ] 
MB-BP All day retreats ............................................. [   ] 
Meditation group not related the MB-BP Study ........ [   ] 
Mindful yoga group not related the MB-BP Study .... [   ] 
Other 1 describe: _______________ ....................... [   ] 
Other 2 describe: _______________ ....................... [   ] 
Other 3 describe: _______________ ....................... [   ] 
Don’t Know ................................................................ 77 
Prefer not to answer .................................................. 88 
 
 
MP1_06 
We are interested in the ways in which mindfulness practice may or may 
not impact your life.  Please describe below your relationship to mindfulness since 
completing your course. 
 
 
 
 
 
Don’t Know ................................................................................ 7 
Prefer not to answer ................................................................... 8 
 

."ff :ii,."o,.X'u""iÏåtå,.
Institutional Review Board
Modification Request
Date of Request: 8/9/16 Investigator's Name and Title: Eric Loucks, PhD, Assistant Professor
Study Title: Mindfulness-based Hypertension Therapy Pilot Study (#1412001171)
original rype of Review: ! Exempt 
! Expedited 
I nutt Board
l) Provide a brief lay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form)
See attached summary
2) Provide a detailed description of the changes being requested (Use additional pages, if necessary):
See attached summary
3.) State the reason (iustification) for the requested modification. (Use additional pages, if
necessary):
See attached summary
4.) What is your assessment of how the changes will afl'ect the overall risk/bcnefît ratio of the stutly
and the rvillingness of intlividuals to participate?
See attached summary
5.) Does the requested modification require nevy documents or changes to the approved consent
form or other documents?
n Consent/assent documents (attach revised version with changes highlighted)
[] New/revised instrurnents (attach - if revised, highlight changes)
! 
New/revised advertising rnaterials (attach - if revised, highlight changes)
Do you have a conflict of interest on this project according to Brown's policy? nyns XNO
If YES, has this conflict been previously disclosed to the IRB? 
EynS nNO
PI signature:
'-' l-
-':* '*
Date:
f 
" ..
t\

1. Provide a brief lay summary of the overall project. Include enough 
detail to allow the IRB to evaluate the requested change(s) within 
the context of the overall project.   
  
The World Health Organization reported that suboptimal blood pressure (BP) is responsible 
for more than half of cardiovascular disease mortality world-wide. Furthermore, greater than half 
of those with hypertension have uncontrolled BP. A 2009 Institute of Medicine report 
recommended prioritizing research to “Compare the effectiveness of mindfulness-based 
interventions (e.g. yoga, meditation, deep breathing training) and usual care in treating… 
cardiovascular risk factors.”  Evidence-based mindfulness interventions, including Mindfulness-
Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant 
effects, but evidence of heterogeneity in effect sizes. The methodologically highest quality 
studies had the smallest effect sizes (range 0-5 mmHg). Mindfulness-Based Stress Reduction 
(MBSR) has been customized to a number of disease processes, such as Mindfulness-Based 
Cognitive Therapy for patients with recurrent depression, and Mindfulness-Based Relapse 
Prevention for patients with substance use addictions. Effect sizes have been increased by 
customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive 
patients have never been investigated. Until methodologically rigorous studies to evaluate 
customized interventions for hypertension are performed, we will not know if the observed 
preliminary effects of general mindfulness interventions on blood pressure reduction could be 
much more effective with a tailored approach. Consequently, we propose to conduct a stage I 
behavioral therapy intervention study to evaluate whether MBSR customized to prehypertensive 
and hypertensive patients has the potential to provide clinically relevant reductions in BP. 
Consequently the specific aims are:  
  
Stage 1a: Therapy Development/Manual Writing  
1. To outline and evaluate key novel elements of mindfulness-based hypertension therapy 
(MBHT), customized from the evidence-based MBSR. We hypothesize that the most 
important novel element will be generation of mindfulness skills specifically applied to 
hypertension risk factors such as diet, physical activity, obesity, alcohol consumption 
and antihypertensive medication adherence. This aim will be achieved using (1) focus 
groups of participants undergoing the MBHT behavioral intervention, (2) discussion with 
experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness 
intervention instructors) prior to, and following pilot testing of MBHT in participants, and 
(3) clinical judgment of the investigators performing the intervention.   
2. To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, 
retention rates, recruitment rates, and adverse effects) and secondary outcomes 
(hypertension risk factors such as diet, physical activity, obesity, and antihypertensive 
medication adherence) in hypertension subgroups, specifically participants with (1) 
prehypertension, (2) controlled hypertension, and (3) uncontrolled hypertension. Initial 
decisions about the targeted sample based on hypertension status will be made.  
3. To develop an MBHT therapist manual and training program, including procedures for 
training, supervising, and evaluating therapists. Furthermore, acceptable therapist 
characteristics will be developed. The manual and training program will include themes 
such as specification of unique and common elements of MBHT vs. other interventions, 
description of interventions excluded from MBHT, and specification of key treatment 
parameters such as frequency and duration of treatment, session length, topics 
addressed, sequence of sessions, as well as therapist adherence and competency 

measures. The MBHT training will consist of a therapist manual, a formal didactic 
training seminar, and at least one closely supervised training session.  
  
Stage Ib: Pilot Trial  
4. To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, 
customized from the evidence-based MBSR, has promise to be an effective behavioral 
therapy for participants with hypertension and/or prehypertension. We will perform a 
randomized controlled pilot trial for MBHT vs. enhanced usual care control. We 
hypothesize that MBHT will have adequate recruitment rates (≥10% of 
prehypertensive/hypertensive participants invited from physicians’ offices), fairly low 
drop out rates (<15%), and medium effect sizes (e.g. 5-10 mmHg systolic BP) for 
reduction in blood pressure.   
  
These findings will provide publishable pilot data that will inform future randomized clinical 
trials that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and 
active control groups. If proven effective, MBHT could be offered as a complementary program 
in the prehypertensive/hypertensive patient population that contributes to over half of the 
cardiovascular disease mortality world-wide.   
  
 
  
 
2. Provide a detailed description of the changes being requested (Use 
additional pages, if necessary): 
 
We are requesting the following changes… 
 
 
Addition of two new questions to the Home Baseline Assessment – We would like to add two 
new questions about hypertension (BP1_1 and BP1_2) to the home baseline assessment (see 
attached pdf with track changes).  Please note that these questions would be administered 
during the Home Baseline assessment only.  However, for participants who have already 
completed the baseline questionnaire, we would capture this information during their next 
follow up assessment. 
 
 
 
Permission to provide financial compensation to participants who withdrew from the study 
intervention but are still willing to complete follow up assessments – since the start of our 
study, we have had two participants who have decided to withdraw from the study after the 
start of the intervention. We would be interested in re-contacting these and future individuals 
who withdraw to invite them to participate in the follow up assessments and would like to be 
able to provide them with $50 per follow up as an expression of gratitude for their time and 
effort. 
 
 
3. State the reason (justification) for the requested amendment:  
  
Please see justifications in Section 2 above.  
  

4. What is your assessment of how the changes will affect the overall 
risk/benefit ratio of the study and the willingness of individuals to 
participate?  
  
We do not anticipate any major changes to the risk/benefit ratio.  Both of the new baseline 
questions are yes/no and take well under a minute to complete. Following up with participants 
who withdrew from the intervention about the possibility of completing the follow ups does not 
cause any significant additional risks. Study staff will be trained to remind participants that their 
participation is voluntary. Some individuals may have withdrawn from the study because of 
reasons related to their ability to complete the 9 week course, but may actually still be interested 
in participating in the research questionnaires. This would allow them that opportunity. 
 
  
 
5. Does the requested amendment require new documents or changes 
to the approved consent form or other documents?  
  
Yes.  Changes to the Home Baseline Assessment (two new questions).  See attached 
document with track changes – only p.43 was affected and is being attached. 
 
 
  
References 
1 Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication 
adherence. Med Care. 1986;24 (1):67-74. 

MB-BP Home Baseline Assessment, Version 1.65, April 22August 8, 2016 
Page 1 of 49 
 
 
 
 
 
 
HOME BASELINE ASSESSMENT 
 
 
 
 
QUESTIONNAIRES ANSWERED BY PARTICIPANTS 
AT BASELINE (VIA ONLINE OR PAPER FORM) 
 
 
 

MB-BP Home Baseline Assessment, Version 1.65, April 22August 8, 2016 
Page 43 of 49 
Blood Pressure and Blood Pressure Medication Use 
 
The following questions are about blood pressure. 
 
BP1_1. Does your blood pressure tend to be HIGHER when you have it measured in a clinical 
setting, such as a doctor’s office? This is sometimes called “white coat hypertension.” 
 
 
 
□ No 
 
 
□ Yes  SKIP TO BM1_01 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
BP1_2. Does your blood pressure tend to be LOWER when you have it measured in a clinical 
setting, such as a doctor’s office? This is sometimes called “masked hypertension.” 
 
 
 
□ No 
 
 
□ Yes 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
BM1_01. Do you currently take medication for your blood pressure? 
□ Yes 
□ No (if responding “no”, please skip to the next page).  
 
 
Yes 
No 
BM1_02. Do you sometimes forget to take your blood pressure pills? 
□ 
□ 
BM1_03. People sometimes miss taking their medications for reasons other than forgetting. Thinking 
over the past two weeks, were there any days when you did not take your blood pressure medicine? 
□ 
□ 
BM1_04. Have you ever cut back or stopped taking your blood pressure medicine without telling your 
doctor because you felt worse when you took it? 
□ 
□ 
BM1_05. When you travel or leave home, do you sometimes forget to bring along your blood pressure 
medicine? 
□ 
□ 
BM1_06. Did you take all your blood pressure medicine yesterday? 
□ 
□ 
BM1_07. When you feel like your symptoms are under control, do you sometimes stop taking your blood 
pressure medicine? 
□ 
□ 
BM1_08. Taking blood pressure medicine every day is a real inconvenience for some people. Do you 
ever feel hassled about sticking to your treatment plan? 
□ 
□ 
 
BM1_09. How often do you have difficulty remembering to take all your blood pressure 
medicine?  
□ Never/rarely 
□ Once in a while 
□ Sometimes 
□ Usually 
□ All the time 
 
 
 

Brown University 
Research Protections Office 
Institutional Review Board 
Modification Request 
Date of Request: 11/6/17 Investigator's Name and Title: Eric Loucks, PhD, Assistant Professor 
Study Title: Mindfulness-based Blood Pressure Reduction (MB-BP) Study (#1412001171) 
Original Type of Review: 
D Exempt 
D Expedited 
[8J Full Board 
1) Provide a brieflay summary of the overall project. Include enough detail to allow the IRB to
evaluate the requested change(s) within the context of the overall project. (Attach summary to this
form)
See attached summary 
2) Provide a detailed description of the changes being requested (Use additional pages, if necessary):
See attached summary 
3.) State the reason (justification) for the requested modification. (Use additional pages, if 
necessary): 
See attached summary 
4.) What is your assessment of how the changes will affect the overall risk/benefit ratio of the study 
and the willingness of individuals to participate'? 
See attached summary 
5.) Does the requested modification require new documents or changes to the approved consent 
form or other documents? 
 x Consent/assent documents (attach revised version with changes highlighted) 
[8J New/revised instruments (attach - if revised, highlight changes) 
D New/revised adve1tising materials (attach - if revised, highlight changes) 
Do you have a conflict of interest on this project according to Brown's policy? DYES [8JNO 
If YES, has this conflict been previously disclosed to the IRB? 
DYES ONO 
Date: <0_	_/7_ 

1. Provide a brief lay summary of the overall project. Include enough 
detail to allow the IRB to evaluate the requested change(s) within 
the context of the overall project.   
  
Original lay summary providing broad overview of the project: 
The World Health Organization reported that suboptimal blood pressure (BP) is responsible 
for more than half of cardiovascular disease mortality world-wide. Furthermore, greater than half 
of those with hypertension have uncontrolled BP. A 2009 Institute of Medicine report 
recommended prioritizing research to “Compare the effectiveness of mindfulness-based 
interventions (e.g. yoga, meditation, deep breathing training) and usual care in treating… 
cardiovascular risk factors.”  Evidence-based mindfulness interventions, including Mindfulness-
Based Stress Reduction, may have some effects on blood pressure, where a recent meta-
analysis and systematic review of 4 randomized controlled trials demonstrated significant 
effects, but evidence of heterogeneity in effect sizes. The methodologically highest quality 
studies had the smallest effect sizes (range 0-5 mmHg). Mindfulness-Based Stress Reduction 
(MBSR) has been customized to a number of disease processes, such as Mindfulness-Based 
Cognitive Therapy for patients with recurrent depression, and Mindfulness-Based Relapse 
Prevention for patients with substance use addictions. Effect sizes have been increased by 
customizing mindfulness interventions to diseases of interest. The same may be true for 
hypertension, however mindfulness interventions customized for prehypertensive/hypertensive 
patients have never been investigated. Until methodologically rigorous studies to evaluate 
customized interventions for hypertension are performed, we will not know if the observed 
preliminary effects of general mindfulness interventions on blood pressure reduction could be 
much more effective with a tailored approach. Consequently, we propose to conduct a stage I 
behavioral therapy intervention study to evaluate whether MBSR customized to prehypertensive 
and hypertensive patients has the potential to provide clinically relevant reductions in BP. 
Consequently the specific aims are:  
  
Stage 1a: Therapy Development/Manual Writing  
1. To outline and evaluate key novel elements of mindfulness-based hypertension therapy 
(MBHT), customized from the evidence-based MBSR. We hypothesize that the most 
important novel element will be generation of mindfulness skills specifically applied to 
hypertension risk factors such as diet, physical activity, obesity, alcohol consumption 
and antihypertensive medication adherence. This aim will be achieved using (1) focus 
groups of participants undergoing the MBHT behavioral intervention, (2) discussion with 
experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness 
intervention instructors) prior to, and following pilot testing of MBHT in participants, and 
(3) clinical judgment of the investigators performing the intervention.   
2. To determine effectiveness of MBHT on primary outcomes (systolic blood pressure, 
retention rates, recruitment rates, and adverse effects) and secondary outcomes 
(hypertension risk factors such as diet, physical activity, obesity, and antihypertensive 
medication adherence) in hypertension subgroups, specifically participants with (1) 
prehypertension, (2) controlled hypertension, and (3) uncontrolled hypertension. Initial 
decisions about the targeted sample based on hypertension status will be made.  
3. To develop an MBHT therapist manual and training program, including procedures for 
training, supervising, and evaluating therapists. Furthermore, acceptable therapist 
characteristics will be developed. The manual and training program will include themes 
such as specification of unique and common elements of MBHT vs. other interventions, 
description of interventions excluded from MBHT, and specification of key treatment 

parameters such as frequency and duration of treatment, session length, topics 
addressed, sequence of sessions, as well as therapist adherence and competency 
measures. The MBHT training will consist of a therapist manual, a formal didactic 
training seminar, and at least one closely supervised training session.  
  
Stage Ib: Pilot Trial  
4. To determine whether a mindfulness-based hypertension therapy (MBHT) intervention, 
customized from the evidence-based MBSR, has promise to be an effective behavioral 
therapy for participants with hypertension and/or prehypertension. We will perform a 
randomized controlled pilot trial for MBHT vs. enhanced usual care control. We 
hypothesize that MBHT will have adequate recruitment rates (≥10% of 
prehypertensive/hypertensive participants invited from physicians’ offices), fairly low 
drop out rates (<15%), and medium effect sizes (e.g. 5-10 mmHg systolic BP) for 
reduction in blood pressure.   
  
These findings will provide publishable pilot data that will inform future randomized clinical 
trials that evaluate effects of MBHT on long-term changes in blood pressure vs. usual care and 
active control groups. If proven effective, MBHT could be offered as a complementary program 
in the prehypertensive/hypertensive patient population that contributes to over half of the 
cardiovascular disease mortality world-wide.   
 
  
Project update as of November 2017: 
The Mindfulness-Based Blood Pressure Reduction (MB-BP) Study, formerly known as 
Mindfulness-Based Hypertension Therapy (MBHT), is currently in Year 2 of a five year NIH UH2 
grant. 
 
Data collection for Stage 1a of the project has ended and analysis is on-going. In total we ran 
three separate Mindfulness-Based Blood Pressure reduction (MB-BP) intervention courses, with 
a total sample size of 43 eligible participants who both enrolled and completed the 9-week 
intervention. We had eight eligible participants enroll in the study who later decided to not 
complete the course. 
 
In June 2017 we began enrollment for the next phase (referenced as Stage 1b above, but now 
called ‘Stage 2a’) of the study, which is to conduct a Randomized Controlled Trial (RCT) with 
enhanced usual care. This phase will continue for the next 12-18 months, at which point we will 
transition to the third and final phase, an RCT with an active control (i.e., Mindfulness-Based 
Stress Reduction - MBSR) as well as ambulatory blood pressure monitoring.  
 
 
 

2. Provide a detailed description of the changes being requested (Use 
additional pages, if necessary): 
 
This amendment covers the following four requests: 
 
(1) Qualitative Phone Interviews - First, we are requesting permission to modify the already 
approved focus group discussion questions into a one-on-one qualitative phone interview (see 
enclosed “Semi-structured qualitative phone interview”).  Our intent is to then randomly select 
and re-contact Stage 1 participants, who did not participate in the focus group discussions, and 
invite them to take part in the one-on-one qualitative phone interviews instead.  We would 
attempt to complete ten interviews. Participants who complete the phone interviews would be 
mailed $25 gift cards for their time and effort.  Related enclosures: Appendices 1-3 
 
(2) 2-year Follow Ups – Second, we would like to re-contact participants who completed the course 
and invite them to come back into the office for a quick two year in-person assessment.  This 
optional assessment is estimated to take 20-30 minutes to complete and would be a small sub-
set of what is already approved by the IRB (i.e., blood pressure, weight, hypertension 
medication questions, and mindfulness practice questions). Participants would be given $50 USD 
for this additional component. For participants who have already been consented, we would 
have them sign the attached addendum to the consent form. For newly enrolled participants we 
would ask them to sign the attached revised consent form.  It is already part of the approved 
study protocol and screening process to ask participants if we can keep their information on file 
to contact them about possible future studies or opportunities to participate in research. We 
would only re-contact participants who gave us permission to do so. Related enclosures: 
Appendices 3-4 
 
(3) Participant Compensation – Third, we are requesting permission to alter the order in which 
participants are compensated. As it is currently written, participants are given $25, $25, and $50 
USD at their 10 week, 6 month and 12 month follow ups respectively.  We are seeking to reverse 
that order and instead provide participants $50, $25, and $25 USD at their three follow ups. The 
total amount provided as compensation for participation would remain the same ($100 USD). 
Participants already enrolled into the study would be compensated in the manner already 
outlined and approved. However, we are proposing that newly enrolled participants would be 
compensated under the new guidelines outlined in this amendment (if approved). See p.1 of the 
revised consent form for this change. Related enclosure(s): Appendix 3 
 
(4) Recruitment assistance for UMass fMRI sub-study – the MB-BP Study is one of several 
concurrent studies being funded under the NCCIH Science of Behavior Change UH2 project 
“Mindfulness Influences on Self-Regulation: Mental and Physical Health Implications.” Our 
collaborators at the UMass medical school have recently received IRB approval from the UMass 
Medical School IRB to conduct a related clinical trial that involves fMRI imaging of MB-BP 
participants to evaluate several mechanistic self-regulation targets of the Mindfulness-based 
blood pressure therapy (MB-BP), their neural substrates, and their potential impact on 
autonomic system measures. Their proposed project (titled, Mindful Self-Regulation for blood 
pressure MRI study) involves recruiting, screening, enrolling, and scanning a sub-set of MB-BP 
participants (i.e., goal is to enroll and image 60 eligible MB-BP participants over the 12-18 
months). Eligible participants who agree to take part in the fMRI study at UMass Medical School 

will be invited to travel up to the UMass facility twice – once at baseline and once at the 10 
week follow up period – to undergo two MRI sessions (~1.5 hours each). Participants will be 
compensated $150 USD for each neuroimaging session. Note: see attached UMass Medical 
School IRB submission for the full version of their study protocol, informed consent form, phone 
screener, and IRB approval letter. 
 
In this amendment we are requesting permission to approach newly enrolled MB-BP 
participants about the UMass Medical School fMRI study and to see if they would be interested 
in being contacted by the UMass medical school research staff to complete a brief 15-minute 
phone screener to determine their eligibility for the related neuroimaging study.  To do this, 
Brown University research staff would use the attached “UMass Medical School fMRI Study 
Recruitment Talking Points” document. This document outlines the main features of the 
neuroimaging study and what participant involvement would entail. However, it is important to 
note that both the screening and the informed consent procedures will be conducted by UMass 
Medical School research staff and not by Brown University. Our role will be to introduce the 
fMRI study to our MB-BP participants and document their consent for UMass Medical School 
staff to contact them by phone for screening.  We will only provide UMass Medical School 
research staff with the contact information of MB-BP participants who agree to be contacted 
regarding the neuroimaging study. Contact information of MB-BP participants who do not wish 
to be contacted by UMass will not be passed along.  Related enclosures: Appendices 5-6 
 
 
 
3. State the reason (justification) for the requested amendment:  
  
(1) The data collected in the proposed qualitative phone interviews will complement the qualitative 
data previously collected in the focus group discussions. It will also hopefully help to address any 
potential selection bias due to the more engaged and enthusiastic participants opting to take 
part in the focus group discussions.  
 
(2) Analysis of the one year follow up data has been very promising, showing sustained reductions 
in blood pressure and other important outcomes. There are very few research studies that 
explore sustained effects at 12 months or even 24 months. Recontacting participants to have 
them complete a 2 year follow up would offer novel research findings to the field of mindfulness 
and cardiovascular health. 
 
(3) We are proposing a change in the compensation protocol for two reasons. First, we believe that 
providing participants the larger sum for the first follow up rather than the last follow up will 
help with retention rates overall. We have often struggled to get participants to come in for the 
first follow up, particularly with members of the control group, who did not get the intervention. 
However, we have not had as much difficulty getting participants to complete their final follow 
up. We find that once individuals have already invested time to complete the first two follow 
ups, they are often intrinsically motivated to complete the final follow up and therefore don’t 
require as much external motivation to participate. The second justification for altering the 
payment structure is that the 12 month data are not as important to the overall study and 
analyses as the 10 week data are. 
 

(4) The UMass Medical School Mindful Self-Regulation for blood pressure MRI study is a related 
concurrent study on the same UH2 grant that is funding MB-BP.  Since it involves recruiting a 
sub-set of MB-BP participants it makes the most sense for the research staff at Brown University 
to be the individuals to recruit.  
 
  
4. What is your assessment of how the changes will affect the overall 
risk/benefit ratio of the study and the willingness of individuals to 
participate?  
  
We do not anticipate any shifts in the risk / benefit ratio of the study. Participation in all aspects 
of the study is optional and will be explicitly stated at the time of recruitment and informed 
consent. This includes when approaching participants about potential involvement in the one on 
one qualitative phone interviews, 2 year follows ups, and possible participation in the fMRI 
study. 
 
 
  
5. Does the requested amendment require new documents or changes 
to the approved consent form or other documents?  
  
See enclosed attachments related to this amendment: 
 
Appendix 1 - Protocol for semi-structured qualitative phone interview scripts and talking 
points. 
 
Appendix 2 – Addendum to consent form to be signed by already enrolled participants 
 
Appendix 3 – Revised Informed Consent (v.2.2) – with track changes 
 
Appendix 4 – Two year in-person follow up assessment 
 
Appendix 5 – UMass Medical School fMRI Study Recruitment Talking Points for research staff 
at Brown University to utilize 
 
Appendix 6 – Umass Medical School IRB submission for fMRI sub-study 
 
 

 
 
 
 
 
Appendix 1 -  
Semi-structured qualitative  
phone interviews  
Created from the already approved focus group discussion 
protocol and modified to be relevant for a one-on-one 
qualitative phone interview. 
 
 

MB-BP qualitative phone interview protocol  
 
Semi-Structured Script and Talking Points 
“Hello, my name is __________ and I am calling from Brown University regarding the Mindfulness Based Blood Pressure Reduction 
Study that you took part in just over a year ago. As we begin to evaluate the intervention we would like to get a better understanding 
of what worked and didn’t work by conducting personalized one-on-one phone interviews with yourself and other graduates of the 
program. 
 
The interview would be done by phone, would take 20 minutes to a half an hour to complete, and could be scheduled at a time that is 
convenient for you. You would also receive a $25 gift card for your time. Would you be willing to offer feedback on your experiences 
with the mindfulness program?” 
 
TALKING POINTS –  
 
● 
Confidentiality: As a reminder, everything you say will remain confidential. No one outside of our project will be able to 
see your answers and your name and other identifying information will not be used in any reports or publications.  
 
● 
Why and How? “We are hoping to get your feedback about the mindfulness course and use it to make the program more 
effective. Please feel free to share your point of view and know that we welcome both positive and negative feedback. 
There are no right or wrong answers just your perspective about the program.”  
 
 
Important points: 
○ 
We are trying to improve the intervention 
○ 
Discussing your opinions on the different activities 
○ 
Please share your point of view 
○ 
No wrong answers 
○ 
We equally welcome positive and negative feedback 
 
● 
Suggestions: “We would like to record this call with your permission so that it can be transcribed later by members of our 
team. If you would prefer not to be recorded, please let me know. Also, please understand that any report we write 
regarding your feedback and what we hear from you today will not be identified with you in any way and remains 
anonymous.”  
 
Suggestions to help us have a good discussion 
■ 
Speak up 
■ 
Audio recording if that is ok 
■ 
Any report that we write about what we hear today will not be associated with your identity 
 
● 
What to expect: “So before we begin I just want to let you know that we will be asking you a series of open ended 
questions. My role is listen and ask questions to better understand your experiences. So I might ask you for clarification or 
more detail about a comment but your thoughts are the important part of this discussion. However, in the interest of 
getting to all the questions I may need to move us along pleas know that this is only due to time considerations.” 
 
○ 
My role is to listen ask questions that help to understand your experience   
○ 
In the interest of time, I may move to the next question to get your thoughts regarding the whole program 
 
Any questions before we begin? 
Discuss Class Overview: Each sessions central activity 
 
“First I am going to read through a list of the major class activities you participated in. While I read through the activities I would like 
you to think about which was the most memorable for you and why.” 
 
“So, hearing the course activities, which is most memorable for you? Why?” 
“Next I have a series of 4 questions for you about your experiences in the program.”  
 
1. What was most helpful about this course, and why?  
2. After going through this mindfulness intervention, what is your understanding of how it works to improve your blood pressure? 
3. We want to make this intervention better. You have been through it once. How do you think we can make it better?  
4. Every instructor can improve. How can this instructor improve? 
Read the survey: record responses. 
 
Each weekly session was 2.5 hours long. Do you think the session should be 2 hours, 2.5 or 3 and why? 
 
The retreat day was scheduled to be 7.5 hours long. How long do you think the day should be (5,6,7, or 8) and why? 
 
Please provide us with an additional feedback we may not have asked about at this time.   
 
 
 
 

 
 
 
 
 
Appendix 2 -  
Addendum to Informed Consent  
To be signed by participants who have already enrolled in 
the study and who opt to complete the optional two year 
follow up assessment 
 
 

MB-BP Addendum to Consent 
 v.2017.12.06 
Brown University 
Consent to Participate in a Research Study 
Addendum to provide additional information to subject after original consent and 
to seek permission to complete a two year follow up assessment 
________________________________________________________________________ 
IRB Study #__1412001171___________  
Consent Form Version Date: _12/6/2017__  
Title of Study: Mindfulness-Based Blood Pressure Reduction (MB-BP) Study 
Principal Investigator: Eric B. Loucks, PhD__ 
 
Study Contact telephone number:  401-400-4768 
Study Contact email:  mindfulness@brown.edu 
_________________________________________________________________ 
The following information should be read as an addition to the original Consent form that 
you read and signed at the beginning of the study. Unless specifically stated otherwise in 
the following paragraphs, all information contained in that original Consent Form is still 
true and remains in effect. Your participation continues to be voluntary. You may refuse 
to participate, or may withdraw your consent to participate at any time, and for any 
reason, without jeopardizing your future care at this institution or your relationship with 
your health care provider. 
 
New or additional information 
You are being asked to participate in an optional two year follow up assessment that will 
take place in-person at the Brown University Mindfulness & Cardiovascular Health Lab 
located at 121 South Main Street, Providence, RI 02912. The two year follow up 
assessment is estimated to take around 20 to 30 minutes to complete and will consist of a 
subset of measures that you previously completed as a participant in the MB-BP Study. 
Specifically, we will be taking your blood pressure and weight as well as asking you a 
series of questions about hypertension medications and mindfulness practices. 
 
Subject’s Agreement:  
I have read the information provided above.  I have asked all the questions I have at this 
time.  I voluntarily agree to continue to participate in this research study. 
 
_________________________________________________ 
_________________ 
Signature of Research Subject 
 
Date 
 
_________________________________________________ 
Printed Name of Research Subject 
 
_________________________________________________ 
_________________ 
Signature of Research Team Member Obtaining Consent 
 
Date 
 
_________________________________________________ 
Printed Name of Research Team Member Obtaining Consent 

 
 
 
 
 
Appendix 3 -  
Revised Informed Consent  
(v.2.2 – with track changes)  
For newly enrolled participants to complete 
 at time of screening. The revisions in this document cover 
the request to follow up at two years as well as the change 
in payment structure. 
 
 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
  Page 1 of 9 
The Mindfulness-Based Blood Pressure Reduction (MB-BP) Study 
Agreement to Participate in a Research Study 
 
Investigation of the Effects of Mindfulness on Blood Pressure and Well-Being 
 
You are being asked to take part in a Brown University research study about the effects of 
mindfulness and hypertension education on blood pressure and risk factors for hypertension. 
This form will explain the purpose of the study, how the study will be carried out and what you 
will be expected to do.  It will also explain the possible risks and possible benefits of being in the 
study.  If any part of the following description is not clear to you, you are encouraged to contact 
the researcher to answer any questions before you decide whether to take part in the study. If you 
decide to participate, please fill out and sign the last page of this form. 
 
1a.  Nature and Purpose of the Study      
The purpose of the study is to investigate the impact of mindfulness practices and health 
education on blood pressure. You have been selected for this study because you expressed 
interest in the project and because you met entrance criteria for having prehypertension or 
hypertension, or another cardiovascular risk factor that could be influenced by this program. 
Eligibility for the study is still being assessed. Therefore, it is possible you may not be eligible 
for the study even after signing this consent form. Your participation in this study is voluntary 
and can be withdrawn at any point in the project. 
 
In order to assess the effects of the customized mindfulness intervention, you will be asked to 
complete some questionnaires and laboratory assessments before and after the intervention. 
Specifically, assessments will be completed at: baseline, 10 weeks, 6 months and 1 year. To 
express our gratitude for participation, you will be given $2550, $25, and $50 25 (up to $100 
USD total) at the 10 week, 6 month and 12 month follow ups respectively. As part of the study 
you will also be given a wireless blood pressure monitor (estimated value of $90) to use 
throughout the study. There is an optional 2 year follow up that you may be invited to complete, 
for which you will be given an additional $50 USD. 
 
This is a Randomized Control Trial. Participants enrolled into the study will be randomly 
assigned to one of two groups: (1) the intervention group or (2) the wait-list control group. The 
wait-list control group will be given the opportunity to participate in the intervention after the six 
month follow up assessments are completed.  Both the intervention and the control group will be 
asked to participate in the research assessments. 
 
 
1b.   Explanation of Procedures   
 
If you agree to participate, you will be asked to consent to the following:  
 
1) Participation in an interview in which you will be asked questions about past and present 
mental health, including depression and suicide (previously completed with your verbal 
consent). 
 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
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2) Completion of an in-person screening assessment, during which your blood pressure, height, 
weight and other basic demographic and health data will be collected and assessed in order to 
determine eligibility for the study. 
 
3) Completion of questionnaires administered in-person and online that ask about a wide range 
of topics, including your diet, physical activity, smoking, medication use, personality, 
emotions, attention and past experiences, including stressful or traumatic experiences. These 
questions will probe sensitive psychological areas, including physical, emotion and sexual 
abuse. These questionnaires may take up to 3 hours to complete. By completing the 
interviews and questionnaires, you are giving the researchers permission to use the 
information you have provided. You have the right not to answer any of the questions.  
 
4) Directly assessed blood pressure, heart rate, height, weight, physical activity, and 
antihypertensive (blood pressure) medication use at baseline and after the mindfulness 
course. Physical activity will be assessed for a week at a time using small actigraphy 
monitors (i.e., Fitbits) that attach to your wrist. If you take antihypertensive medication, we 
will provide you with an electronic bottle cap that will automatically record when the pill 
bottle is opened during the study. This will help us measure how often the medication is 
used. We will also provide you with a wireless blood pressure monitor and will ask that you 
take your blood pressure at home systematically during each of the research assessment 
periods (i.e., baseline, 10 week, 6 month and 12 month). 
 
5) You will be asked to perform some cognitive tasks. Some of these tasks may involve 
computer-based tests of attention or decision-making. Together these tests may take as long 
as 20 minutes. 
 
6) During the in-person assessments you will also be given a battery of stress tests that are 
designed to induce a stress response so that we can monitor your cardiovascular response and 
recovery. 
 
7) Attendance at an information session that is to be held within two weeks of the start of the 
intervention. 
 
8) If randomized into the intervention group, you will participate in the mindfulness program, 
which consists of 9 weekly sessions of 2.5 hours each and will include one 7.5 hour weekend 
retreat. Daily at home practice assignments may take as long as one hour and consist of 
practicing mindfulness exercises with the aid of a guided meditations and completing 
worksheets related to stress, thoughts, and common reactions to various types of events. If 
you are randomized into the wait-list control group, you will be invited to take part in the 
mindfulness class after the completion of the 6 month follow up assessments. 
 
9) Class sessions may be audio taped so we can analyze the quality of the treatment you receive. 
The recordings will be transcribed so that we may analyze the text. The recordings will be 
identified by study number, will only be heard by study staff and will be destroyed after 
transcription.  
 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
  Page 3 of 9 
10) You may be asked to complete a few short questionnaires each week during the 9 week 
condition. 
 
11) After 10 weeks from the start of the intervention, you will be asked to complete 
questionnaires and return to the laboratory to repeat the same procedures for a second day of 
testing. If in the intervention arm, you will also be invited to participate in a focus group to 
share any advice you may have on how to improve the intervention.  
 
12) Six months and one year after the beginning of the study, you will be asked to return to the 
laboratory to repeat the same testing procedures. 
 
12)13) In addition to the six month and one year follow up, you will also be re-contacted to 
participate in an optional, very brief two year follow up assessment. The two year follow up 
assessment is estimated to take around 20 to 30 minutes to complete and will consist of a 
subset of measures that you would have previously completed as a participant in the MB-BP 
Study. Specifically, we will be taking your blood pressure and weight as well as asking you a 
series of questions about hypertension medications and mindfulness practices. For this 
additional follow up you will be given $50 USD. 
 
 
 
 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
  Page 4 of 9 
Table Summarizing Activities and Time Commitment for this Study.  
 
Activity 
Estimated Time Commitment 
In-person screening assessment 
0.5 hours 
Baseline  
 
In-person assessment 
 
Online questionnaire 
 
At home health monitoring (e.g., fitbit, BP, etc.) 
 
2.0 hours 
1.0 hours 
1.0 hours 
Information session 
1.0 hour 
Intervention* 
 
Mindfulness course 
 
Home practice assigned during course 
 
*Intervention group only; control group will be invited to take part in 
a class post 6 month follow up but it will not be required as part of 
the study. 
 
Nine 2.5 hour sessions  
7.5 hour all day retreat 
Up to 1hr daily home practice 
assignments  
Total course time: 30.0 hours 
Max. practice time: 48 hours 
Focus group participation post intervention (intervention 
group only) 
1.5 hours 
Follow Ups – 10 week, 6 month, 12 month 
 
In-person assessments 
 
Online questionnaires 
 
At home health monitoring (e.g., fitbit, BP, etc.) 
Total follow up time: 
6.0 hours 
3.0 hours 
3.0 hours 
Follow Up – 2 year (in person only) 
30 minutes 
TOTAL ESTIMATED TIME COMMITMENT 
17.518.0 hours – CONTROL 
97.0 5 hours - INTERVENTION 
 
 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
  Page 5 of 9 
Feedback: 
At the end of the study, you will receive individual feedback about the changes that occurred 
since the first assessment. Specifically, you will receive an individualized handout listing % 
change (increase or decrease) on scales of attention, stress, mood, health behaviours, weight, and 
blood pressure across the study. 
 
Uncontrolled Hypertension: 
If during the in-person assessments it appears that you have uncontrolled hypertension (your 
average systolic blood pressure reading is 140 mmHg or greater and/or your average diastolic 
blood pressure is 90 mmHg or greater) AND you indicate to us that you are not currently being 
treated for hypertension, then we will be requesting your permission to contact your health care 
provider to notify him/her of the blood pressure results. If you do not have a health care provider 
and/or do not have health insurance, our staff will provide you with resources to help you search 
for one; although we cannot guarantee that we will be able to find you one nor that it will be free. 
It is your choice on whether or not you would like us to follow up with your health care provider. 
Your participation in the study is not contingent on this communication; however, it is our 
recommendation that all individuals with uncontrolled hypertension be under the care of a health 
care professional. 
 
2.  Discomforts and Risks 
The risks to you in this study are small.  The questionnaires used in the study are routine, 
standardized forms for epidemiologic research.  Certain questions may be upsetting as they may 
probe sensitive psychological areas and inquire about upsetting or traumatic events, including 
physical, sexual or emotional abuse and/or current psychiatric symptoms.  The cognitive tests 
and stress battery may also invoke a stress response that may be uncomfortable. All aspects of 
the study are voluntary; you have the right to skip anything during the study that makes you 
uncomfortable. 
 
Meditation-based interventions may results in discomfort with attention to unpleasant thoughts, 
feelings or body sensations. Some individuals may experience an initial increase in undesirable 
feelings with increased attention to them. 
 
It is possible that injuries could be sustained during the study either from the gentle mindful 
movements (i.e., yoga), or from physical activities that participants engage in as a way to reduce 
blood pressure.  To help limit this, you will receive a handout showing the yoga poses that will 
be offered during the course that you can show your health care provider so that they can advise 
on which poses to do, and which to avoid. Modifications of poses will be available as needed. 
None of the poses (or the yoga as a whole) are mandatory to be done. You will also be 
encouraged to explore physical activities that promote strength and conditioning as a way to 
reduce blood pressure. You will be encouraged to not go beyond any physical limits of your 
body, and will be encouraged to ask your healthcare provider about advised physical activities 
and mindful movements if you have any physical limitations. 
 
While physical and mental injury is always a possibility the potential for harm is limited.  Note 
that a research injury is any physical or mental injury or illness caused by your participation in 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
  Page 6 of 9 
the study. If you are injured by a medical treatment or procedure that you would have received 
even if you were not in the study, that is not a research injury.  To help avoid research injury and 
potential added medical expenses, it is important to follow all study directions carefully. If you 
are covered by insurance and suffer a research injury, it is possible that some or all of the costs of 
treating your condition could appropriately be billed to your insurance company.  If such costs 
are not covered your health insurance company, it is possible you would have to pay for these 
costs out of pocket. Brown University’s policies do not cover payment for such things as lost 
wages, medical care expenses, or pain and suffering. 
 
Precautions should be taken to avoid injuries.  If you do become injured during the study, you 
should call your doctor immediately.  You should also alert the study staff that you have been 
injured.  Heart attack and sudden death related to heart problems have been known to occur in 
people while they are exercising.  This is very rare, however.  Estimates of sudden cardiac death 
range from 0 to 2 per 100,000 hours.  However, the researchers cannot guarantee that no 
complications will happen to you. 
 
3.  Benefits 
We cannot and do not guarantee or promise that you will receive any direct benefits from this 
study.  However, participation in the study creates the potential benefit of a) identifying effective 
treatments for elevated blood pressure, b) gaining knowledge of the effects of mindfulness 
practices, c) receiving information about your psychological and physical functioning. As part of 
the study, you will receive a wireless blood pressure monitor that will be yours to keep. This 
monitor may provide additional opportunity to monitor your blood pressure at home, which may 
benefit your health by providing additional biofeedback. 
 
4.  Alternative Therapies  
A number of different therapies, including antihypertensive medication, diet changes, physical 
activity, and reducing excessive alcohol consumption may also be beneficial for reducing blood 
pressure. Education about these therapies are integrated into this course, but other forms of these 
alternative therapies are also available in the community. 
 
5.  Confidentiality  
Your responses for this study will be kept confidential.  All data that we collect will be linked to a 
study ID# instead of your name.  All questionnaires in this study will be filled out through an 
online survey or a paper version of the survey if you prefer.  All of these questionnaires will be 
linked solely to your study ID#, so that your identity is protected and your answers are confidential.  
Although these measures have been taken to protect your personal information, complete 
confidentiality cannot be guaranteed when transmitting information over the internet. 
 
While your confidentiality is protected to the extent of the law, there are limitations to 
confidentiality. If your questionnaire responses indicate that you pose a serious danger to 
yourself or to another person, then a collaborator (Dr. Ellen Flynn) who is a licensed psychiatrist, 
may contact you to discuss your responses and possible referral to a treatment provider. 
Questionnaire items that may warrant follow-up include endorsements of statements about 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
  Page 7 of 9 
hurting yourself, any high scores in depression, anxiety, or other clinically significant problems. 
You should also know that there are times when the law might require the release of your 
responses without your permission.  For example, State law requires researchers to report abuse 
or neglect of children to the Department of Children, Youth and Families (DCYF).   State law 
also requires researchers to report abuse or neglect of people age 60 and older to the Division of 
Elderly Affairs. 
 
The findings of the study may be used for medical publication. Your name will not be used in 
any published reports about this study. Results will be reported in a summarized manner in such 
a way that you cannot be identified. All personally identifiable information will be "de-
identified" and only a unique code number will be used. Study records will be identified with a 
unique code number and initials. All study records and specimens will be stored in a secure 
storage area. 
 
Keeping study records: The Principal Investigator for this study will keep your research records 
indefinitely for research purposes. 
 
 
Certificate of Confidentiality: This research is covered by a Certificate of Confidentiality from 
the National Institutes of Health. The researchers with this Certificate may not disclose or use 
information, documents, or biospecimens that may identify you in any federal, state, or local 
civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as 
evidence, for example, if there is a court subpoena, unless you have consented for this use. 
Information, documents, or biospecimens protected by this Certificate cannot be disclosed to 
anyone else who is not connected with the research except, if there is a federal, state, or local law 
that requires disclosure (such as to report child abuse or communicable diseases but not for 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see 
below); if you have consented to the disclosure, including for your medical treatment; or if it is 
used for other scientific research, as allowed by federal regulations protecting research subjects.  
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Center for Complementary and Integrative Health, which is 
funding this project.  You should understand that a Certificate of Confidentiality does not 
prevent you from voluntarily releasing information about yourself or your involvement in this 
research. If you want your research information released to an insurer, medical care provider, or 
any other person not connected with the research, you must provide consent to allow the 
researchers to release it. The Certificate of Confidentiality will not be used to prevent disclosure 
as required by federal, state, or local law of situations of child abuse and neglect, or harm to self 
or others.  
 
 
 
 

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6.  Refusal/Withdrawal 
Participation is voluntary, and you may decide to opt out or refuse any part of participation, 
including not answering certain questions. If you decide now to participate, you can change your 
mind later and quit the study.  The decision to not participate or to withdraw from the study will 
not adversely affect current or future interactions with Brown University. The decision to not 
participate or to withdraw from the study will also not adversely affect your relationship with 
your physician. 
 
If you decide not to participate, or if you quit the study, we will provide you with referrals for 
alternative treatments, if desired. 
 
7.  Contact Information 
If you have questions about study procedures at any time you may contact the researchers: Dr. 
Eric B. Loucks, email: eric.loucks@brown.edu, telephone (401) 863-6283. If you would like 
more information about the rules for research studies, or the rights of people who take part in 
those studies, you may contact the Brown University Human Research Protection Program, 
telephone number 1-866-309-2095 or 401-863-3050. 
 
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 

MB-BP Stage 2a - Consent Form, Version 2.2, October 11January, 2, 2018 
  Page 9 of 9 
 
CONSENT FORM:  
Please sign and return. 
 
 
 
 
Please read the following agreement and sign to consent to participating. 
 
I HAVE READ THE ABOVE DESCRIPTION OF THIS STUDY.   ALL OF MY 
QUESTIONS HAVE BEEN SATISFACTORILY ANSWERED, AND, I AGREE TO 
PARTICIPATE IN THIS RESEARCH STUDY. 
 
 
 
____________________________________________ 
         PRINT NAME 
 
 
 
_______________________________________ 
            ___________________ 
 
Signature of participant  
 
 
 
 
      Date 
 
 
 
 
 
 
STUDY PARTICIPANT CONTACT INFORMATION 
 
Name (print):______________________________________________________________ 
 
Permanent Address:________________________________________________________ 
 
Email(s):__________________________________________________________________ 
 
Telephone:__________________________(cell)     __________________________(other) 
 
 
 
 
 
 

 
 
 
 
 
Appendix 4 -  
Two year in-person follow up 
assessment  
Estimated to take 20-30 minutes to complete and consists 
of a subset of already approved measures 
 
 
 
 
 

MB-BP 2yr In-Person Follow up Assessment 
Version 1.0_2017.12.06 
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MB-BP STUDY: 2 YEAR IN PERSON 
FOLLOW UP ASSESSMENT 
 
PID. Participant ID # __________ 
BA01. Staff ID # __________ 
BA02. Today’s date (MMDDYY):   ___________ 
 
Blood Pressure: 
BA03a. Blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA03b. Blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA03c. Blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA03d. Blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA03e. Blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA03f. Blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
If the difference of the 2nd and 3rd systolic BP reading is 20 mmHg or greater OR the 
difference of the 2nd and 3rd diastolic reading is 10 mmHg or greater, then repeat the BP 
readings. Otherwise, skip to BA07. 
 
BA06a. Repeated blood pressure 1st reading, systolic blood pressure: _________ mmHg 
BA06b. Repeated blood pressure 1st reading, diastolic blood pressure:  __________ mmHg 
BA06c. Repeated blood pressure 2nd reading, systolic blood pressure: _________ mmHg 
BA06d. Repeated blood pressure 2nd reading, diastolic blood pressure:  __________ mmHg 
BA06e. Repeated blood pressure 3rd reading, systolic blood pressure: _________ mmHg 
BA06f. Repeated blood pressure 3rd reading, diastolic blood pressure:  __________ mmHg 
 
 
Blood Pressure Safety Protocol – The out-of-range blood pressure values are as follows: systolic blood 
pressure >200 mmHg or <90 mmHg; diastolic blood pressure >110 mmHg.  
 
In absence of symptoms (chest pain, shortness of breath, dizziness, headache), for a SBP>200 or DBP>110 
or both, we will strongly encourage participants to see their doctor right away or to go to urgent care. If there 
are symptoms, we will immediately call 911. 
 
In absence of symptoms (chest pain, shortness of breath, dizziness, passing out), for a SBP<90, we will 
strongly encourage participants to see their doctor right away or to go to urgent care. If there are symptoms, 
we will immediately call 911. 
 
Follow Safety Protocol for Uncontrolled Hypertension (140/90 mmHg or greater) 
 
 
BA07. Blood pressure cuff size used: 
 □ S     □ Reg    □  L        □ XL 
BA08. Arm that cuff was placed on: 
  □ L      □  R 
 
BP monitor BP monitor used: 
 Unit #1 - HEM-705CP (1) 
 Unit #2 - HEM-705CP (2) 
 Other (specify: (3) ____________________ 
 

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We are now going to take your weight.  Have ppt remove his/her shoes and empty his/her 
pockets. Remove bulky clothing as well. 
BA10. Weight: 
______ . __ lb (one decimal place) 
 
Medications (ME) 
 
The next questions are about medications used to treat hypertension or high blood pressure. 
 
ME01. Not including vitamins and supplements, do you currently take any prescription medications or over-the-
counter drugs for high blood pressure? 
 No  
 Yes 
 Don’t know 
 Prefer not to answer
ME01a IF NO, Have you ever taken medication for high blood pressure? 
 No  skip to end of medications questions 
 Yes  skip to end of medications questions 
 
If you brought your medications with you, please take them out now as we will use them to complete the 
next section. 
 
ME01b INTERVIEWER CHECKPOINT - Please select one: 
 Rx info not known or available – skip to end of ME questions; will need to follow up 
 Ppt brought medications -- continue 
 Ppt did not bring medications but knows info – continue, may need follow up 
 
ME01c In total how many different medications and/or over the counter drugs do you currently take for 
high blood pressure? Again, do not count vitamins or supplements. _________ # of BP meds 
 
 
Next we’re going to ask you questions about each of the medications you currently take for high blood 
pressure. 
 
ME02-10a.  What is the name of the first prescription medication or over-the-counter drug that you take? 
 
______________________________________________________________________ 
 
 
 Don’t know  
 Prefer not to answer 
 
 
ME02-10b. 
What is the dosage form? 
 
Oral 
 
 Pill, tablet, or capsule 
 Sublingual or orally-
disintegrating tablet 
 Liquid solution or 
suspension (drink, 
syrup) 
 Powder 
 
 
 
 
 
Topical 
 Liquid, cream, gel, or 
ointment 
 Ear drops (otic) 
 Eye drops 
(ophthalmic) 
 Skin patch 
(transdermal) 
 
 
 
 
 
Inhaled 
 Inhaler or nebulizer 
 
Injected 
 Injection 
 
Suppository 
 Rectal (e.g., enema) 
 Vaginal (e.g., douche, 
pessary) 
 
 
 
Other: 
 Other _________ 
 Don’t know 
 Prefer not to answer 

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ME02-10c. 
How frequently do you take it? 
 _________ times per day  
 _________ times per week 
 _________ times per month 
 Don’t know 
 Prefer not to answer 
 
 
ME02-10d. 
What is the strength? (Record strength of how it is actually taken, not how it is 
prescribed.)_________ % 
 _________ mg 
 _________ mcg 
 _________ grams 
 _________ I.U. 
 _________ Other unit: _____________ 
 Don’t know 
 Prefer not to answer 
 
 
ME02-10f. 
Do you take it regularly or only as needed?  
 Regularly 
 Only as needed 
 Don’t know 
 Prefer not to answer 
 
 
ME02-10g. 
For how long have you been taking it? 
 For _________ days 
 For _________ weeks 
 For _________ months 
 For _________ years 
 Don’t know 
 Prefer not to answer 
 
 
ME02-10h. What is the medication used for? 
 High blood pressure 
 
 Prescribed for something other than high blood pressure but also acts as a hypertensive medication 
(describe: ____________________________________) 
 
 
ME02-10i. 
Interviewer comments:  
_______________________________________________________________________ 
 
Repeat for all blood pressure medications the participant is currently taking. 

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Self-report scales for participant to complete: 
 
PROMIS Global Health Scale v.1.2 – standardized scale (found on proceeding 
pages) 
 
SLEEP – 1 question only taken from the Pittsburgh Sleep Quality Index 
 
Mindful Attention Awareness Scale (MAAS) - standardized scale (found on 
proceeding pages) 
 
Five Facet Mindfulness Questionnaire (FFMQ) - standardized scale (found on 
proceeding pages) 
 
SART and Mindfulness Practice questions found on proceeding pages 

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SLEEP - The following question relates to your usual sleep habits during the past month only. 
Your answer should indicate the most accurate reply for the majority of days and nights in the 
past month. 
 
SL1_04. 
During the past month, how many hours of actual sleep did you get on average 
at night?  
(This may be different than the number of hours you spent in bed.) 
 
 
 
AVERAGE HOURS OF SL1_EEP PER NIGHT ___________  
 
 
 
□ I do not know 
 
 
□ I prefer not to answer  
 
 
 

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MAAS Instructions: Below is a collection of statements about your everyday experience. Using 
the scale below, please indicate how frequently or infrequently you currently have each 
experience. Please answer according to what really reflects your experience rather than what you 
think your experience should be. Please treat each item separately from every other item.  
 
Please indicate the degree to which you agree with each of the following items using the scale 
below. Simply check your response to each item 
 
  
Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost  
never 
MA1_01. I could be 
experiencing some 
emotion and not be 
conscious of it until 
some time later.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_02. I break or 
spill things because 
of carelessness, not 
paying attention, or 
thinking of 
something else.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_03. I find it 
difficult to stay 
focused on what’s 
happening in the 
present. 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_04. I tend to 
walk quickly to get 
where I’m going 
without paying 
attention to what I 
experience along the 
way.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_05. I tend not 
to notice feelings of 
physical tension or 
discomfort until they 
really grab my 
attention.  
□ 
□ 
□ 
□ 
□ 
□ 
MA1_06. I forget a 
person’s name almost 
as soon as I’ve been 
told it for the first 
time. 
□ 
□ 
□ 
□ 
□ 
□ 

MB-BP 2yr In-Person Follow up Assessment 
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Almost 
always 
Very 
frequently 
Somewhat 
frequently 
Somewhat 
infrequently 
Very 
infrequently 
Almost 
Never 
MA1_07. It seems I 
am “running on 
automatic” without 
much awareness of 
what I’m doing.  
□ 
□ 
□ 
□ 
□ 
□ 
MA1_08. I rush 
through activities 
without being really 
attentive to them.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_09. I get so 
focused on the goal I 
want to achieve that I 
lose touch with what 
I am doing right now 
to get there.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_10. I do jobs or 
tasks automatically, 
without being aware 
of what I’m doing.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_11. I find 
myself listening to 
someone with one 
ear, doing something 
else at the same time.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_12. I drive 
places on “automatic 
pilot” and then 
wonder why I went 
there.   
□ 
□ 
□ 
□ 
□ 
□ 
MA1_13. I find 
myself preoccupied 
with the future or the 
past.  
□ 
□ 
□ 
□ 
□ 
□ 
MA1_14. I find 
myself doing things 
without paying 
attention. 
 
□ 
□ 
□ 
□ 
□ 
□ 
MA1_15. I snack 
without being aware 
that I’m eating.    
□ 
□ 
□ 
□ 
□ 
□ 

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FFMQ - Please rate each of the following statements using the scale provided. Write the number 
in the blank that best describes your own opinion of what is generally true for you.  
 
 
 
1 – Never 
or very 
rarely true 
2 – Rarely 
true 
3 – 
Sometimes 
true 
4- Often 
true 
5 – Very 
often or 
always true 
FF1_01. When I’m walking, I 
deliberately notice the sensations of my 
body moving.  
□ 
□ 
□ 
□ 
□ 
FF1_02. I’m good at finding words to 
describe my feelings.  
□ 
□ 
□ 
□ 
□ 
FF1_03. I criticize myself for having 
irrational or inappropriate emotions.  
□ 
□ 
□ 
□ 
□ 
FF1_04. I perceive my feelings and 
emotions without having to react to them.  
□ 
□ 
□ 
□ 
□ 
FF1_05. When I do things, my mind 
wanders off and I’m easily distracted.  
□ 
□ 
□ 
□ 
□ 
FF1_06. When I take a shower or bath, I 
stay alert to the sensations of water on 
my body.  
□ 
□ 
□ 
□ 
□ 
FF1_07. I can easily put my beliefs, 
opinions, and expectations into words.  
□ 
□ 
□ 
□ 
□ 
FF1_08. I don’t pay attention to what I’m 
doing because I’m daydreaming, 
worrying, or otherwise distracted.  
□ 
□ 
□ 
□ 
□ 
FF1_09. I watch my feelings without 
getting lost in them.  
□ 
□ 
□ 
□ 
□ 
FF1_10. I tell myself I shouldn’t be 
feeling the way I’m feeling.  
□ 
□ 
□ 
□ 
□ 
FF1_11. I notice how foods and drinks 
affect my thoughts, bodily sensations, 
and emotions.  
□ 
□ 
□ 
□ 
□ 
FF1_12. It’s hard for me to find the 
words to describe what I’m thinking.  
□ 
□ 
□ 
□ 
□ 
FF1_13. I am easily distracted. 
□ 
□ 
□ 
□ 
□ 
FF1_14. I believe some of my thoughts 
are abnormal or bad and I shouldn’t think 
that way.  
□ 
□ 
□ 
□ 
□ 
FF1_15. I pay attention to sensations, 
such as the wind in my hair or sun on my 
face.  
□ 
□ 
□ 
□ 
□ 

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1 – Never 
or very 
rarely true 
2 – Rarely 
true 
3 – 
Sometimes 
true 
4- Often 
true 
5 – Very 
often or 
always true 
FF1_16. I have trouble thinking 
of the right words to express 
how I feel about things.  
□ 
□ 
□ 
□ 
□ 
FF1_17. I make judgments 
about whether my thoughts are 
good or bad.  
□ 
□ 
□ 
□ 
□ 
FF1_18. I find it difficult to stay 
focused on what’s happening in 
the present.  
□ 
□ 
□ 
□ 
□ 
FF1_19. When I have 
distressing thoughts or images, I 
“step back” and am aware of the 
thought or image without 
getting taken over by it.  
□ 
□ 
□ 
□ 
□ 
FF1_20. I pay attention to 
sounds, such as clocks ticking, 
birds chirping, or cars passing.  
□ 
□ 
□ 
□ 
□ 
FF1_21. In difficult situations, I 
can pause without immediately 
reacting.  
□ 
□ 
□ 
□ 
□ 
FF1_22. When I have a 
sensation in my body, it’s 
difficult for me to describe it 
because I can’t find the right 
words.  
□ 
□ 
□ 
□ 
□ 
FF1_23. It seems I am “running 
on automatic” without much 
aware- ness of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
FF1_24. When I have 
distressing thoughts or images, I 
feel calm soon after.  
□ 
□ 
□ 
□ 
□ 
FF1_25. I tell myself that I 
shouldn’t be thinking the way 
I’m thinking.  
□ 
□ 
□ 
□ 
□ 
FF1_26. I notice the smells and 
aromas of things.  
□ 
□ 
□ 
□ 
□ 
FF1_27. Even when I’m feeling 
terribly upset, I can find a way 
to put it into words.  
□ 
□ 
□ 
□ 
□ 
FF1_28. I rush through 
activities without being really 
attentive to them.  
□ 
□ 
□ 
□ 
□ 

MB-BP 2yr In-Person Follow up Assessment 
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1 – Never 
or very 
rarely true 
2 – Rarely 
true 
3 – 
Sometimes 
true 
4- Often 
true 
5 – Very 
often or 
always true 
FF1_29. When I have 
distressing thoughts or images, I 
am able just to notice them 
without reacting.  
□ 
□ 
□ 
□ 
□ 
FF1_30. I think some of my 
emotions are bad or 
inappropriate and I shouldn’t 
feel them.  
□ 
□ 
□ 
□ 
□ 
FF1_31. I notice visual 
elements in art or nature, such 
as colors, shapes, textures, or 
patterns of light and shadow.  
□ 
□ 
□ 
□ 
□ 
FF1_32. My natural tendency is 
to put my experiences into 
words.  
□ 
□ 
□ 
□ 
□ 
FF1_33. When I have 
distressing thoughts or images, I 
just notice them and let them 
go.  
□ 
□ 
□ 
□ 
□ 
FF1_34. I do jobs or tasks 
automatically without being 
aware of what I’m doing.  
□ 
□ 
□ 
□ 
□ 
FF1_35. When I have 
distressing thoughts or images, I 
judge myself as good or bad 
depending what the thought or 
image is about.  
□ 
□ 
□ 
□ 
□ 
FF1_36. I pay attention to how 
my emotions affect my thoughts 
and behavior.  
□ 
□ 
□ 
□ 
□ 
FF1_37. I can usually describe 
how I feel at the moment in 
consider- able detail.  
□ 
□ 
□ 
□ 
□ 
FF1_38. I find myself doing 
things without paying attention. 
□ 
□ 
□ 
□ 
□ 
FF1_39. I disapprove of myself 
when I have irrational ideas. 
□ 
□ 
□ 
□ 
□ 

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Sustained Attention to Response Task 
The Sustained Attention to Response Task (SART) is a computerized test of sustained 
attention, response inhibition (executive function) and self-regulation. Subjects are instructed to 
press a key in response to rapidly displayed integers (1-9) and withhold response to a 
designated "no-go" integer. SART errors consist of summed commission errors (button press on 
no-go trial) and omission errors (button not pressed on "go" integers). SART performance is 
associated with prefrontal cortex functioning, has been found to increase with mindfulness 
training and is correlated with scores on mindfulness questionnaires (specifically, the Mindful 
Attention Awareness Scale).  
 
MP1_01 
Think about the last 12 months. During that time, have you practiced 
mindfulness, either formally or informally, in any way? 
 
No ...................................................................... 0 (Skip to MP1_03) 
Yes .................................................................... 1 
 
 
On average, how minutes PER WEEK do you engage in 
the following types of mindfulness activities? 
Average # 
Minutes 
per week 
Less 
than 
weekly 
Don’t 
Know 
Prefer not 
to answer 
MP1_02a   Body Scan ........................................................................... 
 
____ 
666 
777 
888 
MP1_02b   Yoga .................................................................................... 
 
____ 
666 
777 
888 
MP1_02c   Awareness of breath meditation .......................................... 
 
____ 
666 
777 
888 
MP1_02d   Sitting Meditation ................................................................. 
 
____ 
666 
777 
888 
MP1_02e   Walking Meditation .............................................................. 
 
____ 
666 
777 
888 
MP1_02f   Loving-kindness Meditation .................................................. 
 
____ 
666 
777 
888 
MP1_02g   Mountain Meditation ............................................................ 
 
____ 
666 
777 
888 
MP1_02h   Visual Meditation ................................................................. 
 
____ 
666 
777 
888 
MP1_02i   Eating Meditation .................................................................. 
 
____ 
666 
777 
888 
MP1_02j   Meditation moving through regions, such as breath, 
  physical sensations, sound, thoughts, and open awareness .............. 
 
____ 
666 
777 
888 
MP1_02k   Goal-related activity (e.g., physical activity, diet change, 
etc.).  Please describe____________________________ ................... 
 
 
 
 
____ 
666 
777 
888 

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MP1_02l   Other mindful activities: 
    Other 1 describe: _______________ ................................................ 
    Other 2 describe: _______________ ................................................ 
    Other 3 describe: _______________ ................................................ 
 
 
____ 
666 
777 
888 
 
 
MP1_03 
Which of the following statements, BEST describes your current attitude 
towards mindfulness? 
 
I do not plan on practicing mindfulness ...................................... 1 
I see value in mindfulness but do not practice it regularly ........... 2 
I practice mindfulness regularly .................................................. 3 
Other (please describe ____________________________) ...... 4 
Don’t Know ................................................................................ 7 
Prefer not to answer ................................................................... 8 
 
 
MP1_04 
Which of the following, if any, have you participated in [since completing 
the course / the last six months]? 
 
None, I have not practiced mindfulness ........................... 00 
 
 
Check ALL that apply 
 
MB-BP Study Regular 1-1.5 hour Booster Sessions ....... [   ] 
MB-BP Study All Day Retreats ........................................ [   ] 
Meditation group not related the MB-BP Study ............... [   ] 
Mindful yoga group not related the MB-BP Study ........... [   ] 
Other 1 describe: _______________ .............................. [   ] 
Other 2 describe: _______________ .............................. [   ] 
Other 3 describe: _______________ .............................. [   ] 
Don’t Know ....................................................................... 77 
Prefer not to answer ......................................................... 88 
 
 
MP1_05 
We are interested in the ways in which mindfulness practice may or may 
not impact your life. Please describe below your relationship to mindfulness since 
completing your course. 
 
 
 
 
 
Don’t Know ................................................................................ 7 
Prefer not to answer ................................................................... 8 
 
 

 
 
 
 
 
Appendix 5 -  
UMass Medical School fMRI Study 
Recruitment Talking Points 
This form will be utilized by research staff at Brown 
University to approach MB-BP participants about possible 
involvement in a related sub-study 
 
 
 

v.2018.01.02_fMRI study recruitment talking points 
 
1 
 
Recruitment Talking Points for UMass Medical School fMRI sub-study  
 
As a participant in the Mindfulness-based Blood Pressure Reduction (MB-BP) you may be eligible to take 
part in a related clinical trial that involves receiving two separate brain scans or functional magnetic 
resonance imaging (fMRI) of your brain. Participation in this additional study in entirely optional and will 
not affect your ability to participate in the MB-BP study in any way. Would you be interested in hearing 
more about the study? 
 
If Yes - Go over study details below with participant. 
 
 
This sub-study is being conducted by investigators at the UMass Medical School and is funded by 
the same NIH grant that is funding the MB-BP Study. 
 
Eligible participants who enroll in the fMRI study will be compensated $150 USD for each 
neuroimaging session ($300 USD total) completed. 
 
Neuroimaging will take place at the UMass Medical School at the Center for Comparative 
NeuroImaging (CCNI). 
 
Travel to and from UMass Medical School from Providence, Rhode Island is around 100 minutes 
(82 miles) round trip.  Part of the compensation is intended to cover the cost of travel. There is 
free parking available for participants. If a participant does not have his/her own mode of 
transportation, study staff can arrange for transportation (e.g., Uber). 
 
Each participant will have two visits to UMass Med School Campus - before and after the MB-BP 
intervention (Visit 1 and 2, respectively). Each visit will include an MRI scan and is expected to 
last approximately 2 hours. 
 
Eligibility for the fMRI study will be determined by the research staff at UMass Medical school by 
completing a brief (15 minute) phone interview. However, some of the exclusion criteria include 
but are not limited to: contraindication(s) to entering the MR scanner such as the presence of 
metal in or on the body that cannot be removed or claustrophobia; pregnancy or trying to get 
pregnant; and a body weight of over 300 lbs. 
 
Informed consent will take place at UMass Medical School in person and all study procedures 
will be carried out by UMass research staff. 
 
The goal of this research is to determine the mental and neural mechanisms implicated in the 
modulation of blood pressure (associated with cardiovascular risk) by the adoption of a 
mindfulness-based blood pressure therapy. 
 
They are looking to enroll and scan up to 60 individuals from the MB-BP study. 
 
Would you be interested in being contacted by the research staff at the UMass Medical School regarding 
this study? Note that by saying yes you’d only be agreeing to allow us to pass along your contact 
information so that someone at CCNI could call you for the 15-minute phone screener. We are not asking 
you to sign up at this time. 

 
 
 
 
 
Appendix 6 -  
UMass Medical School IRB  Submission 
for fMRI sub-study  
This includes the study protocol, informed consent form, 
phone screener, questionnaire, and IRB Approval 
 

Appendix 6A - 
Study Protocol for UMass Medical 
School fMRI sub-study

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 1 of 18 
Template Revised 8/8/2017 
1. TITLE 
Mindfulness Influences on Self-Regulation:   
Mental and Physical Health Implications for blood pressure 
(Mindful Self-Regulation for blood pressure MRI study) 
 
 
 
2. EXTERNAL IRB REVIEW HISTORY* 
NA 
 
3. PRIOR APPROVALS: 
 
Participants recruited will be from those eligible participants already enrolled in a project for 
mindfulness intervention for blood pressure ongoing at Brown University (Dr. Eric Loucks), 
entitled Mindfulness-Based Blood Pressure Reduction (MB-BP) Study (formerly known as 
Mindfulness-Based Hypertension Therapy (MBHT). 
 
There are no conflicts of interest, medical devices, biohazardous agents, or radiation.  
 
4. OBJECTIVES* 
 
The goal of this research is to determine the mental and neural mechanisms implicated in the 
modulation of blood pressure (associated with cardiovascular risk) by the adoption of a 
mindfulness-based blood pressure therapy. All Participants, pre-selected based on Brown 
University MB-BP study enrollment, will have met entrance criteria for having prehypertension 
or hypertension, or another cardiovascular risk factor that could be influenced by this program. 
We aim to assess the neural correlates of mindfulness training on self-regulation, specifically 
inhibitory control, self-compassion, interoceptive attention, and emotion regulation, in these 
chronic disease patients.   
 
We hypothesize that the blood pressure changes induced by the tailored mindfulness-based 
intervention will be associated with the differential engagement of brain regions implicated in 
emotional self-regulation. Specifically, we hypothesize that alterations both in resting state brain 
function and evoked upon prompts such as interoceptive attention, self-compassion, and 
inhibitory control will notably be linked to physiological measures of the autonomic system. We 
hypothesize that the altered cardiovascular risk measures can be understood through using 
advanced neuroimaging techniques such as functional connectivity and diffusion tensor imaging.   
 
5. BACKGROUND* 
Self-regulation, or the ability to intentionally manage cognitive and emotional resources to 
accomplish goals, is crucial to addressing a wide range of health problems influenced by common 
behaviors, such as excessive eating, lack of physical activity, addiction, and poor adherence to 
medical regimens. Mindfulness interventions have initial evidence to influence self-regulation, 
however it is still poorly understood what specific elements of mindfulness interventions are most 
effective at influencing self-regulation, and if those changes in self-regulation translate into clinically 

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 2 of 18 
Template Revised 8/8/2017 
meaningful health behavior changes, such as improved medial regimen adherence. This study 
proposes to test the ability of customized mindfulness interventions to alter self-regulation in an 
ongoing study. 
 
Mindfulness training is an evidence-based approach to patient-centered caring1 and whole-person 
self-management.2 Mindfulness is “the awareness that emerges through purposely, and non-
judgmentally, paying attention to the unfolding of experience moment-by-moment”.3  
 
Developed at the University of Massachusetts Medical School by Jon Kabat-Zinn, Saki 
Santorelli, and colleagues, Mindfulness-based Stress Reduction (MBSR) is an 8-week program 
that serves as the basis for multiple different condition-specific mindfulness-based interventions 
(MBI) provided in medical settings.4 In 2013, National Institutes of Health invested 44.3 million 
U.S. dollars into direct funding for MBI research (NIH Reporter 2014), and publications related 
to mindfulness-related research have exponentially increased over the past 30 years, with more 
than 500 publications in 2013 alone.5 
 
Multiple clinical trials have demonstrated that MBIs improved self-management in major areas 
of community health and chronic illness management.6, 7 One recent meta-analysis demonstrated 
that MBIs are broadly effective for anxiety, depression, and pain.8 MBIs are associated with 
tobacco smoking reduction,9, 10 reduction in alcohol consumption,11, 12 reduction in prescription 
opioid misuse among patients with chronic pain13 and reduced HIV-risk behaviors.14 MBIs 
demonstrate increased asthma-related quality of life with reductions in stress and anxiety.15 
MBIs produce a reduction in systolic and diastolic blood pressure in patients with pre-
hypertension,16 and particularly large reductions in hypertension have been seen within studies of 
African-American patients.17, 18 Among patients with non-insulin dependent diabetes, one small 
MBI study demonstrated improved glycemic control,19 while large studies with active controls 
have demonstrated effective integration of diabetes self-management skills,20 decreased stress 
and improved quality of life.21 MBIs can reduce the stress associated with chronic illness,6, 7 and 
they are particularly effective in reducing depressive relapse in Major Depressive Disorder.22 
 
Despite all the evidence supporting MBIs, several gaps in the current research and models may 
be acting as barriers to rapid dissemination and integration of mindfulness into the healthcare 
delivery system. First, while a multitude of patient studies showing reductions in stress, pain, 
anxiety, and depression exist, little is known about any impact on the ability to self-manage and 
cope with chronic illness—although there is initial evidence for positive outcomes on these 
measures. Second, this study offers an opportunity to identify and test mechanistic self-
regulation targets (physiologic, psychological, neuropsychological, etc.) that are influenced by 
mindfulness, in the context of a chronic medical condition. 
 
The project has been funded as a core clinical trial for the NCCIH Science of Behavior Change 
UH2 project “Mindfulness Influences on Self-Regulation: Mental and Physical Health 
Implications.” We will conduct an experimental MRI study to evaluate several mechanistic self-
regulation targets of the Mindfulness-based blood pressure therapy (MB-BP), their neural 
substrates, and their potential impact on autonomic system measures.  
The 8-week, 9-session MB-BP curriculum (approved for ongoing study at Brown University) is 
based on systematic and intensive training in mindfulness meditation and mindful hatha yoga. 

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The curriculum, which is based on the manualized and standardized MBSR curriculum, is 
designed to teach program participants how to integrate and apply mindfulness in their everyday 
lives to the range of challenges arising from medical and psychological conditions and life 
stresses. Furthermore, this program has been further customized to participants that have 
prehypertension or hypertension. 
 
Embedded within the context of behavioral medicine, the MB-BP curriculum focuses on the 
experiential cultivation of both “formal” and “informal” mindfulness practices as a foundation 
for the cultivation of positive health behaviors and psychological and emotional resilience that 
can be effective utilized across the adult life span. The approach supports the learning, 
strengthening and integration of a range of mindfulness-based self-regulatory skills through the 
development and refinement of inherent internal resources. A primary aim is to cultivate ways of 
learning and being that can be utilized far beyond the completion of the program.  
 
MB-BP builds a foundation of mindfulness skills (e.g. meditation, self-awareness, etc.) through 
the MBSR curriculum. MB-BP then directs attention towards hypertension risk factors. Early in 
the MB-BP, the importance of hypertension for health and mortality is described, along with 
hypertension risk factors. Participants will have their blood pressure and hypertension risk 
factors assessed at baseline, and be provided with this information during the first in-person MB-
BP session. This phase aims to engage participants’ interest in hypertension risk factors, and 
increase motivation for behavior change. MB-BP encourages participants to explore personal 
readiness for change in the different hypertension risk factors, and explore utilizing mindfulness 
practices to engage with those risk factors that they choose to. Each week, focus is provided on 
different hypertension risk factors. However, common themes exist across all hypertension risk 
factors including (1) awareness of thoughts, emotions and physical sensations particularly 
surrounding hypertension risk factors such as overconsumption of palatable foods, sedentary 
activities, alcohol consumption, medication adherence; (2) craving, particularly for hypertension 
risk factors such as overconsumption of palatable foods, sedentary activities, and alcohol 
consumption; (3) the impact of bringing mindfulness to every moment, particularly in relation to 
hypertension risk factors. For example, when consuming highly palatable food, bringing 
awareness to the emotions, thoughts and physical sensations prior to eating it, during eating it, 
along with the many minutes, if not hours, afterwards. Participants are trained to bring non-
judgmental attention to the often short-term pleasure of overconsumption of foods, sedentary 
activities, heavy alcohol consumption, or not taking medications, and bring non-judgmental 
attention to the longer term suffering associations with these activities. Through this process, 
participants are encouraged to reflect on if behavioral choices provide more benefit or harm to 
their well-being, and to choose the behaviors that bring benefit. (4) Self-care: as awareness of 
thoughts, emotions and physical sensations increases, and self-regulation will likely increases as 
a result of the meditation practices, the curriculum will emphasize to participants that it is 
common for people to start caring for themselves more. It is a way of better knowing ourselves, 
and through knowing ourselves in in each moment, we often want to care for ourselves in each 
moment. This may mean taking medication that will help our health, or being more physical 
active, eating more healthily, or consuming more moderate amounts of alcohol. The intervention 
can be modified to change the dose of any of these 4 components, for example via (1) Increased 
use of specific meditations focused on health behaviors such as diet and physical activity. (2) 
Increased use of meditations focused on craving. Participants will be trained to notice craving 

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arising, and fading away in relation to hypertension risk factors such as palatable high caloric 
foods, sedentary activities, and alcohol consumption. (3) Increased used of mindfulness practices 
related to long term experiences of health behaviors such as alcohol consumption, diet, physical 
activity and medication use on thoughts, emotions, physical sensations and well-being. (4) Self-
care: Increased use of modules that show how mindfulness practice increased self-awareness and 
in doing so can increase people’s desire to care for themselves. The potential use of loving 
kindness meditation will be considered. 
 
 
 
REFERENCES 
 
1. 
Krasner, M.S., R.M. Epstein, H. Beckman, A.L. Suchman, B. Chapman, C.J. Mooney, 
and T.E. Quill, Association of an educational program in mindful communication with 
burnout, empathy, and attitudes among primary care physicians. Jama, 2009. 302(12): p. 
1284-1293. 
2. 
Benzo, R.P., Mindfulness and motivational interviewing: two candidate methods for 
promoting self-management. Chronic respiratory disease, 2013. 10(3): p. 175-182. 
3. 
Kabat-Zinn, J., Wherever you go, there you are: Mindfulness meditation in everyday life. 
1994, Hyperion: New York. p. 277. 
4. 
Cullen, M., Mindfulness-based interventions: An emerging phenomenon. Mindfulness, 
2011. 2(3): p. 186-193. 
5. 
Black, D., Research publications on mindfulness. 2014. 
6. 
Merkes, M., Mindfulness-based stress reduction for people with chronic diseases. 
Australian Journal of Primary Health, 2010. 16(3): p. 200-210. 
7. 
Niazi, A.K. and S.K. Niazi, Mindfulness-based stress reduction: a non-pharmacological 
approach for chronic illnesses. North American journal of medical sciences, 2011. 3(1): 
p. 20. 
8. 
Goyal, M., S. Singh, E.M. Sibinga, N.F. Gould, A. Rowland-Seymour, R. Sharma, Z. 
Berger, D. Sleicher, D.D. Maron, and H.M. Shihab, Meditation programs for 
psychological stress and well-being: a systematic review and meta-analysis. JAMA 
internal medicine, 2014. 174(3): p. 357-368. 
9. 
Brewer, J.A., S. Mallik, T.A. Babuscio, C. Nich, H.E. Johnson, C.M. Deleone, C.A. 
Minnix-Cotton, S.A. Byrne, H. Kober, and A.J. Weinstein, Mindfulness training for 
smoking cessation: results from a randomized controlled trial. Drug and alcohol 
dependence, 2011. 119(1): p. 72-80. 
10. 
Bowen, S., K. Witkiewitz, S.L. Clifasefi, J. Grow, N. Chawla, S.H. Hsu, H.A. Carroll, E. 
Harrop, S.E. Collins, and M.K. Lustyk, Relative efficacy of mindfulness-based relapse 
prevention, standard relapse prevention, and treatment as usual for substance use 
disorders: a randomized clinical trial. JAMA psychiatry, 2014. 71(5): p. 547-556. 
11. 
Garland, E.L., N.R. Schwarz, A. Kelly, A. Whitt, and M.O. Howard, Mindfulness-
oriented recovery enhancement for alcohol dependence: Therapeutic mechanisms and 
intervention acceptability. Journal of social work practice in the addictions, 2012. 12(3): 
p. 242-263. 
12. 
Ostafin, B.D., K.T. Kassman, and I. Wessel, Breaking the cycle of desire: Mindfulness 
and executive control weaken the relation between an implicit measure of alcohol 

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valence and preoccupation with alcohol-related thoughts. Psychology of addictive 
behaviors, 2013. 27(4): p. 1153. 
13. 
Garland, E.L., E.G. Manusov, B. Froeliger, A. Kelly, J.M. Williams, and M.O. Howard, 
Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid 
misuse: results from an early-stage randomized controlled trial. Journal of Consulting 
and Clinical Psychology, 2014. 82(3): p. 448. 
14. 
Margolin, A., Z. Schuman‐Olivier, M. Beitel, R.M. Arnold, C.E. Fulwiler, and S.K. 
Avants, A preliminary study of spiritual self‐schema (3‐S+) therapy for reducing 
impulsivity in HIV‐positive drug users. Journal of clinical psychology, 2007. 63(10): p. 
979-999. 
15. 
Pbert, L., J.M. Madison, S. Druker, N. Olendzki, R. Magner, G. Reed, J. Allison, and J. 
Carmody, Effect of mindfulness training on asthma quality of life and lung function: a 
randomised controlled trial. Thorax, 2012: p. thoraxjnl-2011-200253. 
16. 
Hughes, J.W., D.M. Fresco, R. Myerscough, M. van Dulmen, L.E. Carlson, and R. 
Josephson, Randomized controlled trial of mindfulness-based stress reduction for 
prehypertension. Psychosomatic medicine, 2013. 75(8). 
17. 
Schneider, R.H., F. Staggers, C.N. Alexander, W. Sheppard, M. Rainforth, K. Kondwani, 
S. Smith, and C.G. King, A randomized controlled trial of stress reduction for 
hypertension in older African Americans. Hypertension, 1995. 26(5): p. 820-827. 
18. 
Palta, P., G. Page, R. Piferi, J. Gill, M. Hayat, A. Connolly, and S. Szanton, Evaluation of 
a mindfulness-based intervention program to decrease blood pressure in low-income 
African-American older adults. Journal of Urban Health, 2012. 89(2): p. 308-316. 
19. 
Rosenzweig, S., D.K. Reibel, J.M. Greeson, and J.S. Edman, Mindfulness-based stress 
reduction is associated with improved glycemic control in type 2 diabetes mellitus: a 
pilot study. Alternative Therapies in Health and Medicine, 2007. 13(5): p. 36. 
20. 
Miller, C.K., J.L. Kristeller, A. Headings, and H. Nagaraja, Comparison of a mindful 
eating intervention to a diabetes self-management intervention among adults with type 2 
diabetes: a randomized controlled trial. Health Education & Behavior, 2014. 41(2): p. 
145-154. 
21. 
van Son, J., I. Nyklíček, V.J. Pop, M.C. Blonk, R.J. Erdtsieck, P.F. Spooren, A.W. 
Toorians, and F. Pouwer, The effects of a mindfulness-based intervention on emotional 
distress, quality of life, and HbA1c in outpatients with diabetes (DiaMind). Diabetes care, 
2013. 36(4): p. 823-830. 
22. 
Piet, J. and E. Hougaard, The effect of mindfulness-based cognitive therapy for prevention 
of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. 
Clinical psychology review, 2011. 31(6): p. 1032-1040. 
 
 
 
 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
 
Participants will have been enrolled in Brown University study with the following criteria 
 

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Inclusion Criteria: 
-men or women  
-between the ages of 18 and 65 
-participants that have prehypertension or hypertension. 
 
Exclusion Criteria: 
-Current regular mindfulness practice (>1 week) or lifetime mindfulness meditation practice 
-Diagnosis of an active medical illness 
-Diagnosis of an active major psychiatric disorder 
-Current medication use consistent with an active medical illness or psychiatric disorder 
-A priori unable to commit time required for the study 
-Inability to consent 
 
 
Exclusion Criteria for the present MRI application 
 
-Contraindication(s) to entering the MR scanner such as the presence of metal in or on the body 
that cannot be removed or claustrophobia 
-Pregnancy 
-Weight > 300 lbs 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
 
60 participants in total, from those already recruited for ongoing, non-MRI study through 
Brown University study, all meeting study entrance criteria for having prehypertension or 
hypertension, or another cardiovascular risk factor that could be influenced by this 
program; half enrolled in MB-BP at Brown University, whereas the other half will be 
waitlist controls.  
 
8. STUDY-WIDE RECRUITMENT METHODS* 
 
All participants will have been previously recruited for a study at Brown University. Eligible and 
interested participants will be further recruited for this MRI add-on.  
 
 
9. STUDY TIMELINES* 
Each participant will have two visits to UMass Med School Campus - before and after the 
MB-BP intervention (Visit 1 and 2, respectively). Each visit will include an MRI scan 
and is expected to last approximately 2 hours.  
The endpoint of the study is after the second study visit (Visit 2) has been completed. 
However, the PI and study personnel may make study termination decisions in 
coordination with participants. A participant’s involvement in this study will also end if 
the subject withdraws their consent, is unable to adhere to the study protocol (e.g., finds 

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the MRI procedure excessively uncomfortable), or is determined to be ineligible during 
the study by the investigators. 
We anticipate that it will take approximately 3 years to enroll all 60 study participants, 
and that it will take 1 year to complete the primary analyses. 
 
10. STUDY ENDPOINTS* 
The primary outcome will be differential over-time change in MRI resting-state 
functional connectivity (rsFC) patterns for the intervention versus comparison group (e.g. 
default-mode, salience, and central executive, networks comprising regions such as 
anterior cingulate cortex, medial orbital cortex, insula, amygdala, and hippocampus). A 
significant group x time interaction will represent differential over-time change in the 
outcome (rsFC) for the intervention versus comparison group. The model for Hypothesis 
1 will be parameterized with indicator variables for study group, time, and a group-time 
interaction (for example using FSL general linear model (GLM), which can estimate 
multivariable models, where the response Y at each voxel is modeled as a linear 
combination of one or more predictors; applying “Randomise” permutation function). As 
such we will also apply such a technique of regression modeling to predict change in 
hypertensive functional status, specifically blood pressure [standard-of-care clinic-
assessed systolic and diastolic BP for monitoring hypertension treatment: baseline clinic 
BP obtained at two in-person screening visits ≥1 week apart, followed by in-person 
assessments at all follow-up periods (8w, 3m, 6m), all as part of Brown University 
project], while considering important clinical and demographic covariates. 
The secondary outcomes will be in-scanner self-regulation task functional connectivity outcomes 
(1. emotional Go/NoGo inhibitory control task; 2. self-compassion task, which contrasts self-
reassurance conditions with a self-criticism condition; 3. interoceptive attention task, which 
contrasts an interoceptive attention condition with an exteroceptive attention condition). We will 
test for differential brain connectivity relation to each self-regulation manipulation between the 
intervention versus comparison group. Finally, associations between any differential intervention 
effect on self-regulation-task associated brain connectivity change will be further modeled for 
predictive ability of blood pressure change. 
 
 
11. PROCEDURES INVOLVED* 
 
Participation will entail a total time commitment of about 4.5 hours over the course of the 
study.  
 
Telephone Screen:~15 minutes 
Potential participants, already enrolled in Brown University study, will be prescreened by 
telephone. Respondents are informed that everything they say will be kept strictly 
confidential and they may stop or ask questions at any time.   

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Respondents will already have satisfied age and medical or psychiatric illness inclusion 
and exclusion criteria for participation enrollment in Brown University study.  
For this MRI study, women will be asked if they are currently pregnant or planning to 
become pregnant. If the subject meets all inclusion criteria and no exclusion criteria (see 
#6 Inclusion and Exclusion Criteria, above), they will be asked for their contact 
information (phone number and email address) and about scheduling considerations for 
providing consent, and determine study visits. This information will be stored in a locked 
cabinet.  
Participants who do not meet eligibility criteria will be asked to verbally provide consent 
to be re-contacted for future studies. If consent is obtained, this will be recorded on the 
phone screen which will be stored in a locked cabinet, accessible only by study staff. 
Informed and Written Consent:~15 minutes 
Consent will be obtained at Umass Medical School. The subject consent form will be 
reviewed in detail with the participant by trained study personnel. If needed, the 
participant will be given the consent form to take home for further consideration and 
discussion prior to signing. Sufficient time will be provided so that the subject can 
understand the study, ask questions, and express concerns.  
Once the subject has read and understood the consent form and determined that they wish 
to participate in study, the IRB-approved written informed consent form will be signed 
and dated by the subject and the study personnel obtaining consent. The participant will 
be given a copy of the signed informed consent form; originals shall be kept on file by 
the investigator in a locked cabinet.   
The study visit will proceed with the neuroimaging session to examine brain function and 
structure using diffusion tensor imaging (DTI), resting state and task-based functional magnetic 
resonance imaging (fMRI), as well as arterial spin labeling. 
 
Neuroimaging sessions: ~1.5 hours each 
Subjects will undergo two MRI sessions – one at each of 2 study visits. These will 
include anatomic scans, arterial spin labeling, Diffusion Tensor Imaging (DTI), as well as 
resting state and task-based fMRI. Imaging will be conducted on a 3 Tesla magnetic 
resonance imaging scanner (Phillips 3 Tesla Ingenia CX dStream), which has been 
approved for research and clinical studies in children and adults by the FDA. Magnetic 
resonance (MR) technology does not use ionizing radiation like an X-ray. Instead, it uses 
strong magnetic fields and radio waves to collect the images and data. There are no 
known hazards or risks associated with these techniques. To ensure subjects can safely 
undergo MRI scanning, all participants will be screened by the Research Coordinator 
prior to scanning for the presence of any MRI incompatible medical implant, external 
decide or metal (including jewelry, body piercings, tattoos with metallic pigments). 

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Acquisitions will include T1 and T2 images (in agreement with NINDS Common Data 
Elements, and suitable for incorporation in FITBIR), T1-weighted, ME-MPRAGE 
sequence; T2-weighted double echo fast spin echo sequence, (2) a multi-flip angle 3D 
spoiled gradient echo (FLASH type) compatible with the BIRN protocol; Resting state 
and functional MRI: a multiband echo-planar imaging sequence with T2*-weighted 
BOLD contrast; a fieldmap for distortion correction; Diffusion Tensor Imaging sequence 
that uses a standard single shot, spin echo, echo planar acquisition with diffusion 
weighting gradient pulses comprised of multiple diffusion-encoding directions with 
additional weighted images; Arterial spin labeling ASL): pseudo-continuous ASL 
(PCASL) pulse sequence complemented by a single PCASL image with long repetition 
time (TR; proton density) for scaling perfusion-weighted maps to absolute units of 
cerebral blood flow (CBF; ml/100g/min). During the imaging session, autonomic system 
measures will also be obtained using respiratory belt, finger plethysmograph for heart 
rate (HRV), and finger sensors for skin conductance. 
A quick questionnaire about mental and physical state during the scanning session 
Amsterdam Resting-State Questionnaire (ARSQ 2.0) will be administered immediately 
after each MRI scanning session (< 5 minutes). 
Post-processing of MRI data will be performed with standard software (Freesurfer, FSL, 
and DTIStudio) to quantify the regional gray and white matter structural properties, as 
well as functional, and arterial properties in the brain. 
 
12. DATA AND SPECIMEN BANKING* 
Neuroimaging data and accompanying physiological, behavioral, and questionnaire, as well as 
participant data including telephone screening informed consent forms will be kept. All 
personally identifiable information will be "de-identified", and coded with the subject’s 
identification number. Thus, all study data will be stored without personal identifiers.  
 
All electronic information will be stored on a password-protected server accessible by 
study personnel only or on personal employee computers, located in locked offices at 
UMass Medical School. All written information will be locked in a file cabinet, located in 
a locked office. The office referred to is in the Center for Comparative NeuroImaging 
(CCNI). The CCNI is a secure building with swipe card entry access. Subjects will be 
assigned a code for all documentation and data analysis sheets. The key linking the 
names and codes will be stored on this password-protected server. Documents that 
contain identifying information will be stored separately from any primary research data.  
Imaging data will be transferred from the MRI system by means of a portable drive. Once 
the transfer is completed, the portable drive will be formatted to clean it of the acquired 
data. The data will only be stored in a password-protected computer accessible to study 
investigator and study staff. We also push the neuroimaging data to a server within the 
UMASS system. This server is accessible only by the authorized personnel and it is 
backed-up regularly to password-protected drives. Aside from UMMS IRB 
representatives, only approved study personnel will have access to raw research data. 

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The master list of subjects’ addresses and phone numbers will be destroyed at the end of the 
study. Data will be kept at least for a minimum of 5 years following publication of results, in 
accordance with American Psychological Association guidelines for data retention, and likely 
indefinitely. While there is no plan to destroy the raw data, if we later decide to destroy the raw 
data, paper raw data will be shredded and electronic raw data will be erased from hard drives and 
any electronic backup media. For the sake of transparency in our research practices, according to 
recommended practices the de-identified neuroimaging, physiological, task, questionnaire, and 
other participant data relevant for analysis may be made available to the public via a web 
repository (e.g. Open Science Framework). In that case, any de-identified data that have been 
posted publicly will remain publicly accessible in perpetuity.  
 
 
13. Data Analysis and Management* 
 
We will follow current recommended methods for MRI data analysis. The fMRI data will be 
analyzed using the standard software package FSL, together with RETROICOR for retrospective 
correction of physiological motion artifacts using our peripheral measures of cardiac and 
respiratory activity as independent assessments of physiological noise in the blood oxygen level-
dependent (BOLD) signal. Following standard preprocessing steps (de-warping, slice timing 
correction, motion correction, removal of physiological noise signals), the statistical analysis of 
brain activation data will be performed.  
 
In addition to time point and group assignment, the statistical models will include among 
regressors of interest blood pressure, gender, age, in-scanner task outcomes, and the following 
regressors of no interest: head motion parameters and cardiac and respiratory components of 
physiological noise. Hypotheses will be expressed as: Is there any significant difference between 
the 2 time points in functional connectivity during resting state and task-specific induction (a, 
NoGo trials versus Go trials; b) self-reassurance versus self-criticism; and c) Interoception-
versus-Exteroception. The null hypothesis will be that any brain network functional connectivity 
changes between the 2 time points is not significantly different between the intervention and the 
comparison groups. Significance testing will be done using permutation methods. 
 
We estimate that after outlier or neuroimaging artifact exclusion and any withdrawals 
from the study, there will be about 50 total participants. Data analysis will be performed 
using standard statistical software. Based on our current observations, we may obtain 
high effect sizes, i.e. 1 or 1.5. We will recruit up to 60 participants so that we can exclude 
outliers.  
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
 
A trained neuroradiologist associated with the MRI imaging center at University of 
Massachusetts Medical School will read the diagnostic MRI scans. In the event that there 
is a suspicious reading on the MRI, the principal investigator will be informed of this and 
arrange for the neuroradiologist to share with the subject the findings and facilitate in 
helping them determine what follow-up care is needed and appropriate. 

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15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
A subject’s participation in this neuroimaging study will normally end at the completion 
of the visit. However, subjects may withdraw at any time and for any reason. If the 
subject decides to withdraw, no special procedures need to be followed. The subject can 
simply leave the study at any time. Also, the trained study personnel may make study 
termination decisions if the subject is not able to adhere to the study protocol.  
 
16. RISKS TO SUBJECTS* 
 
This study will be conducted in a 3T MR scanner which has been approved for research 
and clinical studies in children and adults by the FDA. Magnetic resonance (MR) 
technology does not use ionizing radiation like an X-ray. Instead, it uses strong magnetic 
fields and radio waves to collect the images and data. There are no known hazards or 
risks associated with these techniques.  
As it is the case for any MR scanner, significant risks can arise if ferromagnetic materials 
(this includes many types of common metal objects) are brought into the high magnetic 
field environment of the scanner and immediate vicinity, as they can become hazardous 
projectiles.  
During the scan, some people do report claustrophobia (fear of being in enclosed small 
spaces), dizziness, mild nausea, headaches, a metallic taste in their mouth, double vision, 
or sensation of flashing lights. In rare cases during certain types of scans, a very slight, 
uncomfortable tingling of the back due to the rapid switching of the magnetic field has 
been reported. Although the intensity is not harmful to their hearing, the sounds that 
subjects hear inside the scanner may be annoying.  
During the scan, the comfort of the participant will be checked through the intercom 
system. The MRI technician can talk through the intercom system and the participant can 
hear through the head phones he/she will be wearing during the experiment. Similarly, 
the participants can talk during the experiment (in between the acquisitions) and the MRI 
technician can hear through the intercom system. In the unlikely event of any discomfort 
to the participant, the scan session will immediately be stopped and the participant will be 
taken out of the magnet. 
Identification of a real or false positive abnormality, i.e. lesion or a tumor, during the 
MRI examination is possible. In the existence of such a condition, further investigation 
and/or treatment may be necessary. Although possible abnormalities are not related to the 
study, there may be emotional and physical risks associated with getting the follow-up 
medical evaluations. The initial diagnosis revealed by our scan may be false positive or it 
may be a true positive finding that may lead only to earlier identification of a condition. 
However, this condition may not have a survival possibility and the subject would need 
to live longer with the knowledge of this condition. 

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Breach of Confidentiality: 
As with all studies, there is a chance that data could be linked back to a subject’s true 
identity, breaching confidentiality, and so there is a risk of psychological and social 
stigma that could adversely impact the subject. However, there will be many safeguards 
in place to prevent this occurrence. 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
Not Applicable 
 
18. VULNERABLE POPULATIONS* 
Not Applicable 
 
19. MULTI-SITE RESEARCH* 
This study is a collaboration between UMass Medical School (UMMS), Brown 
University, and MGH. All imaging acquisition will be done at UMMS. All imaging 
analyses will be done at UMMS, in collaboration with MGH for analysis of autonomic 
system data [respiratory belt, finger plethysmograph for heart rate (HRV), and finger 
sensors for skin conductance]. All recruitment, MB-BP intervention and other measures 
are done at Brown University. 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
Not Applicable 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
Results will not be routinely shared with subjects. However, if an MRI reading is 
indicative of pathology, such as hemorrhagic stroke, ischemic stroke, multiple sclerosis, 
tumors, and aneurysms, these results will be shared with subjects. In addition, during the 
clinical interview the study clinicians may determine that the study subject has 
psychiatric symptoms that are in need of treatment, or that the subject might be harmful 
to themselves or someone else. In this case, these results will be shared with the subject, 
and we will help the subject find appropriate care. 
 
22. SETTING 
 
All participants will be recruited from an ongoing MB-BP study at Brown University, for the 
neuroimaging visits at UMMS. 
  
Facilities: 
Center for Comparative NeuroImaging (CCNI): 
- Telephone Screens and Data Analysis will be performed at the CCNI. 

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- Informed Consent will be done at the CCNI in a private office. 
 
The CCNI is a research laboratory of ~3,000sq-ft building on the main campus. This center 
contains a conference room, faculty offices (~140 square feet each), secretary cubicle, shared 
student room, a wet lab, and a small room for mechanical and electronic work.  
CCNI offices and laboratories are networked with switched 10/100 Mb/sec TCP/IP 
communication lines. CCNI currently has five SGI, two Sun stations, and ten PC’s. Some of 
these SGI and PC are in a “common” area where collaborators will have access to them for data 
analysis and software 
In addition to the shared computers in the CCNI, we have computers within the offices located in 
BNRI. There are two identical Mac Pro5.1 with 2 2.4 GHz Quad-Core Intel Xeon processors. 
Each of has 6GB of memory and total of 8 cores. There are also two iMac9.1 with 3.06 GHz 
Intel Core 2 Duo processors. One of these is equipped with 4GB of memory while the other one 
has 6GB of memory and both of them have 2 cores. All of our Macintosh computers have dual 
booth capacity so that we can run Windows7 and use Windows System compatible software if 
needed. In addition, we have a Dell OptiPlex 755 Desktop, which has the Linux operating system 
installed on it. 
Matlab2016 (Natick, MA) is available to perform various analyses. LCModel version 6.2.2 is 
installed on the Dell OptiPlex Desktop to perform proton spectroscopy analysis and to determine 
the measured metabolite levels. SPSS (to perform statistical analysis), Microsoft Office 
Applications as well as Adobe Application (to write our reports and papers and to prepare 
illustrations), EndNoteX8 (to manage references) are available for our researchers. We also have 
free image analysis software such as FreeSurfer (Martinos Center for Biomedical Imaging, 
Charles Town, MA), FSL (FMRIB, Oxford, UK) and SPM (Welcome Trust Centre for 
NeuroImaging, London, UK) to perform the anatomical neuroimaging analysis. 
 
Advanced MRI Center (AMRIC):   
- Neuroimaging data will be acquired at AMRIC. 
 
The AMRIC facilitates a new Philips Ingenia CX dStream 3.0T system with a higher order shim 
function which enables us to obtain improved image quality in field-sensitive applications and 
techniques such as single-voxel spectroscopy, chemical shift imaging, single-shot EPI and 
balanced FFE.  
This Ingenia 3.0T system has a higher order shim function which offers advanced shimming 
capabilities to obtain improved image quality in field-sensitive applications and techniques such 
as single-voxel spectroscopy, chemical shift imaging, single-shot EPI and balanced FFE.  

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 14 of 18 
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This Ingenia 3.0T system features high performance whole body, non-resonant, self-shielded 
gradient technology with new amplifiers that deliver high peak and slew rates for the demanding 
requirements of the latest and emerging clinical imaging techniques. The Quasar Dual gradient 
system provides industry leading performance specifications for peak strength and slew rate with 
a dual mode capability that optimizes advanced applications requiring very high peak mode 
capabilities. The maximum gradient amplitudes and slew rates corresponding to the dual mode 
are 80 mT/m, 100 mT/m/ms and 40 mT/m, 200 mT/m/ms respectively.  
This Ingenia 3.0T system has a multiple RF sources, which adapts the RF signals to suit each 
individual patient. This results in faster scans, enhanced image uniformity/consistency, over a 
broader range of applications.  
This Ingenia 3.0T system features MultiBand SENSE which allows to use state-of-the-art 
acceleration factors in the brain by simultaneously exciting multiple slices. Due to a shorter 
minimum TR for fMRI, larger anatomical coverage or higher temporal resolution can be used. In 
the DWI/DTI sequences larger anatomical coverage or higher number of diffusion directions can 
be acquired. With MultiBand SENSE, fMRI and DTI exams can be performed with high speed 
and high resolution, simultaneously. 
This Ingenia 3.0T system is equipped with a Multi-nuclear spectroscopy (MNS) system, which 
provide the ability to perform 13C, 31P, 7Li, 23Na, 19F and other nuclei spectroscopy and 
imaging. The multiple RF amplifiers in this system includes two 18 kW solid-state 1H channel 
narrowband amplifier and one 4 kW broadband (10-130 MHz) Multi-nuclear amplifier. 
This Ingenia 3.0T system has a bore diameter of 60 cm and provides a full-size 50 cm field-of-
view.  
fMRI Stimulus Delivery System 
A fully integrated fMRI stimulus delivery system from MRA (Model: fMRI-0502-STD1; MRA; 
Washington, PA, USA; http://www.mra1.com/) and Presentation (Neurobehavioral Systems, Inc; 
Albany, CA, USA; http://www.neurobs.com/) is available for both clinical and research. The 
MRA complete system includes the fMRI stimulus delivery console, Windows computer system, 
patient response hand switches, video projection into the MRI bore, and MRI compatible patient 
headphones.  
 
Presentation is the world's most popular experimental control software for neuroscience, is a 
stimulus delivery and experimental control program. It runs on PC, and delivers auditory, visual 
and multimodal stimuli with sub-millisecond temporal precision. Presentation is powerful 
enough to handle almost any behavioral, psychological or physiological experiment using fMRI, 
ERP, MEG, psychophysics, eye movements, single neuron recording, reaction time measures, 
other performance measures, and more.  
 
MRI Compatible Goggle Set 

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 15 of 18 
Template Revised 8/8/2017 
MediGoggle Adult Research Set (Cambridge Research Systems Ltd, England; 
http://www.crsltd.com/) has interchangeable prescriptive goggles suitable for use in MRI and 
fMRI environments. It is fully MRI compatible with no metallic components and an easy 'click' 
lens system -6 to +6 dioptre lens sets in 0.5 dioptre increments. 
 
In Vivo Physiological monitoring system 
Medrad Veris 8600 MR Vital Signs Monitor (Model: 8600; S/N: 023426; Medrad, Inc; 
Warrendale, PA, USA; http://www.medrad.com/) is available to monitor patients while they are 
undergoing an MR exam. It interprets and displays physiologic data as waveforms and numeric 
information which include ECG, NIBP, SpO2, CO2, respiration, temperature, O2, anesthetic 
gases, and IBP. 
 
The Advanced MRI Center also includes a nurses’ station, two patient holding rooms, and two 
patient changing rooms with lockers.  
 
 
- Recruitment sites: 
The Subjects will be recruited through the Brown University study.  
 
 
23. RESOURCES AVAILABLE 
All staff are required initially and every 3 years to successfully complete a UMass -
designated CITI program. All participating personnel will thoroughly review the study 
protocol and will review their roles and responsibilities with experienced study personnel 
and the Principal Investigator. Personnel are notified of protocol changes, and 
questions/discussion points are addressed at weekly lab meetings. 
Below are the Roles, Responsibilities, and Training for the research staff involved in this 
study: 
 
Role 
Responsibilities 
Training 
Principal 
Investigator 
Overseeing and managing all activities related to 
this protocol, including recruitment, data 
collection, analysis and interpretations. This also 
includes manuscript preparation and presenting 
data at conferences. The PI will oversee all IRB 
Holds a graduate-level 
degree (PhD, MD, RN, 
PsyD, or equivalent) and 
has had 5 or more years of 
experience in the field of 

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 16 of 18 
Template Revised 8/8/2017 
communications. 
imaging in psychiatry. 
Data Analyst 
 
Collection, analysis and interpretation of data, 
including neuroimaging data and combining the 
neuroimaging data with clinical data. Participates 
in manuscript preparation and data presentation at 
conferences. 
Formally trained in 
neuroimaging data 
collection, analysis. 
Study 
Coordinator: 
 
Assists with maintenance of regulatory documents, 
IRB communications, assists with subject 
recruitment. Administer telephone screen, consent 
subjects, coordinate visit dates/times with subjects, 
arrange subject compensation, measure 
height/weight, administer mood and psychological 
assessments, as well as other scales/questionnaires, 
administer neuropsychological/neurocognitive 
assessments, manage subject documentation. 
Participates in manuscript preparation. 
Thoroughly review 
protocol, consenting 
process, and relevant 
study procedures with 
Principal Investigator 
and/or co-Investigators. 
 
 
 
24. LOCAL RECRUITMENT METHODS 
Dr. Eric Loucks at Brown University and his team have worked on several mindfulness projects. 
For the current MB-BP project, they have successfully recruited over 40 participants in a 
previous enrollment cycle for the MB-BP study, and they anticipate recruiting as many in each of 
the upcoming cycles, from which will be identified potential participants in the present MRI 
study. Recruitment will occur by Dr. Louck’s team informing participants that we are actively 
looking for subjects who fit our research criteria, of the opportunity to participate in clinical 
research, and if the candidates are interested, ask them if they accept our study staff to approach 
them. Interested candidates will undergo a phone screen to determine their eligibility. If they 
appear eligible, they will be invited to participate in the study. 
 
Describe the amount, method, and timing of any payments to subjects. 
 
Participants will be compensated $100 per imaging visit, plus $50 in travel expenses 
(participants will receive free parking). Thus, a total of $300 per participant for baseline 
and follow-up visit. 
 
25. LOCAL NUMBER OF SUBJECTS 

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 17 of 18 
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60 participants enrolled in total. As the participants will be recruited from an ongoing study of 
persons already screened, typical screen failures will be reduced to those individuals failing to 
satisfy the MRI requirements, which a fraction of usual screen failures. Nevertheless, we 
anticipate that more than 100 participants may need screening from the Brown University 
project. 
 
 
26. CONFIDENTIALITY  
All data/documents will be stored in locked cabinets and/or on password protected 
computers, accessible only by study staff. Data/documents will be stored by subject ID 
number to avoid linkage of data to identity. Subject number and corresponding 
identifying information will be kept in separate locked file cabinets, accessible only by 
study staff. All data/documents will be stored indefinitely.  
Approved study personnel are responsible for receipt or transmission of data/documents and 
specimens locally. Imaging data will be transferred from the AMRIC MRI system by means of a 
portable drive. All portable drives used to transfer data are encrypted in accordance with UMMS 
data security policies. Once the transfer is completed, the portable drive will be formatted to 
clean it of the acquired data. Data will be stored on a password-protected computer indefinitely, 
accessible only by study staff. Data will also be pushed to servers within the UMASS systems, 
this server is accessible only by the authorized personnel and it is backed up regularly to 
password-protected drives.   
 
 
For the sake of transparency in our research practices, according to recommended practices the 
de-identified neuroimaging, physiological, task, questionnaire, and participant data will be made 
available to the public via a web repository (e.g. Open Science Framework). Only researchers 
who apply and get permission to use the information for a specific research project will be able 
to access the information. Qualified researchers who can access the national databases can be 
from government, academic, or commercial institutions.   
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
Subjects interact with and provide information to approved study staff only. Subjects are 
informed that study information will be kept strictly confidential, and that study staff will 
do everything that they can to prevent others from learning about the subject’s 
participation. As frequently as possible, study procedures take place in rooms with 
closable doors, with a minimum number of participating staff.  
For all study procedures, subjects are informed that study related information will be kept 
strictly confidential, and that study staff will do everything that they can to prevent others 
from learning about the subject’s participation. Subjects are informed that their 
participation is entirely voluntary, and that they may stop and ask questions, or choose to 
not take part in/quit the study at any time. 

INVESTIGATOR STUDY PLAN - REQUIRED 
 
 
Page 18 of 18 
Template Revised 8/8/2017 
All information acquired through research procedures is stored in locked cabinets and/or 
on password protected computers.  
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
No funds have been set aside for research-related injury compensation. In the unlikely 
event of injury, subjects or their insurance are responsible for coverage.  
 
29. ECONOMIC BURDEN TO SUBJECTS 
Not Applicable 
 
30. CONSENT PROCESS 
Participants are expected to be competent to give consent for themselves; no vulnerable 
populations are to take part in this study. 
The consenting process will take place in the CCNI or AMRIC facilities. Consent will be 
obtained in person by Dr. King or a research coordinator, or a trained member of 
personnel. In order to obtain consent, the study protocol, purpose, risks, and benefits will 
be explained to the subject. Subjects will be asked to indicate their understanding of the 
key elements of the protocol including the purpose, risks, and benefits in order to 
determine that the participant understands the elements required for informed consent. 
We will only obtain consent if these direct questions have been answered appropriately.   
The subject will have the option of thinking about participation for as long as they would 
like. This includes the option to take the informed consent form home and re-schedule the 
consent visit for a later date, if that would be helpful to the subject. The subject will also 
be informed that they can contact Dr. King or the research coordinator at any time if they 
have a question about the consent form and/or study procedure. 
We will be following SOP: Informed Consent Process for Research (HRP-802). 
 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
We will be following SOP: Written Documentation of Consent (HRP-803) 
 
32. DRUGS OR DEVICES 
We are not testing any devices for safety or effectiveness 
 
 

Appendix 6B - 
Phone Screener for UMass 
Medical School fMRI sub-study
- to be administered by UMass 
research staff

Mindful Self-Regulation for blood pressure MRI study – PHONE SCREEN 
11/2017 Version 1 
Page 1 of 5 
 
Date: ________________   
Time:  _________ Interviewer: ____________________________ 
Screening # ___________________________ (month.date.year.hour.minute) 
 
 
My name is __________________. I am calling from the Center for Comparative NeuroImaging 
at the UMass Medical School, because you expressed interest in participating in our brain 
imaging study through your participation in the Brown University Mindfulness-Based Blood 
Pressure Reduction Study, formerly known as Mindfulness-Based Hypertension Therapy. Is that 
correct? 
[If yes, proceed, if no, note in Potential Subject Log]. 
 
In order to determine if you are a good match for this particular study, I will be asking you some 
questions about your health and history which will take from 10 to 15 minutes. Is now a good 
time to speak? [If yes, proceed, if no, ask for other times and note in Potential Subject Log]. 
 
There are a few things that I’d like to make clear before we start the interview. First of all, some 
of the questions will be very personal and sensitive. Are you in a private place to talk? Because 
this interview is of a personal nature, it is important that you understand that everything you say 
will be kept strictly confidential. No one outside of our project will ever be able to see your 
answers, and we will not keep your name in the same place as any of your answers. Your 
answers to our brief questions about marijuana and other “recreational” drug use will also be 
kept strictly confidential and will not be reported. 
 
I am asking these questions because you are participating in the Mindfulness for Blood Pressure 
Intervention Study at Brown University, we would we would like you to participate in a study 
where we will image your brain 2 times, before and after the intervention. Everything you say in 
this interview will be kept strictly confidential, and you may stop or ask questions at any time. If 
you don’t understand what I am asking, please stop me and ask me to explain. If you are eligible 
for the study we will ask for your name once we finish with this interview, otherwise we will not 
ask for your name. If you like, though, we can keep your information on file for future studies. 
 
These phone screens are kept in a ring binder in a secure location. They will not be destroyed.  
Are you comfortable with starting the interview now? 
 
INCLUSION CRITERIA: Need YES to all Yes/No questions 
1. How old are you?______    D.O.B. ________ Between 18 and 65? 
Yes ___ 
No ___ 
2. Are you participating in Brown University Mindfulness for Blood 
Pressure Intervention Study? 
Yes ___ 
No ___ 
 
Additional information 
3. Are you male or female or identify as male or female? 
Male ___ 
Female: ___ 
4. Are you right or left handed? 
Right: ___ 
Left: ___ 
5. Current occupation? 
 
6. Are you currently diagnosed with Attention Deficit Hyperactivity 
Disorder? 
• When were you diagnosed? ________________ 
• If diagnosis was age 7+: How young can you recall symptoms and 
Yes ___ 
No ___ 

Mindful Self-Regulation for blood pressure MRI study – PHONE SCREEN 
11/2017 Version 1 
Page 2 of 5 
what kind of issues did you experience? 
 
 
7. Are you currently taking medication(s) for ADHD? 
• Drug:__________Dose?______ Freq:_________ 
• Since when:________________ 
 
Yes ___ 
No ___ 
8. Have you taken medications for ADHD before? 
• Drug(s): _______________________________ 
• Dose(s): ____________Freq(s):_____________ 
• When/How long: ________________________ 
 
Yes ___ 
No ___ 
9. Do you currently smoke tobacco cigarettes? 
• If yes, about how many cigarettes a day/week? __________ 
• How long have you smoked?__________ 
Yes: ___ 
No: ___ 
10. Do you currently smoke marijuana? 
• If yes, how many times per day/week do you smoke? _________ 
• How long have you smoked marijuana?_________ 
Yes: ___ 
No: ___ 
11. Do you currently use any other recreational drugs? 
• If yes, what? How often? For how long?  
Yes: ___ 
No: ___ 
 
Medical History 
12. Have you ever had a neurological problem? (such as a seizure 
disorder, epilepsy, migraines or multiple sclerosis) 
• Describe _____________________- 
• Any medications/treaments?(name, dose, frequency, how 
long?) 
Yes: ___ 
No: ___ 
13. Have you ever had a head trauma or lost consciousness? 
Describe (eg. when, severity, diagnosed and by whom, how long the 
loss of consciousness): 
 
Yes: ___ 
No: ___ 
14. Are you currently on any medications? 
Drug: ___________ Dose:________ Reason: 
 
Drug: ___________ Dose:________ Reason: 
 
Yes: ___ 
No: ___ 
15. Have you ever brain surgery or had a stroke? (Condition associated 
with structural brain alteration on MRI) 
Yes: ___ 
No: ___ 
16. Do you experience claustrophobia? 
Yes: ___ 
No: ___ 
17. Have you ever had an operation or other surgical procedure? 
• If yes, which types? When? 
Yes: ___ 
No: ___ 
18. [If applicable] Are you pregnant? 
Yes: ___ 
No: ___ 
 
 
 
 
 
 
 

Mindful Self-Regulation for blood pressure MRI study – PHONE SCREEN 
11/2017 Version 1 
Page 3 of 5 
 
 
 
 
 
 
 
 
 
 
Psychiatric History 
19. Do you have a serious psychiatric, cognitive or medical disorder 
which could interfere with completion of the study? 
Yes: ___ No: ___ 
• Do you have a current or past diagnosis with any of these 
psychological disorders? 
• Schizophrenia or schizoaffective disorder 
• Autism or other Pervasive Developmental Disorder 
• Obsessive-Compulsive Disorder 
• Claustrophobia 
• Alcohol or substance abuse or dependence (past six months). 
(>14/week  or >4 drinks at any one time for a male, or  >7 
drinks/week or >3 drinks at any one time for a female) or 
substance abuse) ? 
(above are exclusionary conditions) 
• Anxiety/Depression 
• Other _____________ 
 
Details: 
 
• Are you currently taking medications for any psychological 
problems?  
Drug: __________ Dose: _______ Freq: __________ 
 
Duration: _______________________ 
 
 
_____ 
_____ 
_____ 
_____ 
_____ 
 
 
_____ 
 
 
_____ 
_____ 
 
 
_____ 
_____ 
_____ 
_____ 
_____ 
 
 
_____ 
 
 
_____ 
_____ 
 
20. Have you ever been hospitalized for psychosis or suicidal thoughts?   
When? ____________ How long? ________ 
 
 
Yes ___ 
No ___ 
 

Mindful Self-Regulation for blood pressure MRI study – PHONE SCREEN 
11/2017 Version 1 
Page 4 of 5 
 
MRI and Safety 
 
 
21. Do you have any metal in/on your body that cannot be removed? E.g.  
 surgical implants  
 pins 
 pacemakers 
 prosthetic heart valve 
 aneurism clips or other vascular stent, filters, or other devices 
 surgical clips 
 staples 
 neuro-stimulator devices 
 implanted infusion pumps 
 cochlear (ear) implants 
 Ocular (eye) implants or metal fragments in eyes 
 other prostheses 
 other: _________ Describe: ___________________________ 
Yes: ___ 
No: ___ 
22. Do you have braces or any other metal which may be potentially 
magnetic? 
• This includes braces, false teeth, retainer, special hair dye, etc. 
Yes: ___ 
No: ___ 
23. Do you have any tattoos? 
• If yes, is there any chance that it/they contain metallic pigments? 
Yes: ___ 
No: ___ 
24. Have you ever been exposed to shrapnel or metal filings (e.g. 
employed as a machinist, metal worker, welder, or other? 
Yes: ___ 
No: ___ 
25. Is there any chance that you have ever been hit with any stray metal 
(BB’s, metal shavings, etc) 
Yes: ___ 
No: ___ 
26. Any condition known to be incompatible with MRI scan 
Yes: ___ 
No: ___ 
27. Have you ever had an MRI or other scan? 
• If yes, were there any difficulties? 
Yes: ___ 
No: ___ 
28. Are you over 300 lbs? (weight______) 
Yes: ___ 
No: ___ 
 
 At conclusion of the pre-screen, enter name and screening # in screen log  
 
If the candidate is NOT eligible for the current study: 
“I’m sorry, but you are not eligible for our study. if we have another 
study in the future that you might be eligible for, would you like to be 
contacted for that?” 
 
 
Yes ___ 
 
 
No ___ 
 
If the candidate appears to be eligible for the current study, and is interested: 
Phone #’s: 
_______________   ________________ Ok to leave a message?   Yes____  No____ 
Email address: ____________________________ 
Preferred method of contact?  Phone/email (circle one) 
Scheduling considerations: 
 
 separate pages 1-4 from page 5, add the subject’s study ID number to the top of pages 1-4 and 
store in locked file separate from page 5 and the screen log. 
 
Investigator Signature:  
           /            /                    .. 
 
d d 
m m     y y y y 

 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Screen 
Mindful Self-Regulation for blood pressure MRI study 
Name: 
Email: 
Screening Date: 
            /              /                        . 
d     d      m    m     y     y    y    y  
Phone 
Phone 
 

Appendix 6C - 
Informed Consent form
 for UMass Medical School 
fMRI sub-study to be 
administered by UMass 
research staff

 
 
Informed Consent MB-BP MRI 
                                 Page 1 of 7 
 
                                                                                             
Docket #14090 
 
 November December 43, 2017 
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UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH 
 
CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
Title of research study:  
Mindfulness Influences on Self-Regulation:   
Mental and Physical Health Implications for blood pressure 
(Mindfulness MB-BP Self-Regulation MRI) 
Investigator:  Jean King, Ph.D. 
Sponsor:  The National Institutes of Health 
Why are you being invited to take part in a research study? 
You are being asked to participate because you are between 18 and 65 years of age and 
participating in the Mindfulness-Based Blood Pressure intervention study, have thus met 
entrance criteria for having prehypertension or hypertension, or another cardiovascular risk 
factor that could be influenced by this program, and do not have any other active medical or 
psychiatric illness, and are able to have MRI scanning done.  
What should you know about a research study? 
Your participation is entirely voluntary. 
You may decide not to take part or decide to quit the study at any time, without any changes in 
the quality of the health care you receive. 
You will be told about any new information or changes in the study that might affect your 
willingness to participate. 
You are free to ask all the questions you want before deciding if you want to be in this study. 
Why are we doing this research? 
The purpose of the study is to begin to find out if a mindfulness-based blood pressure 
intervention affects brain function and whether any alterations are associated with mechanisms 
of self-regulation that accompany participation in such a program. We hope that such 
relationships exist, so that we can better understand the effect of mindfulness on self-regulation 
mental and behavioral changes that could impact blood pressure regulation. This knowledge may 
help researchers hone in on effective mechanisms, and healthcare providers to improve the care 
of people with prehypertension, hypertension, or other related cardiovascular risk factors. 

 
 
Informed Consent MB-BP MRI 
                                 Page 2 of 7 
 
                                                                                             
Docket #14090 
 
 November December 43, 2017 
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How long will the research last? 
We expect that you will be in this research study for 2 Visits, which should take approximately 
4.5 hours in total to complete.  
How many people will be studied? 
We expect about 60 people to be in this portion of the research study at UMass Medical School. 
1 - What happens if I say yes, I want to be in this research? 
If you want to participate in this research, you will be asked to come in for a total of two visits –  
before and after the Mindfulness-Based Blood Pressure intervention (Visits 1 and 2). Each visit 
includes an MRI scan, and should take about 2 hours total to complete.  
 
Magnetic Resonance Imaging (MRI) ~1.5 hours: 
This study includes two magnetic resonance imaging (MRI) scans. An MRI is a technique for 
taking images of the brain. It uses a magnetic field and radio waves - no ionizing radiation is 
used. We will take you to the MRI imaging suite at the University of Massachusetts Medical 
School’s main campus and ask you a series of safety questions before we bring you into the MRI 
room. Some of these questions might be repetitive but is important that we make sure it is safe 
for you to have an MRI scan. 
Because the scanner contains an extremely strong magnet you will be asked to remove all metal 
objects on you. This includes things like: watches, rings, necklaces, bracelets, earrings and other 
body piercings, belts, loose change, wallet (with credit cards), items of clothing containing 
magnetic materials (for example, under wire bras, certain types of zippers), and shoes. We will 
ask you change into a hospital gown and pants (“scrubs”) before you go into the scanning room. 
Your clothing and personal items will be locked up in a safe place until the session is completed. 
You will spend 90 minutes in an MRI scanner, which looks like a large cylinder with a tube 
running down the center.  You will be asked to lie down on your back on a foam-padded table 
and to put your head into a special holder. The table slides inside the “hole” of the scanner.  Soft 
foam rubber sponges may be placed on both sides of your head for comfort and to keep your 
head still. A headset with microphone allows you to hear and talk to the technician operating the 
scanner at all times. 
During the scanning procedure, you will hear a number of different sounds.  These sounds, 
which can be loud, are part of the normal operation of the scanner. These noises vary with the 
particular scan being performed, and include sounds like a hammer hitting a piece of wood, 
repetitive buzzing noises, and long series of loud beeps. Some scans are silent. These sounds, or 
combinations of them, will then be repeated several times, depending upon the specific scan 
sequence being used.  The sounds you hear during the scanning session will not harm your 
hearing, but you will be given a pair of earplugs to wear for your comfort. Even with these 
earplugs in you will always be able hear the technician because they do not block all sound. You 
are free to talk during the preparation time and during the breaks, but you should not talk during 
the actual scanning process.  During these sessions, you should try to remain as still as possible.  
Formatted: Indent: Left:  0", Hanging:  0.25",  No bullets or
numbering

 
 
Informed Consent MB-BP MRI 
                                 Page 3 of 7 
 
                                                                                             
Docket #14090 
 
 November December 43, 2017 
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The entire time that you will be in the scanner will be no longer than 90 minutes.  When the 
session is over the technician will move you out of the scanner and assist you from the table.  At 
this time, you will be asked a series of questions from a questionnaire that asks your experiences 
while in the MRI scanner (Amsterdam Resting-State Questionnaire).  This survey will take 
approximately 5 minutes to complete.  
The MRI scanner takes moment-to-moment images of your brain’s blood-flow and tissue. These 
images are digitally stored. Thousands of patients across the country safely undergo such 
procedures in radiology departments every day. The MRI procedure itself is not experimental; 
rather, it is well known to be safe.  
What are the risks of being in this study? 
Magnetic resonance (MR) technology does not use ionizing radiation like an X-ray.  Instead, it 
uses strong magnetic fields and radio-frequency waves to collect the images and data.  There are 
no known serious health hazards or risks associated with these techniques for most people.  
However, significant risks may exist for people with: 
• Cardiac pacemakers 
• Aneurysm clips (in your brain) and other vascular stents (tubes in your veins), filters, 
clips or other devices that have been surgically put in you for any reason 
• Prosthetic heart valves (a mechanical device that helps your heart pump blood) 
• Other prostheses (a piece of equipment that replaces a missing part of the body) 
• Neuro-stimulator devices (a piece of equipment that activates nerves) 
• Implanted infusion pumps (a device that stays in your body and helps give you medicine) 
• Cochlear (ear) implants (a device used to help you hear) 
• Ocular (eye) implants (a device put in your eye to help you see) 
• Known metal fragments or pieces in eyes 
• Contact with shrapnel (pieces of metal from something that has exploded) 
• Contact with metal filings (people who are sheet metal workers, welders, or others could 
have this contact) 
• Any surgeries where something metal was put in you 
• Certain tattoos (please tell the study doctor if you have a tattoo so that we can make sure 
it is safe) 
• Certain intrauterine contraception devices (IUD’s) 
 
You will be asked whether you have such devices and if so, you will not be able to participate in 
this study.  Significant risks also can arise if certain types of metal objects are brought into the 
scanning area, as they can become hazardous projectiles.  These types of items are not permitted 
in the scanning area.  The exams are painless, and except for the pulsating sounds, you will not 
be aware that MR scanning is taking place. 
This study will be conducted in an MR scanner which has been approved by the FDA for clinical 
and research studies. Although there are no known significant health risks from these scans, there 
could be adverse effects that are delayed or very mild, such that they have not yet been 
recognized.  Most people experience no ill effects from the large magnetic field, but some people 

 
 
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do report claustrophobia (fear of being in small spaces), dizziness, mild nausea, headaches, a 
metallic taste in their mouth, double vision or sensation of flashing lights.  These symptoms, if 
present, disappear shortly after leaving the MR machine. If you experience discomfort from 
being in the scanner, you should notify the examiner immediately and you will be removed from 
the scanner. You should also note you will be asked to remain as still as possible during the  
scanning session. Remaining motionless can result in physical discomfort. 
You may feel cramped inside the scanner.  The technologist will be able to hear you at all times 
and you are free to end the procedure at any time. 
In rare cases, a very slight, uncomfortable tingling of the back due to the rapid switching of the 
magnetic field has been reported during certain types of scans. In case you have such a sensation, 
you are asked to report this immediately, so the scan can be changed to avoid this. Although 
these precautions will avoid all known risks associated with MR, this procedure may involve 
risks to you that are currently unforeseeable. 
A qualified neuroradiologist will interpret your brain scan, as you are having images taken of 
your brain tissue and brain blood flow. We will retain your contact information in the event that 
it is medically important to tell you of any aspect of your brain scan. Any medically important 
findings on the MRI will be identified and reported to you. This process could also produce some 
discomfort, and would only be done if believed in your medical best interests. Please note that 
you will not be billed for the procedure, and that we will also help you get any follow-up care 
you might need. 
Another  risk of being in this study is a loss of your personal information. This is very unlikely to 
happen, and we will do everything to make sure that your information is protected.   
What are my responsibilities if I take part in this research? 
If you take part in the research, it is important for your safety that you: 
• Follow the directions of the study doctor and research staff.  
• Tell your health care providers that you are in a research study. 
• Tell your study doctor and staff about all medications you are taking (prescription and 
over the counter) and all of your health issues.  
• Call the study doctor or staff at 774-455-4272 if you have any questions. 
Will being in this study help me in any way? 
There may be no benefit to being in this study. However, knowledge gained from this study may 
help others with your condition in the future.  
Will being in this study cost me any money? 
Participating in this study will NOT require a payment, co-pay, or insurance charge. There will 
be no cost to you from being in this research study other than the cost of your transportation to 
UMass Medical School. 

 
 
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What happens to information about me? 
Efforts will be made to limit access to your personal information, including research study and 
medical records, to people who have a need to review this information. We cannot promise 
complete secrecy. The UMMS Institutional Review Board (the committee that reviews, 
approves, and monitors research on human subjects) and other representatives of UMMS may 
need to review records of individual subjects.  As a result, they may see your name, but they are 
bound by rules of confidentiality not to reveal your identity to others. Your identity will remain 
confidential in any study results that are made public.  
We will communicate the reults results of this study to others by publishing the reults in 
scholarly books or journals, presenting them at professional conferences, or using them for 
teaching purposes. In addition, for transparency in our research practices and according to 
current recommendations, we will make available the de-identified data  (including your and 
other participants’imaging, physiological, questionnaire, behavioral), we collect from you nd and 
other participants accessible to through a public bankthe public vis via or a web repository such 
as through the Open Science Framework. This means that only researchers who apply and get 
permission to use the information for a specific research project will be able to access the 
information. Qualified researchers who can access the national databases can be from 
government, academic or commercial institutions. This will enable interested parties, like other 
researchers, to reproduce our results and use the acquired data in other analyses. All of your 
information will be kept in strict confidence; you will never be personally identified in any 
communication or publicly-accessible data sets.”  
What happens if I am injured because I took part in this research? 
If you are injured while on study, seek treatment and contact the study doctor as soon as you are 
able.   
The University of Massachusetts Medical School does not provide funds for the treatment of 
research-related injury. If you are injured as a result of your participation in this study, treatment 
will be provided. You or your insurance carrier will be expected to pay the costs of this 
treatment. No additional financial compensation for injury or lost wages is available. 
You do not give up any of your legal rights by signing this form. 
 
Will I be given any money or other compensation for being in this study? 
For both your first visit,s involving MRI’s you will receive $1050 each for completing both the 
MRI and the questionnaires, and $50 in travel expenses (free parking),  even if you choose to 
discontinue your participation due to any discomfort you might experience during the scanning 
session. If your first visit is successful, you will be asked to return for a second visit, with the 
same compensation scheme, for a possible total of $300. 
What happens if I do not want to be in this research? 
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If you decide not to take part in the research, it will not affect your usual care and it will not be 
held against you. 
What happens if I say yes, but I change my mind later? 
You are free to leave the study at any time. There are no penalties and you do not lose any 
benefits to which you are otherwise entitled. Data that has already been used will remain part of 
the study database and may not be removed in order to maintain the integrity of the research  
However, any identifiable information will be destroyed so that no one can tell the data belonged 
to you.  If you decide to stop your participation, we may ask if you are willing to have us contact 
you for safety follow-up purposes or to provide further data collection from routine medical care. 
 
There are no risks to dropping out of the study.  
 
Can I be removed from the research without my OK? 
The person in charge of the research study or the sponsor can remove you from the research 
study without your approval. Possible reasons for removal include inability to comply with study 
procedures. 
 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, you can talk to 
the Dr. Jean King, PhD’s research team at 774-455-4272 or Dr. Eric Loucks’ research team at 
401-400-4768401-XXX-XXXX. 
This research has been reviewed and approved by an Institutional Review Board. You may talk 
to them at (508) 856-4261 or irb@umassmed.edu for any of the following: 
• Your questions, concerns, or complaints are not being answered by the research team. 
• You cannot reach the research team. 
• You want to talk to someone besides the research team. 
• You have questions about your rights as a research subject. 
• You want to get information or provide input about this research. 
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Signature Block for Capable Adult 
Your signature documents your permission to take part in this research. 
 
 
 
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
Printed name of person obtaining consent 
 
 
 
 

Appendix 6D - 
Questionnaire for UMass 
Medical School fMRI sub-study

Amsterdam Resting‐State Questionnaire 2.0 
Administer either version 1.A or 1.B in counterbalanced fashion  
9‐23‐15 
 
Below is a collection of statements about your experience in the scanner. Using the responses below, 
please indicate how you felt. Please answer according to what really reflects your experience rather 
than what you think your experience should be. 
 
Version 1.A 
 
Completely 
disagree 
Somewhat 
disagree 
Neither 
agree or 
disagree 
Somewhat 
agree 
Completely 
agree 
I imagined talking to myself. 
 
 
 
 
 
I pictured events.  
 
 
 
 
 
I felt relaxed.  
 
 
 
 
 
I thought about people I like. 
 
 
 
 
 
I thought about my heartbeat.  
 
 
 
 
 
I felt pain. 
 
 
 
 
 
I had difficulty staying awake.  
 
 
 
 
 
I thought about myself.  
 
 
 
 
 
I had difficulty holding on to my 
thoughts. 
 
 
 
 
 
I felt comfortable.  
 
 
 
 
 
I thought about the future. 
 
 
 
 
 
I thought in images. 
 
 
 
 
 
I thought in words.  
 
 
 
 
 
I felt tired.  
 
 
 
 
 
I was conscious of my body. 
 
 
 
 
 
I thought about my health.  
 
 
 
 
 
I thought about solving problems. 
 
 
 
 
 
I had busy thoughts. 
 
 
 
 
 
I felt ill.  
 
 
 
 
 
I thought about others.  
 
 
 
 
 
I felt sleepy.  
 
 
 
 
 
I felt happy.  
 
 
 
 
 
I thought about my feelings.  
 
 
 
 
 
I pictured places.  
 
 
 
 
 
I thought about things I need to do. 
 
 
 
 
 
I placed myself in other people’s 
shoes. 
 
 
 
 
 
I had rapidly switching thoughts. 
 
 
 
 
 
I thought about my breathing.  
 
 
 
 
 
I had silent conversations. 
 
 
 
 
 
I thought about my behavior.  
 
 
 
 
 
I had my eyes closed 
 
 
 
 
 
I was able to rate the statements 
 
 
 
 
 
 

Amsterdam Resting‐State Questionnaire 2.0 
Administer either version 1.A or 1.B in counterbalanced fashion  
9‐23‐15 
 
 
Version 1.B 
 
Completely 
disagree 
Somewhat 
disagree 
Neither 
agree or 
disagree 
Somewhat 
agree 
Completely 
agree 
I thought about my heartbeat.  
 
 
 
 
 
I thought about solving problems. 
 
 
 
 
 
I felt sleepy.  
 
 
 
 
 
I had difficulty holding on to my 
thoughts. 
 
 
 
 
 
I thought about people I like. 
 
 
 
 
 
I had rapidly switching thoughts. 
 
 
 
 
 
I pictured places.  
 
 
 
 
 
I thought about my behavior.  
 
 
 
 
 
I had difficulty staying awake.  
 
 
 
 
 
I was conscious of my body. 
 
 
 
 
 
I had silent conversations. 
 
 
 
 
 
I thought about others.  
 
 
 
 
 
I had busy thoughts. 
 
 
 
 
 
I thought about the future. 
 
 
 
 
 
I felt comfortable.  
 
 
 
 
 
I thought about things I need to do. 
 
 
 
 
 
I felt tired.  
 
 
 
 
 
I thought about my health.  
 
 
 
 
 
I thought about my feelings.  
 
 
 
 
 
I placed myself in other people’s 
shoes. 
 
 
 
 
 
I felt pain. 
 
 
 
 
 
I thought in words.  
 
 
 
 
 
I thought in images. 
 
 
 
 
 
I pictured events.  
 
 
 
 
 
I felt relaxed.  
 
 
 
 
 
I thought about my breathing.  
 
 
 
 
 
I thought about myself.  
 
 
 
 
 
I imagined talking to myself. 
 
 
 
 
 
I felt happy.  
 
 
 
 
 
I felt ill.  
 
 
 
 
 
I had my eyes closed 
 
 
 
 
 
I was able to rate the statements 
 
 
 
 
 
 

Appendix 6E - 
UMass Medical School fMRI 
sub-study IRB Approval Letter

1
12/12/2017
Jean King, PhD
University of Massachusetts
Psychiatry
Dear Dr. King:
The IRB reviewed the following:
Type of Submission:
Study
Review Type:
Non-Committee
Project Title:
Mindfulness Influences on Self-Regulation:  
Mental and Physical Health Implications for blood 
pressure
(Mindfulness MB-BP Self-Regulation MRI)
Investigator:
Jean King, PhD
IRB ID:
H00014090
Funding Agency:
NATIONAL INSTITUTES OF HEALTH
Grant Title:
MINDFULNESS INFLUENCES ON SELF-
REGULATION: MENTAL AND PHYSICAL HEALTH 
IMPLICATIONS
Grant ID:
3UH2AT009145-03S1
IND or IDE:
None
IRB Review Date:
12/3/2017
Documents Reviewed:
umms-hrp-504---ISP MB-BP MRI-2017.12.12.docx 
Amsterdam Resting-State Questionnaire 2017.11.06.docx
Phone Screen MB-BP MRI H00014090 2017.12.05.doc
Consent_MB-BP MRI 2017.12.05.doc
The IRB approved the research from 12/12/2017 to 12/11/2018 inclusive. Before 10/27/2018 or 
within 30 days of closing the study, whichever is earlier, you are required to submit a completed 
Continuing Review Progress Report and necessary attachments to request continuing approval or 
study closure.
If continuing review approval is not granted before the expiration date of 12/11/2018, approval 
of this research expires on that date. 
Stamped consent documents are included with this approval. Use these to document consent. 

2
In conducting this research, you are required to follow the requirements listed in the 
INVESTIGATOR MANUAL.
Sincerely,
Crystal Davis, MPH
IRB Protocol Specialist
cc:
Payne, Laurellee

Research Protections Office
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Research Protections Office
Date:
March 12, 2015
RE:
Protocol Entitled: Mindfulness-Based Hypertension Therapy Pilot
Study (#1412001171).
The above referenced protocol received a full board review and approval by the Brown University
IRB on January 15, 2015. IRB approval is valid for 1 year from January 15, 2015 through January
15, 2016.
Should the research continue, the next progress report must be submitted two months prior to the
expiration date for review and approval.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is March 31, 2015.
All pertinent federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Research Protections Office (RPO) at

http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Research Protections Office
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Research Protections Office
Date:
July 01, 2015
RE:
Protocol Entitled: Mindfulness-Based Hypertension Therapy Pilot
Study (#1412001171).
Amendment #1
The above amendment to the protocol, received an expedited review and approval by the IRB on
July 01, 2015.
This amendment dated 6/17/15, (originally submiited 4/8/15) includes changing the survey
 software to Qualtrex, updating the phone screening questionnaire, clarifying the study safety
 plan, modifying the consent form, adding questionnaires to the baseline survey, and modifying
 recrutiment procedures.
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***

The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is July 31, 2015.
All pertinent federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Research Protections Office (RPO) at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Research Protections Office
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Research Protections Office
Date:
August 07, 2015
RE:
Protocol Entitled: Mindfulness-Based Hypertension Therapy Pilot
Study (#1412001171).
Amendment #2
The above amendment to the protocol, received an expedited review and approval by the IRB on
August 06, 2015.
This amendment dated 7/15/15 (revised and re-submitted on 8/5/15) included: The addition of a
 new participant population (NEFS sub-set) and new recruitment procedures for that population,
 revisions to the In-person Screening Assessments 1 and 2, revisions to wording of the phone
 screening questionniare, addition of a place for staff to note contact information on the safety plan
 document, adding a version footer to the consent document. 
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***

The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is August 31, 2015.
All pertinent federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Research Protections Office (RPO) at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Research Protections Office
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Research Protections Office
Date:
September 03, 2015
RE:
Protocol Entitled: Mindfulness-Based Hypertension Therapy Pilot
Study (#1412001171).
Amendment #3
The above amendment to the protocol, received an expedited review and approval by the IRB on
September 03, 2015.
This amendment dated 9/1/15 included the addition of a funding source (grant #1 UH2
 AT009145-01, grant title: Mindfulness Influences on Self-Regulation: Mental and Physical Health
 Implications), a change in scope of work and related study activities secondary data analyses
 involving concurrent studies, additional measures and study procedures, and revised informed
 consent document. 
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***

The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is September 30, 2015.
All pertinent federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Research Protections Office (RPO) at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Research Protections Office
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Research Protections Office
Date:
January 08, 2016
RE:
Protocol Entitled: Mindfulness-Based Hypertension Therapy Pilot
Study (#1412001171).
Amendment #4
The above amendment to the protocol, received an expedited review and approval by the IRB on
January 07, 2016.
This amendment (dated: 11/11/2015) requests approval to (a) add compensation, (b) add a NIH
 safety monitoring plan, (c) update the names and content of the phone screen and assessments,
 (d) add a 1-year follow-up visit, and (e) update the consent document to incorporate these
 changes.
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***

The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is February 01, 2016.
All pertinent federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Research Protections Office (RPO) at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Research Protections Office
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Research Protections Office
Date:
February 26, 2016
RE:
Protocol Entitled: Mindfulness-Based Hypertension Therapy Pilot
Study (#1412001171).
Amendment #5
The above amendment to the protocol, received an expedited review and approval by the IRB on
February 26, 2016.
This amendment (dated: 2/26/16) requests approval to allow participants, who are not able to
 come to the study site in person, the option to participate by online video conferencing.
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is February 29, 2016.

All pertinent federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Research Protections Office (RPO) at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Office of Research Integrity
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Human Research Protection Program
Date:
May 09, 2016
RE:
Protocol Entitled: The Mindfulness-Based Blood Pressure Reduction
Study (MB-BP) (#1412001171).
Amendment #6
The above amendment to the protocol, received an expedited review and approval by the IRB on
May 09, 2016.
This amendment (dated: 4/11/2016) requests approval to (a) change the study title; (b) revise
 the NCCIH Safety Monitoring Protocol; (c) separate the Baseline and Follow-up Assessments
 into two visits; (d) change the data collection mode to Qualtrics for Daily Practice Forms and
 Class questionnaires; (e) revise study recruitment material and use online advertising; (f) revise
 the in-class worksheets and assessments; and (g) revise the MB-BP Questionnaire, In-Person
 Assessment, Home Assessment, and Measurement of Mindfulness Practices.
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.

*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is May 31, 2016.
All pertinent Federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Human Research Protection Program at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Office of Research Integrity
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Human Research Protection Program
Date:
September 13, 2016
RE:
Protocol Entitled: The Mindfulness-Based Blood Pressure Reduction
Study (MB-BP) (#1412001171).
Amendment #7
The above amendment to the protocol, received an expedited review and approval by the IRB on
September 13, 2016.
Approval of the amendment (memo dated August 9, 2016) includes the addition of 2 new
 questions to the Home Baseline Assessment. 
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is September 30, 2016.

All pertinent Federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Human Research Protection Program at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Office of Research Integrity
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Human Research Protection Program
Date:
January 25, 2018
RE:
Protocol Entitled: The Mindfulness-Based Blood Pressure Reduction
Study (MB-BP) (#1412001171).
Amendment #10
The above amendment to the protocol, received an expedited review and approval by the IRB on
January 25, 2018.
This amendment (dated: 11/6/2017) requests approval to (a) modify the approved focus group
 discussion questions into a one-on-one qualitative phone interview, (b) re-contact Stage 1
 participants for a 2-year in-person assessment, (c) rearrange compensation amounts, (d) add
 recruitment for and data sharing from the UMass Medical School fMRI study, (e) add the "UMass
 Medical School fMRI Study Recruitment Talking Points," (f) add a consent addendum for enrolled
 participants to complete the phone interview, and (g) revise the approved consent to reflect the
 appropriate changes.
This amendment approval date does not change the continuing review date for the overall project.
Should the research continue, the next progress report must be submitted for review and approval
two months prior to the expiration date.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.

*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is January 31, 2018.
All pertinent Federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Human Research Protection Program at
HRPP. This includes the Belmont Report, 45 CFR 46, and the Brown University Federal Wide
Assurance #00004460.

Research Protections Office
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Research Protections Office
Date:
December 17, 2015
RE:
Protocol Entitled: Mindfulness-Based Hypertension Therapy Pilot
Study (#1412001171).
Continuing Review #1
The above referenced progress report received a full board review and approval by the Brown
University IRB on December 17, 2015. Continuation of this study is approved through January 15,
2017.
The Board determined that future progress reports of this full board protocol may be reviewed
 under expedited category #9.
Should the research continue, the next progress report must be submitted two months prior to the
expiration date for review and approval.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is January 04, 2016.

All pertinent federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Research Protections Office (RPO) at
http://www.brown.edu/research/institutional-review-board-irb. This includes the Belmont Report, 45
CFR 46, and the Brown University Federal Wide Assurance #00004460.

Office of Research Integrity
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Human Research Protection Program
Date:
December 16, 2016
RE:
Protocol Entitled: The Mindfulness-Based Blood Pressure Reduction
Study (MB-BP) (#1412001171).
Continuing Review #2
The above referenced progress report received an expedited review and approval under Expedited
Category 9 by the Brown University IRB on December 15, 2016. Continuation of this study is
approved through January 15, 2018.
Should the research continue, the next progress report must be submitted two months prior to the
expiration date for review and approval.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is January 03, 2017.
All pertinent Federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Human Research Protection Program at

HRPP. This includes the Belmont Report, 45 CFR 46, and the Brown University Federal Wide
Assurance #00004460.

Office of Research Integrity
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Human Research Protection Program
Date:
January 02, 2018
RE:
Protocol Entitled: The Mindfulness-Based Blood Pressure Reduction
Study (MB-BP) (#1412001171).
Continuing Review #3
The above referenced progress report received an expedited review and approval under Expedited
Category 9 by the Brown University IRB on January 02, 2018. Continuation of this study is
approved through January 15, 2019.
Should the research continue, the next progress report must be submitted two months prior to the
expiration date for review and approval.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is January 31, 2018.
All pertinent Federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Human Research Protection Program at

HRPP. This includes the Belmont Report, 45 CFR 46, and the Brown University Federal Wide
Assurance #00004460.

Office of Research Integrity
Box 1986
Providence, RI 02912
Tel:  (401) 863-3050
Fax: (401) 863-7292
Memorandum
To:
Eric Loucks, Box G-S121-2
From:
Human Research Protection Program
Date:
January 09, 2019
RE:
Protocol Entitled: The Mindfulness-Based Blood Pressure Reduction
Study (MB-BP) (#1412001171).
Continuing Review #4
The above referenced progress report received an expedited review and approval under Expedited
Category 9 by the Brown University IRB on January 09, 2019. Continuation of this study is
approved through January 15, 2020.
Should the research continue, the next progress report must be submitted two months prior to the
expiration date for review and approval.
Any amendments or changes to the research protocol including changes to the consent documents
and questionnaires/surveys must be submitted to the IRB for review and approval prior to
implementation. Also, any change in the status of participants to any of the vulnerable populations
(as identified in 45 CFR 46) including, pregnant women, prisoners, or those with diminished
capacity, requires IRB review and approval prior to their continuing in the study.
The IRB anticipates that investigators will employ recruitment procedures that allow for the
equitable recruitment of women and minorities into research studies.
Note: All research staff must successfully complete the Brown University Education Program in the
Protection of Human Research Participants (CITI at http://www.citiprogram.org) prior to beginning
work on the project.
*** For Your Information ***
The next deadline for submission of new protocols, amendments to protocols, and annual progress
reports requiring full board review is January 31, 2019.
All pertinent Federal and University policies and guidelines related to the involvement of
participants in research can be obtained through the Human Research Protection Program at

HRPP. This includes the Belmont Report, 45 CFR 46, and the Brown University Federal Wide
Assurance #00004460.
cc:
Webb, Julie