Mindfulness Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
Phase: NA
Conditions: Hypertension, Prehypertension
Sponsor: Brown University

Clinical Intervention Study Protocol 
NCT03859076
FULL PROTOCOL TITLE
Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT 
Study Chairman or Principal Investigator:
Eric B. Loucks, PhD
Associate Professor, Department of Epidemiology
Brown University School of Public Health
Supported by: 
The National Center for Complementary and Integrative Health
5UH3AT009145-04

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Clinical Intervention Study 
Protocol  

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FULL PROTOCOL TITLE 
Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT 
Study Chairman or Principal Investigator: 
Eric B. Loucks, PhD 
Associate Professor, Department of Epidemiology 
Brown University School of Public Health 
Supported by:  
The National Center for Complementary and Integrative Health 
5UH3AT009145-04 
Study Intervention Provided by: 
N/A 
Sponsor of IND (IDE): 
N/A 

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Tool Revision History 
Version Number: 2.1 
Version Date: July 6, 2018 
Summary of Revisions Made:  
- 
Revised sample size from 202 to 122. The total sample size of n=122 is comprised of 
n=50 for the MB-BP intervention group; n=50 for the enhanced usual care control group; 
and n=22 for the exploratory MBSR group. This sample size reflects recruitment during 
UH3 phase rather than during both the UH2 and UH3 phases.  
- 
Mediation analyses will be performed via meta-analysis of both samples from the UH2 
and UH3 phases, for which the participants were assessed using identical methods. This 
will maximize statistical power for mediation analyses, which require greater power.  
- 
Narrowed primary outcome to one (Multidimensional Assessment of Interoceptive 
Awareness), in order to minimize issues of multiple statistical testing and maximize 
statistical power, given the smaller sample size when analyses are restricted to the data 
collected during the UH3 phase.  
- 
A unique clinicaltrials.gov registration will be created based on the UH3-specific aims, 
data collection, and analyses.  
 
Version Number: 2.2 
Version Date: August 9th, 2018 
Summary of Revisions Made: Replaced Dr. Wen-Chih Wu with Dr. Gaurav Choudhary as the 
clinical cardiologist on the DSMB. This was done because Dr. Wu and Dr. Loucks have 
published together in the past three year. Dr. Choudhary and Dr. Loucks have not published 
together.  
 
Version Number: 2.3 
Version Date: August 16, 2018 
Summary of Revisions Made:  
- 
Addressed comments and requested revisions per OCRA 8/9/18 review. Comments 
were relayed by Program Director, Merav Sabri, to study PI, Eric Loucks in an email sent 
on August 10, 2018. 
- 
Revised Appendix B as requested by OCRA. Also removed sub-Appendix A, Conducting 
Orientation Sessions at the Center for Mindfulness in Medicine, Health Care and Society 
University of Massachusetts Medical School, as it is not utilized in this study 
- 
Updated phone screener document (Appendix C) to reflect OCRA review comments and 
updated study protocol. 
- 
Replaced informed consent form (Appendix D) with updated version (v.3.2) 
 
Version Number: 2.4 
Version Date: November 14, 2018 

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Summary of Revisions Made: The modifications made to the study protocol outlined below were 
largely the result of items brought to the research team’s attention during the NCCIH/Westat 
September 13, 2018 Site Initiation Visit (SIV) and in the related SIV Report sent on October 9, 
2018.  
- 
Updated the study team roster to include the co-PI (King); data safety monitoring expert 
(Britton); and the study clinicians (Wu and Flynn). 
- 
Clarified the role UMass Medical School will play in conducting the fMRI imaging study 
and explicitly stated that the details of said study will be documented separately. 
- 
Removed the MBSR exploratory arm. (Refer to Nov. 6, 2018 PI email to NCCIH PO for 
rationale. NCCIH provided written approval in Nov. 12, 2018 email response to PI) 
- 
Revised (clarified) descriptive language around recruitment; screening; inclusion criteria; 
blinding; randomization procedures; intervention timing, duration, and content; 
assessment windows; and data management to more accurately reflect the plan for UH3 
study procedures. 
- 
Updated the full list of measures for UH3, which included the removal of: actigraphy 
devices, Mindful Skill Acquisition scale, dietary self-efficacy, and the readiness to 
change for hypertenstive risk factors questionnaire. Additionally, the following measures 
were added: the PROMIS Global Health v.1.2 scale, childhood food insecurity 
questionnaire, alcohol consumption, mindfulness home practice questions, the Connor-
Davidson Resilience scale, the Self-efficacy for chronic disease management 
questionnaire, and 6-month semi-structured exit interview questions. 
- 
Revised Section 7 (Safety Assessments) to reflect the new Data safety and monitoring 
plan (DSMP) put forth for UH3. 
- 
Clarified language around the estimated enrollment and analyzable sample size for the 
fMRI Study. 
- 
Corrected clerical and grammatical errors and cleaned up the language to be more 
concise and clear. 
 
Version Number: 2.5 
Version Date: December 11, 2018 
Summary of Revisions Made: Addressed the comments and requested clarifications sent to 
study PI (Loucks) by NCCIH Program Director (M. Sabri) on December 6, 2018 at 6:18 PM 
EST. The specific revisions include: 
 
- 
Adding clarifying language on study randomization and cohort size to section 6.2.4 
(Randomization and Intervention Allocation). 
- 
Expounding upon circumstances that might possibly lead to Investigator-initiated 
withdrawals, which are discussed in section 7.3.3. of the Safety Assessment section of 
the protocol.  
 

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TABLE OF CONTENTS 
Page 
Clinical Intervention Study Protocol ................................................................................................ 1 
FULL PROTOCOL TITLE ............................................................................................................... 2 
Tool Revision History .................................................................................................................. 3 
TABLE OF CONTENTS .................................................................................................................. 5 
MB-BP STUDY TEAM ROSTER  ............................................................................................... 8 
PARTICIPATING STUDY SITES ............................................................................................... 9 
PROTOCOL SUMMARY ............................................................................................................ 9 
1. STUDY OBJECTIVES .............................................................................................................. 12 
1.1 
Primary Objective .......................................................................................................... 12 
2. BACKGROUND AND RATIONALE .......................................................................................... 12 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ........................... 12 
2.2 
Study Rationale ............................................................................................................. 15 
3. STUDY DESIGN ....................................................................................................................... 15 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ......................................................... 17 
4.1 
Inclusion Criteria ........................................................................................................... 17 
4.2 
Exclusion Criteria .......................................................................................................... 17 
4.3 
Study Enrollment Procedures ....................................................................................... 17 
5. STUDY INTERVENTIONS ....................................................................................................... 18 
5.1 
Interventions, Administration, and Duration ................................................................. 18 
5.2 
Handling of Study Interventions .................................................................................... 19 
5.3 
Concomitant Interventions ............................................................................................ 19 
5.4 
Adherence Assessment ................................................................................................ 19 
6. STUDY PROCEDURES ........................................................................................................... 21 
6.1 
Schedule of Evaluations ............................................................................................... 21 
6.2 
Description of Evaluations ............................................................................................ 22 
6.2.1 Screening Evaluation and Consenting Procedure ................................................... 22 
6.2.2 Enrollment ................................................................................................................. 22 
6.2.3 Baseline Assessments .............................................................................................. 22 
6.2.4 Randomization and Intervention Allocation .............................................................. 24 

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6.2.5 Blinding ..................................................................................................................... 25 
6.2.6 Follow-up Visits ......................................................................................................... 25 
6.2.7 Completion/Final Evaluation ..................................................................................... 25 
7. SAFETY ASSESSMENTS  ....................................................................................................... 25 
7.1 
Expected Risks and Specification of Safety Parameters ............................................. 25 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ... 28 
7.3 
Adverse Events and Serious Adverse Events, Reporting Procedures, and Follow-up 28 
7.3.1 Mental Health ............................................................................................................ 29 
7.3.2 Physical Health ......................................................................................................... 30 
7.3.3 Other ......................................................................................................................... 30 
7.4 
Safety Monitoring .......................................................................................................... 31 
8. INTERVENTION DISCONTINUATION .................................................................................... 33 
9. STATISTICAL CONSIDERATIONS ......................................................................................... 33 
9.1 
General Design ............................................................................................................. 33 
9.2 
Sample Size and Randomization ................................................................................. 33 
9.3  
Definition of Populations ............................................................................................... 35 
9.4 
Interim Analyses and Stopping Rules .......................................................................... 35 
9.5 
Outcomes ...................................................................................................................... 35 
9.5.1 Primary Outcome ...................................................................................................... 35 
9.5.2 Secondary Outcomes ............................................................................................... 35 
9.6 
Data Analyses ............................................................................................................... 35 
10. DATA COLLECTION AND QUALITY ASSURANCE ............................................................. 36 
10.1 
Data Collection Forms .................................................................................................. 36 
10.2 
Data Management ........................................................................................................ 36 
10.3 
Quality Assurance ......................................................................................................... 36 
10.3.1 
Training ................................................................................................................. 36 
10.3.2 
Quality Control Committee.................................................................................... 36 
10.3.3 
Metrics ................................................................................................................... 36 
10.3.4 
Protocol Deviations ............................................................................................... 38 
10.3.5 
Monitoring ............................................................................................................. 38 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................................... 38 

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11.1 
Institutional Review Board (IRB) Review...................................................................... 38 
11.2 
Informed Consent Forms .............................................................................................. 38 
11.3 
Participant Confidentiality ............................................................................................. 38 
11.4 
Study Discontinuation ................................................................................................... 38 
12. COMMITTEES ........................................................................................................................ 39 
13. PUBLICATION OF RESEARCH FINDINGS .......................................................................... 39 
14. REFERENCES ....................................................................................................................... 39 
15. SUPPLEMENTS/APPENDICES ............................................................................................ 55 
Appendix A 
MB-BP Curriculum Guide ................................................................................. 55 
Appendix B 
MBSR Curriculum Guide .................................................................................. 55 
Appendix C 
MB-BP Phone Screener (verbal consent process) .......................................... 55 
Appendix D 
MB-BP Informed Consent ................................................................................. 55 
Appendix E 
Anthropometric Quality Control Manual ........................................................... 55 
Appendix F 
Blood Pressure Quality Control Manual ........................................................... 55 
 
 

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MB-BP STUDY TEAM ROSTER  
Eric B. Loucks, Ph.D. 
Principal Investigator 
Brown University School of Public Health 
121 South Main St., Providence, RI 02912 
Phone: 401-863-6283 
Fax: 401-863-3713 
Email: eric.loucks@brown.edu 
 
Jean A. King, Ph.D. 
Co-Principal Investigator 
100 Institute Road, Worcester MA 01609-2280 
Phone: 508-831-4677 
Email: jaking@wpi.edu 
 
Frances Saadeh, MPH 
Senior Project Coordinator 
121 South Main St., Providence, RI 02912 
Phone: 401-863-6361 
Email: frances_saadeh@brown.edu 
 
Yu Li, PhD 
Statistician  
121 South Main St., Providence, RI 02912 
Phone: 401-863-6792 
Email: yu_li1@brown.edu 
 
Roee Gutman, PhD 
Senior Statistician  
121 South Main St., Providence, RI 02912 
Phone: 401-863-2682 
Email: rgutman@stat.brown.edu 
 
 
Study Clinicians 
 
Ellen Flynn, MD – Clinical Psychiatrist 
Women’s Medicine Collaborative 
146 West River Street, 3rd Floor, Providence, RI 02904 
Phone: 401-793-7020 
Email: eflynn@lifespan.org 
 
Wen-Chih (Hank) Wu, MD, MPH – Cardiologist  
164 Summit Ave, Providence, RI 02906 
Providence, RI 02906 
Phone: 401-793-5810 
Fax: 401-793-5815 
Email: wen-chih_wu@brown.edu 
 
 

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Data and Safety Monitoring Board (DSMB) 
 
Donald Edmondson, PhD, MPH 
DSMB Chair 
622 W 168th Street, PH 9-317 New York, NY 10032 
Phone: 212-342-3674 
Fax: 212-305-0312 
Email: dee2109@cumc.columbia.edu 
 
Gaurav Choudhary, MD 
Providence VA Medical Center 
830 Chalkstone Avenue 
Providence, RI  02908 
Tel: 401-273-7100 ext 2029 
Gaurav_Choudhary@brown.edu 
 
Tao Liu, PhD 
121 South Main Street, Providence, RI 02912 
Phone: 401-863-6480 
Fax: 401-863-9182 
Email: tliu@stat.brown.edu 
 
Data and Safety Monitoring Expert 
 
Willoughby Britton, Ph.D. 
Director, Clinical and Affective Neuroscience Laboratory 
Assistant Professor (Research) 
Department of Psychiatry and Human Behavior 
Warren Alpert Medical School at Brown University 
Phone: 520-245-1855 
Email: willoughby_britton@brown.edu 
 
PARTICIPATING STUDY SITES 
There is one study site, Brown University, carrying out the Mindfulness-Based Blood Pressure 
Reduction (MB-BP) study protocol outlined in this document. The University of Massachusetts 
Medical School is conducting the fMRI Imaging study that will recruit and scan a subset of MB-
BP study participants (see separate fMRI study protocol and related MOP for full detail).  
 
PROTOCOL SUMMARY  
Study Title  
Mindfulness Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial 
 
 

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Objectives  
1. Impacts of MB-BP on Primary Self-Regulation Targets: Identify the impacts of MB-BP vs. 
enhanced usual care on the primary self-regulation target, specifically an assay of self-
related processes (MAIA), described in Table 1. We hypothesize that MB-BP will 
significantly improve the MAIA in directions of better self-regulation, compared to control.  
a. Secondary analyses will evaluate impacts on secondary self-regulation targets 
including an assay of emotion regulation (DERS), and cognitive processes (SART), 
described in Table 1.  
b. Exploratory analyses will evaluate engagement of MB-BP vs. enhanced usual care 
with triangulated self-regulation target assays described in Table 1 such as emotion 
regulation and stress (Pittsburgh Stress Battery, Perceived Stress Scale), self-
related processes (Heart Beat Detection Task, Interoceptive Awareness fMRI Task), 
and cognitive processes (Mindful Attention Awareness Scale).  Measures such as 
the neuroimaging Interoceptive Awareness fMRI Task will replicate assays in the 
MINDFUL-PC study.  
2. Self-Regulation Targets as Mediators of MB-BP Effect on Medical Regimen Adherence 
and Health Behavior Change:  Evaluate the degree to which the engagement of MB-BP 
with self-regulation targets translates into improved prehypertension/hypertension medical 
regimen adherence, specifically for the Dietary Approaches to Stop Hypertension (DASH)-
consistent diet. We hypothesize that MB-BP will increase the DASH diet score compared to 
control, in participants with low DASH diet adherence at baseline (DASH diet score <5.5), 
and that the self-regulation primary outcome in Aim 1 (i.e. MAIA) is a significant mediator.  
3. Further develop an MB-BP therapist manual and training program, including 
procedures for training, supervising, and evaluating therapists. The PI will implement 
training he receives from the University of Bangor in the United Kingdom in May 2018 to 
implement the Mindfulness-Based Interventions Teacher Assessment Criteria (MBI-TAC) for 
MB-BP instructors, which is the most respected quantitative and qualitative tool developed 
to provide feedback for enhancing MBI teacher effectiveness, and establishing teacher 
certification.1-3  
 
Design and Outcomes  
During the UH3 phase, we will perform a Stage 2a4 two-arm RCT of MB-BP vs. enhanced usual 
care control, enrolling 50 individuals aged 18 years of age and older per group. This is a 
pragmatic control group designed to inform physicians if MB-BP would be of service to refer 
patients, compared to enhanced usual care they could provide patients in well-resourced 
settings. This control group was decided upon through recommendations by the Research 
Coordinating Center at Columbia University, the Data Safety Monitoring Board, and several 
collaborating cardiologists and family physician clinician-researchers. Enhanced usual care 
involves every participant being provided with a validated home blood pressure monitor (Omron, 
Model PB786N), which has evidence in and of itself to potentially lower blood pressure,5,6 and is 
beyond usual care at this time. All participants who have Stage 2 hypertension (blood pressure 
>140/90 mmHg) will be offered to have their physicians notified, if not already being overseen 
for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have 
a physician, we will work with participants to provide access within constraints of their health 
insurance. Enhanced usual care group participants receive an educational brochure from the 
American Heart Association entitled “Understanding and Controlling Your High Blood Pressure 
Brochure” (product code 50-1731). 
 
 

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Blinding 
All study staff will be blinded to the participant treatment allocation with the exception of the 
instructor, individual who performs the randomization, and staff member coordinating 
participants within each course. All staff performing participant assessments will be blinded to 
the participant treatment allocation to promote equipoise. Data analyses will be performed by a 
statistician blinded to treatment allocation type. The data manager will be able to break blinding 
if needed (e.g. for Data and Safety Monitoring Board). 
  
Intervention Allocation 
Stratified randomization will be used, as simple randomization can fail if it creates groups 
unbalanced for critical features known to affect outcomes.7,8 Stratified randomization can reduce 
both types I and II error, improve trial efficiency, and facilitate subgroup and interim analyses.7 
Randomization will be done using an online computer software program known as Research 
Randomizer (Version 4.0).9 The randomization process will occur after each new round of 
enrollment. Study enrollment will continue until target enrollment goals are reached (i.e., n=50 
for MBBP intervention group, n=50 for enhanced usual care control group).   
 
Interventions and Duration  
Two-arm RCT comparing MB-BP vs. enhanced usual care. Follow-up assessments will take 
place within pre-defined assessment windows occurring around 10 weeks, 6 months, and 1 year 
post- intervention commencement. For participants on waitlist enhanced usual care, they will be 
offered MB-BP after the 6-month follow-up with no additional assessments unless they would 
like the assessments for follow-up information on changes in their health. Participants in the 
intervention group will be asked to come back at the 1-year follow up window for an abbreviated 
follow up assessment. Thus the total length of involvement for study participants will be up to 
one year from the time of enrollment to the time of the final research assessment. The study 
intervention lasts 9 weeks, may be nonconsecutive weeks in the event of a holiday or instructor 
availability, and takes place in the first three months for individuals in the intervention arm. 
 
Sample Size and Population  
We anticipate needing to recruit and enroll a total of 100 eligible individuals during Phase 3. 
This will consist of 50 individuals per group for both the MB-BP intervention arm and the 
enhanced usual care arm. (see Figure 1 below for detail).  
 
For more detailed discussion of group allocation, stratification factors, and how it influences 
study population, please refer to Section 6.2.4.  
 
 
Inclusion/exclusion criteria:  
Inclusion Criterion: Elevated blood pressure defined as ≥120 mmHg systolic or ≥80 mmHg 
diastolic pressure;10 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:11 (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 

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because they may disrupt group participation, require additional or specialized treatment, or are 
already participating in practices similar to the intervention. 
1. STUDY OBJECTIVES 
1.1 
Primary Objective 
1. Impacts of MB-BP on Primary Self-Regulation Targets: Identify the impacts of MB-
BP vs. enhanced usual care on the primary self-regulation target, specifically an 
assay of self-related processes (MAIA) described in Table 1. We hypothesize that 
MB-BP will significantly improve the MAIA in directions of better self-regulation, 
compared to control.  
a. Secondary analyses will evaluate impacts on secondary self-regulation targets 
including an assay of emotion regulation (DERS), and cognitive processes 
(SART), described in Table 1.  
b. Exploratory analyses will evaluate engagement of MB-BP vs. enhanced usual 
care with triangulated self-regulation target assays described in Table 1 such as 
emotion regulation and stress (Pittsburgh Stress Battery, Perceived Stress 
Scale), self-related processes (Heart Beat Detection Task, Interoceptive 
Awareness fMRI Task), and cognitive processes (Mindful Attention Awareness 
Scale).  Measures such as the neuroimaging Interoceptive Awareness fMRI Task 
will replicate assays in the MINDFUL-PC study.  
2. Self-Regulation Targets as Mediators of MB-BP Effect on Medical Regimen 
Adherence and Health Behavior Change:  Evaluate the degree to which the 
engagement of MB-BP with self-regulation targets translates into improved 
prehypertension/hypertension medical regimen adherence, specifically for the Dietary 
Approaches to Stop Hypertension (DASH)-consistent diet. We hypothesize that MB-
BP will increase the DASH diet score compared to control, in participants with low 
DASH diet adherence at baseline (DASH diet score <5.5), and that the self-regulation 
primary outcomes in Aim 1 are significant mediators.  
3. Further develop an MB-BP therapist manual and training program, including 
procedures for training, supervising, and evaluating therapists. The PI will 
implement training he receives from the University of Bangor in the United Kingdom in 
May 2018 to implement the Mindfulness-Based Interventions Teacher Assessment 
Criteria (MBI-TAC) for MB-BP instructors, which is the most respected quantitative 
and qualitative tool developed to provide feedback for enhancing MBI teacher 
effectiveness, and establishing teacher certification.1-3  
 
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
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.12 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, may have some effects on blood pressure, where a 
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significant effects, but evidence of heterogeneity in effect sizes.14 The methodologically highest 
quality studies had the smallest effect sizes (range 0-5 mmHg).14 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.15-17 Effect sizes may be 
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.  
 
The development of effective interventions that enhance the capacity for self-regulation among 
people with chronic health conditions is a major public health challenge in the United States and 
worldwide. The process of healthcare system transformation that is underway focuses on 
moving accountability for healthcare costs to healthcare systems.18 Meanwhile, in order to 
survive, healthcare systems must rapidly learn to deliver interventions that can enhance their 
patients’ capacity to self-manage these deadly and costly chronic health conditions.19 While 
access to care20 and health education21 are essential, a person’s capacity for self-regulation is 
often the primary limiting factor in their ability to adhere to their medical regimen, collaborate on 
illness self-management, and reduce health risk behaviors.22-25 Self-regulation refers to the 
process of managing cognitive, emotional, and self-relevant resources to align mental states 
and behavior with goals.26-28 Changing risk behaviors that influence hypertension risk, such as 
physical inactivity, diet, excessive alcohol use, and poor medication adherence, requires skills 
for self-regulation that are broadly applicable within multiple environments. A research 
collaboration that could test methods for engaging self-regulation mechanisms, identify specific 
target tests, and rapidly integrate these into an empirically-optimized clinical interventions that 
are ready for implementation and rapid dissemination within health care settings for patients 
with chronic illness would make a substantial impact on chronic illness management and the 
entire healthcare system. Mindfulness-Based Interventions (MBIs) have already begun to offer 
feasible basic building blocks for the rapid integration of an empirically-optimized, trans-
diagnostic, self-regulation toolkit into healthcare across multiple contexts and age groups.  
 
Mindfulness meditation, a form of training that involves maintaining a non-judgmental form of 
attention to immediate experience,29 has been employed in both clinical and non-clinical settings 
to facilitate self-regulation and behavior change.30-34 Mindfulness-Based Interventions (MBIs),35 
sometimes referred to as “3rd Wave Behavioral Therapies,”36 have become widely used in both 
clinical and non-clinical settings, including prisons,37,38 the military,39-41 and both K-1242-45 and 
higher education,46 and are emerging as a wide-spread, potentially cost-saving,47 
comprehensive methods for enhancing self-regulation in multiple medical contexts. While MBIs 
efficacy has been demonstrated for several conditions related to self-regulation,48-50 the field 
lacks consensus about the mechanisms through which these interventions engage self-
regulatory processes and impact of MBIs on medical regimen adherence and health behavior 
changes. Without this knowledge, a plethora of MBIs are being developed without 
systematically building on discoveries of which components of the interventions have the most 
impact on specific health behaviors and outcomes. As a result, the interventions are not as 
rigorous in their design, which may limit their efficacy and account for some of the mixed results 
found in the literature. 
 
Self-regulation requires both initiating behavior change and maintaining behavior change,51,52 
implying corrective adjustments originating within a person and taking place as needed in order 

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to maintain and sustain the intended goal. Self-regulatory failure is primarily determined by 
deficits in (or depletion of) self-regulatory strength,53 highlighting the need for interventions that 
strengthen self-regulation capacity. Current behavioral models lack a full integration of tools for 
strengthening self-regulation towards both initiation and maintenance of behavior change.51,52 
Strategies focusing on extrinsic rewards or behavioral economics can help change behavior, but 
intrinsic motivation is ultimately essential to self-regulation.54 Behavioral and psychological 
therapies can provide emotional regulation strategies and some even include motivational 
components;55,56 however, they generally lack tools to strengthen core cognitive resources, such 
as attention and inhibitory control, which are necessary to support maintenance of behavior 
change. In contrast, MBIs uniquely integrate training in the emotional, motivational, and 
cognitive aspects of self-regulation within one therapeutic intervention. By frequently returning 
attention to the present moment with a specific orientation to experience (curious, open-minded, 
and accepting), mindfulness practice strengthens the capacity for frequent daily corrective 
adjustments needed to stay on track with intended goals. Studying how common self-regulation 
targets influence, and are influenced by, various components of MBIs provides a unique 
opportunity to develop an easy-to-disseminate, integrated therapeutic intervention optimized 
with the most potent components for enhancing self-regulation within the context of medical 
regimen adherence and the initiation and maintenance of health behaviors.  
 
Following recent proposals on the mechanisms of action of mindfulness by our group30,57 and 
others,58-62 three broad self-regulation domains of mindfulness can be identified:  
(A) Cognitive processes, including attention (i.e. orienting, alerting,63,64 vigilance,65 and 
conversely sleepiness, cognitive fatigue, attentional lapses, and mind-wandering66); executive 
function, conflict monitoring,67,68 impulsivity and inhibitory control,69,70 and metacognitive 
awareness.71-73 Many studies indicate that meditation training, such as MBIs, engage these 
cognitive processes.74-87 
(B) Emotion regulation, which is the capacity to alter the magnitude or duration of an 
emotional response.88 Poor emotion regulation impairs the capacity for self-regulation behaviors 
that support health behaviors89-92, including medical regimen adherence.93 MBIs favorably 
engage measures of emotion regulation such as amygdala activation,79,94-97 sympathetic 
hyperarousal,98-103 and emotional responses to stressful situations,102,104-111 although opposite 
findings have also been reported112-114 which leads to the question (to be addressed by this 
collaborative) of which conditions affect target engagement.  
(C) Self-related processes, including: (i) self-efficacy – the belief in one’s capabilities to 
execute the courses of action required to manage prospective situations (such as changing and 
maintaining a medical regimen),115,116 which is a central aspect of self-regulation and changes in 
health behavior;117,118 (ii) self-compassion – the capacity to extend compassion to oneself in 
instances of perceived inadequacy or failure rather than engaging in either self-destructive 
behaviors (self-judgment, isolation, rumination) or in permissive, risky behaviors:119-121 self-
compassion has been found to promote health behaviors such as adhering to diets,122 smoking 
cessation,123 physical activity,124 and seeking medical treatment when needed;125 (iii) self-related 
rumination or mind-wandering – which may be beneficial in some cases126-128 but detrimental in 
others129-133 and is a central topic in MBI research, by our group57,134 and others;135 and (iv) 
interoceptive awareness – the awareness of internal manifestations of emotions and feelings, 
considered fundamental to the ‘experiencing self’,136-141 a particular form of awareness which 
can be enhanced by the paying of purposeful, nonjudgmental attention (‘mindfulness’) to inner 
body sensations,32,33,142 which is also of major interest in MBI research.30,62,135,143-160 
 
Consequently, we propose to conduct a Stage 2a behavioral intervention study to evaluate 
whether MBSR customized to pre-hypertensive and hypertensive patients has the potential to 
provide clinically relevant reductions in BP.  

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2.2 
Study Rationale 
The MB-BP Study aims to customize the standardized MBSR161-164 intervention to adult 
participants with prehypertension or uncontrolled hypertension. Similar to MBSR, the MB-BP 
intervention consists of eight 2.5-hour weekly group sessions (plus a 2.5-hour orientation 
session) and an 8-hour one-day session, led by a certified MBSR instructor with extensive 
cardiovascular disease and hypertension expertise.165-178 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. The unique areas of MB-BP are 
education on hypertension risk factors, hypertension health effects, and specific mindfulness 
modules focused on awareness of diet, physical activity, medication adherence, weight loss, 
and alcohol consumption and their effects on well-being. A curriculum guide has been created 
based on the standardized MBSR manual (Appendix A), and was further developed through 
the approaches described above, and sequentially revised based on participant feedback and 
preliminary findings.163,164 MB-BP participants 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.  
 
3. STUDY DESIGN 
We will perform a Stage 2a4 two-arm RCT of MB-BP vs. enhanced usual care control. This is a 
pragmatic control group designed to inform physicians in well-resourced settings if MB-BP 
would be of service to refer patients to as compared to enhanced usual care patients. The study 
is intended to evaluate the impacts of MB-BP on the primary self-regulation outcome of 
interoceptive awareness (i.e.  MAIA) as compared to an enhanced usual care group. Secondary 
self-regulation outcomes are described in the Objectives section outlined previously. This study 
also aims to evaluate the degree to which the engagement of MB-BP with self-regulation targets 
translates into improved prehypertension/hypertension medical regimen adherence, specifically 
for the Dietary Approaches to Stop Hypertension (DASH)-consistent diet.  
 
The enhanced usual care control group was decided upon through recommendations by the 
Research Coordinating Center at Columbia University, the Data Safety Monitoring Board, and 
several collaborating cardiologists and family physician clinician-researchers. Enhanced usual 
care involves every participant being provided with a validated home blood pressure monitor 
(Omron, Model PB786N),179  which has evidence in and of itself to potentially lower blood 
pressure, and is beyond usual care at this time.6,180 All participants who have Stage 2 
hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if 
not already being overseen for uncontrolled hypertension. For participants with uncontrolled 
hypertension who do not have a physician, we will work with participants to provide access 
within constraints of their health insurance. Enhanced usual care group participants receive an 
educational brochure from the American Heart Association entitled “Understanding and 
Controlling Your High Blood Pressure Brochure” (product code 50-1731). 
 
All research assessments will take place in the Brown University Mindfulness and 
Cardiovascular Health Lab in Providence, RI. The MB-BP intervention classes will be offered in 
both a University and community-based setting. 
 

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Baseline assessments for all enrolled participants will 
take place within four weeks of the start of the 
intervention. Follow-up assessments will take place 
during the 10 week, 6 month, and 1 year assessment 
windows, which are defined as: (a) “10 week” follow up 
assessments are to occur at least one day after and up to 
five weeks after the end of the intervention (i.e. the Week 
8 class). Staff will prioritize completing 
the assessments within the first three weeks of 
the assessment window, but will allow for participants to 
complete up to five weeks after. (b) The “6-month” follow 
up assessments will be scheduled to occur six months 
from the orientation class date plus or minus 2.5 weeks. 
This allows for a five-week data collection period with 
prioritization given to the three-week window surrounding 
the official six-month date. (c) The “1 year” follow up 
assessments are to be completed with the intervention 
group participants only and will occur one year plus or 
minus a month after the start of the intervention (i.e., 
orientation date).   
 
If a participant is unable to complete 
an assessment within the defined data collection window, 
but still wishes to participate, we will allow for the 
participant to complete an online home survey and/or in 
person follow up assessment beyond the parameters 
defined above. 
 
Participants who were randomized to the waitlist 
enhanced usual care group will be offered MB-BP after 
the 6 month follow-up assessment is complete with no 
additional assessments unless they would like the final 
one year assessment for follow-up information on 
changes in their health. Thus the total length of involvement for study participants will be up to 
one year from the time of enrollment to the time of the final research assessment. The study 
intervention lasts 9 weeks and takes place in the first two months for individuals in the 
intervention arm. The intervention will be offered several times a year over the course of the 
total study duration. 
 
Prehypertension/Hypertension Medical Regimen Adherence Outcomes Assessment Methods:  
 
Primary Prehypertension/Hypertension Medical Regimen Adherence Outcome: Dietary 
Approaches to Stop Hypertension (DASH) eating pattern score,181 measured via 80-item Willet 
food frequency questionnaire,182 assessing adherence to American Heart Association/American 
College of Cardiology (AHA/ACC) clinical practice hypertension guidelines DASH eating pattern 
score (range 0-8).10,181,183   
 
Secondary outcomes of medical regimen adherence include the following: (1) Alcohol 
consumption: Amount and frequency of alcohol consumption, will be assessed via self-report 
utilizing standard questions from the Behavioral Risk Factor Surveillance Survey.184  AHA/ACC 
hypertension clinical practice guideline cut-point of healthy alcohol intake is ≤ 2 drinks (e.g. 24 

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oz. beer, 10 oz. wine, or 3 oz. 80-proof whiskey) per day in men and ≤1 drink per day in 
women.10 (2) Electronically-Measured Antihypertensive Medication Adherence: measured 
continuously using electronic medication bottle caps (eCAPS, Ottawa, Canada)185 (3) Body 
Mass Index: height and weight directly assessed using standard epidemiologic methods, with 
change evaluated in participants considered overweight or obese (BMI≥25 kg/m2).186 (4) 
Physical activity: measured using the International Physical Activity Questionnaire which has 
undergone substantial validity and reliability testing.187-189 Adherence to Joint National 
Commission-7 (JNC-7) guidelines is 30 min aerobic physical activity ≥4 days per week.183  
 
Please see Section 6.2.4 for randomization, blinding and stratification methods.  
 
Please see Figure 1 for study groups including sample sizes. Please note that sample size 
recruited for the UH3 phase will be 50 participants per group for MB-BP and enhanced usual 
care control.  
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 
Inclusion Criteria 
 Elevated blood pressure or hypertension defined as ≥120 mmHg systolic or ≥80 
mmHg diastolic pressure.10 Able to speak, read, and write in English. All adults (≥18 
years of age), genders and racial/ethnic groups are eligible to be included.  
4.2 
Exclusion Criteria 
Exclusion criteria follow standard guidelines and recommendations:11 (a) current 
regular mindfulness meditation practice (>once/week); (b) serious medical illness or 
cognitive condition (e.g., dementia) precluding regular class attendance and/or 
participation; (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. Additionally, we will be asking participants randomized to the control 
group to restrain from engaging in any type of formal mindfulness practice more than 
weekly during the first six months of study involvement so as to not introduce 
confounding variables.  Individuals will be made aware of this requirement at the time 
of informed consent (first in-person screening). Anyone who is unwilling to follow the 
treatement requirement would be ineligible for the study.  
4.3 
Study Enrollment Procedures  
Participants will be recruited in part through cardiology and family practices via 
established relationships with physicians in Rhode Island and Massachusetts. 
Graduates from the MP-BP program have proven effective at recruiting their 
contacts. Furthermore, advertisements will be posted throughout Rhode Island and 
southern Massachusetts, and distributed via social media, inviting participants 
interested in lowering their blood pressure to enroll. Additionally, we will partner with 
local providers to recruit hypertensive patients through methods such as direct 
mailings and targeted recruitment at the Rhode Island Hospital Emergency 
Department.  

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Participants are randomly assigned a participant identifier at the time of screening. 
The key to participant name and identifier is kept in a secure location separate from 
the research data. The outcome of every screener completed is recorded in a 
password protected tracking system and reason for ineligibility is noted. 
Circumstances surrounding situations where eligible participants decline participation 
and cases where participants enroll but later withdraw are also documented in a 
tracking system. 
Informed consent is collected at the time of the first in-person screener. Individuals 
wishing to enroll in the study are provided two copies of the written informed consent 
form which has been approved by the Brown University Institutional Review Board 
(IRB). In addition to allowing the participant time to read over the consent form, 
trained research staff review the important points of consent with each participant. 
The informed consent process is documented. A signed copy of the consent is kept 
on file in a secure location in the research lab separate from study data and a copy is 
offered to the participant to keep with his/her personal records. Due to the nature and 
delivery of the intervention, all participants must be able to read and write in English 
and be able to provide informed consent for their participation. 
5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
MB-BP Intervention Description: This study proposes to customize MBSR to 
participants with prehypertension/hypertension creating an intervention called 
Mindfulness Based Blood Pressure Reduction Study (MB-BP). Specifically, MB-BP is 
based on the standardized MBSR intervention described elsewhere,161-164 and will 
consist of eight 2.5-hour weekly group sessions, a 2.5 hour orientation, and an 8-
hour one-day session. MB-BP will be performed by qualified or certified MBSR 
instructors190 with formal training in cardiovascular health (e.g. dietician, physician 
assistant, health and wellness coach, and those with an Associate’s or Bachelor’s 
degree in relevant health sciences), and further certification in MB-BP. MB-BP 
instructor training involves: (1) An initial 40 hour in-person or online videoconference 
training where the unique elements of MB-BP are introduced. (2) Two half-day in-
person training retreats where MB-BP-specific teaching modules are practiced in 
peer groups, supervised by the senior MB-BP trainer, with peer and trainer feedback. 
(3) Studying specific evidence-based articles on hypertension etiology, treatment and 
prevention, as well as articles synthesizing evidence of mindfulness on hypertension 
and hypertension risk factors. 10,183,191-193 A written exam evaluates knowledge in this 
area, for which instructors-in-training need to pass. (4) Supervised teaching of MB-
BP in non-study participants is done using the Mindfulness-Based Intervention 
Teacher Assessment Criteria (MBI-TAC), 1,2,194 and an annotated MB-BP Curriculum 
Guide until adequate quality is established within predefined criteria.  
The unique areas of MB-BP are 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 Curriculum Guide has been created based on the 
standardized MBSR manual developed at UMass Medical School (Appendix 
B).163,164 MB-BP 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 

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practicing skills for ≥45 min/day, 6 days/week. All MB-BP classes are to be held in 
either University or community-based locations in a comfortable, accessible 
environment where privacy is able to be maintained. 
 
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, during eating, and in the time 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. 
 
5.2 
Handling of Study Interventions  
Please see Appendices A and B for the MBSR and MB-BP curriculum guides. 
5.3 
Concomitant Interventions  
Please see inclusion/exclusion criteria in Sections 4.1 and 4.2.  
5.4 
Adherence Assessment  
Adherence to the prescribed MB-BP practices will be monitored through class 
attendance, practice logs and weekly health goals. Adherence data will be collected 
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technologically enhanced forms of meditation logs (e.g. accelerometer-based 
ecological momentary assessment and actigraphy score; NCT01314378), and found 
large proportions of participants had difficulty using the device properly (e.g. failing to 
stop meditation timers), which hampered data quality (paper in progress). We 
discussed this issue with leading meditation researchers, and meditation logs remain 
their recommended method at this time. However, innovative approaches are being 
explored by Dr. Lazar, including smartphone apps linked to audio homework files, 
with timers linked to data exports. These technologies are not yet ready for use, but 
we will incorporate technological advances for homework monitoring once 
demonstrated to be effective. Data analyses will evaluate effect modification by 
adherence to the MB-BP practices.  
 
 

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6. STUDY PROCEDURES 
6.1 
Schedule of Evaluations 
  
Assessment Times 
Variables Measured 
Baseline 10 weeks 
6 months 
1 year* 
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 
X 
Anti-Hypertensive Medication Adherence 
X 
X 
X 
Blood pressure 
X 
X 
X 
X 
Anthropometry 
X 
X 
X 
X 
Physical Activity 
X 
X 
X 
Diet  
X 
X 
X 
X 
Alcohol consumption 
X 
X 
X 
X 
Cigarette Smoking 
X 
X 
X 
Sleep Duration 
X 
X 
X 
X 
Mindfulness 
X 
X 
X 
Mindfulness home practice 
X 
X 
X 
X 
Emotional Eating  
X 
X 
X 
Self-Compassion 
X 
X 
X 
Perceived Stress 
X 
X 
X 
Emotional Regulation 
X 
X 
X 
X 
Interoception 
X 
X 
X 
X 
Heartbeat Detection 
X 
X 
X 
 
Decentering 
X 
X 
X 
Attention Control  
X 
X 
X 
Craving for Hypertensive Risk Factors 
X 
X 
X 
Social Integration 
X 
X 
X 
Loneliness 
X 
X 
X 
 
PROMIS Global Health 
X 
X 
X 
 
Self-Control 
X 
X 
X 
Resilience 
X 
X 
X 
 
Self-efficacy for managing chronic disease 
X 
X 
X 
 
Stress Reactivity 
X 
X 
X 
Delay Discounting 
X 
X 
X 
 
Semi-structured exit interviews at 6 months 
 
 
X 
 
*1-year assessments consist of a subset of the other two follow ups and will be completed only with 
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6.2 
Description of Evaluations  
6.2.1 Screening Evaluation and Consenting Procedure 
Please see Appendices C and D for the consenting process prior to the phone 
screening, and prior to the in-person screening.  
Final screening evaluations will occur at least one week prior to baseline 
assessments. Baseline assessments will occur within 4 weeks of intervention 
initiation.  
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 is elevated (≥120 mmHg systolic and/or ≥80 
mmHg diastolic pressure), 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 or ≥80 mmHg diastolic pressure, they will be invited to 
participate in the study.  
6.2.2 Enrollment 
The enrollment date is the day that the individual has met all the screening criteria, 
signs the informed consent form, and confirms agreement to participate in the study. 
6.2.3 Baseline Assessments 
(1) Demographics: age, race/ethnicity, socioeconomic status (education, 
employment), and household structure.  
(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 Childhood 
Trauma Questionnaire (CTQ), Childhood food insecurity questionnaire, and the 
Childhood Experiences of Care and Abuse Inventory neglect subscale. 184,195-200 
(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.201 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.202 
(6) Anxiety: Assessed using the validated Beck Anxiety Inventory.203-209 
(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 continuously using electronic 
medication bottle caps (eCAPS, Ottawa, Canada).185  

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(9) Systolic and diastolic blood pressure: Clinical blood pressure will be measured 
using a calibrated Omron HEM-705CPN following American Heart Association 
and Joint National Committee (JNC) guidelines.183,210,211 Additionally, 
participants will be asked to complete three at home blood pressure readings 
using a validated home blood pressure monitor (Omron, Model PB786N) 
provided at baseline.  
(10) Anthropometry: height and weight directly assessed using standard 
epidemiologic methods.186  
(11) Physical activity:  The International Physical Activity Questionnaire which has 
undergone substantial validity and reliability testing.187-189 Adherence to Joint 
National Commission-7 (JNC-7) guidelines is 30 min aerobic physical activity ≥4 
days per week.183  
(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.182 
(13) Alcohol consumption: additional self-report standardized questions assessing 
current alcohol consumption taken from the Behavioral Risk Factor Surveillance 
Survey (BRFSS).212 
(14) Cigarette smoking: current smoking assessed using self-report standardized 
questions from the New England Family Study.  
(15) Sleep duration: Sleep duration is assessed using a single question on sleep 
duration from the validated Pittsburgh Sleep Quality Index (PSQI).213-215 
(16) Mindfulness: Assessed using the validated Five Facet Mindfulness 
Questionnaire.216 
(17) Mindfulness Home Practice: questions capturing individuals at home 
mindfulness practice pre- and post- intervention are administered at each of the 
time points.  
(18) Emotional eating: measured using the Three Factor Eating Questionnaire 
Revised 21-item (TFEQ-R21).217,218 
(19) Self-compassion: Assessed using the validated Self-Compassion Scale Short 
Form (SCS-SF).121  
(20) Perceived stress: Assessed using the validated 14-item Perceived Stress 
Scale.219,220 
(21) Emotion regulation: Measured using the validated Difficulties in Emotion 
Regulation Scale.221  
(22) Interoception: Assessed directly using the Heartbeat Detection Task and in 
secondary self-report using the validated Multidimensional Assessment of 
Interoceptive Awareness (MAIA).222-225 
(23) Decentering: Assessed using the validated Experiences Questionnaire.226,227 
(24) Attention control: Assessed using the Sustained Attention to Response Task 
(SART). The SART is a validated computerized test of sustained attention, 
response inhibition (executive function) and self-regulation.228-230 231-233  
(25) Craving: craving for hypertension risk factors, including palatable foods, alcohol, 
and sedentary activities will be assessed using the validated Craving 
Experiences Questionnaire. 234 
(26) Social integration: Measured using the validated 12-item Interpersonal Support 
Evaluation List (ISEL-12) measure of social support.235 
(27) Loneliness: Assessed using the validated R-UCLA Loneliness Scale.236  
(28) Global Health: individual physical, mental and social health are measured using 
the validated NIH PROMIS Global Health v1.2 scale.237 

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(29) Self-control: assessed using the validated Self-Control Scale short form.238,239 
(30) Resilience: measured using the validated 10-item Connor-Davidson Resilience 
Scale (CD-RISC-10).240 
(31) Self-efficacy for chronic disease management: measured using the 6-item Self-
efficacy for Managing Chronic Disease scale (SECD-6).241 
(32) Stress Reactivity: Assessed using the Pittsburg Stress Battery a standardized 
protocol of 3 computerized tasks designed to induce a stress response indicated 
by evaluated cardiovascular (CV) reactivity.242 
(33) Delayed Discounting: Assessed using the validated 5-Trial Adjusting Delay 
Discounting Task. 243 
(34) Functional Magnetic Resonance Imaging (fMRI): Participants in the UH3 phase 
who elect to take part in the fMRI imaging study will undergo an fMRI scanning 
session for approximately 40 minutes at baseline and 10-week follow-up. Scans 
will be acquired with a 3T scanner while the subject is in the resting state. Final 
sample size will be 24 per group (n=48); enrolling up to 60 participants in total to 
reach target sample size. Participants will undergo a separate informed consent 
and screening process for the fMRI imaging, so that they can be in the MB-BP 
study without imaging if they prefer. Refer to the separate fMRI study protocol 
for details.  
 
6.2.4 Randomization and Intervention Allocation 
Randomization will occur following the completion of baseline assessments prior to 
the initiation of study intervention. Only individuals who complete the baseline 
assessments and indicate they are available for the upcoming courses will be 
included in the randomization process. 
Stratified randomization will be used, as simple randomization can fail if it creates 
groups unbalanced for critical features known to affect outcomes.7,8 Stratified 
randomization can reduce both types I and II error, improve trial efficiency, and 
facilitate subgroup and interim analyses.7 Variables used to create strata include age 
(≤60 vs. >60 years), gender (male vs. female), and/or uncontrolled hypertension 
(≥140 mmHg systolic pressure, or ≥90 mmHg diastolic pressure) vs. prehypertension 
(120 to <140 mmHg systolic pressure, and 80 to <90 mmHg diastolic pressure). 
Simple random sampling will occur within each of the eight strata, thus allowing for 
each arm of the study to be more balanced with respect to age, gender, and 
hypertension category. The total size of each stratum will vary from cohort to cohort. 
To conduct the randomization, a list of participant IDs and strata characteristics will 
be provided, and a trained researcher not affiliated with the study will perform the 
randomization on participants after baseline assessment and final determination of 
eligibility is complete. Randomization will be done using an online computer software 
program known as Research Randomizer (Version 4.0).9 The randomization process 
will occur after each new round of enrollment (i.e., unique cohort). If the cohort 
sample size is such that there are not enough participants for balance within the 
three strata, we will prioritize stratification by two key strata instead of three, 
specifically by baseline blood pressure status and gender. Furthermore, after 
randomization within strata, if sample sizes in the entire sample for cohort differ by 
more than one participant per group, then all imbalanced groups are re-randomized 
until the entire sample differs by no more than 1 participant per group (e.g. n=8 MB-
BP, n=9 enhanced usual care control). Expected cohort sizes, consistent with the 

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SARP are 15-20 participants. We anticipate needing to run 6 to 7 cohorts to reach 
the target sample size. 
 
Study enrollment will continue until target enrollment goals are reached (i.e., n=50 for 
MBBP intervention group and n=50 for enhanced usual care control group).   
 
6.2.5 Blinding  
All study staff will be blinded to the participant treatment allocation with the exception 
of the instructor, individual who performs the randomization, and staff member 
coordinating participants within each course. All staff performing participant 
assessments will be blinded to the participant treatment allocation to promote 
equipoise. Data analyses will be performed by a statistician blinded to treatment 
allocation type. The data manager will be able to break blinding if needed (e.g. for 
Data and Safety Monitoring Board). Circumstances for breaking the blind would be a 
large number of adverse experiences (>10% of enrolled participants reporting AEs 
rated as severe or life threatening) taking place in one or more study group. In this 
case, the data safety monitoring board would be notified, and could break the blind to 
help determine the cause of the adverse experiences.  
 
6.2.6 Follow-up Visits 
Follow-up assessments will be scheduled and conducted within the pre-defined 
assessment windows outlined previously in section 3, study design. 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 and documented at each of the follow-up periods as well as throughout 
the duration of an individual’s study involvement according to the data safety 
monitoring protocol put forth in this grant. Participants are also asked a set of semi-
structured questions at the end of their six month follow up that inquire about their 
experience as either a control group member or intervention group participant.   
 
6.2.7 Completion/Final Evaluation 
For control group participants, the 6-month evaluation is the final visit. Upon 
completion of this assessment, they will be eligible to participate in the MB-BP 
training. Individuals in the intervention group will be assessed at 1 year follow up with 
a subset of measures (see Table 6.1 Schedule of Evaluation) in order to assess long 
term effects of the intervention. 
7. SAFETY ASSESSMENTS  
7.1 Expected Risks and Specification of Safety Parameters 
Meditation-related risks: NCCIH states that meditation is generally safe for healthy people, but 
that adverse effects have also been reported. 5 Undesirable side effects and risks of meditation 
have been documented in more than 40 scientific reports [for reviews see 6-8] and are listed in 
the Mindfulness-Based Intervention Guidelines.9,10 More common, less serious side effects that 

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have been reported by individuals within the context of MBIs or of individuals who are 
meditating less than an hour per day include: increased depression, anxiety or panic, re-
experiencing of traumatic memories, dissociation, executive dysfunction, headaches/body pain 
and insomnia.6,11-16 A few case reports of more serious side effects including mania, psychosis, 
and suicidality have been reported, mostly in the contexts of intensive retreats (>5 hrs/day) or in 
conjunction with pre-existing psychopathology.6,8,9,17 The frequency of serious adverse effects in 
the context of MBIs is estimated to be less than 1%, although adequate estimates are not 
available.18 
 
A number of actions have been taken to minimize meditation-related risks at different stages of 
the study. During the pre-enrollment stage, individuals with severe mental illness are excluded 
from the study and all risks are clearly communicated in the consent form. During treatment, 
meditations are relatively short and interspersed with dyads and reflections. Mindfulness 
homework assigned as part of the intervention is optional and is recommended to not exceed 1 
hour per day. Teachers query participants about their experiences with meditation, and provide 
corrective feedback or modifications when needed. Developing strategies for working with 
physical and emotional discomfort is an explicit goal of the program. Because not all participants 
feel comfortable disclosing difficulties in class, an online “safety check-in” questionnaire will 
query meditation-related risks (see section 6.2.1). Dr. Ellen Flynn, a licensed psychiatrist, will be 
available to advise on any psychological events that occur, and provide referrals for treatment if 
needed. Additionally, Dr. Willoughby Britton will provide expert consult on safety monitoring and 
reporting, including providing DSMP specific training to research staff and investigators. 
 
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 asked during the in-person and online questionnaires 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 MB-BP 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.”244 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 using 
deidentifying data sets.  All paper forms and data collection tools, including the informed 
consent forms, will be kept in a locked filing cabinet in a secure location. All electronic data files 
containing identifying information will be encrypted with a cloud-based software.  Note that 
although these measures have been taken to protect participants’ personal information, 
complete confidentiality cannot be guaranteed when transmitting information over the internet. 
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 encouraging exploration of physical activity as a way to reduce blood pressure. (1) 
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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: The fMRI study will be conducted using 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, but instead uses 
strong magnetic fields and radio waves. Individuals interested in participating in the fMRI study 
will complete a screening questionnaire to assess eligibility, including asking whether they have 
devices that can be affected by MRI or conditions (e.g., claustrophobia, body mass greater than 
300 lbs.) that prohibit the ability to be scanned. Participants are screened immediately prior to 
each MRI scan to ensure participant safety. 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 schizophrenia, history of psychosis, bipolar depression, suicidal 
ideation, borderline personality disorder, post-traumatic stress disorder, obsessive compulsive 
disorder, panic attacks, current alcohol or substance abuse, or an eating disorder are ineligible 
for the study. We expect risk of adverse events to be very low. For further discussion of AE and 
SAE monitoring and reporting refer to Section 6.2 below. 
 
Impact statement: These risks are considered to be minimal and are addressed in the protocol 
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7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
Safety monitoring will occur continuously throughout the study using both active and passive 
monitoring methods outlined and discussed in further detail below. All reported AEs, SAEs, and 
unanticipated problems will be recorded throughout the study using the data collection systems 
set up and detailed in the Data and Safety Monitoring Plan (DSMP) 
The research staff will record all reportable events with start dates occurring any time after 
informed consent is obtained but no later than the final 1-year assessment. At each study visit, 
the research staff will inquire about the occurrence of AE/SAEs since the last visit (or time of 
most recent reporting).  Events will be followed for outcome information until resolution or 
stabilization or until the grant funding ends. 
 
7.3 Adverse Events and Serious Adverse Events, Reporting Procedures, and 
Follow-up 
An adverse event (AE) is generally defined as any unfavorable and unintended diagnosis, 
symptom, sign (including an abnormal laboratory finding), syndrome or disease which either 
occurs during the study, having been absent at baseline, or if present at baseline, appears to 
worsen.  A serious adverse event (SAE) is generally defined as any untoward medical 
occurrence that results in death, is life threatening, requires inpatient hospitalization or 
prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or 
is a congenital anomaly. 
 
Per NCCIH safety monitoring requirements, all AEs and SAEs captured and/or observed 
involving enrolled study participants will be recorded regardless of their relationship to the study 
intervention. Below we outline possible AEs and SAEs that may occur related to this research 
study and intervention; present our procedures for capturing and recoding; and detail the 
protocol for follow up of AEs. For further discussion of the procedures related to safety 
monitoring and follow up procedures refer to Section 7.4. Safety Monitoring. 
 
Safety Check-ins: All participants enrolled in the study, regardless of treatment allocation, will 
receive a two-tiered safety monitoring ‘check-in’ every 2 weeks during the treatment phase of 
the study; every month during months 3-6 of the follow-up phase; and at the final 1-year time 
point. The two-tiered system is designed to detect and follow up on AEs that are at least 
moderate in severity (interfere with ADL), and to minimize staff and participant burden that 
would otherwise occur if all mild events were queried and documented. 
 
Tier 1 of the safety check-in involves sending all active, enrolled participants an email (or 
placing a phone call from a research staff member, if no email provided) containing a link to a 
brief online survey that queries events with moderate or greater levels of severity. Any 
participant who endorses one or more tier 1 questions will automatically receive a tier 2 survey 
and follow-up phone call from study staff. 
 
The Tier 2 survey specifically queries the most common meditation-related side effects (e.g. 
anxiety, depression, dissociation, flashbacks etc.) using patient-reported outcomes 
measurement information system (PROMIS) or NeuroQol items (or other validated scales if 
construct is not available), and PROMIS response options (never- very often). 
 

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Additionally, the tier 2 survey will ask participants to provide further detail (i.e., date of onset, 
symptomology, circumstance surrounding the event, relatedness to the intervention, etc.) 
regarding the AE/SAE reported in the tier 1 survey. Detail provided will be used to guide the tier 
2 phone calls made by research study staff. 
 
Tier 2 Safety Check-in phone call: Any participant who indicates that he or she experienced an 
AE or SAE will then receive a follow up call from a trained research staff member. The purpose 
of the follow up call will be to further document the details of the AE/SAE, assess need for 
treatment modification, referrals and reporting. 
 
Research staff members conducting the safety monitoring phone interviews will document the 
details of the AE/SAE using the Adverse Events Form, which will then be included in the 
participant file as well as in the annual Data Safety Monitoring Reports presented to the DSMB.  
Reporting procedures for AEs and SAEs related to the study will be followed including reporting 
all SAEs to the study PI and DSMB committee chair. 
 
7.3.1 Mental Health 
Participants assigned to any treatment group may experience mental health or suicidal ideation 
during the course of their study involvement. All study participants will be monitored for AEs and 
SAEs by study staff on a monthly basis until the time of their study completion.  Additionally, 
participants will be asked to complete questionnaires about anxiety, depression and suicidal 
ideation, specifically the Beck Anxiety Inventory and the Center for Epidemiology Study 
Depression Scale Revised (CESD-R), at each of their in-person assessments, excluding the 
one year follow up. Dr. Flynn, a licensed psychiatrist with extensive experience evaluating 
research participants for clinical deterioration or suicidality, will serve as the study clinician.  
Beck Anxiety Inventory (BA): If participant scores ≥26 on the Beck Anxiety Inventory, a safety 
flag will appear notifying the research assistant (RA) administering the assessment. The RA will 
then implement the MB-BP safety protocol, which is reviewed and approved by the Brown 
University IRB. Staff are trained on the safety protocol and a hard copy of the protocol is kept in 
an accessible location in the assessment office at all times. 
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 
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assistant (RA) administering the assessment. The RA will then implement the MB-BP safety 
protocol, which is reviewed and approved by the Brown University IRB. Staff are trained on the 
safety protocol and a hard copy of the protocol is kept in an accessible location in the 
assessment office at all times. 
 
If participants respond having any suicidal ideation (CES-D questions 14 or 15), staff will again 
be instructed to follow the IRB approved safety protocol. 
 
7.3.2 Physical Health 
Possible atrial fibrillation detected during Heartbeat Detection Task: If possible atrial fibrillation is 
indicated by the Kardia Mobile device during the “Heart Beat Detection Task” a safety flag will 
appear notifying the research assistant (RA) administering the assessment. The RA will then 
implement the MB-BP safety protocol.  
 
Out-of-range blood pressure readings: If during an in-person assessment the participants 
systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) falls outside of the 
acceptable range outlined in the safety protocol, the RA will be notified and the IRB approved 
safety protocol will be implemented.   
 
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.  
 
Note that adverse events related to physical injuries will be captured during the routine safety 
check-ins (discussed above). 
 
7.3.3 Other 
Participant Initiated (Passive monitoring): Participants are encouraged to contact meditation 
instructors and/or study staff if any physical or mental health symptoms arise or other study or 
meditation-related problems occur. Participants may report AEs at any time throughout the 
study. Events will be evaluated with the Adverse Events Form by study staff. 

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Attrition:  Reasons for attrition are also an important source of AEs, but are rarely assessed 
adequately, as participants are unlikely to give honest answers if queried directly by study staff. 
To increase the accuracy of attrition reason reporting, participants will be asked to complete a 
brief online Participant-initiated dropout reason survey (see Appendix A7). 
Investigator-initiated withdrawals: In rare circumstances, a study participant may be withdrawn 
from the study and/or intervention by the researcher. In this case, the researcher or other study 
staff should complete the Attrition information form, and describe reasons for attrition. Note, 
however, that this scenario would be very unusual, and has not happened once in the in the 
approximately 130 participants who have gone through the MP-BP study to date. Potential 
reasons for investigator-initiated withdrawal would be MB-BP classroom or assessment 
disruption in ways that are causing harm or an unsafe environment for other classroom 
participants, the instructor, or study staff. The screening questionnaire excludes participants 
with mental health criteria that puts them at higher risk for disruption. We expect this scenario to 
occur extremely rarely (as evidenced to date), but remains a possibility. 
fMRI Study Safety Monitoring: it is possible participants may experience or report an AE or SAE 
during their involvement with the fMRI Study. Research staff will use the Adverse Events Form 
and accompanying documents found in the Appendices to document all AE/SAE discovered at 
the time of involvement in the fMRI imaging study. The logged events will then be 
communicated to the Coordinating Center, so that they can be included in the participant file as 
well as in the annual Data and Safety Monitoring Reports presented to the DSMB.  Reporting 
procedures for AEs and SAEs related to the study will be followed including reporting all SAEs 
to the study PI and DSMB committee chair. 
 
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. 
 
The data collection systems we have set up to monitor and record AEs and SAEs are 
specifically designed to avoid double capture. Unique participant identifiers, dates and details 
surrounding events, as well as steps taken to follow up are recorded. 
 
7.4 Safety Monitoring 
Oversight of internal monitoring of the participants’ safety will be conducted by the local PI, Dr. 
Eric Loucks. 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 (Choudhary), psychology/psychiatry (Edmondson), epidemiology (Choudhary), 
and biostatistics (Liu).  
 
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 investigator (Dr. Loucks) and the Brown University IRB. The Data 
Safety Monitoring Committee will provide external monitoring, and will meet annually by phone, 
video conference, or in-person. They will be provided data annually in order 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 investigator (Loucks) and the 
committee chair. 
 

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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 intention 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 as they 
are documented by the study staff in accordance with the protocol (Please see section 7.3). 
Participants will be given contact information so that they can inform us of events that occur in 
between study visits. The PI will meet with staff weekly as schedules allow to review participant 
progress and to check in about the experiences with the experimental procedures, including 
adverse events. Any adverse events that are observed and/or reported will be reported to Dr. 
Loucks and the Data Safety Monitoring Committee chair under the proposed timelines in the 
DSMP. The Investigators and DSMB members will be available to meet outside of the regularly 
scheduled meetings (scheduled annually), 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 related to the study are then reported to the Brown University IRB and to NIH. 
Brown University’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 related to the study will also be reported in writing to 
the NIH Project Officer within 48 hours of the PI becoming aware. All serious adverse events 
related to the study will be reported annually in the Progress Report sent to the NIH Project 
Officer. Data on all AEs and SAEs will be recorded.  
 
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 approved in writing by both the Brown University IRB as well as by the funding agency, 
NCCIH. 

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8. INTERVENTION DISCONTINUATION  
This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the study endpoints; (3) 
any new information becomes available during the trial that necessitates stopping the trial.  
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design  
Analyses will evaluate (1) whether MB-BP influences self-regulation targets, (2) whether the 
MB-BP-induced changes in self-regulation targets are associated with changes in medical 
regimen adherence, and (3) whether MB-BP is associated with medical regimen adherence. 
Analyses will incorporate generalized linear models (GLM) with properly chosen link 
functions, performed using generalized estimating equations (GEE) with robust standard 
error estimators.245,246 This provides an extension of regression analysis to the case of 
correlated or repeated observations, allows for inclusion of both continuous and discrete 
dependent variables, and enables modeling of covariance structures when observations are 
correlated across time. Following “intention-to-treat” principles, analyses will be conducted 
on all participants in the randomized controlled trial, regardless of intervention completion. 
Analyses will use GLM with identity links for normally distributed data. The between-groups 
independent variable in the GEE analysis is intervention condition, with control conditions as 
distinct referent groups. Categorical variables will be included in GLM/GEE models as 
indicator variables with one level chosen as referent. Continuous independent variables 
such as age and baseline blood pressure would be included as linear terms. In addition, we 
will include assessment time as a linear term and possibly with an additional quadratic term 
to capture possible non-linear relationship of time with the outcomes. It is conceivable that 
one would observe a steeper slope in the initial months that would decrease in the pursuing 
months. Thus, the use of a quadratic term for assessment time would be able to capture 
these phenomena. To evaluate self-regulation targets as mediators of the effects of MB-BP 
on medical regimen adherence, mediation analyses described by Valeri and VanderWeele 
will be employed.247 Such analyses will allow for potential interactions between the exposure 
and mediator of interest and account for potential confounders of the exposure-mediator, 
mediator-outcome, and exposure-outcome relationships using standard regression 
techniques. These methods estimate total, indirect and direct effect sizes, as well as 
statistical variance.247 
9.2 
Sample Size and Randomization 
Treatment Assignment Procedures 
Statistical Power: 
Utilizing effect sizes and statistical variance from the Stage 1 MB-BP clinical trial showed an 
increase of MAIA from baseline of mean 22.6 (SD=6.5) to mean 26.3 (SD=6.0) at 6-month 
follow-up, demonstrating a 3.7 increase in MAIA score (p<0.001). Power analyses using the 
T statistic and non-centrality parameter, with alpha (two-tailed) set at 0.05 and beta at 0.2, 
shows with a MAIA increase of 3.7 in MB-BP vs. control, sample size requirements are 46 
per group. With DASH diet score increasing from 2.78 (SD=0.61) at baseline to 3.37 
(SD=0.81) at 6-month follow-up in the Stage 1 MB-BP study in the 67% of participants with a 
low DASH score (<5.5), demonstrating a DASH diet score increase of 0.59 (p<0.001). Using 
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suggest that, with alpha (two-tailed) set at 0.05 and beta at 0.2, a sample size of 33 per 
group will be sufficient.  
 
Using simulations from Fritz and MacKinnon,248 for 80% power to detect a mediated effect 
when effect of exposure on mediator, and mediator on outcome, is of small to medium 
strength (standardized Cohen’s d effect sizes of 0.26-0.39 each), based on Sobel first-order 
test, we will need 90 participants. Given that 67% of Stage 1 participants had DASH diet 
score <5.5, recruiting a sample size of 160 participants across the UH2 and UH3 phases 
(Figure 1), this would allow for 107 participants with low DASH diet to be included in primary 
mediation analyses with DASH diet score as the outcome. Stage 1 effect sizes on DASH 
diet score were large Cohen’s d (d=0.82). Effect sizes on the primary self-regulation 
outcome was medium (MAIA Cohen’s d=0.59). Assuming associations between the MAIA 
and DASH diet score are in the small to medium range, the study should be adequately 
powered for mediation analyses. Please note that Stage 1 analyses also demonstrated 
significant improvements in other health behaviors, including alcohol consumption and 
physical activity following the MB-BP intervention. Secondary analyses will evaluate impacts 
of MB-BP on these health behaviors, but are not adequately powered for mediation 
analyses due to the lower proportion of participants that do not adhere to these behavioral 
AHA guidelines (i.e. approximately 15% of participants do not comply to AHA alcohol 
guidelines, and 32% do not adhere to physical activity guidelines in our Stage 1 sample).  
 
The fMRI imaging analyses (n=24 per group) should be adequately powered, based on 
power calculations shown in the MINDFUL-PC study below and by power calculations 
outlined in the fMRI study protocol and MOP. To achieve this, we estimate having to enroll 
up to 60 eligible study participants into the fMRI study.  
 
For fMRI self-regulation neural targets, resting State Functional Connectivity (rs-FC) will be 
expressed as correlation coefficients, transformed using Fisher’s z-transformation for 
analysis. rs-FC will be obtained at two time points (baseline: T1; post-training: T2) for 
participants and controls. We will use a mixed effects model with baseline rs-FC as an 
additional predictor for the change outcome. There are two elements to the hypotheses – 
the determination of the significance of the change within group and the comparison of the 
change in the treatment group compared to the control group. For the comparison in change 
between treatment and control group, with a mixed analysis of variance (within-subjects rs-
FC at T1 and T2, and between-subjects according to intervention; sample size, total n = 48, 
24/group), we are able to detect an ES of 0.3 between the two treatment groups with 81.3% 
power (and an ES of .21 with 81.3% power for within-group mindfulness effect; an ES of 
0.23 with 87.7% power for an interaction of treatment and time), with two-sided tests at 
alpha=0.05. Thus is reasonable power to detect small- to moderate-size differences in 
BOLD.249  
 
Our calculations assume drop-out rates will average around 10-15% across each group, 
with the control group exhibiting the highest rates of withdrawal and loss to follow up. These 
estimates are based on the Stage 1 and 2a MB-BP trials in the UH2 phase. 
 
Randomization procedure: Please see Section 3 (study design) above. 
Blinding protocol: Please see Section 3 (study design) above.  

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9.3  
Definition of Populations 
Please see Section 9.1 for Intention-To-Treat analysis approach. 
9.4 
Interim Analyses and Stopping Rules 
Please see Section 8 for stopping rules and related analyses. 
9.5 
Outcomes  
9.5.1 Primary Outcome  
Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive 
Awareness (MAIA), a validated measure of body awareness.222-224 We hypothesize 
that MB-BP will significantly improve the MAIA in directions of better self-regulation, 
compared to control. 
 
 
9.5.2 Secondary Outcomes 
Self-regulation outcomes foster triangulation, including further validated measures of 
interoceptive awareness (Heartbeat Detection Task,250,251 Interoceptive Awareness 
fMRI Task252-254), stress and emotion regulation (Difficulties in Emotion Regulation 
Scale,221 Pittsburgh Stress Battery,255-259 Perceived Stress Scale,219,220 Beck Anxiety 
Inventory,203-209  CESD-R201,202), attention control (Sustained Attention to Response 
Task,228-233), self-compassion (Self-Compassion Scale Short Form121), and self-
efficacy (Self control scale and SECD-6 Scale260-267). 
 
Medical regimen adherence outcome: Diet, assessed utilizing Dietary Approaches to 
Stop Hypertension (DASH) eating pattern score,181 measured via diet history food 
frequency questionnaire.182 The measure assesses adherence to JNC-7 guidelines 
DASH eating pattern score (range 0-8).181,183   
 
Medical regimen adherence secondary outcomes: (1) Alcohol consumption: Amount 
and frequency of alcohol consumption, will be assessed via self-report utilizing 
standard questions from the behavioral Risk Factor Surveillance Survey.184  
AHA/ACC hypertension clinical practice guideline 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.10 Medical regimen adherence will be defined as 
adherence to JNC-7-recommended behavioral and medication treatment of 
hypertension.183 (2) Electronically-Measured Antihypertensive Medication 
Adherence: measured continuously using electronic medication bottle caps (eCAPS, 
Ottawa, Canada)185 (3) Body Mass Index: height and weight directly assessed using 
standard epidemiologic methods, with change evaluated in participants considered 
overweight or obese (BMI≥25 kg/m2).186 (4) Physical activity: We will use the 
International Physical Activity Questionnaire which has undergone substantial validity 
and reliability testing.187-189 Adherence to Joint National Commission-7 (JNC-7) 
guidelines is 30 min aerobic physical activity ≥4 days per week.183  
 
9.6 
Data Analyses  
Please see Section 9.1 for analytic approach. 

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10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
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 
within the defined assessment windows, 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 (described in Section 6.2.2) to allow for a safety protocol to be 
followed if there are high levels of depression, anxiety or suicidal ideation. In the event that 
participants are uncomfortable or unable to use a computer for tests data will be collected 
using hard copies of surveys and entered by a trained member of the research staff.  
Assessments of blood pressure, height, weight, 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 held by the 
Project Coordinator and used for the purposes of contacting participants. The principal 
investigator will only be given access to identifiable personal information for the purposes of 
patient safety or monitoring by the NIH, data safety monitoring boards or HIPPA compliance 
officer approved agents. 
10.2 Data Management  
Data management will be performed by downloading data at minimum every 2 weeks during 
active 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.  
Please see Section 10.1 for data collection forms description.  
10.3 Quality Assurance  
10.3.1 Training 
Describe types and mechanisms of training of staff for the study. 
Please see Appendices E and F for manuals to perform staff training for 
assessments. Only trained, experienced, culturally competent interviewers will be 
hired to perform assessments.  
10.3.2 Quality Control Committee 
There is no formal quality control committee. 
 
10.3.3 Metrics 
Please see Appendices E and F for quality control metrics of blood pressure and 
anthropometry assessments.  
MB-BP 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 

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of treatment skills,268 as follows. Study design: All session durations will be recorded 
and any deviations from the planned duration will be documented.  All class sessions 
will be taped (as conditions allow). Audiotapes will undergo a quality assessment 
audit by research technicians, who will review a ten percent randomly selected 
sample of the recordings. Research staff completing the audit will conduct 
competency ratings on these tapes using validated adherence scales (MBCT 
Adherence Scale, where items 1-11 in the scale are for MBSR, MB-BP and 
MBCT269). Data from the audit will be used to 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 MB-BP instructors in the event that specific instructors no longer 
teach classes. Instructor attrition will be tracked.  
Provider training: MB-BP will be performed by qualified or certified MBSR 
instructors191 with formal training in cardiovascular health (e.g. dietician, physician 
assistant, health and wellness coach, and those with an Associate’s or Bachelor’s 
degree in relevant health sciences), and further certification in MB-BP. MB-BP 
instructor training involves: (1) An initial 40 hour in-person or online videoconference 
training where the unique elements of MB-BP are introduced. (2) Two half-day in-
person training retreats where MB-BP-specific teaching modules are practiced in 
peer groups, supervised by the senior MB-BP trainer, with peer and trainer feedback. 
(3) Studying specific evidence-based articles on hypertension etiology, treatment and 
prevention, as well as articles synthesizing evidence of mindfulness on hypertension 
and hypertension risk factors. 10,183,192-194 A written exam evaluates knowledge in this 
area, for which instructors-in-training need to pass. (4) Supervised teaching of MB-
BP in non-study participants is done using the Mindfulness-Based Intervention 
Teacher Assessment Criteria (MBI-TAC), 1,2,195 and an annotated MB-BP Curriculum 
Guide until adequate quality is established within predefined criteria.  
 
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.191 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 Working Alliance 
Inventory,270 and Therapist Empathy Scale271 at Weeks 4 and 8 of the intervention. 
Feedback will be provided to the interventionist, and measures of warmth and 

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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: Adherence to the prescribed 
MB-BP practices will be monitored through class attendance, practice logs and 
diaries. Adherence data will be collected weekly during the course of the 
intervention. Mindfulness will also be measured through the use of the validated Five 
Facet Mindfulness Questionnaire218 as well as by asking about at home mindfulness 
practices post-intervention.  
 
10.3.4 Protocol Deviations 
Protocol deviations will be reported to the Brown University IRB and NCCIH. A 
description of the deviations, and any effects on the protection of human subjects will 
be documented. Investigator(s) will review protocol deviations and determine on a 
case by case base which data (if any) will be excluded from the final data set.  
10.3.5 Monitoring 
Please see Section 10.3.4. for description of the monitoring approaches.  
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
The protocol, the informed consent document (Appendix D), and any subsequent 
modifications, will be reviewed and approved by the Brown University IRB 
responsible for oversight of the study.  
11.2 Informed Consent Forms 
A signed consent form will be obtained from each participant. The consent form will 
describe the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. A signed copy will be offered to each participant and this 
fact will be documented in the participant’s record.  
11.3 Participant Confidentiality  
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 help by the Project 
Coordinator. All paper-based records (i.e. signed consent forms) will be kept in a 
secure physical location (e.g., locked filing cabinet). All computer entry and 
networking programs will be done using PIDs only. The principal investigator will only 
be given access to identifiable personal information for the purposes of patient safety 
or monitoring by the NIH, data safety monitoring boards or HIPPA compliance officer 
approved agents.  Information will not be released without written permission of the 
participant, except as necessary for monitoring by IRB, the FDA, the NIH, and the 
OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the 
FDA, or other government agencies as part of their duties to ensure that research 

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participants are protected.  
12. COMMITTEES 
Data Safety Monitoring Board: 
Oversight of internal monitoring of the participants’ safety will be conducted by the PI, Dr. Eric 
Loucks. Investigators on this application have extensive experience with clinical trials for 
mindfulness-based interventions and cardiovascular health outcomes. Oversight of the external 
Data and Safety Monitoring Committee will be conducted by the chair, Dr. Donald Edmondson, 
PhD, who 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 
psychosocial factors on cardiovascular disease outcomes, along with clinical trials methods 
expertise. 
 
The Data and Safety Monitoring committee will also include a board-certified cardiologist, Dr. 
Gaurav Choudhary, and a biostatistician, Dr. Tao Liu. Dr. Choudhary, MD, is Associate 
Professor of Medicine at Brown University. He is a practicing clinical cardiologist with research 
in epidemiology and cardiology. He will be able to advise on clinical outcomes and any 
cardiovascular complications arising from the study. Dr. Liu, PhD, is an Associate Professor of 
Biostatistics at Brown University, experienced in clinical trials. 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.  
 
These individuals are not associated with this research project and thus work independently of 
the PI. They are also not part of the key personnel involved in this grant. They are qualified to 
review the patient safety data generated by this study because of their unique expertise in the 
areas of 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 principal investigators (Dr. 
Loucks) 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 phases (phase 3 & 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).  
13. PUBLICATION OF RESEARCH FINDINGS  
Any presentation, abstract, or manuscript will be made available for review by the sponsor and 
the NCCIH prior to submission.  
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15. SUPPLEMENTS/APPENDICES 
Note that minor modifications may be made to the individual documents listed in the appendices 
during the course of the study. 
 
Appendix A 
MB-BP Curriculum Guide 
 
Appendix B 
MBSR Curriculum Guide 
 
Appendix C 
MB-BP Phone Screener (verbal consent process) 
 
Appendix D 
MB-BP Informed Consent 
 
Appendix E 
Anthropometric Quality Control Manual 
 
Appendix F 
Blood Pressure Quality Control Manual