MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home - A Comparative Effectiveness Trial of Chronic Illness Self-Management and Action Plan Initiation Among Primary Care Patients
Phase: NA
Conditions: Depression, Anxiety, Stress Related Disorder, Adjustment Disorders
Sponsor: Cambridge Health Alliance

 
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STUDY PROTOCOL 
 
 
Integrating Mindfulness into the  
Patient-Centered Medical Home 
 (MINDFUL-PC) 
NCT03265600 
 
 
and  
 
Mindfulness Influences on Self-Regulation:   
Mental and Physical Health Implications 
(Mindful Self-Regulation fMRI pilot study) 
NCT02972853 
 
 
Principal Investigator:   
MINDFUL-PC PI: Zev Schuman-Olivier, MD 
Mindful Self-Regulation UH2 CHA Site PI: Zev Schuman-Olivier, MD 
Overall UH2 Collaboration PIs: Eric Loucks, PhD and Willoughby Britton, PhD (Brown 
University); Jean King, PhD (UMASS Medical School) 
 
MINDFUL-PC Supported by:  
Arthur Vining Davis, Arnold P. Gold Foundation, CHA/HMS Department of Psychiatry, 
Cambridge Health Alliance 
 
The Mindful Self-Regulation experimental fMRI pilot study is supported by:  
National Center for Complementary and Integrative Health through grant “Mindfulness 
Influences on Self-Regulation: Mental and Physical Health Implications” (UH2AT009145) 
 
This protocol integrates funding from multiple sources. All protocol elements that derive 
from NCCIH funding are represented in blue text throughout the protocol. 
 
Dated: June 27, 2018 
 
 

 
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NCCIH protocol template 
Version 1.3 (Submitted 7/21/16) 
 
Revisions made: 
 
Version Number: 1.1 
Version Date: 1/08/2016 
1. Clarified language about group termination and assessment completion (section C.3.h.) 
(1/8/2016). 
 
Version 1.2: 
Version Date: 05/11/2016  
2. Changed order of DSMP sections, to create more logical flow (sections D, and separate 
DSMP document.) (05/11/2016). 
3. Changed goals related to recruitment numbers for patients and PCP (A.2.b., C.2., D.3.b.) 
(05/11/2016). 
4. Adjusted Patient screening, inclusion/exclusion, and scheduling procedures for 
MINDFUL-PC participants (C.3.b.) (05/11/2016). 
5. Adjusted dates in Implementation Staging Map (C.4.b., and Table 4. MTPC 
Implementation Schedule) (05/11/2016). 
6. Adjusted Study flow schema for Patient participants (Figure 1b.) (05/11/2016). 
7. Removed plans for Haitian-Creole MINDFUL-PC groups (C.3.d.2. ) (05/11/2016). 
8. Added licensed clinician to conduct screening evaluations for the MTPC groups 
(C.3.d.2.) (05/11/2016). 
9. Added questionnaires (Mindfulness Resources Use Survey, Emotion regulation (DERS) 
and interoception awareness (MAIA) in section C.3.f.10.) and removed questionnaires 
(PROMIS-SDSF, PROMIS-PISF, PROMIS-GHSF) (05/11/2016). 
10. Added electronic informed consent possibility (C.3.d.1. Informed Consent Visit) and 
possibility to fill in questionnaires electronically through REDCap (Pre-treatment 
Assessment Visit, Mid-Training Assessment Session, Post-Treatment Survey Session). 
11. Added: food can be provided during the informed consent session (C.3.d.2.) 
(05/11/2016). 
12. Clarified language about Follow-up Survey Sessions (C.3.d.2.) (05/11/2016). 
13. Changed participant remuneration related to main MINDFUL-PC study (C.3.d.2., D.7.) 
(05/11/2016). 
14. Added waitlist Biweekly Engagement Phone Call (PT Study Week 1-8) (05/11/2016). 
15. Added section on Data Monitoring and Quality Assurance (D.2.c.6.) (05/11/2016). 
16. Added description of Session Quality and Protocol Adherence (D.8.) (05/11/2016). 
17. Added procedures for Unanticipated Problems that are not Adverse Events: Possible Risk 
of Suicide (D.2.c.7.) (05/11/2016). 
18. Added Description of Sources of Research Materials for all study arms and the fMRI 
study and describe Data Linkage to subjects and access to data (D.10.) (05/11/2016). 

 
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19. Added paragraph on present study personnel, responsibilities and inclusion (D.11.), and 
added personnel for fMRI study (postdoctoral fellow) (05/11/2016). 
20. Added paragraph on Human Subjects and Confidentiality and Recruitment procedures 
(D.3.) (05/11/2016). 
21. Added a fourth task during fMRI scanning (emotion regulation task using pain stimuli) 
(A.2.a.), including respective additional hypotheses (A.2.b.), and analyses (C.5.b.), and 
risk assessment (D.2.d.2.), adjusted the timing of the 4 tasks and added a structural (DTI) 
scan (C.3.a.) (05/11/2016). 
22. Changed task choice and reference for the specific inhibitory control task (C.5.b.) 
(05/11/2016). 
23. Adjusted recruitment and informed consent procedure for fMRI participants (C.2.c, 
C.3.d.3., D.5.c.) (05/11/2016). 
24. Adapted and added to fMRI participant inclusion/exclusion criteria (C.1.c.) (05/11/2016). 
25. Added a phone-protocol for screening and scheduling participants to the fMRI study, to 
the group-scheduling phone-call (C.3.d.3.) (05/11/2016). 
26. Added details about toxicology and pregnancy screenings of fMRI participants (C.3.d.3.) 
(05/11/2016). 
27. Changed subject remuneration and reimbursement of travel expenses for fMRI 
participants (D.7.b.) (05/11/2016). 
28. Adjusted Study Visit and Assessment Schedule for fMRI Pilot Study Participants (Table 
4) (05/11/2016). 
 
Version 1.3: 
Version Date: 8/16/2016 
29. Corrected typos in protocol and flyer and clarified language around identification code 
(07/21/2016). 
30. Added additional detail about fMRI contraindications and screening process to the ICF 
and protocol (C.1.c.1./2., C.3.d.3. Group Scheduling Phone Call, and C.3.d.3. fMRI 
Session Visit) (07/21/2016). 
31. Clarified number of subjects in fMRI pilot study in Figure 1b Study flow schema for 
Patient participants, and consistently added the maximal recruitment number of n=30 for 
the fMRI pilot study in the text (07/21/2016). 
32. Clarified timing and content of pre-fMRI phone calls (C.3.d.3.) (07/21/2016). 
33. Specified information on screened drugs (C.3.d.3. Pre-treatment fMRI Session 
Visit)(07/21/2016). 
34. Clarified language around the total payment for the fMRI pilot in the protocol and ICF 
(protocol section D.7.b, and Table 4. Study Visit and Assessment Schedule for fMRI 
Pilot Study Participants) and clarified that drug screening completion is necessary for 
reimbursement (07/21/2016). 
35. Removed F. Markovski as Research Assistant, added Angela Lozada and Andrea Chen as 
Research Assistants (D.11.) (07/21/2016). 
36. Added sensors as possible sources of incidental findings (07/21/2016). 

 
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37. Added risk of noise during scanning (07/21/2016). 
38. Included NIH version dates and numbers on all documents (07/21/2016). 
39. Clarified processes after incidental findings (D.2.d.2.3.) (07/21/2016). 
40. Clarified that result of drug screenings will not be added to participants’ medical records 
and will only be kept in their research records, and added language about Certificate of 
Confidentiality application (D.1.a.) (07/21/2016). 
41. Clarified how MRI data will be kept at imaging site (Martinos Center) and how it will be 
incorporated with other CHA study data (D.1.a.) (07/21/2016). 
42. Changed nature of response inhibition task to an emotional response inhibition task, 
using standardized and validated emotional pictures (A.2.b.6, C.5.b.) (07/21/2016). 
43. Deleted redundancy in Confidentiality section (07/21/2016). 
44. Updated Randomization Schema (C.3.c. Table 1) (07/21/2016). 
45. Standardized font type, consolidated text and formatting, and improved readability of 
protocol organization (7/21/2016).  
46. Deleted D.1.c. Sending Data to Research Collaborators Outside CHA, as it is not longer 
relevant (8/16/2016). 
47. Added information about the emotional pictures, used in the emotional Go/NoGo task 
(C.5.b.6., D.2.d.1.3) in line with the new ICF information (8/16/2016). 
48. Added information about storing fMRI data under unique numeric identifier and acrostic, 
but adding year of birth, in case a radiologist has to assess the brain scan (D.1.a.) 
(8/16/2016). 
49. Added links to Martinos security and imaging manuals for reference (D.1., D.2.d.2) 
(8/16/2016). 
 
Version 1.4: 
Version Date:  (February 8th, 2017) 
 
1. Added post-treatment study visits 2 (12 weeks after baseline) and 3 (16 weeks after 
baseline).  For each of these additional visits, patient participants will fill out the Action 
Plan Initiation Survey (APIS-5).  Compensation is $5 for each of these study visits, which 
will be dispersed at the final 6-month follow-up visit for a total of $30 as the final 
payment (C.3.d.3.) (10/31/16). 
2. Modified APIS-5 and APA-10 instruments to include 6 categories of action plan goals for 
patient participants to choose from (activity level/exercise, diet/eating/drinking, sleep, 
self-care practice, medication, and reducing substance use) (C.3.f.6.) (10/31/16).   
3. Adapted orientation and informed consent procedure, so that information sheet instead of 
informed consent are distributed at the orientation session (C.2.c, C.3.d.3, D.2.d.2.3, 
D.5.c) (11/7/16). 
4. Elimination of two survey sessions (10-12 week and 56-week) survey sessions for PCPs 
who enroll in the study from this point onwards.  We are naming this PCP group "Group 
3" to distinguish from existing PCP Groups 1 and 2 (11/7/16).    

 
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5. Addition of 2 questions regarding actual pain level during the scan and 18 questions, 
immediately after scanning, regarding the subjective experience with the tasks during the 
scans (fmri questions) (C.3.f.14.) (11/7/16).  
6. Changed instance of first contact about the optional fMRI pilot study from the 
MINDFUL-PC orientation session to a phone call prior to the MINDFUL-PC orientation 
session, with the option of sending the fMRI pilot study flyer and information sheet about 
the optional fMRI pilot study via email prior to the MINDFUL-PC orientation session. 
 
Version 1.5: 
Version Date:  (April 6, 2017) 
1. PCP Enrollment has been completed as of February 10th, 2017  
2. Remove PCP Visit Study Session for Patient Participants 
3. Expand referral requirements: patients can be referred to MINDFUL-PC by either a 
licensed CHA primary care provider, or a licensed CHA mental health clinician.   
4. Add Action Plan Study Session for Patients during Study Weeks 6-7 
5. Add Action Plan Worksheet as a study material to be completed by patients during 
Action Plan Study Session 
6. Modify APIS-5 Survey to reflect changes in Action Plan Worksheet  
7. Change APIS-5 study sessions to Weeks 9,10, and 16 ($5 compensation each) 
8. Add Study Completion Bonus of $30 to be disbursed at end of study if all study 
participation items have been completed (Total compensation is now $140).   
9. Study payments occur three times:  at baseline (up to $20), at 8 weeks (up to $40), and at 
24 weeks (up to $80).   
10. Clarified which/how many surveys waitlist participants need to complete in order to be 
eligible for a spot in the next MTPC group once their 6-month study participation is over  
11. Clarified how surveys completed on paper will be handled  
12. Add two research assistants:  Alissa Yap and Yuki Ebihara 
 
Version 1.6: 
Version Date: (April 25, 2017) 
1. Add one research assistant: Alexandra Brunel 
 
Version 1.7: Version Date:  (May 24, 2017) 
1. Add one research assistant (Ekaterina Protsenko) 
 
Version 1.8: Version Date: (Add date of approval of Amendment 23) 
1. Add one research coordinator (My Ngoc To) 
 
Version 1.9: Version Date: (June 13, 2017) 
1. Add one research assistant (Thomas Fatkin) 
Version 1.10: Version Date: (July 25, 2017) 
1. Add two research assistants (Nermin Hasanovic and Liza Hoffman) 

 
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2. Add patient participant adverse events self-report form to be completed at the 8-week and 
6-month study sessions 
3. Add “STOP ACHE GO” to the patient participant mindfulness practice diary.  STOP 
ACHE GO stands for:   
Stop or Slow down 
Turn towards experience or Take notice of breathing 
Observe with Openness 
Pleasantness/UnPleasantness 
Allow it to be as it is/Accept the ACHE is here/Anchoring to present with breathing 
Compassion/Curiosity 
Holding the experience with warmth 
Expand awareness from ACHE to breathing, then to body, then to all the senses 
Gratitude/Grounding in values 
Open to life, its challenges and beauty/Orient towards experience with kindness  
 
Version 1.11: Version Date: (Retracted on September 26, 2017) 
1. Add one research assistant (Sumayyah S. Ahmed) 
 
Version 1.12:  Version Date: (October 2, 2017) 
1. Add Health, Eating, Activity, and Rest Tracking (HEART) pilot study informed consent 
and procedures for alumni cohort and concurrent cohort 
2. Remove scales HCCQ, VAS, PDRQ, and action plan interview  
3. Add compensation related to HEART pilot study  
4. Revise analytic methods to include the more robust and flexible mixed methods analysis  
 
Version 1.13: Version Date: (September 29, 2017) 
1. Add one research assistant (Tenzin Desel) 
 
Version 1.14: Version Date: (October 19, 2017) 
1. Add two research assistants (Alyssa Craparotta and Michael Berry) 
 
 Version 1.15:  Version Date: (November 17th, 2017) 
1. Add research Assistant (Feyisayo Falayi)  
2. Add engagement calls for alumni cohort of HEART study protocol 
3. Add engagement calls for alumni cohort of HEART study informed consent form 
 
 
 Version 1.16:  Version Date: (December 18th, 2017) 
1. Add action plan interview for MINDFUL-PC completers 
2. Add action plan interview to MINDFUL-PC patient informed consent form 
3. Add payment of $15 for action plan interview. 
 
 
Version 1.17:  Version Date: (January 11th, 2018) 
1. Remove daily diet picture tracking with a mobile app from the HEART study 
measures.  
2. Remove daily sleep tracking with a mobile app from the HEART study measures 
3. Remove ASA24 from HEART study measures 

 
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4. Add “Food, Activity, and Sleep Tracking (FAST) Questionnaire” to HEART study 
measure.  
5. Adjust HEART pilot study payment structure to match modifications to health 
behavior tracking activities 
6. Add 3-Factor Eating Questionnaire-R18 as a study measure to MINDFUL-PC patient 
participant battery 
 
Version 1.18:  Version Date: (March 6, 2018) 
1. Add Bridget Kiley to protocol 
 
 
 
Version 1.19:  Version Date: (April 12, 2018) 
1. Add Behavioral Measures study visit to HEART Study, and modify HEART Study 
Informed Consent Form and payment structure accordingly. Behavioral Measures 
consists of 3 tasks: (Sustained Attention Response Task (SART), Heartbeat Detection 
Task (HBDT), and 5-Trial Adjusting Delay Hypothetical Discounting Task (HDT).  
2. Remove alumni cohort from HEART Study informed consent form and alter the 
definition of concurrent cohort to include MINDFUL-PC participants who are joining 
an MTPC group after being in the LDC. 
3. Modify Weekly Mindfulness Practice Diary to indicate how blanks will be treated by 
adding one line that states, “If you leave any field blank we will treat this as a “0” or 
“No” 
4. Add to MINDFUL-PC patient demographics survey optional sections that ask about 
gender and sexual identity in order to ensure adequate access and representation 
among underrepresented populations. 
 
Version 1.20: Version Date (May 18, 2018) 
 
1. Add permission for SPEXT.com transcription service to be used on Action Plan 
interview recordings. 
 
Version 1.21:  Version Date: (June 8, 2018) 
1. Add Wallis Slater to protocol 
 
Version 1.21:  Version Date: (June 27, 2018) 
1. Add Annamarie Vu to protocol 
 
 

 
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Outline: 
 
A. Introduction, Specific Aims and Hypotheses 
B. Background and Significance 
C. Clinical Research Plan: Design and Methods 
D. Human Subjects Procedures and Confidentiality 
 
A. Introduction, Specific Aims and Hypotheses: 
 
A.1. Introduction: 
 
This project aims to integrate mindfulness training into the heart of the standard healthcare 
delivery system. Since Patient-Centered Medical Homes (PCMHs) are recommended by the 
Affordable Care Act as a model for the current wave of health care reform, this project focuses 
on harnessing the momentum for change by creating a replicable and sustainable implementation 
model for mindfulness in the PCMH. This project will train primary care providers (PA, APRN, 
DO, MD) in Mindfulness-based Stress Reduction (MBSR) and Mindful Communication. In 
addition, we have developed a modified version of MBSR for primary care called Mindfulness 
Training for Primary Care (MTPC), which will be implemented directly into the PCMHs 
throughout a culturally and socio-economically diverse community health system. This project 
will investigate the effects of MTPC for patients, the effects of MBSR and Mindful 
Communication for providers, and the effects of the combination of both trainings on patients’ 
experiences of care and providers’ experiences of caring. This project will also evaluate the 
effects of MTPC, Mindful Communication, and the combination of both on patient health 
outcomes, health maintenance behaviors, and rates of medications prescribed for symptom-relief. 
This innovative project was developed by a multidisciplinary team with strong support from 
CHA executive leadership and will become the core project of our new academic Center for 
Mindfulness and Compassion at CHA. 
 
In addition, the project has been funded as a core clinical trial for the NCCIH Science of 
Behavior Change UH2 project “Mindfulness Influences on Self-Regulation: Mental and Physical 
Health Implications.” For this project our research team has integrated a PCP-patient visit into 
this mindfulness-based intervention, while also adding a self-management assessment battery 
and an evaluative process for measuring rates of initiation and maintenance of jointly-selected 
health action plans.  
In addition, we will conduct an experimental pilot fMRI study to evaluate several mechanistic 
self-regulation targets and their potential impact on medical regimen adherence as measured by 
initiation and maintenance of health action plan goals.  
 
A.2. Aims and Hypotheses: 
 
A.2.a. Specific Aims: 
 

 
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1. We aim to train primary care providers in Mindful Communication and implement 
MTPC directly into PCMHs throughout a culturally and socio-economically diverse 
community health system (Implementation Aim). 
 
2. We aim to investigate the effects of MTPC for patients, MBSR and Mindful 
Communication for providers, and the combination of the trainings on patients’ 
experiences of care and providers’ experiences of caring (PCP-Patient Relationship 
Aim). 
 
3. We aim to evaluate the effects of MTPC for patients, MBSR and Mindful 
Communication for providers, and the combination of the trainings on patient health 
outcomes, capacity for self-management of chronic illness, health maintenance behaviors, 
and rates of medication prescribed for symptom-relief (Behavioral Health Outcomes 
Aim). 
4. We aim to investigate the main effects of MBSR and Mindful Communication for 
providers on provider wellbeing, resilience, and work-place satisfaction (Provider 
Resilience Aim). 
 
5. We aim to investigate the effects of MTPC for patients, MBSR and Mindful 
Communication for providers, and the combination of the trainings on medical regimen 
adherence (Medical Regimen Adherence Aim).  
 
6. We aim to assess the effect of patient mindfulness training on chronic disease self-
efficacy and neuroimaging targets of inhibitory control, self-compassion, interoceptive 
attention and emotion/pain regulation. This study also aims to evaluate the effects size of 
the influence of these mechanistic targets on medical regimen adherence outcomes (Self-
Regulation Mechanisms Aim).  
 
7. HEART Study: We aim 1) to demonstrate feasibility of using commercially available 
activity/sleep/diet trackers and online daily surveys for ecological behavior tracking in a 
MBI RCT and 2) to use the daily behavior tracking to validate the action plan goal setting 
process and the self-report action plan initiation measure. 
 
 
A.2.b. Specific Goals and Hypotheses: 
 
1. Implementation Goal: Our implementation goals are a) to implement at least two MTPC 
groups in at least 8 CHA primary care sites within two years, b) to train at least 25-40 
primary care providers in Mindful Communication, c) to enroll a socioeconomically-
diverse population of patients, and d) to enroll a culturally-diverse population of patients 
with at least 30% of patients completing the program being non-Caucasian or having a 
primary language other than English.   
 
2. PCP-Patient Relationship Hypothesis: We hypothesize greater satisfaction with the PCP-
patient relationship among patients with the combination of provider and patient 
mindfulness training compared with only one or neither training types. 
 

 
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3. Health Outcomes Hypotheses: We hypothesize reductions in depression, anxiety and 
stress as a main effect of MTPC. We hypothesize reductions in use of medications 
prescribed for symptom reduction (benzodiazepines, opioids, etc.), and overall 
improvement in markers of health maintenance and chronic illness management (i.e. 
PQRS data). We hypothesize the highest levels of initiation and maintenance of self-
management action plans will be demonstrated among the MTPC group with 
Mindfulness-trained providers. 
 
4. Provider Resilience Hypothesis: We hypothesize greater workplace well-being, reduced 
experience of burnout, and increased resiliency among providers as a main effect of 
provider MBSR + Mindful Communication training. 
 
5. Medical Regimen Adherence Hypotheses: We hypothesize a main effect of MTPC group 
status on levels of initiation and maintenance of medical regimen health behavior change. 
The highest levels will be demonstrated among the MTPC group with Mindfulness- 
trained providers. We hypothesize that total formal mindfulness practice, post-study total 
mindfulness score, baseline mindful non-judgment score, and self-compassion will be 
associated with successful initiation and maintenance of action plans. 
 
6. Self-Regulation Mechanisms Hypotheses: In 4 different fMRI tasks, we hypothesize (a) 
greater activation of anterior cingulate cortex (ACC) and medial orbitofrontal cortex 
(OFC) and decreased activation in amygdala/hippocampus after MTPC intervention 
compared to before intervention (i.e, a pre-post increase) in an emotional Go/NoGo 
inhibitory control task; (b) greater activation of insula after (compared to before) MTPC 
in a self-compassion task (that contrasts self-reassurance conditions with a self-criticism 
condition); (c) greater insula activation during an interoceptive attention task (that 
contrasts an interoceptive attention condition with an exteroceptive attention condition); 
and (d) greater rostral ACC (rACC) and ventromedial prefrontal cortex (vmPFC) 
activation during the anticipation of pain and greater activation in the lateral prefrontal 
cortex (LPFC) and somatosensory areas during pain in an emotion/pain regulation task, 
after compared to before the MTPC intervention. 
We hypothesize that all inhibitory control and interoceptive targets will be associated 
with higher levels of initiation of regimen adherence, while self-compassion, 
interoceptive targets and emotion/pain regulation will be associated with higher levels of 
regimen maintenance. 
 
HEART Pilot Study Hypotheses 
 
7. HEART pilot study validation goal:  Our goal is to implement activity and heart-rate 
tracking, nutrition, sleep, and mindfulness practice tracking in a cohort of MINDFUL-PC 
alumni to determine whether this suite of behavioral monitoring tasks can behaviorally 
validate the signal from the self-reported action plan initiation protocol.  
 
We hypothesize that self-reported action plan initiation with activity, diet, sleep or 
mindfulness practice will be associated with a behavioral change as assessed with the 
daily tracking devices.  
 

 
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8. HEART pilot study concurrent cohort:  We hypothesize that participants who are in an 
8-week MTPC group will demonstrate higher levels of action plan initiation, with an 
associated change in behavioral monitoring, than participants who are randomized to the 
waitlist condition.  We also hypothesize that participants who chose to increase activity 
will have a greater increase in daily activity than those who chose a diet-, mindfulness- or 
sleep-related action plan goal.  
 
 
 
B. Background and Rationale: 
 
The Affordable Care Act (ACA) promotes the Patient-Centered Medical Home (PCMH) delivery 
model as a tool to reshape the healthcare delivery system [1]. The PCMH model encourages a 
whole-person orientation, self-management skills for patients with chronic diseases (NCQA, 
element 4B [2]), and enhanced collaboration for these patients by requiring interdisciplinary 
integration of clinical, community prevention, and health promotion services (Section 3502, 
ACA p.1050). In the ACA, both the PCMH and Accountable Care Organization (ACO) models 
have incentive systems that support initiatives to encourage patient-centered care (PCMH: ACA 
Section 3502, p.1050; ACO: ACA Section 3022, p.731). If a healthcare delivery system 
transformation project could demonstrate enhanced levels of patient-centeredness in primary care 
while also enriching patient self-management skills to cope with chronic illnesses, this project 
would be innovative and ripe for dissemination within the national PCMH movement. 
 
Mindfulness training is an evidence-based approach to patient-centered caring [3] and whole-
person self-management [4]. Mindfulness is “the awareness that emerges through purposely, and 
non-judgmentally, paying attention to the unfolding of experience moment-by-moment” [5]. 
Mindfulness-based Stress Reduction (MBSR) is an 8-week program that serves as the basis for 
multiple different condition-specific mindfulness-based interventions (MBI) provided in medical 
settings [6]. In 2013, National Institutes of Health invested 44.3 million U.S. dollars into direct 
funding for MBI research (NIH Reporter 2014), and publications related to mindfulness-related 
research have exponentially increased over the past 30 years, with more than 500 publications in 
2013 alone [7]. Several studies have demonstrated that Mindful Communication training for 
healthcare providers, which involves training in MBSR followed by 10 months of 
communication training [3], can reduce provider burnout and increase resiliency, while also 
increasing patient-centered communication, improving provider empathy and enhancing patient 
satisfaction [3,8, 9, 10]. Multiple clinical trials have demonstrated that MBIs improved self-
management in major areas of community health and chronic illness management [11, 12]. One 
recent meta-analysis demonstrated that MBIs are broadly effective for anxiety, depression, and 
pain [13]. MBIs are associated with tobacco smoking reduction [14, 15], reduction in alcohol 
consumption [16,17,18], reduction in prescription opioid misuse among patients with chronic 
pain [19], and reduced HIV-risk behaviors [20]. MBIs demonstrate increased asthma-related 
quality of life with reductions in stress and anxiety [21]. MBIs produce a reduction in systolic 
and diastolic blood pressure in patients with pre-hypertension [22], and particularly large 
reductions in hypertension have been seen within studies of African-American patients [23, 24]. 
Among patients with non-insulin dependent diabetes, one small MBI study demonstrated 
improved glycemic control [25], while large studies with active controls have demonstrated 
effective integration of diabetes self-management skills [26], decreased stress and improved 

 
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quality of life [27]. MBIs can reduce the stress associated with chronic illness [11, 12], and they 
are particularly effective in reducing depressive relapse in Major Depressive Disorder [28]. 
 
We have been developing a modified version of MBSR called Mindfulness Training for Primary 
Care (MTPC), which is a MBI adapted specifically for the primary care environment. MTPC 
combines MBSR skills with additional attention to patient/provider relationships, cultural and 
socio-economic diversity, coping with chronic illness, reducing unnecessary medical care, and 
encouraging self-management skills acquisition. In this project, we plan to bring mindfulness 
directly into the heart of our healthcare delivery system, by offering high-quality training for our 
primary care providers in MBSR and Mindful Communication [3] while also integrating the 
innovative MTPC program directly into the PCMH. 
 
Despite all the evidence supporting MBIs, several gaps in the current research and care delivery 
models may be acting as barriers to rapid dissemination and integration of mindfulness into the 
healthcare delivery system. First, while there are several provider studies showing increased 
levels of patient-centered care and provider resiliency, no studies examine the effects of provider 
mindfulness training on patient health outcomes. Second, while a multitude of patient studies 
showing reductions in stress, pain, anxiety, and depression exist, no previous studies have been 
designed to identify whether the combination of training both patients and providers offers a 
synergistic effect on overall health outcomes as well as the quality of the provider/patient 
relationship, the level of motivation for health maintenance, and the ability to self-manage and 
cope with chronic illness. Third, the overwhelming majority of MBSR courses have been 
conducted in educated, Caucasian, English-speaking populations, leading some to criticize 
mindfulness as unready for the cultural and socio-economic diversity in the standard healthcare 
delivery system. Finally, most MBIs are offered through behavioral health or as a 
complementary private-pay service delivered outside the standard health care system without 
coverage by insurance payers. This project will address these important gaps in the current 
research and delivery system, by evaluating the integration of the novel MTPC model into a 
system of urban, community, multi-cultural, safety-net PCMHs, while also assessing the 
influence of provider training on outcomes. 
 
In addition, this study offers an opportunity to identify and test mechanistic self-regulation 
targets (physiologic, psychological, neuropsychological, etc.) that are influenced by mindfulness 
and potentially account for its effect on medical regimen adherence. Since the majority of 
medical regimen adherence and health behavior change occurs within primary care, the 
development of a paradigm for measuring action plan initiation and maintenance among patients 
within the patient-centered medical home is needed. 
 
Feasibility and Facilities: 
 
The Cambridge Health Alliance (CHA) employs about 160 primary care providers at 15 primary 
care practices in the Boston Metro-North cities of Cambridge, Somerville, Everett, Malden and 
Revere.  CHA currently has approximately 140,000 primary care patients. Language interpreters 
are available at every primary care site. The study will be conducted at several CHA primary 
care health centers, including Cambridge Primary Care Center, Cambridge Family Health, 
Cambridge Family Health North, East Cambridge Health Center, Windsor Street Health Center, 
Everett Family Health Center, Revere Family Health Center, Malden Family Health Center, 
Broadway Health Center, Union Square Family Health, and Somerville Primary Care.  Currently, 

 
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CHA is undergoing a delivery system transformation initiative integrating mental health into 
primary care sites, creating patient-centered medical homes across the entire healthcare system 
over the next 2-3 years.  
 
In addition, the Cambridge Health Alliance has awarded a yearlong grant to the CHA Center for 
Mindfulness and Compassion (CMC), and CMC faculty and staff eagerly offer support for the 
MINDFUL-PC project.  
 
The MGH/HST Martinos Center for Biomedical Imaging is a leader in translational research 
with and development of a host of state-of-the-art imaging technologies. Martinos faculty 
include world-class experts in disciplines spanning the basic biosciences and clinical 
investigation. The backbone of the Martinos Center is the Imaging and Computational Core 
Resources. The Imaging Cores include the MRI, MEG and Optical Imaging Cores, with an 
extensive and expanding inventory of state-of-the-art imaging facilities and equipment, including 
related laboratories and testing rooms. The Computational Core oversees data processing, 
computational infrastructure, software and hardware issues. Together, the Imaging and 
Computational Cores develop and provide state-of-the art biomedical imaging and image 
processing technology and techniques to the Center's research faculty and user community.  
 
C. Clinical Research Plan: Study Design and Methods: 
 
C.1. Study population:  
 
This study will have two types of participants: CHA primary care providers (PCP) and CHA 
patients. In addition, patient participants will be screened for eligibility to participate in an 
optional fMRI neuroimaging experimental pilot study (fMRI participants).  
 
C.1.a. PCP Participants: 
 
C.1.a.1. PCP Participant Inclusion Criteria: 
All of the following are required criterion for inclusion in the study: 
1. Current primary care provider at a CHA PCMH 
2. Completion of health care training degree, including MD, DO, APRN, and PA 
3. Willing to participate in interviews and engage in all procedure. 
 
C.1.a.2. PCP Participant Exclusion Criteria: 
Any of the following is regarded as a criterion for exclusion from the study: 
1. Previous enrollment or randomization of treatment in the present study 
2. . 
 
C.1.b. Patient Participants: 
 
C.1.b.1. Patient Participant Inclusion Criteria: 
All of the following are required criterion for inclusion in the study: 
1. Current CHA patient with an enrolled CHA primary care doctor. 
2. CHA patients 18 years of age and older. 
3. Able to tolerate and participate in interviews and engage in all procedures. 

 
14 
 
4. Able to give written consent in English OR willing and able to provide consent and 
complete assessments through a professional language translator when necessary. 
5. Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, 
depression, insomnia, pain syndrome, or adjustment disorder related to chronic illness, 
etc.). 
 
 
C.1.b.2. Patient Participant Exclusion Criteria: 
Any of the following is regarded as a criterion for exclusion from the study: 
1. Any cognitive impairment that precludes informed consent. 
2. Patients who, in the opinion of the Principal Investigator, pose an imminent risk of 
suicide or danger to self or others. 
3. Likelihood of potential incarceration such as a conviction or pending charges that may 
potentially result in imprisonment. 
4. Previous enrollment or randomization of treatment in the present study within the 12 
months. 
5. Behaviors that may cause disruption to a mindfulness group. 
6. Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, 
including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of 
major depressive disorder. 
7. Refusal of insurance to cover group psychotherapy treatment may lead to exclusion from 
participation in groups. 
8. Patients in their third trimester of pregnancy who foresee conflicts that preclude their 
commitment to completing all activities. 
9. Patients with highly unstable medical problems that put them at a high risk of 
hospitalization. 
10. Temporal Exclusion: Patients with limited English Proficiency as defined by less than 4 
out of 7 correct on REALM-SF health literacy screening assessment (equivalent to 7th 
grade reading level or above) [Note: Patient with limited English Proficiency will be 
placed on a wait list for specific clinical pilot groups designed for this population, which 
will be developed for 2016]. 
 
C.1.c. Patient Participant fMRI Pilot: 
 
All of the above criteria for patient participants apply to the subset who will take part in the 
fMRI experiment. In addition, the following criteria will apply:  
 
C.1.c.1. Patient Participant fMRI Pilot additional Inclusion Criteria: 
1. Adults 21-60 years old enrolled for participation in the MINDFUL-PC study. (Assessed 
before the phone-screening using the main study database.) 
2. During baseline visit, patient has a history of either major depressive disorder, 
dysthymia, or generalized anxiety disorder, OR has current mild to moderate symptoms 
of depression (score range of 10-20 on DASS-21 Depression subscale) or anxiety 
(score >7 on DASS-21 anxiety subscale). (Assessed before the phone-screening using the 
main study data from the baseline visit.) 
3. Participant does not have a substance use disorder nor intoxication at the time of 
scanning. Participants must report no more than infrequent recreational cannabis use (i.e., 

 
15 
 
no more than two times a month) and must report capacity for abstinence from both 
cannabis and ethyl alcohol for the 72 hours prior to the scan. (Assessed during the phone-
screening.) 
4. Normal or corrected-to-normal vision, and correction must be with contact lenses. (The 
fMRI tasks require ability to read on a screen and there is not enough space for 
glasses/goggles in the scanner). (Assessed during the phone-screening.) 
5. Right-handed as defined by Edinburgh Handedness Inventory [29]. (Assessed during the 
phone-screening.) 
 
C.1.c.2. Patient Participant fMRI Pilot additional Exclusion criteria: 
1. Current severe panic disorder, active severe PTSD symptoms, or psychosis. 
2. Current suicidality OR severe depression as evidenced by a score of 20 or higher on the 
DASS-21 Depression subscale. 
3. Standard direct exclusion criteria for undergoing magnetic resonance imaging (MRI) 
procedures for research purposes (safety standards), i.e., Meniere’s disease, epilepsy, 
strong claustrophobia, currently pregnant or breastfeeding or planning to conceive or 
breastfeed during the study, cardiac pacemaker, prosthetic heart valve, neurostimulator, 
implanted pumps, non-MR-compatible implants or devices. (Assessed during the phone-
screening.) 
4. A history of neurological disease or injury, including a history of seizures or significant 
head trauma (i.e., extended loss of consciousness, neurological sequelae, or known 
structural brain lesion), or previous brain surgery. These participants are excluded 
because they may confound the results of the study due to potential abnormalities in their 
nervous system. (Assessed during the phone-screening.) 
5. Severe skin disease, skin allergies, or multiple reactions to topical preparations, dressings 
or tapes (because we will be placing sensors on the skin to record cardiac activity and 
skin conductance). (Assessed during the phone-screening.) 
6. Age greater than 60 years old because age effects may confound the results of the study, 
because white matter integrity decreases with age and reduced inhibitory control. 
(Assessed before the phone-screening using the main study database.) 
7. Current meditation or intense yoga practice of more than 30 min a week or meditation 
experience of more than 20 hours in the past 10 years. (Since this pilot is focused on 
investigating mechanisms, we will limit the sample to participants who are new to 
mindfulness techniques). (Assessed before the phone-screening using the main study 
database.) 
8. Participants with body weight >230 lbs or BMI > 38 will require additional in-person 
screening and PI approval, because of potential tight fit in the MRI scanner. (Assessed 
during the phone-screening.) 
9. Participants with vascular disease, such as peripheral vascular disease, varicose veins, or 
lymphedema, in both lower limbs. (Participants may be included with PI approval, if they 
have vascular disease only in the right limb, which will not receive cuff-pain stimulation 
and no signs of disease in the left limb.)  (Assessed during the phone-screening.) 

 
16 
 
10. Based on clinical judgment and safety assessment by the PI, the participant is 
inappropriate for fMRI or unable to complete experiments. (Assessed only if after the 
phone-screening and other interactions with the patient, the study personnel has doubts 
about the patients’ ability to participate in this additional study.) 
 
C.1.c.3. Patient Participant HEART Pilot Additional Inclusion Criteria: 
1. Participant must be currently enrolled in, or have completed, the MINDFUL-PC study. 
2. Participant must have access to a smartphone that is compatible with the activity tracker 
application. 
3. Participant must be willing to use the smartphone application and/or wear a wristband 
activity tracker every day for activity monitoring periods of the HEART study and be 
willing to take pictures of their food and drink intake. 
4. Participant must be able to fill out the study questionnaires daily on a computer or 
compatible mobile device.   
 
 
 
Screening will be conducted by study staff and research assistants. Decisions on the 
inclusion/exclusion will be made by the study staff under the supervision of the neuroimaging 
postdoctoral fellow and Principal Investigator in cases where no additional clarifications are 
needed. In cases where MRI safety needs further assessments, the postdoctoral fellow or imaging 
consultants at the Martinos Center for Biomedical Engineering will coordinate the assessment 
with the MRI physics staff at the Martinos Center, and will decide on inclusion or exclusion of 
the participant. 
 

 
17 
 
C.2. Recruitment: 
 
C.2.a. PCP Recruitment:  
 
PCP recruitment has been completed for this study as of February 10, 2017.    No further PCP 
enrollment or study sessions will take place after this date.   
The study aims to enroll 50-120 PCPs as participants.  PCPs will be recruited through print/flyer 
advertisements in department offices and health centers, email invitations, announcements at 
departmental meetings, and a presentation at CHA medical grand rounds and family medicine 
grand rounds. The presentation for Medicine grand rounds will take place on October 1st, 2014, 
and the presentation for Family Medicine grand rounds will take place on September 30th, 2014.  
The study aims to enroll at least 25-40 PCPs into an intervention group (Group 1) and at least 25-
40 into a control group (Group 2 and 3). 
 
C.2.b. Patient Recruitment: 
 
The study aims to enroll a total of 434-1,000 CHA patients as participants during the project. 
Patients will be recruited through print/flyer advertisements in health centers, CHA marketing 
materials, community informational meetings, and referral by PCPs and other members of the 
health care team. In addition, we aim to develop a video introduction about mindfulness to be 
played in patient waiting areas within health centers with translations into the primary languages 
of the health centers (Once developed these videos will be provided for review by the CHA IRB 
prior to implementation).  This study aims to randomize 290 patients to an 8-week study 
intervention and another 144 to a control group.   
 
C.2.c. Experimental fMRI Pilot Patient Recruitment: 
The study aims to enroll a maximum of 30 patients into an experimental fMRI pilot study to be 
conducted at the Athinoula A. Martinos Center for Biomedical Imaging in Charlestown, MA. 
Participants will be informed about this fMRI pilot study during the reminder phone call before 
the MINDFUL-PC orientation session. Participants will be told that this is an optional pilot study 
and that they do not need to participate in this pilot study in order to participate in the larger 
study. Participants will also be informed that they will ONLY be able to participate in the fMRI 
pilot study if they get randomized to the MTPC intervention condition. In the email confirmation 
for the orientation session, we will further include the fMRI neuroimaging study flyer with 
information on the fMRI pilot study and the fMRI information sheet about the fMRI study. 
Participants will hear again about the fMRI pilot as part at the MINDFUL-PC orientation session 
at their primary care health center.  Again participants will be told that this is an optional pilot 
study and that they will ONLY be able to participate in the fMRI pilot study if they get 
randomized to the MTPC intervention condition. Patients are further informed about 
inclusion/exclusion criteria related to the fMRI study and that the number of scanner time slots 
may be limited, so all participants who enroll and qualify may NOT be offered an opportunity to 
attend a scanning session. All participants interested in participating will be ranked on the call-
list in numerical order based on the order that they expressed interest as well as their level of 
reliability and timeliness during previous recruitment steps and interactions. The call-list ranking 
is to ensure that this study enrolls participants who are most motivated and most likely to be able 
to complete the extra demands related to the fMRI scanning and additional visits, and also to 
ensure that the limited scan slots for this study are allocated efficiently. During the orientation 
session, participants will receive the flyer with information on the fMRI pilot study with 

 
18 
 
potential scan times and we will again make available the information sheet about the fMRI 
study to read and review at home. Phone screening of MRI inclusion/exclusion criteria will be 
completed after the orientation and randomization to the mindfulness group, for interested 
mindfulness group participants (see attached phone script). We will phone screen interested 
mindfulness group participants during the group-scheduling phone call. The phone screen will 
include questions based on the Martinos Center MRI safety screening form and the Edinburgh 
Handedness Inventory to verbally screen participants and make sure they fulfill MRI safety 
criteria and all other criteria related to the fMRI study. After the phone screening, and if 
participants fulfill all criteria, they are given the opportunity to ask any questions they might still 
have about the study. We will then schedule an fMRI measurement scan session. If the 
participant needs additional time to make an informed decision or if we have to make additional 
inquiries based on the MRI eligibility phone screening process, we will arrange a follow-up 
phone call with the patient (within 1-3 days of the group-scheduling phone call), to decide on 
study participation and potentially schedule the fMRI measurement session. 
 
C.3. Experimental Design and Study Procedures: 
 
C.3.a. Design Overview and Study Participants: 
 
This study uses a mixed 2 x 2 factorial design embedding a randomized controlled trial within a 
naturalistic quasi-experimental implementation project.   
 
The implementation project, developed in collaboration with the CHA Center for Mindfulness 
and Compassion (CMC), will encourage CHA PCPs from across all CHA health care centers to 
participate in a mindfulness training program. All PCPs will be invited to participate in the study 
procedures, and those who enroll in the study will naturalistically be assigned to two different 
groups: those who engage in the mindfulness training program (Group 1) and those who decline 
to engage in the training program but are still willing to complete study procedures (Groups 2 
and 3). The mindfulness training program includes an 8-week MBSR training course of 2.5 hours 
weekly with an 7-hour day of silent practice at the beginning of week 7 (Group 1a), or an 
abbreviated 18-hour weekend-long Mindfulness training course (Group 1b). Members of Group 
1a will first receive MBSR training from senior MBSR teachers and Group 1b will receive 
training from CMC faculty and staff. After this MBSR training, members of Group 1a and Group 
1b will be able to participate in a once-monthly 2.5 hour-long Mindful Communication course 
for 10 months during Year 1 of the study. We expect that this Mindful Communication training 
will eliminate between-group differences from MBSR course models, allowing us to collapse 
Groups 1a & 1b for research analysis.  Both Group 1 and Group 2 will be invited to participate in 
several survey sessions: prior to starting the mindfulness training implementation project, 
between PCP study weeks 10 and 14, and then again after PCP study month 12 (see Figure 1a).  
Group 3 PCPs, enrolled after October, 2016, will not receive mindfulness training, and will only 
be required to participate in the initial survey session at baseline.   
 
Figure 1a. Study flow schema for PCP participants: 
 

 
19 
 
 
Within this naturalistic implementation project, we will conduct a randomized controlled trial of 
CHA patients with a PCP referral. Patients will be randomized using a stratification algorithm to 
receive either MTPC training or one 60-min introduction to mindfulness session.  This 
randomization will be based on the level of mindfulness training of the patient’s primary care 
provider (Group 1 vs. Group 2 and 3).  Those patients who are randomized to receive MTPC 
training (MTPC Group) will be instructed by behavioral health specialists who are trained as 
MTPC Group Leaders, as described later in section C.4.a. of the protocol. The MTPC group is a 
group psychotherapy intervention held within a primary care health center on 8 consecutive 
weeks with 10-12 enrolled patients with 2 hour-long sessions, including a 7-hr day of silent 
practice. As the level of desire to participate in mindfulness training may be a confounding 
factor, we will use a 60-min introduction to mindfulness group as a control in order to eliminate 
bias related to expectation and selection that could otherwise influence measures of treatment 
effect.  In contrast, those patients who are randomized to receive only the 60-min introduction to 
mindfulness (Control Group) will be given preference to enroll in MTPC after the study’s 
completion.  Both groups of patients will complete surveys at the induction of the study, again 
after patient study week 8, and at study week 26 (see Figure 1b). Patients will complete an 
interview with a research coordinator to assess their maintenance of their action plan goal at 
week 26. 
 
Figure 1b. Study flow schema for Patient participants 
 
 
 
In this RCT, we will also conduct an optional experimental fMRI pilot study. This study will 
include a pre/post within-subjects design with 90 minutes of neuroimaging before and after 
completion of the MTPC group. Each scanning session will begin with setting up the equipment 
for autonomic monitoring (i.e., respiratory belts, finger plethysmograph, finger sensors for skin 

 
20 
 
conductance and a belt for monitoring breathing rate). The scanning session will consist of a 
localizer scan (3 min), an anatomical scan (7 min), and a resting state scan (7 min), followed by 
an inhibitory control task (the emotional Go/NoGo inhibitory control task; 15 min), a self-
compassion task (15 min), a DTI-scan measuring white matter tracts (8 min), an interoceptive 
attention task (10 min) and an emotion/pain regulation task (10 min). The neuroimaging will take 
about 10 minutes for setting up autonomic monitoring outside the scanner and 75-90 minutes in 
the scanner.  
 
C.3.b. Patient Screening 
 
C.3.b.1. EPIC Chart Review 
In order for patients to be screened for enrollment in the MINDFUL-PC study, they will be 
required to have a CHA PCP, and a referral from a CHA PCP or licensed CHA mental health 
clinician. The MINDFUL-PC Research Coordinator or other IRB-approved, EPIC-trained study 
staff will review the patient’s EPIC chart for information on inclusion and exclusion criteria 
using the template attached.  The Research Coordinator or other IRB-approved, trained study 
staff will consult with the Medical Director or Principal Investigator if there are any questions on 
the patient’s eligibility, per their inclusion/exclusion criteria.  Only the Medical Director or 
Principal Investigator will make decisions about patient exclusion.   
 
C.3.b.2. Informational and Scheduling Phone Call 
If the patient is eligible from this chart review process, the Research Coordinator or other IRB-
approved, trained study staff will call the patient to inform them of their referral.  During this 
screening phone call, the MINDFUL-PC Research Coordinator or other IRB-approved, trained 
study staff will inform the patient of the MINDFUL-PC study and ask screening questions using 
the phone script attached.  Using information from these screening questions, the PCMH 
behavioral health care specialist, the MINDFUL-PC Principal Investigator, or the Center for 
Mindfulness and Compassion Medical Director will assess for the patient’s eligibility for the 
study. If the patient is eligible but has not had a behavioral health evaluation within the past 6 
months, or met with a behavioral health provider within the last 3 months, the patient will be 
scheduled for a 1-hour behavioral health evaluation with a behavioral health care specialist in the 
PCMH.  The behavioral health care specialist will complete the MINDFUL-PC Patient 
Screening Form.  If the patient has had a behavioral health evaluation within the last 6 months 
and met with their behavioral health provider within the last 3 months, the current behavioral 
health care specialist of record will complete the MINDFUL-PC Patient Screening Form without 
scheduling an additional evaluation.  Once a patient is eligible for the study, the PCMH 
behavioral health care specialist will refer the patient to the MINDFUL-PC Research 
Coordinator, who will schedule the patient for an Informed Consent Session which will be 
followed by a mindfulness group orientation session.   
 
C.3.c. Participant De-identification, Randomization, Allotment, and Blinding: 
 
A unique numeric identifier and acrostic will be created for all participants (PCPs and patients) 
who have signed an informed consent and a list linking these identifiers with the participant’s 
name, birthday, and MRN (if applicable) will be kept in a password-protected file by the 
principal investigator.  All data will be linked to these coded identifiers and no direct patient 
identifiers will be transmitted from REDCap to SAS 9.3 for analysis. 
 

 
21 
 
For patient participants, the name, birthday, and MRN will be entered into an initial REDCap 
database strictly for the purpose of screening and consent process.  Next, a unique numeric 
identifier and acrostic will be created for all participants (PCPs and patients) who have 
completed an informed consent and the linking list will be kept in a password-protected file by 
the principal investigator.  All further study data collected in a second REDCap database will 
reference this unique numeric identifier and acrostic.  All data will be linked to these identifiers 
and no direct patient identifiers will be transmitted from REDCap to SAS 9.3 for analysis.  
Through a collaboration with the CHA Quality Office and CHA information technology, we will 
generate medical record reports for participants who are in our study and this information will 
remain protected with the CHA system, and will not include any study data except name, MRN, 
and birthday. 
 
Any patient participant who is eligible with a screen, has completed the informed consent form at 
the orientation session, and has completed the baseline assessment battery will be eligible for 
placement on our program list and ultimately randomization into either of the two groups using a 
stratification algorithm. Randomized patients will be stratified with two layers based on PCP 
group and health center location.  PCPs who refer after the PCP portion of the study closes will 
be considered “non-trained” (equivalent to Groups 2 and 3) for purposes of randomization.  We 
will begin with 4 health center regions (Malden, Revere, Somerville, and Cambridge) and health 
centers within each region will have their own list, but ultimately hope to expand so that each 
participating health center location with a mindfulness-trained behaviorist will have its own 
waitlist for new groups. When a new group is scheduled to open at a health center location, those 
patients with PCPs at that health center location will be randomized to either intervention group 
or control (First stratification layer—Location). Patients with a PCP from another health center 
but who have a specific language need may be included on the waitlist for capability of that 
health center. We hypothesize an increased rate of MTPC patient referrals from PCPs who are 
enrolled in the mindfulness training program versus those who only received information about 
mindfulness-based interventions. Therefore, within each group location, in order to achieve an 
optimal 2 x 2 factorial structure (see randomization schema figure), patients will be randomized 
using a second stratification layer based on the primary care provider’s level of mindfulness 
training (Group 1 vs. Group 2 or Group 3) to either 8-week MTPC or one 60-min introduction to 
mindfulness, using a 2:1 randomization ratio, respectively (Second stratification layer—PCP 
Group), based on the second layer of stratification (See Table 1). Study staff will maintain the 
waitlists and then notify the patient participants of their acceptance into either group.  
 
Table 1. Randomization Schema: 
  
 
MTPC Group Control Group 
Group 1: Providers with Mindfulness Training  
145 
72 
Group 2 and 3: Providers with introduction & community 
referral  
145 
72 
2 x 2 Factorial design testing main effects of patient training and primary care provider training, 
as well as the interaction of the combination.  
 
This study will not be blinded; however, upon referral, all patients will receive a screening from 
the primary care behavioral health care provider, complete an informed consent, complete a set 
of pre-treatment baseline surveys and then will be informed that they will be given a random 

 
22 
 
number and placed on the waiting list for upcoming groups. They will be told about capacity 
restrictions, that there will be two groups consisting of different group lengths, and that if they 
would like to do more groups after completion of the program, they will be notified about groups 
that become available sometime in the next year or two.  
 
C.3.d. Study Visits: 
 
In this section, the flow of study visits will be described for both PCPs and Patient participants. 
 
PCP Study Visits have been completed as of February 10, 2017.  No additional PCP study visits 
will take place after this date.   
C.3.d.1. Overview of PCP Study Visits (SEE TABLE 2 IN APPENDIX A): 
Phone Screen Visit (PCP Group 1a or Group 1b): 
PCPs who express interest in the MBSR program or the weekend 18-hr mindfulness retreat will 
be screened by phone or email by the study Research Coordinator who will register PCP 
participants for the study at one of the Patient-Centered Medical Homes. At the time of 
registration, the PI, Research Coordinator or a research assistant will conduct a brief screening 
interview to determine the PCP’s eligibility for the study. This will take 10 minutes by phone or 
email.   
 
Phone Screen Visit ([PCP Group 2 and 3]): 
PCPs who express interest in referring patients to mindfulness groups will be asked to fill out an 
eligibility questionnaire on paper or through a secure REDCap link.  Eligible PCPs will be given 
the opportunity to continue on to the informed consent session.   
 
Informed Consent Visit (PCP Study week 1 [Group 1a, s, or Group 2 and 3] or Week 10 [Group 
1b]): 
PCP participants will be provided with written descriptions in English of the research study 
procedures, timeline and participant commitments electronically through a secure REDCap link 
for review prior to enrollment. PCPs will be given an opportunity to email and/or call the study 
staff for answers to any questions about the consent document and they will be asked to complete 
a consent quiz to ensure understanding of the most crucial points.  
 
PCPs will be given the opportunity to review and sign the informed consent form and ask any 
remaining questions about the research either online through a secure REDCap link or in-person 
at their primary care location [Groups 1a, 1b, 2, and 3], or during the first hour of the first group 
[Groups 1a and 1b]. The Principal Investigator, Research Coordinator, or other IRB-approved, 
trained study staff will review each PCP’s consent quiz and will be fully responsible for any 
issues related to informed consent, and will ensure that participants receive adequate oral and 
written information about the aims, procedure, possible risks and benefits of the study. When 
participants are ready, they will be asked to sign a written or electronic informed consent form 
approved by the CHA Institutional Review Board (IRB).  Signed paper informed consent forms 
will be stored in a double-locked filing cabinet.  Electronically signed informed consent forms 
will be printed out and stored in a double-locked filing cabinet.  This document includes a full 
description of the study procedures and associated risks. Participants will receive an additional 
electronic or paper copy of the signed informed consent form for their own records.  Participants 
must give written informed consent in order to participate in the study. Participation in the study 
is voluntary.  All participants will be notified that they are free to discontinue from participating 

 
23 
 
in the study at any time.  All participants will be asked to complete and sign a section 
acknowledging that sessions will be audio-recorded for research purposes. No study-specific 
procedures or investigations will be performed before the participant has signed and dated the 
Informed Consent Form. Consent quiz forms will be reviewed prior to starting study procedures, 
a score of at least 90% on the consent quiz is required to start the study. The principal 
investigator will review any errors on the consent quiz with PCPs prior to starting the study. The 
Principal Investigator will store the original, signed Informed Consent Form. The informed 
consent portion of the visit should take 30 minutes. 
 
Pre-treatment Assessment Visit (PCP Study Week 1 [Group 1a,Group 2, and Group 3] or 10 
[Group 1b]): 
PCP participants will complete a 20 minute long set of survey batteries before beginning the 
program. PCPs will be given the opportunity to complete survey batteries on paper or 
electronically through a secure REDCap link.  Paper surveys will be stored in a double-locked 
filing cabinet, and will be transferred electronically to the secure REDCap database by IRB-
approved MINDFUL-PC study personnel with double-audit to minimize errors in data entry.  In 
this survey session, PCP participants will complete the PCP Baseline Battery, the PCP 
Mindfulness Self-Report Battery, the PCP Clinical Assessment Battery, and the PCP Experience 
of Caring Battery. 
 
Mindfulness-Based Stress Reduction (MBSR) course (PCP Study weeks 1-10): 
PCPs who choose to enroll in the mindfulness training course may participate in Mindfulness-
based Stress Reduction (MBSR) training with 8 sessions lasting 2.5-hours over 9 weeks with a 7-
hour day of silent practice. The first hour of the first week’s group will be for completing the 
consent and pre-treatment assessment visit. 
 
Mindfulness Weekend Intensive Retreat (PCP Study Week 10): 
PCPs who do not elect to receive MBSR training with 8 weekly sessions will be able to 
participate in an intensive 18-hour weekend retreat. The first hour of the first day will be for 
completing the consent and pre-treatment assessment visit.  
 
Mid-Training Assessment Session (Completed between PCP Study Weeks 10-14): 
After 8 weeks or the intensive weekend retreat, PCPs will be asked to fill out another survey 
battery electronically through a secure REDCap link, or on paper.  Paper surveys will be stored 
in a double-locked filing cabinet, and will be transferred electronically to the secure REDCap 
database by IRB-approved MINDFUL-PC study personnel with double-audit to minimize errors 
in data entry.   In this 20-minute session, PCP participants will complete the PCP Mindfulness 
Self-Report Battery, the PCP Clinical Assessment Battery, and the PCP Provider Resilience 
Battery. The Adverse Event Reporting Form will also be completed. 
 
Mindful Communication Course (PCP Study Weeks 14-56): 
PCPs assigned to receive Mindfulness training will then take a course in Mindful 
Communication for the next 10 months.  They will receive 10 monthly sessions of 2.5-hour 
Mindful Communication instruction. 
 
Post-Treatment Survey Session (PCP Week 56): 
After completing 10 months of Mindful Communication [Group 1a or 1b], at Study Week 56 
[Group 2], PCPs will be asked to complete another series of surveys electronically through a 

 
24 
 
secure REDCap link, or on paper.  Paper surveys will be stored in a double-locked filing cabinet, 
and will be transferred electronically to the secure REDCap database by IRB-approved 
MINDFUL-PC study personnel with double-audit to minimize errors in data entry.  These 
surveys will take approximately 20 minutes.  In this session, PCP participants will complete the 
PCP Mindfulness Self-Report Battery, the PCP Clinical Assessment Battery, the PCP Provider 
Resilience Battery, and the Adverse Event Reporting Form. 
 
C.3.d.2. Overview of Patient Study Visits (SEE TABLE 3 IN APPENDIX A): 
 
Screening Visit: 
Behavioral health care providers in primary care will screen patients who express interest in 
participating in a MTPC group and already have a referral from an eligible CHA PCP. In order 
for patients to be screened for enrollment in the MINDFUL-PC study, they will be required to 
have a referral from a participating PCP.   We will create a new EPIC referral process for PCPs, 
such that when a PCP checks off Mental Health, under Question 2 “Where will the patient be 
seen for Psychiatry,” the PCP will be able to select MINDFULNESS.  Then, under “Services 
Requested,” a PCP will be able to specify his or her health center region: “MINDFUL-PC 
Malden”, “MINDFUL-PC Revere”, “MINDFUL-PC Somerville”, or “MINDFUL-PC 
Cambridge”. This streamlined EPIC order will be sent to the MINDFUL-PC Research 
Coordinator via CHA Central Intake.   
 
The “6-3 Rule”: All patients must have a 1-hour behavioral health evaluation within the past 6 
months documented by a CHA clinician in EPIC in order to be eligible to participate in the 
study.  In addition, all patients must have had a visit with their behavioral health care provider 
within the last 3 months.  If a patient has not received a behavioral health evaluation within the 
last 6 months or has not had a behavioral health care visit within the last 3 months, he or she will 
be scheduled for a 1-hour behavioral health evaluation with one of the licensed clinicians who 
have been trained to lead MTPC groups or a licensed clinician who has been trained to conduct 
screening evaluations for the MTPC groups.   
 
In order to be eligible to participate in the MINDFUL-PC study, all patients must have a CHA 
PCP, and a referral from their CHA PCP or a licensed CHA mental health clinician.  . 
 
In order to be eligible to participate in the MINDFUL-PC study, all patients must have a 
MINDFUL-PC Patient Screening Form completed by a behavioral health care provider upon 
performing a behavioral health evaluation.  Patients must fill out a Patient Eligibility 
Questionnaire electronically via an e-mail link to a secure REDCap form or by voice over phone.  
This questionnaire will be reviewed by the MINDFUL-PC PI or Center for Mindfulness and 
Compassion Medical Director, who will then assess the eligibility of the patient and schedule a 
1-hour behavioral health evaluation, if appropriate.  The behavioral health clinician will conduct 
a behavioral health evaluation to determine the patient’s eligibility for the study and to enroll 
patients into the program. Data from the screening interview, MINDFUL-PC Patient Screening 
Form, and Patient Eligibility Questionnaire will be entered into a secure REDCap form.  
 
Since the research study is overlaid on an implementation pilot program, we will rely on the 
assessment of the referring mental health clinician (either a masters or doctoral level clinician) to 
identify patient diagnoses and the presence of any severe mental illness. The Research 
Coordinator or other IRB-approved study staff with non-clinical training, but background in 

 
25 
 
psychology will be reviewing diagnoses on the submitted screening forms. Any diagnoses that 
suggest major mental illness will be reviewed with the PI daily. The PI is a board-certified 
psychiatrist and will decide if a patient with mental illness will be included and excluded from 
the study. If the decision is unclear from the referral documentation, then the principal 
investigator will contact the screening behavioral care provider to discuss the patient’s 
appropriateness for the study. If the patient passes the screening interview, he or she will be 
offered to be scheduled to attend the Mindfulness Orientation Session.  
 
Mindfulness Orientation Session (Prior to Randomization; To be scheduled prior to PT Study 
Week 1): 
This will be a 2.5 hour session.  For the first 1.5 hours, interested patients consent to participate 
in the study and will then complete the pre-treatment survey session.  For the remaining hour, 
patients will be invited to attend a 1-hour orientation to MTPC. Patients will be paid 20 dollars 
for completion of surveys and attendance of 60 minute orientation session. 
 
Informed Consent Session: 
Prior to the beginning of the Mindfulness Orientation Session, patients will be asked to complete 
an Informed Consent Form.  This session will be held either prior to the Mindfulness Orientation 
Session within a clinical space at each participating CHA primary care health center or at the 
CHA Center for Mindfulness and Compassion. Patients will complete informed consent and 
consent assessment in-person upon arrival at the orientation.  Because this intervention is well-
established with more than 1000 studies demonstrating the safety and efficacy of Mindfulness-
based interventions [30], the group represents a low-risk psychoeducational experience.  To 
ensure all patients have access to study personnel and an opportunity to ask questions, patients 
will complete the informed consent form in-person during an Informed Consent group Session 
prior to the beginning of the Mindfulness Orientation Session. With the permission of primary 
care site leadership, we will provide food for patients during the informed consent session.  The 
MINDFUL-PC Research Coordinator or Program Manager and other trained study personnel 
will be present at this Informed Consent Session in order to answer any individual questions.  
The informed consent document will include a full description of the study procedures and 
associated risks. The participant will also be asked to complete an Informed Consent Assessment 
to ensure comprehension of the study procedures, rights of participants, as well as understanding 
of the risks and benefits of the study. The patient will not be able to sign the document without 
having completely correct answers on the consent assessment. After completion, participants will 
be given an additional copy of the signed informed consent form for their own records.  
Participants must give written informed consent in order to participate in the study.  Participation 
in the study is voluntary.  All participants will be notified that they are free to discontinue from 
participating in the study at any time.  All participants will be asked to complete and sign a 
section acknowledging that sessions will be audio-recorded for research purposes. No study-
specific procedures or investigations will be performed before the participant has signed and 
dated the Informed Consent Form.  The signed informed consent forms will be stored in a binder 
in a double-locked cabinet at the Center for Mindfulness and Compassion.  Only IRB-approved 
study staff will have access to this cabinet.     
 
Patients who scored less than 90% on the informed consent assessment will meet individually 
with the Research Coordinator or other approved study personnel who will administer the Rapid 
Estimate of Adult Literacy in Medicine—Short Form (REALM-SF) form [31] to assess patient 
literacy levels.  This is a 7-item word recognition test, which takes about 2 minutes, offers a valid 

 
26 
 
quick assessment of patient health literacy and has excellent agreement with the 66-item 
REALM instrument in terms of grade-level assignments. Patients are instructed to read seven 
words aloud for a member of the study team.  Patients who pronounce fewer than four of the 
words correctly read at a literacy level of 4th to 6th grade.  
 
Initially, in pilot groups in the year 2015, only patients with an English reading proficiency of at 
least a 7th grade level will be included.  Patients with less than a 7th grade reading level in 
English will be excluded from pilot groups in 2015.  In 2016, we will begin to offer MTPC 
groups in other language, to serve patients with limited English proficiency (LEP).  It is our goal 
to offer MTPC groups in Portuguese, Spanish by mid-2016, and to pilot a LEP group for English 
speakers with low levels of literacy.  Once the study protocol and informed consent documents 
are approved by the IRB, we plan to develop translations of the consent form into at least the 3 
most common languages at CHA. The translated informed consent forms will be translated by 
the CHA Department of Translation Services (DTS) and approved by the IRB. Written consent 
will be given by the non-English speaking participant on a translated Informed Consent Form, 
and the participant will receive a copy for his or her own records.   
 
Patients can reach study staff during the Informed Consent Session to review any difficulties 
with the consent assessment or other questions, so that patients have an opportunity to ask any 
necessary questions about the research study prior to completion of the consent. Patients will be 
given the opportunity to review the protocol with a trained study staff member if they fail the 
consent assessment.  Patients will also be given an opportunity to correct their answers on the 
consent assessment. If they can’t pass the assessment after reviewing it and the protocol with the 
coordinator, then they will evaluated by study staff for the presence of low literacy versus 
cognitive deficits disrupting their ability to complete study tasks. If they have cognitive deficits 
that disrupt the ability to complete study tasks, then they may be unable to participate in the 
study. Patients with a score of 90% or higher on the Informed Consent Quiz will be eligible for 
participation in the study. The Principal Investigator is fully responsible for any issues related to 
informed consent, and will ensure that the participant receives adequate written information 
about the aims, procedure, possible risks and benefits of the study and opportunity for oral 
discussion of questions if needed.  
 
Pre-treatment Survey Session Visit: 
The Research Coordinator or other approved study personnel will inform the patient participant 
that he or she must complete a series of surveys before the start of the 1-hour MTPC group 
orientation. Patients will complete the surveys through a link to the secure REDCap database 
using an electronic device in the primary care health center, or using paper surveys, which will 
be entered into REDCap by our IRB-approved study staff.  Any paper surveys will be stored in 
our double-locked filing cabinet in the CMC Research Office.  Electronic devices will be 
provided for patients to take surveys at each participating CHA health center.  
 
In this session, patient participants will complete the Patient Baseline Battery, the Patient 
Mindfulness Self-Report Battery, the Patient Clinical Assessment Battery, the Patient Self-
Management Battery, and the Patient-PCP Relationship Battery. These surveys are expected to 
take the average patient 60 minutes to complete. 
 
MTPC Orientation Session: 

 
27 
 
Patients who have consented to participate in the study and have completed the pre-treatment 
survey session will be invited to stay for the 60-minute mindfulness orientation session.  During 
this session, interested patients will meet for one visit with a behavioral care provider in groups 
of up to 30 participants. This group will be held within a clinical space at each participating CHA 
primary care health center. It will be one hour in length and the behavioral care provider will 
offer a list of mindfulness resources available in the community.  Patients will be reminded that, 
after this session, they will be randomly assigned to either the 8-week or referral to community 
resources and electronic resources and placed on a 6-month waiting list. Details about this 
intervention can be found in section C.3.e.3. 
 
Scheduling Phone Call: 
Once an eligible individual has demonstrated an understanding of the study procedures and 
potential risks of participating, provided written informed consent, completed pre-treatment 
assessments on REDCap, and attended the MTPC orientation session, then he or she will be 
placed onto the waitlist for randomization for the respective health center and assigned a 
randomization ID by health center.  This ID will be entered into a randomized algorithm with 
stratification, which will be used to allot the participant to a study group.  The Research 
Coordinator or another approved member of the research personnel will contact the patient by 
phone to schedule him/her for the specified study group, and a scheduling email will be sent.  
Patient participants will be assigned either to an 8-week MTPC group or to a 6-month waiting 
list for the MTPC group, and will be informed of their placement during the phone call. Patients 
will also be encouraged at this time to ask any questions they might have.   
 
If a participant cannot attend the assigned group, he or she will have to wait to be rescheduled for 
at least 6 months from the completion of his/her pre-treatment assessments.   
 
Biweekly Engagement Phone Call (PT Study Week 1-8): 
All patient participants will receive an ongoing 3-5 minute Participant Engagement phone call 
from a member of the study staff.  This call will be made according to the brief phone script 
attached.  This call will be made every two weeks during Study Weeks 1-8.  The purpose of this 
outreach call will be to provide support for patients in both groups, help participants cultivate a 
relationship with study staff, give participants a place to ask questions, and support participants 
in completing study visits.  The call will have five talking points:  1) How have you been in the 
last 2 weeks?  2) Have you had any issues with completing the weekly Mindfulness Practice 
Diary or the Mindfulness Resources Use Diary?  3) Have there been any issues with your 
participation in the study in general?  4) We appreciate your contribution to the research study 
and encourage you to continue filling out the diaries – just as a reminder you will receive $20 for 
each survey session and $20 if you complete all the weekly diaries.  5) Is there anything else 
you’d like to share with us?  Study staff will complete a call log for all engagement calls, and 
issues raised in these calls will be discussed twice a week in research staff meetings.   
 
Mindfulness Intervention (MTPC Intervention Group; PT Study Week 1-8): 
Patients in the 8-week MTPC program will meet with a behavioral care provider for 8 weeks in 
groups of approximately 6-12 participants, to receive 2 hours of instruction in MTPC. MTPC 
groups will be generally held in the evenings in clinical spaces within each participating CHA 
primary care health center. Between weeks 6 and 7 there will be a weekend 7 hour long day of 
silent practice at locations within the local community or within a nearby CHA hospital facility 
space.  The total duration of the program is 23 hours over 8 weeks with additional expectations 

 
28 
 
for daily home practice by participants. Details about this intervention can be found in section 
C.3.e.4. 
 
Action Plan Study Session (Completed between PT Study Weeks 6-7): 
During Patient Study Weeks 6-7, all patients participating in the MINDFUL-PC program will fill 
out an Action Plan Worksheet and watch a brief SMART goal video (for example: 
https://www.youtube.com/watch?v=1-SvuFIQjK8), which is designed to support the creation of 
a short-term health goal.  Patients randomized to the 8-week MTPC group will receive 
instruction and support during the group in developing health goals for a short-term action plan, 
and communicating these goals effectively to people in their life who might be important 
stakeholders in their health.  Duration:  15 minutes.   
 
After completing the Action Plan Worksheet, patient participants will complete the Action Plan 
Assessment (APA-10), a 10-item scale that evaluates patient behavior in the domains of self-
determination, motivation, shared decision-making, and barrier appraisal.  This survey will be 
completed online in REDCap or on paper, and is expected to take the average patient 5 minutes 
to complete. 
 
Post-treatment Survey Session Computer Visit 1 (Completed between PT Study Weeks 8-12): 
After eight weeks, participants in both groups will be asked to complete another series of surveys 
online on REDCap or on paper. Patient participants will again be given the option to either 
complete the surveys on a device at their PCMH or outside of the office on a computer of their 
choosing.  Electronic devices will be provided to patients in the 8-week MTPC group so that 
they may complete their surveys at their PCMH in the hour following their final weekly meeting.  
Paper survey answers will be transferred to a secure REDCap database by MINDFUL-PC study 
staff, and all paper surveys will be stored in a double-locked filing cabinet.  Research assistants 
(to be hired later) will be available at several scheduled 1-hour sessions at PCMH sites to bring 
electronic devices and offer support for survey completion. Patients assigned to the 6-month 
waiting list may visit their PCMH to use a device to complete their surveys during one of these 
scheduled sessions.  
 
In this session, patient participants will complete the Patient Mindfulness Self-Report Battery, 
the Patient Clinical Assessment Battery, the Patient Self-Management Battery, the Patient-PCP 
Relationship Battery, the Action Plan Initiation Survey (APIS-5), the Weekly Mindfulness 
Practice Diary, the Patient Satisfaction Survey, and the Adverse Event Reporting Form.  These 
surveys are expected to take the average patient 65 minutes to complete. 
 
Post-treatment Survey Session Computer Visit 2 (Completed at PT Study Week 9): 
In this session, patient participants will complete the Action Plan Initiation Survey (APIS-5).  
This survey is expected to take approximately 5 minutes to complete.   
 
Post-treatment Survey Session Computer Visit 3 (Completed at PT Study Week 10): 
In this session, patient participants will complete the Action Plan Initiation Survey (APIS-5).  
This survey is expected to take approximately 5 minutes to complete.   
 
Post-treatment Survey Session Computer Visit 2 (Completed at PT Study Week 16): 
In this session, patient participants will complete the Action Plan Initiation Survey (APIS-5).  
This survey is expected to take approximately 5 minutes to complete.   

 
29 
 
 
 
Follow-up Survey Session Computer Visit (Completed between PT Study Weeks 24-26): 
After six months, both patient groups will complete a survey about attitudes about primary care 
providers. Patient participants will again be given the option to either visit their PCMH to 
complete the surveys on a CHA device, on paper, or complete the surveys outside of the office 
on a computer of their choosing.  Patients requiring interpreters or electronic devices can 
schedule a meeting visit at their PCMH to complete the surveys. These surveys are expected to 
take the average patient 70 minutes to complete. 
 
In this session, patient participants will complete the Patient Mindfulness Self-Report Battery, 
the Patient Clinical Assessment Battery, the Patient Self-Management Battery, the Patient-PCP 
Relationship Battery, the Action Plan Initiation Survey (APIS-5), the Weekly Mindfulness 
Practice and Resources Diaries, and the Adverse Event Reporting Form. 
 
Waitlist patient participants must complete the following study requirements in order to be 
eligible for a spot in the next MTPC group once their 6-month study participation has ended:  
three 45-minute study survey batteries, the Action Plan Worksheet, 1 of 3 Action Plan Follow-
Up Surveys, and 6 of 8 weekly Mindfulness Practice/Resource surveys. 
 
Action Plan Interview (Completed after PT Study Week 26):  After completing the study, 
participants will have an opportunity to give comments about their experience in the MINDFUL-
PC program.  
 
This interview will last for 20-30 minutes and will be conducted according to the Action Plan 
Interview Guide.  Participants will be invited to interview via e-mail. Interviews will be recorded 
using a USB-based device that attaches directly to the telephone line.  No identifying 
information beyond first name will be used in the interviews.  Participants will always be asked 
permission before turning on the recording device – if they decline permission, no recording will 
be made.  Recording devices will be stored in the secure research office double-locked filing 
cabinet when not in use, and will only be accessed by IRB-approved study staff.  Recording files 
will be kept on CHA’s secure study G Suite server and will only be accessible by IRB-approved 
study staff.   Recordings will be transcribed using a transcription service with whom we have a 
HIPAA BAA agreement in place following IRB approval, such as Spext.com.  A sample of the 
email communication to participants is presented below: 
 
“Dear (Participant Name),  
 
Thank you so much for your participation in the MINDFUL-PC study. We would like to invite 
you to share your experience with the MINDFUL-PC Program, especially the action planning 
process. This will take place in a 20-30 minute phone call with one of our research staff. Your 
response is confidential, and will be incredibly useful feedback on how we can make this 
program better for future participants. You may decline this invitation if you do not wish to share 
your experience. If you are interested, please let us know and we will arrange a time with you.” 
 
The calls will be conducted by a research assistant who has a strong background in qualitative 
research methods and phone interviewing and who has also fully grasped the objectives of the 
Action Plan Interview Guide (see supporting materials). If needed, other team members may be 

 
30 
 
trained to conduct the action plan interview by learning the objectives in the Action Plan 
Interview Guide, sitting in on two Action Plan Interview calls, and conducting one “test” call 
with another study staff member.  
 
C.3.d.3. Overview of Patient Study Visits in Experimental fMRI pilot study (SEE TABLE 4 IN 
APPENDIX): 
 
Orientation Session Reminder Phone Call and Email Confirmation: 
Participants will be informed about the fMRI pilot study during a phone call before the 
MINDFUL-PC orientation session. In the email-confirmation for the orientation session, we will 
further include the flyer with information on the fMRI pilot study and the information sheet 
about the fMRI study.  We will also let participants know about the possibility to enroll as part of 
the concurrent cohort in an optional health behavior tracking study, the Health, Eating, 
Activity, and Rest Tracking (HEART) pilot study.   
 
Orientation: 
During the orientation session, patients will be informed on the voluntary, additional fMRI pilot 
study. Patients will also be informed that they will only be able to participate in the fMRI pilot 
study if they get randomized to the MTPC condition and are eligible to this fMRI study. 
Randomization will be conducted based on the MINDFUL-PC study protocol. Patients will hear 
basic information about neuroimaging (e.g. safety, experience in the scanner, such as noise, 
limited space to move, etc.) and they will receive a flyer with information on the 
inclusion/exclusion criteria for the fMRI study, as well as further information on MRI and fMRI, 
and contact information for reaching neuroimaging personnel at the Martinos Center. 
Participants will also be given an informational flyer and a brief verbal description of the 
HEART study. Participants wishing to participate in the HEART study may do so without 
participating in the fMRI pilot study. 
 
 
Group Scheduling Phone Call: 
During the scheduling phone call for the mindfulness group only, patients are asked about their 
interest in the optional fMRI pilot study. We will then screen interested mindfulness group 
participants verbally, using a phone screening interview based on the Martinos Center MRI 
Patient Screening form and the Edinburgh Handedness Inventory (see phone script Pt Protocol - 
Randomization Status Phone Call). We will assess if participants fulfill all criteria related to the 
fMRI study. Participants will be given the opportunity to ask questions they have regarding the 
study, the flyer, the information sheet or other aspects regarding the fMRI. Some screening 
questions represent an immediate exclusion from the study (see phone screening script), other 
items represent potential risks, and require further clarification. In this case, the responsible 
Operations Manager and Chief MRI Technologist at the Martinos Center for Biomedical 
Engineering will be contacted by the neuroimaging post-doctoral fellow, with the necessary 
information to decide the safety for fMRI scanning for a patient with a certain condition. In case 
the responsible Operations Manager cannot confirm MRI safety, the patient will be excluded 
from the fMRI study. Participants will also be asked if they have used any illicit drugs in the past 
30 days, and any drug use could result in exclusion from the study based on the clinical judgment 
of the PI. If a patient fulfils all eligibility criteria, we will then schedule an fMRI measurement 
scan session. If the patient needs additional time to decide about participating in this study or if 
we have to make additional enquiries based on the MRI eligibility screening, we will arrange a 

 
31 
 
follow-up phone call with the patient (within 1-2 days of the group-scheduling phone call), to 
decide on study participation and potentially schedule the fMRI measurement. 
 
C.3.d.4. Overview of Patient Visits in HEART pilot study (see Table 4 in APPENDIX) 
 
HEART Pilot Study Informed Consent Session: 
 
Concurrent Cohort:   
 
Participants are first notified of the opportunity to enroll in the HEART study during the 
MINDFUL-PC confirmation phone call to attend MINDFUL-PC orientation. Following this, at 
the in-person orientation, participants will be led through the verbal and written consent process 
for MINDFUL-PC.  Once they have signed their MINDFUL-PC consent forms, they are eligible 
for the HEART study and will be given the HEART study information packet, as well as the 
HEART study informed consent form. A doctoral level member of the research staff will then 
guide participants through a verbal introduction of the HEART study, informing them of the 
invitation to voluntarily participate, reviewing study inclusion and exclusion criteria, and 
providing a chance to ask any questions. If after this in-person review, interested participants will 
be invited to sign the HEART study consent form.  If an interested participant does not 
understand or agree to study requirements after the verbal introduction and a chance to ask 
questions, the doctoral level research staff member conducting the orientation session will decide 
to exclude the participant from the HEART study.   
 
Upon completion of the HEART study informed consent form, participants will be given an 
additional copy of the signed informed consent form for their own records.  The signed informed 
consent forms will be stored in a binder in a double-locked cabinet at the Center for Mindfulness 
and Compassion.  Only IRB-approved study staff will have access to this cabinet. 
 
The study staff member will then create a unique Participant ID, specific to the HEART study, 
for each participant, which will be used for all data collection in the HEART study.  The form 
that contains the linking information between each Participant ID and each participant will be 
stored in a double-locked filing cabinet in the CMC Research Office, and will only be accessible 
by IRB-approved study staff.  The participant will also be assigned a study-specific Gmail 
address and password, which will serve as their login credentials for the smartphone activity 
tracking application. To ensure confidentiality, the Gmail address will have no identifiable 
information or information related to their Participant ID.  
 
At the end of the MINDFUL-PC orientation, participants who express interest in participating in 
the HEART study will be scheduled by one of the research assistants to come for an in person 
45-minute Behavioral Measures visit, which will be conducted on an individual basis. In this 
visit participants will complete three behavioral measures tasks, install any required smartphone 
applications, be introduced to wristband activity trackers if applicable, and be given a chance to 
ask any questions. Participants are reminded that they will repeat the Behavioral measures visit 
once more during weeks 8-9 of the study.   
 
 
HEART Pilot Study Sessions: 
Concurrent Cohort:   

 
32 
 
 
Timing: HEART study participants participating in the concurrent cohort will complete the 
behavioral tasks 1 week prior to MTPC Session 1 of the intervention (Part 0) (applies to both 
waitlist and intervention arms), and will complete daily behavioral tracking surveys during Part 
0, and for 4 weeks starting at MINDFUL-PC Study Week 5 (Parts 1 and 2).  Part 1 is study 
weeks 5-6, and Part 2 is Study Weeks 7-8.  Participants will complete the second behavioral 
tasks visit between Study Weeks 8 and 9.     
 
Inclusion/Exclusion criteria:  Participants must either be newly enrolling in the MINDFUL-PC 
study or be joining a MINDFUL-PC primary care group after having completed their 6-month 
study requirements in the low-dose comparator group. Participants must have access to a 
smartphone that is compatible with the activity tracking application, participants must be willing 
to attend the two behavioral task sessions, to use the smartphone application and/or wristband 
tracking device each day during the study collection periods, and participant must be willing to 
fill out online surveys at home.   
 
HEART Study Tasks: Participants will do the following tasks on a daily basis for the duration 
of the HEART study: 
 
 Mindfulness Practice Diary:  Fill out the MINDFUL-PC weekly mindfulness practice 
diary and resource use diary daily for 1 week prior to MTPC Session 1 of the intervention 
and then for 4 weeks during Weeks 5 through 8.    
 
 Activity Tracking:  Install and use a smartphone application related to activity tracking, 
e.g., Argus or a similar version of commercially available activity tracking app, etc., and 
use this app every day for 1 week prior to MTPC Session 1 of the intervention and then 
for 4 weeks during Weeks 5 through 8. The Argus App is compatible on both Android 
and iOS platforms. Participants will install any required smartphone applications during 
their first Behavioral Tasks visit, with the guidance of a research study staff member. 
Participants will sign into the application using a coded Participant ID.  During feasibility 
testing, we will assess the utility of wristband trackers. If feasible and appropriate for the 
study, the principal investigator may decide for all participants to also be given a 
wristband activity tracker to wear on the wrist each day. Data will be collected using a 
coded Participant ID.  If they are given a wristband, then the participant will need to 
return the wristband to the study team upon completion of the study in order to receive 
final reimbursement  
 
 Food, Activity, and Sleep Tracking (FAST) Questionnaire:  Participants will be asked 
to fill out the FAST Questionnaire on a daily basis for 1 week prior to MTPC Session 1 
of the intervention and then for 4 weeks during Weeks 5 through 8. This questionnaire 
will contain questions adapted from the Automated Self-Administered 24-Hour Dietary 
Assessment Tool (ASA24) and the National Sleep Foundation Sleep Diary.   
 
 Behavioral Tasks Session 
 
Participants will be asked to complete the Behavioral Tasks component during an in-
person behavioral tasks session that takes place prior to Week 1 of the MINDFUL-PC 

 
33 
 
study and then again between Weeks 8 and 9.  This behavioral tasks session will be 
scheduled during the orientation session to the MINDFUL-PC and HEART studies. 
During this behavioral tasks session, participants will first download any required 
smartphone applications for activity tracking with the guidance of a research study staff 
member. Then, they will complete three behavioral tasks in the following order: the 
Heartbeat Detection Task (HBDT), 5-Trial Adjusting Delay Hypothetical Discounting 
Task (HDT), and Sustained Attention to Response Task (SART). Each task is described 
in brief below (see Section C.3.f.7 for more a detailed description):  
 
 Heartbeat Detection Task (HBDT): Participants are asked to count their heartbeat  
during three varying time intervals (30s, 30s, 60s).  In parallel, individuals’ heart-rate 
will be measured by Kardia Mobile technology. Participants will place their index 
and middle fingers of both hands on top of the Kardia Mobile device and will be 
instructed to count their heartbeat for a period of 30 or 60 seconds. The readings from 
this device are linked to the Kardia Mobile App, which will be on a screen faced 
away from the participant[1].  Participant data stored in the Kardia Mobile app will be 
identified with the HEART Study participant ID, which will not be linked to any 
identifying information.   
 
 5-Trial Adjusting Delay Hypothetical Discounting Task (HDT): This is a brief 
delay discounting task performed on a computer that assesses an individual’s 
impulsivity by presenting a series of 5 discrete choice questions between some 
amount of a delayed commodity (in this case, dollars) and half that amount available 
immediately (e.g. “Gain $1000 in 3 weeks or gain $500 now”).   Individuals choose 
whether they would rather receive a smaller amount of money now, or a larger 
amount in the future[2, 3].   
 
 Sustained Attention to Response Task (SART): Participants will complete a series 
of computerized tests focused on sustained attention, response inhibition, and self-
regulation. They are asked to press a key in response to rapidly displayed integers (1-
9) and withhold a response to a designated “no-go” integer[4].  
 
These tasks will be conducted in a quiet, closed, and gently lit room located at the Center 
for Mindfulness & Compassion (26 Central St, Somerville, MA 02143) or at a CHA 
primary care location. Participants will sit on a chair with their feet flat on the floor, 
forearms on the table, and with a desktop or laptop computer screen in front of them. The 
research staff member will explain each task to the participant before conducting the trial, 
and will provide a one-minute break between each task.  
 
 
fMRI Pilot Study Informed Consent: 
Participants will be given the informed consent form for the fMRI study at the fMRI session. 
During the fMRI session, we give participants time to read the consent and answer any questions 
they might have regarding the informed consent form. We will ask the participant to sign the 
informed consent in the presence of a doctoral-level staff. 
 
Pre-fMRI Session Preparation Phone Call: 

 
34 
 
Participants will be contacted 96 hours prior to the session and reminded to abstain from alcohol 
and cannabis for at least 72 hours and from other illicit drugs throughout the study. If a person is 
not ready to comply with this rule the PI may exclude the patient from the fMRI pilot study 
(while the patient can still participate in the main study).  
Participants will be given $10 towards the taxi fare or public transport costs to and from the 
Athinoula Martinos Center for Biomedical Imaging. Participants can also receive free parking at 
the Martinos Center. If a participant expresses discomfort or insecurity to reach the 
neuroimaging site, study staff can offer to accompany participants to the Athinoula Martinos 
Center for Biomedical Imaging. 
 
Pre-fMRI Session Reminder Phone Call: 
Patients will again be contacted 24 hours prior to the session and reminded to abstain from 
alcohol or cannabis and to make sure patients are still able to come to the scheduled fMRI visit. 
 
Pre-treatment fMRI Session Visit: 
At the fMRI visit, participants will be asked to complete a salivary oral fluid toxicology test for 
alcohol and illicit drug use. For alcohol-testing we will use the One Step Alcohol Saliva Test 
Strip (Confirm Biosciences). Participants will apply saliva directly to the reaction pad for 10 
seconds. After 2 minutes the test will inform us about alcohol blood level concentration. For 
illicit drug testing, we will use the SalivaConfirm Premium - 5 Panel Instant Oral Cube Drug 
Test Kit (Confirm Biosciences), which tests for the use of Amphetamine and Methamphetamine 
(detects use within the last 72 hours), Cocaine (last 24 hours), Opiates (last 48 hours), Marijuana 
(last 14 hours). Participants will put the sponge end of the collection stick into the mouth and 
soak into saliva for 3 minutes. If the patient is positive representing any level of intoxication with 
substances, then the patient will be excluded immediately from the experimental fMRI study, 
and will not undergo the fMRI scan. The excluded patient can still participate in the main 
MINDFUL-PC study. Women will be asked during the screening phone-call if they are pregnant 
or planning to conceive, which would result in exclusion from the fMRI study. Women of 
childbearing potential (without active contraception) are further offered to take a urine pregnancy 
test at the fMRI visit, to confirm that they are not currently pregnant (TestCountry's Strip 
Pregnancy Tests). Results are available within 5 minutes. A positive pregnancy result on site will 
result in immediate exclusion from the fMRI study, but not from the MINDFUL-PC study. After 
toxicology and pregnancy testing, participants will fill in the Martinos Center Patient Screening 
Form. This form is mandatory before every scan session. All items have been screened during 
the Group Scheduling Phone Call so that potential risks can been assessed, before scheduling the 
fMRI visit. If however the Martinos Center Patient Screening Form shows any contra-indications 
for fMRI, the responsible Operations Manager and Chief MR Technologist at the Martinos 
Center will be contacted immediately. In case the responsible Operations Manager can not be 
reached or cannot confirm MRI safety, the patient will be excluded immediately from the fMRI 
study, and will not be scanned. 
 
Before the fMRI measurement, study staff will place sensors and a belt on the participant to 
measure heart rate, breathing rate, and skin conductance during fMRI tasks. Participants will 
complete structural scans, a resting state scan, inhibitory control task, self-compassion task, 
diffusion tensor scan, interoceptive attention task and emotion/pain regulation task. The pain 
regulation task involves a pressure cuff which is placed on participant’s calf and is inflated for 
periods of 30 seconds to a medium intense pain, as rated by the participants (50 out of 100, with 
100 being the worst pain imaginable). After the scan, patients will answer questions regarding 

 
35 
 
experiences during the task (tiredness, pain, concentration, experience during the resting state 
and tasks). Patients will also schedule a time slot for their post-treatment fMRI Session Visit. 
 
Post-treatment fMRI Session Visit: 
Patients will complete salivary testing for illicit drugs and alcohol to prevent anyone who is 
intoxicated from participating in the fMRI session. If the patient is intoxicated with alcohol or 
cannabis, then the patient will be asked to reschedule for the experimental fMRI follow-up 
session to prevent a wasted session; however, given the initial fMRI data collection, post-
treatment fMRI scanning will still be obtained if the patient can return in a sober state. All 
participants will need to complete the fMRI testing within 2 weeks after completion of the 
MTPC group. Patients will complete the same sequence of structural and resting state scans, an 
inhibitory control task, self-compassion task, diffusion tensor imaging, interoceptive attention 
task and emotion/pain regulation task. 
 
C.3.e. Study Interventions: 
 
C.3.e.1. MBSR: 
Mindfulness-based Stress Reduction (MBSR) [32] was created by Jon Kabat-Zinn, Ph.D., in 
1979.  The program includes eight weekly classes, each 2.5 hours in duration, as well as a 7-hr 
day of silent practice.  MBSR emphasizes both ‘formal’ and ‘informal’ mindfulness meditation 
practices.  Formal methods include sitting meditation, walking meditation, body scan meditation, 
and gentle hatha yoga.  Informal practices emphasize mindfulness in daily life, and include 
awareness of breathing, awareness of pleasant and unpleasant events, and purposeful awareness 
of everyday activities like eating, walking, and interpersonal communication.  MBSR involves 
weekly home assignments for both formal and informal practice.  Classes have a common flow 
and involve group exercises, guided formal practice, and opportunities for group and individual 
dialogue about difficulties and developments of formal and informal practices.  
 
C.3.e.2. Mindful Communication: 
Mindful Communication [33] offers a 10-month continuation phase following MBSR for 
medical providers, which meets monthly for 2.5 hours.  This course emphasizes three major 
components: mindfulness; narrative medicine, “the creation and sharing of reflective stories that 
explore the profound and meaningful experiences one has as a physician”; and appreciative 
inquiry which focuses on examining and framing patterns of individual thinking and behavior as 
“strengths and capacities to be enhanced and extended.”  Each class has a common flow of 
activities maintained from MBSR, as well as an overarching theme.  Themes include 
“teamwork”, “uncertainty in medicine”, “aspiration”, and “suffering in medicine.” 
 
C.3.e.3. Mindfulness Orientation Session: 
This hour-long informational session will involve both experiential and informational 
introduction sections.  The class will begin by answering the question “What is mindfulness?” 
and group leaders will offer evidence for supporting mindfulness.  Group leaders will then guide 
the class in an experiential session.  The orientation session is designed to foster a commitment 
to do the 30 minutes or more per day at home practice; to give the participants a ‘taste’ of the 
mindfulness practices that will be presented in the classes and to process with the prospective 
participant the experience of the practice; to inform the patient about the logistics of the class; to 
review the specific upcoming course schedule; to meet the specific leaders for the upcoming 
group; to learn about risks and benefits of the MTPC program; and to give patients an 

 
36 
 
opportunity to ask questions. The orientation session will conclude with an explanation of 
internal and external resources for continuing mindfulness education, and will offer patients a 
referral to these resources.   
 
C.3.e.4 MTPC: 
Mindfulness Training for Primary Care (MTPC), is a modified version of MBSR for delivery as 
group psychotherapy modality within patient-centered medical homes. MTPC offers a series of 
eight weekly, two-hour core sessions delivered in a group format with a seven hour day of silent 
practice between weeks 6 and 7.  MTPC will follow the same structure as MBSR, but will also 
include a weekly topic to be discussed for 20 minutes per class for each of the 8 weeks and the 
integration of a PCP illness management/health maintenance appointment to be held during week 
6-7 of the group.  The weekly themes are as follows: 
 
 
Part A: Sessions 1-4 are primarily focused on learning to pay attention. 
Week 1: From Autopilot to Befriending the Body and Mind 
Week 2: Perception and Rediscovering “Beginner’s Mind”  
Week 3: Pleasure and Freedom in Being Present 
Week 4: Staying Present with Pain, Difficulty, Illness and Stress 
Part B: Sessions 5-8 are focused on illness self-management and skills for changing health 
behaviors. 
Week 5: Allowing What Is: The Bedrock Needed to Support Change  
Week 6: Skillful Action and Skillful Communication   
Week 6-7 Action Plan Worksheet:  The purpose of this worksheet is to support the 
patient in generating his/her own short-term action plan. 
Week 5-7 Full-Day Session: The purpose of this 7-hour full-day session is to integrate 
mindfulness practices learned in earlier sessions and deepen personal practice.   
Week 7: Cultivating Kindness towards Self and Others 
Week 8: The Rest of Your Life 
 
 
C.3.f. Measures: 
 
The Rapid Estimate of Adult Literacy in Medicine—Short Form (REALM-SF) [34] will be 
used to assess patient literacy levels.  This is a 7-item word recognition test that offers a valid 
quick assessment of patient health literacy and has excellent agreement with the 66-item 
REALM instrument in terms of grade-level assignments. Patients are instructed to read seven 
words aloud for a member of the study team.  Patients who pronounce fewer than four of the 
words correctly read at a literacy level of 4th to 6th grade. Duration: 2 min. 
 
C.3.f.1. Baseline Battery for Patient Participants: 
A Survey of Meditation and Mindfulness Experience (SMME) will assess the participant’s 
previous experience with meditation and Mindfulness-based interventions, both over their 
lifetime and in the past two weeks.  This will be a brief questionnaire.  Duration: 5 min.  
 
A brief demographics survey will note patient race, ethnicity, optional sexual and gender 
identity, primary language, income, and other quantifiable attributes.  Duration: 5 min. 

 
37 
 
 
Patients who note that they smoke in the demographics survey will be prompted to complete the 
Fagerström Test for Nicotine Dependence (FTND) [35] on REDCap.  This is a widely used 
self-rating scale that provides a quantitative measure of nicotine dependence and will be 
administered at the screening visit to determine level of nicotine dependence. The 6-item scale 
includes: smoking rate, time between waking and first cigarette, smoking when ill, difficulty 
refraining from smoking where it is forbidden, smoking more heavily in the morning, and 
reporting that the first cigarette of the day would be the most difficult to give up. A score greater 
than or equal to 6 indicates high nicotine dependence. Duration: 3 min. 
 
C.3.f.2. Baseline Battery for PCP Participants: 
A Survey of Meditation and Mindfulness Experience (SMME) will assess the participant’s 
previous experience with meditation and Mindfulness-based interventions, both over their 
lifetime and in the past two weeks.  This will be a brief questionnaire.  Duration: 5 min.  
 
The Mindfulness Knowledge and Attitudes Questionnaire for Primary Care (MKAQ-PC) is 
adapted from Mindfulness Knowledge and Attitudes Questionnaire Administered to Psychology 
and Medical Students from McKenzie et al. [36].  This is an 8-item scale that examines 
providers’ previous experience with and general outlook on the incorporation of Mindfulness 
into health care.  Some of the items ask providers to rate their experience with or knowledge of 
Mindfulness from (a) nonexistent to (e) extensive.  Providers are also asked about their 
willingness to incorporate Mindfulness into patient care.  An example item is “To what extent do 
you think MBIs may have further potential for treating a range of other health problems? (a) 
nonexistent (b) mild (c) moderate (d) good (e) extensive.”  Duration: 5 min. 
 
A brief demographics survey will note PCP race, ethnicity, gender, and other quantifiable 
attributes.  Duration: 5 min. 
 
C.3.f.3. Mindfulness Self-Report Battery for Patient and PCP Participants:  
The Five Facet Mindfulness Questionnaire (FFMQ) [37] is a 39-item scale that examines five 
factors that represent aspects of the current empirical conception of mindfulness.  These five 
facets include: “observing, describing, acting with awareness, non-judging of inner experience, 
and non-reactivity to inner experience.”  An example item is “I pay attention to how my 
emotions affect my thoughts and behavior.” Participants rate their degree of agreement with each 
of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or 
always true), with higher scores indicating higher experience of mindfulness. Duration: 8 min.  
 
The short-form Self-Compassion Scale (SCS-SF) [38] is an abbreviated 12-item form of the 
original 26-item Self-Compassion Scale.  This scale evaluates six different aspects of self-
compassion: Self-Kindness (e.g., ‘‘I try to be understanding and patient toward those aspects of 
my personality I don’t like’’), Self-Judgment (e.g., ‘‘I’m disapproving and judgmental about my 
own flaws and inadequacies’’), Common Humanity (e.g., ‘‘I try to see my failings as part of the 
human condition’’), Isolation (e.g., ‘‘When I feel inadequate in some way, I try to remind myself 
that feelings of inadequacy are shared by most people”), Mindfulness (e.g., ‘‘When something 
painful happens I try to take a balanced view of the situation’’), and Over-Identification (e.g., 
‘‘When I’m feeling down I tend to obsess and fixate on everything that’s wrong.’’).  The scale is 
scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale 
items are reverse scored. Duration: 4 min. 

 
38 
 
 
The Difficulties in Emotion Regulation (DERS) Scale [39] is a 36-item self-report scale 
designed to assess emotional dysregulation.  The scale assess 6 aspects of emotional 
dysregulation:  non-acceptance of emotional responses (“When I’m upset, I become embarrassed 
for feeling that way”), difficulties engaging in goal directed behavior (“When I’m upset, I have 
difficulty thinking about anything else”), impulse control difficulties (“When I’m upset, I lose 
control over my behaviors”), lack of emotional awareness (“When I’m upset, I take time to 
figure out what I’m really feeling (reverse-scored)”, limited access to emotion regulation 
strategies (“When I’m upset, it takes me a long time to feel better”), and lack of emotional clarity 
(“I have no idea how I am feeling”).  Duration: 5 min.  
The Multidimensional Assessment of Interoceptive Awareness (MAIA) [40] is a 32-item self-
report scale designed to assess multiple aspects of interoception and interoceptive awareness.  
The scale assesses 8 aspects of interoceptive awareness:  noticing (“I notice when I am 
uncomfortable in my body”), not-distracting (“I do not notice (I ignore) physical tension or 
discomfort until they become more severe”), not-worrying (“I start to worry that something is 
wrong if I feel any discomfort”), attention regulation (“When I am in conversation with 
someone, I can pay attention to my posture”), emotional awareness (“I notice that my breathing 
becomes free and easy when I feel comfortable”), self-regulation (“When I am caught up in 
thoughts, I can calm my mind by focusing on my body/breathing”), body listening (“I listen to 
my body to inform me about what to do”), and trusting (“I feel my body is a safe place”).  
Duration:  5 min.   
 
C.3.f.4. Clinical Assessment Battery for Patient Participants : 
The Depression Anxiety Stress Scale (DASS-21) [41] is a 21-item scale that evaluates distress 
in the subscales of depression, anxiety, and stress.  Each subscale receives a total score that 
corresponds to a numerical value defining the aspect as mild, moderate, severe, or extremely 
severe.  Each item is scored on a 4 point Likert scale (0 = Never; 5 = Almost Always) 
considering the participant’s experience in the past week.  An example item includes “I found it 
difficult to relax.”  Duration: 3 min. 
 
The Patient Health Questionnaire-2 (PHQ-2) [42] is a 2-item scale that is used to screen for 
depression.  PHQ-2 asks participants to indicate the frequency with which they have experienced 
the items on the scale in the past two weeks, ranging from 0 (Not at all) to 3 (Nearly every day).  
For example, the scale asks patients how often in the past few weeks they have felt “Little 
interest or pleasure in doing things.” A participant’s total score can be used to evaluate the 
probability that the participant expresses major depressive disorder or any depressive disorder. 
(Note: The PHQ-2 will not be used with PCPs). Duration: 1 min.  
 
The Perceived Stress Scale (PSS) [43] measures the degree to which situations in life are 
stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one 
finds one’s life.  Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often).  
An example question is, “In the last month, how often have you felt difficulties were piling up so 
high that you could not overcome them?”  Positively stated items are reverse scored before all 
scale items are summed to yield a total score. Duration: 3 min.   
 

 
39 
 
The consumption subscale of the Alcohol Use Disorders Identification Test (AUDIT-C) [44] 
is a 3-item modified version of the original 10-item AUDIT scale, used to identify harmful 
drinking behavior or alcohol use disorders in patients.  Each question has a set of five possible 
answer choices, ranging in frequency.   For example, the question “How often do you have six or 
more drinks on one occasion?” is followed by these five possible answers:  “(a) Never; (b) Less 
than monthly; (c) Monthly; (d) Weekly; (e) Daily or almost daily.”  The points allotted to each 
score are: a = 0 points, b = 1 point, c = 2 points, d = 3 points, e = 4 points.  A score of four or 
greater indicates harmful drinking behavior or alcohol use disorder in men.  A score of three or 
greater indicates the same in women.  The greater the score, the more likely the drinking 
behaviors are affecting the patient’s health or safety.  Patient participants will complete this 
survey before they begin the study group and again after 8 weeks.  Duration: 1 min. 
 
The DSM-V Survey of Substance Use is adapted from the DSM-5 Self-Rated Level 1 Cross-
Cutting Symptom Measure [45].  The 23-item original measure is intended to be used in research 
or clinically to help clinicians rapidly identify areas of patient behavior that require further 
examination.  This 11-item adapted version includes only the domain of substance use, which 
asks three questions about drinking, smoking, and substance use in the past two weeks. Items are 
rated on a 5-point scale of frequency, from 0 (Not at all) to 4 (Nearly every day). The survey 
includes questions such as “During the past TWO (2) WEEKS, about how often did you use any 
of the following medicines ON YOUR OWN, that is, without a doctor’s prescription, in greater 
amounts or longer than prescribed? … Painkillers (like Vicodin, Percocet, Oxycodone).” The 
answers to each item will be summed to yield a total score.  Duration: 3 min. 
 
The Patient Reported Outcomes Measurement Information System – Depression Short 
Form 8a (PROMIS-DSF) [46, 47, 48] is an 8-item scale used to assess patient-reported health 
status for depression.  PROMIS instruments are funded by the National Institutes of Health 
(NIH) and used to reliably and validly measure patient-reported outcomes for clinical research 
and practice.  Participants are asked to rate their experience of the item in the past seven days on 
a 5-point scale from 1 (Never) to 5 (Always).  With use of the PROMIS Assessment Center 
Scoring Service, a T score is generated from participant responses.  A sample item includes “I 
felt that nothing could cheer me up.” Duration: 4 min. 
 
The Patient Reported Outcomes Measurement Information System – Anxiety Short Form 
8a (PROMIS-ASF) [49, 50] is an 8-item scale used to assess patient-reported health status for 
anxiety.  PROMIS instruments are funded by the National Institutes of Health (NIH) and used to 
reliably and validly measure patient-reported outcomes for clinical research and practice.  
Participants are asked to rate their experience of the item in the past seven days on a 5-point 
scale from 1 (Never) to 5 (Always).  With use of the PROMIS Assessment Center Scoring 
Service, a T score is generated from participant responses.  A sample item includes “My worries 
overwhelmed me.” Duration: 4 min. 
 
C.3.f.5. Clinical Assessment Battery for PCP Participants: 
The Depression Anxiety Stress Scale (DASS-21) [51] is a 21-item scale that evaluates distress 
in the subscales of depression, anxiety, and stress.  Each subscale receives a total score that 
corresponds to a numerical value defining the aspect as mild, moderate, severe, or extremely 
severe.  Each item is scored on a 4 point Likert scale (0 = Never; 5 = Almost Always) 
considering the participant’s experience in the past week.  An example item includes “I found it 
difficult to relax.”  Duration: 3 min. 

 
40 
 
 
The Perceived Stress Scale (PSS) [52] measures the degree to which situations in life are 
stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one 
finds one’s life.  Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often).  
An example question is, “In the last month, how often have you felt difficulties were piling up so 
high that you could not overcome them?”  Positively stated items are reverse scored before all 
scale items are summed to yield a total score. Duration: 3 min.   
 
C.3.f.6. Self-Management Battery for Patient Participants:  
The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) [53] is a 6-item scale that is 
used to evaluate a participant’s ability to self-manage care for a chronic disease. SECD-6 asks 
participants to rate their confidence in their own ability to do certain activities, on a scale from 1 
(not at all confident) to 10 (totally confident).   For example, the scale asks patients to indicate 
“How confident are you that you can do the different tasks and activities needed to manage your 
health condition so as to reduce your need to see a doctor?”  A participant’s score for the scale is 
calculated as the mean of the six items.  Duration: 3 min. 
 
The Patient Activation Measure (PAM) [54] is a 13-item scale that is designed to evaluate a 
participant’s ability to be an effective and informed manager of his or her own health and health 
care.  Participants are asked to rate their agreement with each statement on a 0-100 metric where 
0 = the lowest possible activation and 100 = the highest possible activation as measured by this 
set of items.  The PAM survey generates an overall score on a 0-100 scale for each patient, and 
can segment patients into one of four activation levels along an empirically derived continuum.  
Statements include: “I am confident that I can follow through on medical treatments I may need 
to do at home.” Duration: 4 min. 
 
The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control 
measure from Jerant et al. [55] and a previously validated survey from Armitage et al. [56].  This 
5-item scale ask participants to rate their sense of control over chronic illness self-management 
on a 7-point scale from 1 (None) to 7 (Total).  Items include “How much personal control do you 
have over your self-management behaviors?”  Duration: 3 min. 
 
Action Plan Worksheet/SMART Goal Video:  Patient participants will complete the Action 
Plan Worksheet and watch a brief video about creating SMART goals (for example, 
https://www.youtube.com/watch?v=1-SvuFIQjK8) in PT Study Week 7.  The Action Plan 
Worksheet is a 13-item worksheet that incorporates information about SMART goals to support 
patient participants to make a goal about their health in one of 3 categories (activity 
level/exercise, diet/eating/drinking, or mindfulness meditation practice).  Patients are encouraged 
to share this worksheet with a person who may help the patient in accomplishing the goal, and/or 
a healthcare provider.  Duration:  15 min. 
 
Patients will complete the self-report Action Plan Assessment (APA-10) questionnaire after 
filling out the Action Plan Worksheet, at PT Study Week 7.  This survey instrument is developed 
as an adaptation of two self-determination theory scales [57] [58] and incorporates elements of 
shared decision-making [59] and self-efficacy and barrier appraisal [60].  This 10-item scale 
evaluates patient behavior in the domains of self-determination, motivation, shared decision-
making, and barrier appraisal.  Participants are asked to rate their agreement with a statement on 

 
41 
 
a 7-point scale from 1 (Strongly Disagree) to 7 (Strongly Agree).  A sample item includes “I 
have agreed to this action plan because I want to do it for myself.” Duration: 5 minutes. 
 
Patient self-reported Action Plan Initiation Survey (APIS-5) will be administered at post-
treatment (PT Study Week 8, 12, and 16).  This 5-item questionnaire is adapted from a measure 
used by Guck et al. [56].  In this questionnaire, patients are asked to list their action plan goals 
generated with their PCP, and determine whether they met or did not meet each goal. Patients are 
asked to categorize their goals into one of six categories:  diet/eating/drinking, exercise/activity, 
sleep, medication, reducing substance use, and self-care. For each unmet goal, patients are asked 
to rate the cause of not meeting the goal on an attributional rating scale using a 7-point format. 
Higher scores indicate internal rather than external and uncontrollable rather than controllable 
attributions.  A sample item includes: “Was the cause of not meeting this goal controllable by 
you?” where 1 is “Extremely controllable” and 7 is “Not at all controllable.” Duration: 5 
minutes.  Participants in the HEART pilot study in the concurrent cohort will fill this out as per 
the main study timeline.  Participants in the HEART pilot study alumni cohort will fill this out at 
the end of HEART study Weeks 4 and 5.   
 
The Three-Factor Eating Questionnaire-R18 (TFEQ-R18) is an 18 item questionnaire that 
refers to current dietary practice and measures 3 different aspects of eating behavior: restrained 
eating (conscious restriction of food intake in order to control body weight or to promote weight 
loss), uncontrolled eating (tendency to eat more than usual due to a loss of control over intake 
accompanied by subjective feelings of hunger), and emotional eating (inability to resist 
emotional cues). The TFEQ-R18 consists of 18 items on a 4-point response scale (definitely 
true/mostly true/mostly false/definitely false). Responses to each of the 18 items are given a 
score between 1 and 4 and item scores are summated into scale scores for cognitive restraint, 
uncontrolled eating, and emotional eating. An example item includes “Sometimes when I start 
eating, I just can’t seem to stop.” Duration: 5 minutes.  
 
C.3.f.7. HEART Pilot Study Battery: 
 
Activity Tracking Smartphone Application:  Participants will install a free activity tracking 
smartphone application, which is compatible on both Android and iOS platforms. One example 
is the Argus application by Azumio or another commercially available Smartphone application 
with similar features, which can track the number of steps taken. Participants will be asked to 
carry their phone on their person (can be in a bag or pocket) during the day to enable activity 
tracking.   
 
The Argus application (http://www.azumio.com/s/argus/index.html) and other Azumio 
applications have been included in multiple NIH-funded studies, including the Big Data to 
Knowledge (BD2K) at Stanford University Mobilize Center (http://mobilize.stanford.edu/), and 
has shown feasibility as a compatible and safe method for collecting data in their clinical trials. 
We also may use wrist-worn devices offered by MD2K, which is a NIH-funded national 
initiative to use mobile sensor data in clinical trials (https://md2k.org/). Recognizing the rapid 
changes in the consumer market, we hope to keep flexibility in the activity tracking app used; 
Argus currently stands as a good example, and we will notify the IRB if we choose an app that is 
substantially different in function or safety profile. 
 
Activity Monitoring Duration: 2 minutes daily 

 
42 
 
 
Wristband Activity Tracker: During feasibility testing, we will assess the utility of wristband 
trackers. If feasible and appropriate for the study, the principal investigator may decide for all 
participants to also be given a wristband activity tracker to wear on the wrist each day. We are 
considering use of one of several types of wristbands: Fitbit, Moov, Jawbone, Withings, MD2K 
Cerebrum, or Garmin Vivosmart. Recognizing the rapid changes in the consumer market, these 
are examples of what we may use and are listed here for flexibility of choice.  Study staff will 
notify the IRB if we choose a wristband tracker that is substantially different in function or safety 
profile.  Participants will be given instructions on how to wear, charge, and sync their wristband 
tracker. Data will be collected, stored, and extracted using a coded Participant ID.  The 
participant will need to return the wristband in working condition to the study team upon 
completion of the study in order to receive final reimbursement. For information about 
confidentiality related to use of the wristband, please refer to section D.1a: Protection of Subject 
Privacy.  
 
Food, Activity, and Sleep Tracking (FAST) Questionnaire: Participants will be asked to fill 
out a daily questionnaire about their food, activity, and sleep tracking. The survey is adapted 
from the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) and the 
National Sleep Foundation Sleep Diary.  
 
The ASA24 was released in 2009 by the NIH and the National Cancer Institute as a web-based 
tool that enables multiple, automatically coded, self-administered 24-hour recalls. This tool was 
designed for use by research participants, clinicians, patients, and students. The ASA24 asks 
detailed questions about food form, preparation, portion size, and additions using an extensive 
branching logic database. The ASA24 was designed to be culturally sensitive and accessible by 
individuals using assistive technologies. Features of the ASA24 respondent website can be found 
here (https://epi.grants.cancer.gov/asa24/respondent/features.html). A demo version of the 
respondent site can be found here (https://asa24.nci.nih.gov/demo/).  
 
The FAST Questionnaire asks participants what time they went to bed, what time they got out of 
bed, the total hours slept, any naps taken during the day, then about the timing and amount of 
alcoholic and caffeinated drink consumption. It also asks if they exercised throughout the day 
and then further asks how long they performed each type of exercise.  
 
The food tracking portion asks subjects what main meals they ate in a day. For each main meal, 
subjects are asked how fast they ate, what they were doing while they ate, what food groups were 
included in their meals, and how much they ate. It also asks subjects if they ate any food outside 
of their main meals, and then asks how many times they eat each type of food.  
 
Duration: 10 minutes.   
 
Action Plan Creation – Participants in the concurrent cohort of the HEART pilot study will 
fill out the Action Plan Worksheet, the APA-10, and the APIS-5 as regularly scheduled for the 
main MINDFUL-PC study.  Participants in the alumni cohort of the HEART study will fill out 
the Action Plan Worksheet and the APA-10 at the end of HEART study Week 3. They will fill 
out the APIS-5 at the end of HEART study Weeks 4 and 5.   
 
Action Plan Creation Duration: 20 minutes 

 
43 
 
Action Plan Initiation Survey Duration: 5 minutes 
 
Behavioral Tasks 
 
Participants will be asked to complete the Behavioral Tasks component during an in-person 
behavioral tasks session that takes place prior to Week 1 of the MINDFUL-PC study and then 
again between Weeks 8 and 9.  This behavioral tasks session will be scheduled during the 
orientation session to the MINDFUL-PC and HEART studies. During this behavioral tasks 
session, participants will first download any required smartphone applications for activity 
tracking with the guidance of a research study staff member. Then, they will complete three 
behavioral tasks in the following order: the Heartbeat Detection Task (HBDT), 5-Trial Adjusting 
Delay Hypothetical Discounting Task (HDT), and Sustained Attention to Response Task 
(SART). Each task is described in brief below.  Each task is described in further detail below:  
 
Heartbeat Detection Task (HBDT) [Total time:  10 minutes]: Participants are asked to count 
their heartbeat during three varying time intervals (30s, 30s, 60s).  In parallel, individuals’ heart-
rate will be measured by Kardia Mobile technology. Participants will place their index and 
middle fingers of both hands on top of the Kardia Mobile device and will be instructed to count 
their heartbeat for a period of 30 or 60 seconds.  Participants will place their hands on top of the 
Kardia Mobile devices and then will be given instructions on how to count their heartbeat (e.g. 
“We will have you complete this task three times at varying time intervals. When I say ‘begin’ I 
want you to try your best to detect and count your heart beat. When I say ‘stop’ please let me 
know how many times you think your heart beat during the time interval. Try your best.”). The 
readings from this device are linked to the Kardia Mobile App, which will be on a screen faced 
away from the participant[1]. Participant data stored in the Kardia Mobile app will be identified 
with the HEART Study participant ID, which will not be linked to any identifying information.  
The Kardia Mobile app will be installed onto an iPad that is kept within the research office.  Data 
from the  Kardia mobile app will be wirelesswritten down by hand on a handout that is filed in 
the study binder and then entered by a study staff member into the secure CHA REDCap 
database once the behavioral tasks session has been completed.    
 
 
Figure 1: Kardia Mobile device and interface. Participants place two fingers on either side 
of the Kardia Mobile Device, which will then produce a live reading of their EKG** (Image 
taken from alivecor.com)[1].   

 
44 
 
 
 
 
 
**Although Kardia Mobile can be used 
as an FDA-approved EKG, in this study, 
we will not be conducting analysis on 
participants’ heart rhythms and will not be 
able to determine whether a participant’s 
heartbeat rhythm is irregular. This task 
does not, in any way, serve as a diagnostic 
test for heart disease or heart rhythm 
abnormalities. If the reading does register 
any heartrate abnormalities, such as 
arrhythmia, we will not inform the 
participant of the readings as the research 
staff are not trained to deliver healthcare 
related information. We will also not 
document any information about 
abnormalities in the database. Only heartrate will be measured. This will be clearly stated in the 
consent form.    
 
5-Trial Adjusting Delay Hypothetical Discounting Task (HDT) [Total time:  5 minutes]. 
This is a brief delay discounting task performed on a computer that assesses an individual’s 
impulsivity by presenting a series of 5 discrete choice questions between some amount of a 
delayed commodity (in this case, dollars) and half that amount available immediately (e.g. “Gain 
$1000 in 3 weeks or gain $500 now”).   Individuals choose whether they would rather receive a 
smaller amount of money now, or a larger amount in the future This task will be run using a 
Python script on a designated research study laptop which will be password-secured and stored 
in a double-locked cabinet in the CMC research office, only accessible by approved study staff.  
Participants will be identified by their HEART study Participant ID, and data will be transferred 
from this laptop to a CHA-secure research drive using secure CHA wireless[2, 3].     
 
Sustained Attention to Response Task (SART) [Total time:  25 minutes]. Participants will 
complete a series of computerized tests focused on sustained attention, response inhibition, and 
self-regulation. They are asked to press a key in response to rapidly displayed integers (1-9) and 
withhold a response to a designated “no-go” integer.  This task will be run using E-Prime 
software on the password-protected study laptop.  Participants will be identified using their 
HEART study Participant ID and data will be transferred to a CHA-secure research drive using 
secure CHA wireless[4].     
 
 
These tasks will all be conducted in a quiet, closed, and gently lit room located at the Center for 
Mindfulness & Compassion (26 Central St, Somerville, MA 02143). Participants will sit on a 
chair with their feet flat on the floor, forearms on the table, and with the computer screen in front 
of them. The research staff member will explain each task to the participant before conducting 
the trial, and will provide a one-minute break between each task.  
 
 

 
45 
 
C.3.f.8. Provider Resilience Battery for PCP Participants: 
The Maslach Burnout Inventory (MBI) [61] is the primary scale for assessing burnout.  This 
study will use the original measure, MBI-Human Services Survey, a 22-item scale created for 
professionals in the human services.  This scale examines the perspective with which 
professionals view their occupation and the people they work with.  Items are rated on a 7-point 
Likert scale from 0 (never) to 6 (every day).  An example item is: “I worry that this job is 
hardening me emotionally.” The survey contains subscales for examining the factors of 
emotional exhaustion, depersonalization, and personal accomplishment.  Scores are summed for 
each subscale, and indicate high, moderate, or low levels of the subscale factor (for example, 
high emotional exhaustion).  Scores are usually reported as an average rating for each subscale, 
rather than a total score. Duration: 4 min.     
 
The 31-item Workplace Wellbeing Scale (WWS) [62] measures workplace satisfaction and can 
be used to compare data across various categories such as gender and occupational level.  Items 
on this scale are evaluated as four subscales: work satisfaction, organizational respect for the 
employee, employer care, and intrusion of work into private life.  Summed items for each 
subscale generate a numerical score that corresponds to low, medium, or high levels of each 
subscale (for example, low employer care is indicated by a score between 0-7 for the employer 
care subscale).  The WWS includes questions such as “Does your work eat into your private 
life?”  Each item is scored on a 5-point Likert scale from 0 (Not at all) to 4 (Extremely).  Positive 
questions are reverse scored. Duration: 4 min. 
 
The Jefferson Scale of Empathy (JSE) [63] is a 20-item scale that evaluates self-reported 
empathy among health care professionals.  This study will make use of the JSE HP-version for 
practicing health care professionals.  Items are scored on a 7-point Likert scale from 1 (Strongly 
Disagree) to 7 (Strongly Agree).  An example item includes “I try to imagine myself in my 
patients’ shoes when providing care to them.” Duration: 5 min. 
 
C.3.f.9. Weekly Mindfulness Practice Diary Card: 
The Weekly Mindfulness Practice Diary Card will be completed for the week preceding its 
administration.  Carmody et al. [64] emphasizes that improvements in mindfulness, symptoms, 
and wellbeing are significantly related to formal and informal mindfulness practice.   This card 
asks participants to specify the type and duration of formal mindfulness techniques they 
completed each day for the past week, as well as the type and frequency of informal techniques 
each day.  Formal mindfulness techniques include body scan, sitting meditation, loving kindness, 
and informal mindfulness practices include techniques like connecting with breath and mindful 
awareness of eating.  A participant’s total practice for the week will be calculated by study 
personnel, based on the information on the diary card that will collected by group leaders 
weekly.  This will also be completed by all patient participants, despite their group assignment, 
during the Post-Treatment Survey Session at patient study week 8, as well as during the Follow-
up Survey Session, at patient study week 36.  Participants in the MTPC group will fill out the 
practice diary on a scantron sheet, and participants in the control group will fill out the practice 
diary on an online REDCap form.  Duration: 6 min. 
 
This card will be completed each week by PCP participants in Group 1 for study weeks 1-8, the 
mid-study survey session, Mindful Communication months 1-10, and the post-study survey 
session.  PCP participants in Group 2 will complete this card for the week preceding the mid-
study survey session and the week preceding the post-study survey session.   

 
46 
 
 
Patient participants in the MTPC Group and in the Waitlist Group will complete the mindfulness 
practice diary card every week for patient study weeks 1-8, throughout their MTPC training.  
Both groups of patient participants will complete this card for the week preceding the post-
treatment survey session and the week preceding the follow-up survey session. Participants in the 
concurrent cohort of the HEART pilot study will also complete this survey for 1 week prior to 
MTPC Session 1 and for four weeks during MINDFUL-PC study weeks 5 and 9.   
 
C.3.f.10.  Mindfulness Resources Use Survey: 
The Mindfulness Resources Use Survey is a 7-item weekly survey that asks about the 
frequency of use of community or mobile mindfulness resources as listed on the Community 
Resources handout given to all patients during the orientation session.  This survey asks patients 
whether they have visited local mindfulness or meditation centers in person, whether they have 
used mindfulness guided recordings or apps online, and whether they have read any mindfulness-
related books. It also asked about some related activities where people often practice mindfulness 
such as yoga, spiritual activities, and places of worship. A patient’s total mindfulness resource 
utilization will be calculated by study personnel weekly.  This survey will be completed by every 
study participant for Study weeks 1-8, and during the Follow-Up Survey Session at patient study 
week 36.  Participants in the MTPC group will fill out the resources diary on a scantron sheet, 
and participants in the control group will fill out the resources diary on an online REDCap form.    
Participants in the concurrent cohort of the HEART pilot study will also complete this survey 
for 1 week prior to MTPC Session 1 and for four weeks during MINDFUL-PC study weeks 5 
through 9.  Duration:  5 min.   
 
C.3.f.11. Reports from Electronic Medical Records for Patient Participants: 
The Physician Quality Reporting System (PQRS) [65] is used by Center for Medicare and 
Medicaid Services to provide incentive payments that are dependent on quality measures in 
health care.  This list includes several community and behavioral health outcomes for PCPs to 
complete and document. Patient electronic medical records reports will be generated on a 
monthly basis by the executive office of the Chief Quality Officer at CHA for several specific 
data points for all patients for the month that they enter the study and again at one year after 
entrance into the study. The PQRS variables include documentation of patient alcohol use, body 
mass index (BMI), patient health questionnaire (PHQ-2), HgAlc, LDL-C, smoking cessation 
attempts, cigarettes per day, frequency of meat eating, blood pressure, risky sexual behaviors, 
quantity of prescribed opioids and sedatives, and illicit drug use. If the research personnel cannot 
find patient health outcome values for the previous year, they will contact the patient’s primary 
care provider via EPIC to encourage the provider to document the current relevant PQRS quality 
variables into the medical record prior to the start of the patient’s participation in the study. After 
study week 18, study staff will again send an EPIC note to flag PCPs to remind them about 
entering their patients’ upcoming annual health quality variables into EPIC, which will be 
assessed around week 26. Patients who were on the waitlist will be requested to have an 
appointment at PCP office to get PQRS data documented prior to return to study for new group 
orientation. 
 
Patient responses to the Patient Health Questionnaire-2 (PHQ-2) during the course of standard 
primary care and the number of current psychotropic medications prescribed will be downloaded 
to the research database from EPIC on a yearly basis for up to 3 years after the start of the study 

 
47 
 
in order to assess for longitudinal effects on depressive mood and psychiatric symptoms among 
each group. 
 
Number of medical visits will be collected though EPIC for each patient for the year before and 
the six months after randomization. This will include a record of the number of visits with the 
patient’s PCP, the number of outpatient medical visits, the number of inpatient medical stays, 
and the number of visits to the emergency department (ED).  Chronic disease self-management 
programs have been shown to reduce patient visits to the ED [39]. In order to account for effects 
of recent health issues and seasonality, ED visits from the past six months and the 7-12 month 
period prior to study entry will both be used as covariates in the analysis. 
 
Patient no-show rates will also be collected through EPIC as frequency counts from the year 
before and the six months after randomization. Programs emphasizing patient activation and 
empowerment have been shown to increase attendance to scheduled patient visits [66].In order to 
account for effects of recent health issues and seasonality, attendance rates from the past six 
months and the 7-12 month period prior to study entry will both be used as covariates in the 
analysis. 
 
Patient action plans, created by patients and providers at the PCP visit and reported in EPIC, 
will be reviewed and collected through EPIC.  Goal-setting exercises can be used to support 
chronic illness management [67]. Using these data, a member of the MINDFUL-PC research 
study team will compile a coded list of patients and their action plan goals. 
 
C.3.f.12. Satisfaction Battery for Patient Participants: 
Patient participants will complete the MTPC Program Satisfaction Survey after 8 weeks of 
participation in the study.  This 18-item survey contains two parts. First is a series of 12 
questions scored on a 5-point Likert scale from 1 (Strongly Disagree/Poor) to 5 (Strongly 
Agree/Excellent), with statements such as “I found this program helpful.”  Next is a series of six 
open-ended questions in which patients enter a written response to statements including “The 
most important thing I learned during this program.”  Duration: 5 min. 
 
C.3.f.13. Adverse Events Reporting Battery for Patients:  
The Adverse Event Patient Participant Self-Report Form will be completed at the 8-week 
survey session and 6-month survey sessions.  This form asks that parameters be described for 
each AE.  The parameters are detailed below in D.2. 
 
C.3.f.14. Experimental fMRI pilot study screening battery: 
We will phone screen interested MINDFUL-PC group participants for fMRI eligibility, using an 
fMRI screening phone interview, including items from the Edinburgh Handedness Inventory 
(EHI) [61]. This is a 10-item standard measurement scale used to assess the dominance of a 
person's right or left hand in everyday activities. Left-handers have less lateralization of brain 
function and can confound fMRI studies.  
 
Further eligibility questions are based on the Martinos Center Patient Screening Form. Questions 
are related to metal implants, pacemakers, aneurism clips and other implants and stimulators that 
might be unsafe for scanning. The form will also ask about pregnancy and breastfeeding, past 
severe head trauma, claustrophobia or other conditions that might exclude them from 
participating in the fMRI study. We will also screen for vascular disease in the legs, such as 

 
48 
 
peripheral vascular disease, lymphedema, and varicose veins, in order to exclude those for whom 
the cuff pain task may not be safe. The fMRI screening form will be assessed during the phone 
call. The duration of the phone screening is 10 minutes total. The Martinos Center Screening 
Form will be acquired again before each scan session, and this will take 3-5 minutes.   
 
We will conduct saliva toxicology for alcohol and illicit drugs at the Martinos Center before 
each MRI session. Duration 5 min. 
 
In case a woman is not on contraception and has doubts about current pregnancy status, she will 
be given the option to conduct a urine pregnancy screen before each MRI session. Duration 5 
min. 
 
We will conduct fMRI neuroimaging before and after the MTPC group. Each session will also 
include autonomic monitoring of heart rate, breathing rate, and skin conductance. Duration 90 
min. 
 
fMRI questionnaire:  Patients who undergo fMRI neuroimaging will be asked to complete a set 
of fMRI questions that ask about fatigue, concentration, and presence of pain before and after the 
pain cuff task (Duration:  5min).    
 
C.3.g. Instructor Experience, Fidelity, and Supervision: 
 
We have developed a detailed plan for training, monitoring and supervising staff that will deliver 
the intensive behavioral training interventions, as well as for maintaining adherence to protocol.   
 
All MTPC groups will be conducted by clinicians with at least a master’s degree and successful 
completion of the MTPC training program (described below in section C.4.) Participant-
observers will be CHA primary care staff, CHA mental health clinicians, CHA mental health 
care partners, or CHA trainees.  MTPC groups, MTPC group leaders, and MTPC participant-
observers will be supervised by the CMC clinical medical director (Todd Griswold, MD), and 
the intervention fidelity will be reviewed by the principal investigator (Zev Schuman-Olivier, 
MD) and expert MBSR teacher trainers, Zayda Vallejo and Elana Rosenbaum. Group Leaders 
will be invited to participate in weekly group supervision by web conferencing with Zayda and 
Elana while they are leading groups. MTPC sessions will be audio-recorded in order to rate 
fidelity (measured as competence and adherence) to the manual, as well as to provide feedback 
to MTPC Group Leaders to prevent therapist drift.  At the end of each MTPC session, group 
leaders will fill out a survey of content covered in each MTPC session, rating each other for 
coverage of content.  Group Leaders will review these surveys during supervision.  A treatment 
satisfaction survey will be given at the end of group session #8 to assess for patient impressions 
of the treatment experience and the group leader’s qualities, and these will be reviewed by the 
Research Coordinator and project manager after the end of each group. If a group leader has 
below average scores, then the principal investigator will be notified in order to take appropriate 
corrective measures. 
 
C.3.h. Participant Withdrawal/Termination Criteria: 
Withdrawal/Termination criteria for Patient Participants: 
Participants may be discontinued from study treatment and assessments at any time.  Specific 
reasons for discontinuing a patient participant from this study are: 

 
49 
 
1. Voluntary discontinuation by the participant who is at any time free to discontinue his or her 
participation in the study, without prejudice to further treatment 
2. Safety reasons as judged by the investigator  
3. Severe non-compliance to protocol as judged by the investigator  
4. Incorrect enrollment (i.e., the participant does not meet the required inclusion/exclusion 
criteria) of the participant 
5. Participant lost to follow-up 
6. Revealing private information about the study 
7. Active substance use disorder or intoxication during study procedures 
8. English proficiency below a 7th grade reading level 
 
Withdrawal/Termination criteria for PCP Participants: 
Participants may be discontinued from study treatment and assessments at any time.  Specific 
reasons for discontinuing a PCP participant from this study are: 
1. Voluntary discontinuation by the participant who is at any time free to discontinue his or her 
participation in the study, without effect on the relationship with CHA 
2. Safety reasons as judged by the investigator  
3. Severe non-compliance to protocol as judged by the investigator  
4. Incorrect enrollment (i.e., the participant does not meet the required inclusion/exclusion 
criteria) of the participant 
5. Participant lost to follow-up 
6. Revealing private information about the study 
7. Active substance use disorder or intoxication during study procedures 
8. PCP withdraws from practice at a CHA PCMH 
 
Participants who discontinue will be asked about the reason(s) for their discontinuation and the 
presence of any adverse events.  If possible, they will be seen and assessed by the Principal 
Investigator.  Serious and Unexpected Adverse events will be followed up. 
 
If participants enrolled in MTPC groups are terminated from group treatment for any reason 
(except incorrect enrollment or safety concerns that endanger the study team), then they will still 
be expected to complete their outcome assessments, unless the participant revokes informed 
consent.   
 
C.4. Implementation plan: 
 
C.4.a. MTPC Group Leader Training (See Figure 2 below): 
As explained above, this study with 2 x 2 factorial design involves both PCPs and patients as 
study participants.  In addition, CHA behavioral health specialists will receive training during the 
course of this study to become MTPC group leaders who will provide MTPC groups for patient 
participants. PCMH behavioral health specialists will concurrently attend the 2.5-hr MBSR 
group with PCPs (Group 1a), and will also attend an additional 30-60 minute long educational 
practicum each week.  After the conclusion of the 8-week MBSR course, behavioral health 
specialists will receive an additional 32 hours of training over two weekends to become staff 
MTPC group leaders.  For the first year following their certification, these MTPC group leaders 
will receive weekly group supervision led by senior mindfulness teachers with supervision from 
the medical director of the Center for Mindfulness and Compassion who is a board-certified 
psychiatrist.  

 
50 
 
Figure 2. Timeline for proposed training activities for PCP participants 
PCP Training 
 
Medicine 
Grand 
Rounds 
 
Phase 1a: MBSR 
training 
 
Phase 1b: 
 
Phase 2: Mindful Communication 
Primary care 
providers 
8 MBSR 
sessions 
(2.5 hours 
each) for 
Group 1a 
MBSR 
all-day 
retreat 
Weekend 
retreat for 
Group 1b 
Monthly meetings for 10 months 
(2.5 hours each) 
Group Leader 
Training 
Psychiatry 
Grand 
Rounds 
Phase 1: MBSR with 
PCPs 
 
Phase 2:  
Group Leader training 
Phase 3: 
Supervision 
Behavioral health 
clinicians  
8 MBSR 
sessions + 
practicum 
(3.5 hrs 
each) 
MBSR 
all-day 
retreat 
Weekend 
Retreat 1 
(16 hrs)  
Jan 2015 
Weekend 
Retreat 2 
(16 hrs) 
Feb 2015 
Weekly 
Group MTPC 
Group 
Leader 
Supervision  
(9 months, 
1.5 
hrs/week) 
 
 
 
 
 
 
 
 
 
Timeline: 
 
10/1/2014 
 
10/22/2014 - 
12/17/2014 
 
1/9/2015-
1/11/2015 
 
1/16/2015 - 12/16/2015 
 
C.4.b. Current Implementation Staging Map: 
 
Each primary care region will be assigned a hub based on space and staffing considerations. 
During training, primary care provider champions and behavioral care leaders will be identified 
within each regional primary care region to support recruitment and implementation at sites in 
their region. This program aims to begin patient enrollment in September 2015 at 2 regional hub 
primary care centers with groups starting around October 2015.  After this first round of groups 
are completed, we will review the process to evaluate for improvements prior to a second round 
of groups. Additional health center group space will likely become available in late 2015 to add 
two additional centers as group sites, as well as the potential use of CHA hospital group rooms to 
provide MTPC groups, bringing the total to 6 PCMHs with on-site groups. We will begin 
recruitment for groups that meet the needs of cultural and linguistically diverse communities 
with several different groups for LEP patients starting in late 2016.  We plan to offer MTPC 
groups in Spanish and Portuguese by early Fall 2016.  Planning for a third implementation step 
will await development of space and a further roll-out in integration of mental health into the 
patient-centered medical homes in order to expand to the full set of sites.   
 
The PCMHs included in the project will be: Cambridge [Cambridge Family Health, Cambridge 
Family Health North, East Cambridge Health Center, Windsor Street Health Center], Somerville 
[Broadway Health Center, Union Square Family Health, and Somerville Hospital Primary Care], 
MCREW [Everett Family Health Center, Revere Family Health Center, Malden Family 
Medicine Center]. Hub centers for the initial rollout are noted with asterisks. All implementation 
plans are still in flux and represent our best estimation for the implementation; however, 
decisions will continue to be made in ongoing collaboration with Lynn Budlong, VP for 
ambulatory operations and primary care, as well as the team leading the primary care behavioral 
health integration (including Christine Claypool, Emily Benedetto, Colleen O’Brien, and Bob 
Joseph).  
 
Table 4. MTPC Implementation Schedule 
 
Location 
Estimated Start Month 

 
51 
 
First PCMH Step (Somerville Hospital Primary 
Care and Malden Family Medicine Center) 
October 2015 
Second PCMH Step (2-4 additional Centers) 
June 2016 
MTPC Groups in Portuguese and Spanish 
September 2016 
Third PCMH Step (3 Final Centers) 
(And continuing to add language-specific 
patient groups) 
Awaiting development of space 
and roll-out of mental health 
integration into primary care  
 
C.5. Data management and analysis: 
 
C.5.a. Data management: 
Research data will be obtained expressly for research purposes and will be in the form of 
responses to questionnaires and assessment tools. Signed informed consent forms, and informed 
consent assessments will be stored in a double-locked filing cabinet at the Center for 
Mindfulness and Compassion.  Only IRB approved research team members will have access to 
this filing cabinet.  All other study data will be collected and managed using REDCap electronic 
data capture tools hosted at The Cambridge Health Alliance [68].  REDCap (Research Electronic 
Data Capture) is a secure, HIPAA compliant, web-based application designed to support data 
capture for research studies.  This platform provides the following elements: 1) an intuitive 
interface for validated data entry; 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common statistical 
packages; and 4) procedures for importing data from external sources. The REDCap software 
was developed by Vanderbilt University and has been obtained and installed for usage at the 
Cambridge Health Alliance.  
 
Patient level and clinician level data for this study will be stored electronically in the REDCap 
platform. Only IRB approved research team members will have access to the REDCap data 
platform. Each team member will be granted access to the REDCap data system through a secure 
login. 
 
C.5.b. Data Analysis: 
 
We will use SAS 9.3 to conduct analyses for each of the specific goals or hypotheses associated 
with the study’s primary aims: 
 
1. Implementation Goal: Our implementation goals are a) to implement at least two MTPC 
groups in at least 8 CHA primary care sites within two years, b) to train at least 25 
Primary care providers in Mindful Communication, c) to enroll a socioeconomically-
diverse population of patients, and d) to enroll a culturally-diverse population of patients 
with at least 30% of patients completing the program being non-Caucasian or having a 
primary language other than English.   
 
We will examine descriptive statistics for each of the stated implementation goals. 
 
2. PCP-Patient Relationship Hypothesis: We hypothesize greater satisfaction with the PCP-
patient relationship among patients with the combination of provider and patient 
mindfulness training compared with only one or neither training types. 

 
52 
 
 
Mixed Effects Modeling to evaluate for main effects of PCP mindfulness training and main 
effects of Patient training level (1 hour vs. 8 week) for each survey, as well as the interaction 
effect with relevant covariates.    
 
3. Health Outcomes Hypotheses: We hypothesize reductions in depression, anxiety and 
stress as a main effect of MTPC. Finally, we hypothesize reductions in use of 
medications prescribed for symptom reduction (benzodiazepines, opioids, etc.), overall 
improvement in markers of health maintenance and chronic illness management (i.e. 
PQRS data). We hypothesize the highest levels of initiation and maintenance of self-
management action plans among MTPC group with Mindfulness-trained providers. 
 
Mixed Effects Modeling to evaluate for main effects of PCP mindfulness training, main effects 
of Patient training level (1 hour vs. 8 week) for each outcome, as well as the interaction effect 
with relevant covariates.       
 
4. Provider Resilience Hypothesis: We hypothesize greater workplace well-being, reduced 
experience of burnout, and increased resiliency among providers as a main effect of 
provider MBSR + Mindful Communication training. 
 
We will use Mixed Effects Modeling to evaluate for main effects of PCP mindfulness training 
and time for each survey and the interaction of the two.    
 
5. Medical Regimen Adherence Hypotheses: We hypothesize a main effect of MTPC group 
status on levels of initiation and maintenance of medical regimen health behavior change, 
as measured by the APIS-5 self-report score. The highest levels will be demonstrated 
among the MTPC group participants with mindfulness-trained providers. We hypothesize 
that total formal mindfulness practice, post-study total mindfulness score, baseline 
mindful non-judgment score, and self-compassion will be associated with successful 
initiation and maintenance of action plans. Action plan initiation will be validated by 
increases in step count, and increases in number of active periods, changes in sleep, 
changes in mindfulness practice, and changes in nutritional habits. 
 
Using an intent-to-treat analysis, we will use logistic regression and Mixed Effects Modeling to 
evaluate for main effects of MTPC, mindfulness-trained PCPS, and the interaction of the two on 
binary and continuous ratings of level of action plan initiation and maintenance. We will conduct 
exploratory linear regression models of post-study mindfulness and self-compassion and overall 
practice dose as independent variables with level of action plan initiation and maintenance as 
dependent variables. 
 
The experimental fMRI pilot analyses methods are described below. 
 
6. Self-Regulation Mechanisms Hypotheses: In 4 different fMRI tasks, we hypothesize (a) 
greater activation of ACC and OFC and decreased activation in the 
amygdala/hippocampus after MTPC intervention compared to before intervention (i.e, a 
pre/post increase) in an emotional Go/NoGo inhibitory control task, as in Perez 2016 
[69], using validated emotional pictures (International Affective Pictures System, IAPS, 
[70]).The task includes 448 IAPS pictures (50% neutral and 50% unpleasant), which will 

 
53 
 
be presented briefly (1.5 seconds), while participants either react (Go) or withold a button 
press reaction (NoGo), depending on abstract symbols presented on top of the pictures; 
(b) greater activation of mid-posterior insula after (compared to before) MTPC in a self-
compassion task (that contrasts a self-reassurance condition with a self-criticism 
condition), as in Longe 2010 [71]; (c) greater insula activation during an interoceptive 
attention task (that contrasts an interoceptive attention condition with an exteroceptive 
attention condition) as in Farb 2013[72], and d) increases in the rostral ACC (rACC) and 
ventromedial prefrontal cortex (vmPFC) during the anticipation of pain after compared 
to before MTPC and increased activation in the lateral prefrontal cortex (LPFC) and 
somatosensory areas during pain after compared to before the MTPC, as in Kim 2013 
[73]. We hypothesize that all inhibitory control and interoceptive targets will be 
associated with higher levels of initiation of regimen adherence, while self-compassion, 
emotion/pain regulation, and interoceptive targets will be associated with higher levels of 
regimen maintenance. 
 
We will follow current recommended methods for fMRI data analysis [74,75], especially in the 
case of longitudinal data [76-82]. Our approach is based on a priori regions-of-interest (ROI), a 
method more statistically powerful than whole-brain analyses since it limits the number of 
statistical tests to the voxels included in the ROI and thereby reduces Type I errors [83, 84]. 
Another advantage of using a ROI-based approach is that it enables precise spatial 
correspondence of the region of interest across subjects, since it does not involve normalizing 
different brains to a common atlas [87]. In this study, our ROIs are the following: OFC and 
amygdala/hippocampus (in the emotional Go/NoGo task), the mid-to-posterior section of the 
insula (in the self-compassion task, and emotion/pain regulation task), the anterior insula (in the 
interoceptive attention task) the DLPFC and rACC/vmPFC in the emotion/pain regulation task 
and Go/NoGo task. 
 
The fMRI data will be analyzed using the following standard software packages: FSL [85, 86], 
FreeSurfer [87-90], AFNI [91, 92], and RETROICOR [93] for retrospective correction of 
physiological motion artifacts using our peripheral measures of cardiac and respiratory activity 
as independent assessments of physiological noise in the blood oxygen level-dependent (BOLD) 
signal. Following standard preprocessing steps (de-warping, slice timing correction, motion 
correction, removal of physiological noise signals), the statistical analysis of brain activation data 
will be performed using a linear mixed effects (LME) model, following recent recommendations 
for longitudinal fMRI analysis [76, 79, 80]. This approach is implemented in the AFNI software 
package with the group analysis program 3dLME [80]. This program will be used to solve the 
LME system (via built-in optimization procedures) and test our hypotheses. Of note, the LME 
approach is more general than the commonly-used General Linear Model (GLM), AN(C)OVA, 
regression, and t-tests, while including those as special cases. The LME approach is 
recommended for longitudinal fMRI data analysis because it includes in the model the 
covariance structure of serial measurements performed in the same subject, whereas the 
commonly-used GLM model assumes that there is no such correlation, which is incorrect in the 
case of longitudinal data [80]. In addition, the LME framework can offer superior statistical 
power in detecting longitudinal group differences [79, 80]. 
 
Self-Regulation hypothesis testing for the fMRI data will be performed as follows. For each of 
the 4 fMRI tasks, we will use a Linear Mixed Effects model of the BOLD signal in the ROIs 
associated with that task (described above), with 2 time points (pre- and post-intervention). The 

 
54 
 
model will include the following regressors of interest: gender, age, and the following pre-
intervention scores: depression (PROMIS-DSF), anxiety (PROMIS-ASF), self-compassion 
(SCS-SF), and mindfulness (FFMQ); and the following regressors of no interest: head motion 
parameters and cardiac and respiratory components of physiological noise. Hypothesis will be 
expressed as: Is there any significant difference between the 2 time points in the task-specific 
ROI activation during a) NoGo trials versus Go trials, b) self-reassurance versus self-criticism, c) 
Interoception-versus-Exteroception, and d) expectation of pain and pain versus rest. The null 
hypothesis will be that the ROI activation at the 2 time points are not significantly different. 
Significance testing will be done using permutation/bootstrapping methods (see [79, 80]). 
 
1. HEART pilot study analysis plan: The HEART pilot study aims to recruit 40 participants 
in the alumni cohort and 30 participants (10-20 in the waitlist arm and 20-40 in the 
intervention arm) in the concurrent cohort for a total of 70 participants. The data would 
be examined for correlations between the action plan initiation 7-item survey and pre-
post differences in step count, the number of active periods, changes in sleep duration, 
changes in mindfulness practice, and change in nutritional habits depending on which 
action plan goal was specified in the patient action plan. We will also examine the 
percentage of action plan initiation events >5 on the APIS-5 that have a corresponding 
behavioral change evidenced in the daily data collection. Finally, we will also examine 
whether the activity changes are greater in the participants who selected exercise as 
compared to those who selected nutrition or dietary changes and vice versa. 
 
C.5.c. Sample Size calculations: 
Using an intent-to-treat analysis with 290 patients receiving mindfulness training and 144 
patients with orientation only, there will be an 80% chance of detecting a significant difference at 
a two-sided 0.05 significance level. This assumes that the rate of action plan initiation is 0.54 in 
orientation only (based on Guck et. al. [70]) and the rate of action plan initiation among patients 
who receive mindfulness training is 0.68 (based on rates of initiation and maintenance of 
meditation practice in previous pilot MBIs [94]). After the first twenty participants complete the 
program, an interim analysis of these pilot data may be used to refine the sample size calculation 
for RCT. 
 
D. Human Subjects Procedures and Confidentiality 
 
D.1. Confidentiality: 
 
D.1.a. Protection of Subject Privacy: 
All of the materials collected are for research purposes only, and data will be kept in strict 
confidence. No information will be given to anyone without permission from the subject. 
Confidentiality will be ensured by use of identification codes. All data will be identified with a 
unique numeric identification code and an acrostic that are unique to the subject. Any data 
collected before a participant discontinues the study is available for use in this research project.   
 
All research session data will be collected using standardized electronic forms on designed using 
the REDCap database hosted by Cambridge Health Alliance. REDCap (Research Electronic Data 
Capture) is a secure, web-based application designed to support data capture for research studies, 
providing an intuitive interface for validated data entry and export procedures to common 
statistical packages.  All data management will be conducted by the research team operating 

 
55 
 
from CHA.  All data collection will take place under the supervision of the Dr. Schuman-Olivier 
and the Data Manager. Data will only be collected by members of the research team. 
 
The name, birthday, and MRN will be entered into an initial REDCap database strictly for the 
purpose of screening and consent process. The list linking any personal identifying information 
with the participant’s study number and acrostic will be kept in a encrypted computer file on a 
confidential shared drive.  A unique numeric identifier and acrostic will be created for all 
participants who have completed an informed consent and this list will be kept in a password-
protected file by the principal investigator.  All data will be linked to these identifiers and no 
direct patient identifiers will be transmitted from REDCap to SAS 9.3 for analysis.  
 
All further study data from survey sessions will be collected in a second REDCap database, 
which will reference this unique numeric identifier and acrostic. MTPC home practice data will 
be recorded on scantron forms, which will be scanned into a password-protected, secure Excel 
database.  
 
Through collaboration with the CHA Quality Office and CHA information technology, we will 
generate medical record reports for participants who are in our study and this information will 
remain protected within the CHA system, and will not include any study data except name, 
MRN, and birthday. 
 
fMRI data will be collected using the same unique numeric identifier and acrostic used for the 
MINDFUL-PC study, and will be maintained on a secure database server at the collaborating 
neuroimaging site (Martinos Center). Thus, only coded data will be stored on the database of the 
collaborating site. fMRI data analysis will take place at the Martinos Center. The exception is the 
addition of the patient’s year of birth to the fMRI data. This is necessary in case a radiologist has 
to review the brain scans for potential incidental findings (compare 
https://www.nmr.mgh.harvard.edu/martinos/userInfo/safety/training_manual_082305.pdf). fMRI 
data analysis will require controlling for certain values, which will have been collected during 
the main study assessment visits (i.e., gender, age, pre-intervention levels of depression, anxiety, 
self-compassion, and mindfulness). Further, behavioral intervention results (e.g. initiation of 
regimen adherence and regimen maintenance) will be correlated with activation in hypothesized 
brain regions. These analyses don’t require a full integration of fMRI data with the study file. 
The relevant data from the main study file will be communicated via REDCap between the two 
institutions, and the data will be integrated, using the MINDFUL-PC unique numeric identifier 
and acrostic. Data from the drug screenings and pregnancy test will not be added to participants’ 
health records, and will only be retained in the participants' research records (REDCap database 
with unique numeric identifier and acrostic). We will apply for a Certificate of Confidentiality 
with the NIH to protect this data from being disclosed in any civil, criminal, administrative, 
legislative or other proceeding. 
 
HEART pilot study data will be collected using a Participant ID (numeric identifier and acrostic) 
that is unique to the HEART pilot study.  This Participant ID will be used for all smartphone 
applications and any other data tracking related to the HEART pilot study.  The linking 
document specifying the link between the Participant ID and the identities of the participants will 
be kept confidential and will be stored in a password-protected file on a secure CHA drive, only 
accessible by IRB-approved study staff.   
 

 
56 
 
Because the data collected from the Argus app is not relating to sensitive information such as 
illegal activity or addiction, we determined it is not necessary to require secure Wi-Fi options for 
participants throughout the study. However, we will inform participants about the risks of using 
unsecure Wi-Fi and encourage them to use only secure Wi-Fi while using the smartphone app.  
 
The study staff will notify the IRB if there is a need to have communication with the device or 
application manufacturers. While all smartphones have GPS capability, the research team will 
not be accessing any information related to current patient location that can be accessed through 
the GPS data. Similarly, while the photo function will be used to take pictures of food, the 
research team and the smartphone application will not be accessing any photos in the 
participant’s photo album. The orientation protocol will show participants how to disable the 
smartphone’s application’s access to GPS, the participant’s photo album, and to manage updates 
and push notifications. The study team will limit its use of data to only specified data points as 
outlined in the HEART study survey battery.  
 
Data collected from the Kardia Mobile App will be written down by hand on a handout that is 
filed in the study binder which is locked in a double-locked cabinet and then entered  into the 
secure CHA REDCap database by a member of the study staff.    
 
  
Each participant will be given a HEART-study-specific study number, which will be used as an 
identifier in the Kardia Mobile app, the SART task, and the hypothetical discounting task (HDT).  
Therefore, the software developers will not have access to any identifiable data about any of the 
participants.   
 
The SART task and HDT task will be done on a study laptop that is password secured and kept 
in a double-locked cabinet in the research office, accessible only by staff who have been IRB 
approved on the study. The data collected will be kept in an additional password protected file 
during retrieval and then transferred to a secure CHA drive after each study session is complete.  
 
 
D.1.b. Database Protection: 
Subject informed consent, screening forms, scantron sheets, and MTPC course documents will 
be stored in locked file cabinets within a locked office at Cambridge Health Alliance.  
 
The REDCap electronic database will be secured with password protection on secure CHA 
servers. Data analysts will receive only coded information that is entered into the database under 
those identification numbers.  
 
The data associated with the smartphone application, wristband tracker, and online surveys of the 
HEART pilot study will be stored only using the HEART study Participant ID in password-
protected files saved on a secure CHA drive, or on the secure REDCap database.  These coded 
data will be accessible to the associated smartphone application and wristband manufacturers, 
but these data will not be linked to participant identities. These data will be linked to the unique 
Participant ID and will not contain any identifying information.   
 

 
57 
 
Access to identifiable data will be limited to researchers directly involved in the study. All 
identifiable data will be destroyed 5 years after study completion and will not be maintained for 
future uses not specified in this research plan.  
 
D.1.c. Minimization:  
The risk of loss of confidentiality is judged to be minimal. Confidentiality will be maintained by 
numerically coding all data, disguising identifying information, and by keeping all data in the 
secure REDCap application. Any coded or de-identified data will be maintained in password-
protected databases. Subject information will be accessible only to study staff. Information about 
study participants will not leave our institution in any form that would identify individual 
subjects. Data will be transmitted to SAS in a pooled form with subjects identified only by 
numeric code and acrostic. In addition, we will ask group participants to agree to a group 
confidentiality agreement.  This agreement would require that information shared within the 
group remain solely within the group. PCP information would not be shared and there would not 
be responsibility for the PI to report this to CHA management.  
 
D.1.d. Confidentiality During Adverse Event (AE) Reporting 
AE reports and annual summaries will not include subject- or group-identifiable material. Each 
report will only include the unique MINDFUL-PC numeric identifier and acrostic.   
 
D.2. Monitoring and Quality Assurance: 
Following NCCIH request, a detailed Data and Safety Monitoring Plan (DSMP) was designed 
and an Independent Monitor was assigned. Please see appendix at the end of this document. 
Adverse event reporting guidelines are detailed in the DSMP and copied below. 
 
D.2.a. Definition: 
An adverse event (AE) is any untoward medical occurrence in a subject during participation in 
the clinical study. An adverse finding can include a sign, symptom, abnormal assessment (from 
vital signs or brain imaging), or any combination of these. 
A serious adverse event (SAE) is any AE that results in one or more of the following outcomes: 
Death 
A life-threatening event 
Inpatient hospitalization  
A persistent or significant disability/incapacity 
A congenital anomaly or birth defect 
An important medical event based upon appropriate medical judgment. 
D.2.b. Classification of AE Severity: 
AEs will be labeled according to severity, which is based on their impact on the patient. An AE 
will be termed “mild” if it does not have a major impact on the patient, “moderate” if it causes 
the patient some minor inconvenience, and “severe” if it causes a substantial disruption to the 
patient’s well-being. Of note, a severe AE and a serious adverse event (SAE) are distinct terms. 
A subject could experience a severe AE that does not meet the above-listed definition of an SAE; 
alternatively, a subject could experience a moderate AE that meets the SAE definition.  

 
58 
 
D.2.c. AE Attribution Scale:  
AEs will be categorized according to the likelihood that they are related to the study intervention. 
Specifically, they will be labeled definitely unrelated, probably related, possibly related, or 
definitely related to the study intervention. 
D.2.c.1. AE Reporting and Follow-up: 
This study will comply with the reporting requirements from the Cambridge Health Alliance 
IRB. The PI will report to the IRB, Independent Monitor, and NCCIH any of the following 
unanticipated problems and adverse events that occur 1) during the conduct of the study, 2) after 
study completion, or 3) after subject withdrawal or completion: 
1. Internal adverse events that are unexpected, and related or possibly related to the 
research and that indicate there are new or increased risks to subjects; 
2. External adverse events that are serious, unexpected, and related or possibly related 
to the research and that indicate there are new or increased risks to subjects that 
require some action (e.g., modification of the protocol, consent process, or informing 
subjects); 
3. Deviation from the approved research protocol or plan without IRB approval in order 
to eliminate apparent immediate hazard to subjects or harm to others; 
4. Deviation from the approved research protocol or plan that placed subjects or others 
at an increased risk of harm regardless of whether there was actual harm to subjects 
or others; 
5. Any event that requires prompt reporting according to the research protocol or 
investigational plan or the sponsor; 
6. Breach of confidentiality or violation of HIPAA (e.g., lost or stolen laptop); 
7. Procedural error regardless of whether subjects experienced any harm; 
8. Interim analysis, safety monitoring report, publication in a peer-reviewed journal, or 
other finding that indicates that there are new or increased risks to subjects or others 
or that subjects are less likely to receive any direct benefits from the research; 
9. Complaint by/on behalf of a research subject that indicates that the rights, welfare, or 
safety of the subject have been adversely affected or that cannot be resolved by the 
investigator; 
10. Incarceration of a research subject during participation in this study (which is not 
currently approved for involvement of prisoners as subjects); 
11. Noncompliance with applicable regulations or requirements or determinations of the 
IRB identified by the research team or others that indicates that the rights, welfare, or 
safety of subjects have been adversely affected; 
12. Suspension or termination of the research, in whole or in part, based on information 
that indicates that the research places subjects at an increased risk of harm than 
previously known or recognized; 
13. Suspension or disqualification of an investigator by the sponsor, or others; 
14. Scientific misconduct; or 
15. Any other problem that indicates that the research places subjects or others at an 
increased risk of harm or otherwise adversely affect the rights, welfare or safety of 
subjects or others. 
 

 
59 
 
D.2.c.2. Procedures for collecting and reporting unanticipated problems: 
All unanticipated problems (including AEs) will be collected by the PI or other study staff on an 
AE Tracking Log form, at the following time points: Baseline session, fMRI session (if 
applicable), on a weekly basis during the intervention (8 weeks), at post study session and at 
follow-up session, and additionally on an ad-hoc basis. 
Reports of unanticipated problems involving risks to subjects or others will be submitted to the 
IRB, IM and NCCIH within 5 working days/7 calendar days of the date the investigator first 
becomes aware of the problem. 
 
D.2.c.3. Reporting Unanticipated Problems that are Adverse Events: 
Any unanticipated untoward or unfavorable medical occurrence, including abnormal sign, 
symptom, or disease, that indicates that the research places subjects at increased risk of physical 
or psychological harm than previously known or recognized will be submitted as an AE to the 
IRB, IM, and NCCIH. The PI will provide the following information in the report: 
(1) a detailed description of the adverse event; 
(2) the basis for determining that the event is unexpected in nature, severity, or frequency; 
(3) the basis for determining that the event is related or possibly related to the research 
procedures; 
(4) the basis for determining that the research places subjects at an increased risk of harm (i.e., a 
serious adverse event); and 
(5) whether any changes to the research or other corrective actions are warranted. 
D.2.c.4. Reporting Unanticipated Problems that are not Adverse Events: 
All other unanticipated problems incidents, experiences, information, outcomes, or other 
problems that indicate that the research places subjects at an increased risk of physical, 
psychological, economic, legal, or social harm than was previously known or recognized will be 
submitted as an Other Event to the IRB. The investigator will provide the following information 
in the report: 
(1) a detailed description of the unanticipated problem; 
(2) the basis for determining that the problem is unexpected; 
(3) the basis for determining that the problem indicates that the research places subjects at an 
increased risk of harm; and 
(4) whether any changes to the research or other corrective action are warranted. 
D.2.c.5. SAE Reporting: 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the IRB, IM, and NCCIH in accordance with requirements.   
Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Officer within 7 days. Other serious and unexpected AEs related to the 
intervention will be reported to the NCCIH Program Official within 15 days. 
Anticipated or unrelated SAEs will be handled in a less urgent manner but will be reported to the 
IRB, IM, and NCCIH in accordance with their requirements. In the annual AE summary, the IM 
Report will state that she has reviewed all AE and SAE reports.  
 
 
D.2.c.6. Monitoring and Quality Assurance: 

 
60 
 
The PI and data manager will review data collection, data completeness and accuracy as well as 
protocol compliance on a monthly basis. Study progress and safety will be reviewed monthly 
(and more frequently if needed). Progress reports, including patient recruitment, 
retention/attrition, and AEs, will be provided to the Independent Monitor following each of the 
monthly reviews (see DSMP for details). 
 
D.2.c.7. Possible Risk of Suicide: 
This study will not be evaluating suicidality.  Surveys will not ask patients or PCPs about their 
thoughts of suicide, and no data will be collected about suicidality for patients or PCPs.   
 
Behavioral care providers will evaluate potential patient participants for suicidality in a pre-
screen prior to participation in the study.  If imminent risk of suicide or danger to self or others is 
evidenced during a screening evaluation, then the patient will be excluded from participation and 
will be referred to the emergency room or the appropriate level of care.  The PI, Zev Schuman-
Olivier, and the CMC medical director, Todd Griswold, will be contacted by page to help with 
clinical management.  
 
If a participant describes feelings of suicidality while participating in a group, the licensed 
mental health clinician present during the group will help to manage this event with the current 
standard of care, and will make immediate contact with the CMC medical director, Todd 
Griswold, and the PI, Zev Schuman-Olivier.  The participant will be referred to the emergency 
room or the appropriate level of care. 
 
We will not ask any CHA staff members or PCP participants about suicidality.  However, if 
during a group, any PCPs express any kind of imminent risk to self or others or any concern that 
might affect their capacity to work, the PI, Zev Schuman-Olivier, will be present to manage this 
event. In this case, the PI would refer a PCP to the EAP or the Physician Health Services if there 
was evidence of risk of imminent patient harm or neglect.     
 
D.2.c.8. Adverse Events Communication with non-English speaking participants: 
The CHA website has the ability to translate all pages into any language, so that any non-English 
speaking participant can read it. The CMC website will list the name of a point person for each 
language that the MINDFUL-PC program has the capacity to provide services.  Patients will be 
able to look up a point person, who is a mental health clinician fluent in each language for which 
mindfulness services will be offered.  The language point persons within CMC will be included 
as a contact on the informed consent in that language.  Point persons will be associated with the 
CMC and the MINDFUL-PC implementation project, and will be able to contact the Research 
Coordinator, who can then arrange for an interpreter to help provide services to the patient. 
 
D.2.d. Expected Risks: 
 
D.2.d.1. Risks to Patients and PCP Participants: 
1.  Time spent learning mindfulness techniques 
 
2.  Increased anxiety due to difficulties in mental training program 
 
Mindfulness practices can sometimes cause anxiety for those who practice.  Support from the 
Group Leader and the group can help participants recognize that this anxiety is part of the 

 
61 
 
process, and can help people learn to manage these feelings. If meditation and mental exercises 
are causing a worsening of anxiety for participants, they will be encouraged within groups to 
change their approach to the practice. If they are unable to find a way to practice without 
eliciting an increase in symptoms, then they may be asked to stop practicing and to meet with 
either the CMC medical director or the principal investigator for an evaluation. The participant 
may ultimately be terminated from the study if they are experiencing an adverse reaction. These 
participants may continue to receive other treatments at CHA as part of their ongoing treatment 
plan.    
 
In some very rare cases, meditation practice can lead to a dissociative state or to psychosis[95].  
This is more likely in participants with current conditions of or a predisposition to psychosis.  
Patients experiencing active psychosis are excluded from participating in this study.  If a 
participant begins to experience these feelings during his or her time in the study, then the 
participant may be asked to stop practicing and to meet with either the CMC medical director or 
the principal investigator for an evaluation. The participant may ultimately be terminated from 
the study if he or she is experiencing an adverse reaction. These participants may continue to 
receive other treatments at CHA as part of their ongoing treatment plan.  
 
3. Physical discomfort due to gentle movement aspect of training 
 
The training will involve gentle movements similar in form to hatha yoga.  Some participants 
could experience physical discomfort during this aspect of training.  If a participant feels 
discomfort, he or she will be encouraged to engage in a less straining manner. If discomfort 
continues, then the participant will be asked to sit out of this brief element of training and 
discuss the areas of discomfort with their PCP before return to practice of physical postures.  
Severe discomfort is not expected, but could possibly occur.  In this case, the participant will be 
treated for this pain, and encouraged to return to practice stationary forms of mindfulness.  
 
4. Feelings of embarrassment or anxiety when asked personal survey question. 
 
Some survey questions are of a sensitive or personal nature, and may cause the participant to 
become upset.  In some rare cases, participants may require mental health support upon feeling 
upset by the survey questions.  A patient’s referring integrated behavioral health clinician will be 
contacted if the patient needs additional mental health support.  The PI and CMC medical 
director will remain available to field questions from PCPs about their experience with 
mindfulness and any adverse experiences. PCPs with adverse events that may influence their 
fitness to safely practice will be referred to the Employee Assistance Program (EAP) or 
Physician Health Services. Todd Griswold, MD, clinical supervisor of the MINDFUL-PC 
implementation project, will help to monitor and coordinate behavioral health care for 
participants.   
 
5.  Risk of loss of confidentiality 
 
D.2.d.2. Risks to Patients in fMRI study: 
1. MRI  
The MRI system used in this study has been approved by the FDA and will be operated within 
the parameters reviewed and accepted by the FDA. MRI is not associated with any known 

 
62 
 
adverse effects except in people with non-MR-compatible features such as certain kinds of 
implants, tattoos, jewelry or other devices. Subjects will be excluded from this study if they have 
any MRI contraindication. The MR Safety Form will be administered prior to every MRI scan to 
confirm eligibility and subjects will be checked with a metal detector prior to entering the 
scanner. Some patients find it unpleasant or feel anxious when confined in the enclosed space of 
the scanner. Subjects will be able to converse with a staff member via a microphone and speaker 
system, and can request that the scan be stopped at any time for any reason. Subjects will be 
required to wear earplugs and have additional padding around their ears to prevent discomfort 
due to scanner noise (https://www.nmr.mgh.harvard.edu/martinos/userInfo/safety/index.php). 
2. Pain task 
In some cases, cuff pain stimulation can result in mild bruising associated with inflation of the 
cuff. The pressure from this cuff is controlled to be within a safe and tolerable range. If 
participants feel distress while wearing the cuff, the procedure will be stopped. Patients will be 
assessed for peripheral vascular disease, varicosities, and lymphedema prior to application of 
cuff pain to prevent the possibility of worsening of symptoms. 
3. Emotional Go/NoGo task 
This task will employ negative and unpleasant pictures to test the relation between emotional 
processing and attention performance, from the IAPS. Pictures include scenes of mutilations, car 
accidents, natural catastrophes, contamination or violence. For this task, we will use 50% neutral, 
and 50% unpleasant pictures. We do not include pictures of sexual content, spiders, or snakes. 
IAPS pictures are frequently used to study emotion processes, and are also commonly employed 
in patient studies and during fMRI. However, the pictures could induce discomfort during the 
task. Patients will receive information about these pictures in the information sheet and informed 
consent form. They will further complete a practice task outside of the scanner, with IAPS 
pictures of similar content. Thus, any concern can be addressed already before the scan, and if 
patients feel too uncomfortable, we will decide to abstain from conducting this task in the 
scanner. The participants are further reminded in the informed consent and orally that they can 
stop any task or their participation, should they feel too uncomfortable with any of the 
procedures. After the task, participants will be asked about their current condition and mood. In 
case of enduring discomfort caused by the pictures, they are instructed to contact the Principal 
Investigator, Dr. Zev Schuman-Olivier, at 617-591-6056 or the Behavioral Health 
Communication Center for CHA Psychological Services (617- 665- 1560) and the respective 
contact information is listed on the informed consent form. 
3. Possible discovery of findings related to medical imaging 
If the brain images collected in this study show what seem to be abnormalities – as judged by the 
neuroimaging post-doctoral fellow or neuroimaging consultants at the Martinos Center on the 
day of the scan session, a radiologist will be consulted within 1 business day to review the scan, 
following standard procedures at the Athinoula A. Martinos Center for Biomedical Imaging 
(compare 
https://www.nmr.mgh.harvard.edu/martinos/userInfo/safety/training_manual_082305.pdf) . If 
the radiologist thinks there may be a medical abnormality in the scan, the subject will be 
contacted by the PI or the CMC medical director, and will be provided referrals and/or a list of 
options for follow-up medical care.   Similarly, if cardiovascular anomalies and/or cardiac 
arrhythmias were evidenced by the vital signs recordings – as judged by the neuroimaging post-
doctoral fellow or neuroimaging consultants at the Martinos Center on the day of the scan 

 
63 
 
session, the subject will be contacted by the PI or the CMC Medical Director and referred for 
follow-up medical care. 
 
Potential risks for participants in the HEART pilot study: 
1) Feelings of embarrassment or anxiety when asked personal survey questions or due to 
behavior tracking. Some survey questions are of a sensitive or personal nature, and may 
cause the participant to become upset.   In addition, tracking behaviors related to activity, 
sleep, mindfulness practice, or eating and drinking may cause a participant to feel 
embarrassed or become upset.  In some rare cases, participants may require mental health 
support upon feeling upset by the survey questions or behavior tracking.  A patient’s 
referring integrated behavioral health clinician will be contacted if the patient needs 
additional mental health support.  The study staff, PI and CMC medical director will 
remain available to field questions from participants about their experience with 
mindfulness and any adverse experiences. 
2) Extra time associated with completing the behavioral task tracking.  Participants will be 
asked to spend time tracking behaviors each day during the HEART pilot study.   
3) Participants will be asked to carry their smartphone during the day for activity tracking. 
This may cause participants inconvenience.   
4) Mild discomfort due to wristband tracker. Participants may experience mild discomfort 
when wearing the wristband activity tracker.  Participants who are experiencing 
discomfort will be encouraged to speak with study staff who will help participants adjust 
the wristband if necessary.  If discomfort is not tolerable to participants, they will be 
encouraged to discontinue wearing the wristband at any time.  
5) Potential to impact development of mindfulness as participants enrolled in MTPC will be 
doing the tracking during weeks 5-8 of their training.   
6) Despite efforts to prevent data breaches, any use of electronic devices and internet data 
transmission can result in a breach of confidentiality. 
7) Eye strain from performing Behavioral computerized tasks. 
 
 
D.2.e. Potential Benefits: 
 
D.2.e.1. Benefits to Patient Participants: 
1.  Learn techniques for improved behavioral control and psychological wellbeing 
2.  Improve health maintenance and self-management of chronic illness 
3.  Greater satisfaction with the provider-patient relationship 
4.  Decrease anxiety, depression, insomnia, and pain  
5.  Reduce substance use and tobacco smoking  
6.  Reduced reliance on prescription opioids and sedatives  
7.  Feeling of greater behavioral control over risky behaviors in general 
8.  Improve quality of life, with reductions in stress and anxiety   
9.  Reduce stress associated with chronic illness 
 
D.2.e.2. Benefits PCP Participants:  
1.  Learn techniques for improved behavioral control and psychological wellbeing 
2.  Reduce burnout and increase resiliency 
3.  Increase patient-centered communication, improve provider empathy and increase 
patient satisfaction 

 
64 
 
4.  Reduce stress, anxiety, depression, and insomnia 
 
D.2.e.3. Alternatives to Participation: 
Participation in this research study is voluntary.  Patient participants can choose not to 
participate, and their decision will in no way affect the quality of care they receive at 
CHA or their working relationship with CHA; however, they will be unable to participate 
in the MTPC groups until after completion of the study if they choose not to participate in 
the study. PCPs will not be required to participate in this study, but they will need to at 
least enroll in the control group if they intend to refer patients to the study. Participants 
may elect at any point to discontinue their participation in this study. 
 
D.3. Human Subjects and Confidentiality: 
 
D.3.a Human Subjects Procedures: 
 
D.3.a.1 Equitable Selection of Subjects:  
People of all races and ethnicities will be included in this study.  
 
D.3.b. Recruitment Procedures: 
 
D.3.b.1. PCP Recruitment:  
PCP enrollment is complete as of February 10th, 2017.  No additional PCPs will be enrolled after 
this date, and no further PCP study sessions will take place.  The study aims to enroll 50-80 
PCPs as participants.  PCPs will be recruited through print/flyer advertisements in department 
offices and health centers, email invitations, announcements at departmental meetings, and a 
presentation at CHA medical grand rounds and family medicine grand rounds. The study aims to 
enroll at least 25 PCPs into an intervention group (Group 1) and at least 25 into a control group 
(Group 2 and 3). 
 
The principal investigator is not in a supervisory role for anyone in this study.  Behavioral health 
providers are not study subjects and this training program is integrated in the mental health 
integration into primary care. Therefore, mental health providers in primary care will be 
encouraged to participate in the program by their supervisor.  
 
The primary care providers will be encouraged to participate primarily through grand rounds 
presentations, but we will take care to inform supervisors not to pressure providers to participate 
in the Mindfulness group as it must be fully voluntary. Since this is primarily an implementation 
project, supervisors may encourage staff to participate in the program and refer patients, but 
supervisors will be reminded that non-participation at any level cannot affect employment. 
 
D.3.b.2. Patient Recruitment: 
The study aims to enroll a total of 434-1,000 CHA patients as participants within 18 months of 
beginning the project. Patients will be recruited through print/flyer advertisements in health 
centers, CHA marketing materials, community informational meetings, and referral by PCPs and 
other members of the health care team. In addition, we aim to develop a video introduction about 
mindfulness to be played in patient waiting areas within health centers with translations into the 
primary languages of the health centers (Note: Once developed these videos will be provided for 

 
65 
 
review by the CHA IRB prior to implementation).  This study aims to randomize 290 patients to 
an 8-week study intervention and 144 to a control group.   
 
The HEART pilot study aims to recruit 40 participants in the alumni cohort and 30-60 
participants (10-20 in the waitlist arm and 20-40 in the intervention arm) in the concurrent 
cohort for a total of 70 participants (40 alumni, 20 intervention, and 10 waitlist). The absolute 
minimum total number would be 47 participants and the maximum total would be 100 
participants (40 alumni, 40 intervention, and 20 waitlist). 
 
D.4.  Data Quality and Safety: 
 
D.4.a. Data Quality and Management: 
 
D.4.a.1. Description of Plan for Data Quality and Management: 
The PI and data manager will review data collection, data completeness and accuracy as well as 
protocol compliance on a monthly basis.  
 
Survey session data will be entered by subjects into REDCap. The data manager will review all 
REDCap data collection forms on an ongoing basis for data completeness and accuracy as well 
as protocol compliance.  
 
All scantron data will be scanned by research coordinators and files will be reviewed by the data 
manager for completeness and accuracy prior to upload to the excel database.  
 
 
Any surveys completed by pencil and paper will be entered by a research assistant. We will 
conduct ongoing verification audits for entry of any data transfer from paper forms. 
Discrepancies will be corrected by data manager and/or the PI, based on source documents. Any 
inconsistencies will be resolved. Exploratory analysis of data with simple range checks may be 
conducted periodically as a second audit of possible entry errors.  
 
Frequency of Review―The frequency of data review for this study differs according to the 
type of data and can be summarized in the following Data Quality Monitoring Table. 
Table 5. MTPC Data Quality Monitoring Table 
Data type 
Frequency  
of review 
Reviewer 
Study progress and safety 
Monthly 
 
Program Manager, PI 
Data collection, data 
quality/completeness/accuracy, 
protocol compliance 
Monthly 
Data Manager, PI 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Quarterly 
PI, Independent Monitor  
Status of all enrolled subjects, 
as of date of reporting  
Quarterly 
PI, Independent Monitor  
Adherence data regarding 
study visits and intervention 
Quarterly 
PI, Independent Monitor  

 
66 
 
Data type 
Frequency  
of review 
Reviewer 
AEs  
 
Quarterly 
PI, Independent Monitor  
Protocol violations 
Per occurrence 
PI, Independent Monitor, 
NCCIH 
SAEs 
Per occurrence 
PI, Independent Monitor, 
NCCIH 
 
D.4.b. Subject Accrual and Compliance: 
 
D.4.b.1. Measurement and Reporting of Subject Accrual, Compliance With Inclusion/Exclusion 
Criteria: 
Review of the rate of subject accrual and compliance with inclusion/exclusion criteria will occur 
monthly by the data manager with reports to PI every 3 months to ensure that a sufficient number 
of participants are being enrolled and that they meet eligibility criteria and the targeted ethnic 
diversity goals outlined in the grant proposal (Targeted/Planned Enrollment Table). 
 
D.4.b.2. Measurement and Reporting of Participant Adherence to Treatment Protocol: 
Data on adherence to the treatment protocol will be collected twice weekly by research staff and 
reviewed quarterly by the PI, the study statistician, and the independent monitor. Adherence of 
patient participants will be evaluated by attendance at MTPC groups, PCP visit, and completion 
of all study sessions. Adherence for each session will be rated on the following scale: 0 = 
absence; 1 = completed; 2 = incomplete (with comments). An explanation of study staff attempts 
to understand and address participant adherence deficits will be documented and reviewed twice 
weekly. 
 
D.4.c. Justification of Sample Size: 
The goal of the study is to determine if Mindfulness Training provided in Primary Care results in 
a greater decreases in anxiety, stress, and depression than referral to community resources. The 
study is also powered to assess for effects of mindfulness training on provider-patient 
relationship. The current RCT is funded by AVDF and Gold Foundation and is sufficiently 
powered to address these aims.  
 
Using an intent-to-treat analysis with 290 patients receiving mindfulness training and 144 
patients with orientation only, there will be an 80% chance of detecting a significant difference at 
a two-sided 0.05 significance level. This assumes that the rate of action plan initiation is 0.54 in 
orientation only (based on Guck et. al.[5]) and the rate of action plan initiation among patients 
who receive mindfulness training is 0.68 (based on rates of initiation and maintenance of 
meditation practice in previous pilot MBIs[6]).  
 
The experimental fMRI pilot trial will recruit primary care patients (n= max. 30 subjects) with 
anxiety or depression from the MTPC arm using a within-subject pre/post design, which is an 
adequate size for a pilot neuroimaging trial to be able to assess an effect size of the fMRI and 
medical regimen adherence measures needed to power the trial for the UH3 phase.  
 
The HEART pilot study is underpowered to be able to compare between-group differences in 
outcomes, but the primary aims of the pilot study are 1) to demonstrate feasibility of using 

 
67 
 
commercially available activity/sleep/diet trackers and online daily surveys for ecological 
behavior tracking in a MBI RCT and 2) to use the daily behavior tracking to validate the action 
plan goal setting process and the self-report action plan initiation measure. To do this we aim to 
recruit the 70 participants from both the alumni and concurrent phases and then to examine the 
data for correlations between the action plan initiation 7-item survey and pre-post differences in 
step count, the number of active periods, changes in sleep duration, changes in mindfulness 
practice, and change in nutritional habits depending on which action plan goal was specified in 
the patient action plan. When conducting correlation analysis with 70 participants, using a= 0.05 
type 1 error rate, we would have 80% to find a correlation coefficient of 0.33. If we have lower 
than expected recruitment and only had 47 participants for correlation analysis, using a= 0.05 
type 1 error rate, we would have 80% to find a correlation coefficient of 0.4, which represents 
moderate correlation96. We will also examine whether the activity changes are greater in the 
participants who select exercise as compared to those who selected nutrition or dietary changes 
and vice versa. 
 
 
D.4.d. Stopping Rules: 
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; or 
(4) other situations occur that might warrant stopping the trial. 
 
D.4.e. Designation of an Independent Monitor: 
The Independent Monitor for this study is Dr. Paula Gardiner, MD at Boston Medical Center. Dr. 
Gardiner is not associated with this research project and thus works independently of the PI, Dr. 
Schuman-Olivier. Dr. Gardiner is not a part of the key personnel involved in this grant, and is 
qualified to review the patient safety data generated by this study because of her unique expertise 
in the area of mindfulness training for primary care patients. 
D.4.f. Safety Review Plan: 
Study progress and safety will be reviewed monthly (and more frequently if needed). Progress 
reports, including patient recruitment, retention/attrition, and AEs, will be provided to the 
Independent Monitor following each of the monthly reviews. An Annual Report will be 
compiled and will include a list and summary of AEs. In addition, the Annual Report will 
address (1) whether AE rates are consistent with pre-study assumptions; (2) reason for dropouts 
from the study; (3) whether all participants met entry criteria; (4) whether continuation of the 
study is justified on the basis that additional data are needed to accomplish the stated aims of the 
study; and (5) conditions whereby the study might be terminated prematurely. The Annual 
Report will be sent to the Independent Monitor and will be forwarded to the IRB and NCCIH. 
The IRB and other applicable recipients will review progress of this study on an annual basis. 
The PI will also send copies of signed recommendations and comments from the Independent 
Monitor to the NCCIH Program Officer within 1 month of each monitoring review. 
D.4.g. Study Report Outline for the Independent Monitor (Interim or Annual Reports): 
The study team will generate Study Reports for the Independent Monitor and will provide 
information on the following study parameters: rate of subject accrual and compliance with 
inclusion/exclusion criteria, Status of all enrolled subjects, Adherence data regarding study visits 

 
68 
 
and intervention, AEs, and Protocol violations. Study Report tables will be generated only from 
aggregate (not by group assignment) baseline and aggregate safety data for the study population. 
A separate Closed Safety Report, with masked group baseline and safety data, will be generated 
for the Independent Monitor(s) by a designated unmasked member of the team but will not be 
reviewed by the study team. 
 
D.5. Informed Consent Procedures: 
Written informed consent will be obtained from each subject at entry into the study. Informed 
consent is obtained by the following process: 
D.5.a Consent for Primary Care Providers: 
PCP participants will be provided with written descriptions in English of the research study 
procedures, timeline and participant commitments electronically for review prior to starting the 
course. PCPs will be given an opportunity to email or call the study staff for answers to any 
questions about the consent document and they will be asked to complete a consent quiz to 
ensure understanding of the most crucial points. The Principal investigator will review the 
consent quiz and verbally communicate with each PCP immediately prior to completion of pre-
treatment surveys at the start the first group. 
 
D.5.b. Consent for Patients for the main MINDFUL-PC study: 
1. Patients will complete the Informed Consent Form in-person prior to the beginning of the 
Mindfulness Orientation Visit.  The informed consent document will include a full 
description of the study procedures and associated risks. The participant will also be asked to 
complete an Informed Consent Assessment to ensure comprehension of the study procedures, 
rights of participants, as well as understanding of the risks and benefits of the study. The 
patient will not be able to sign the document without having completely correct answers on 
the consent assessment. Trained study staff will meet with the participant to review the 
assessment to confirm the subject understands the study, and to answer any questions the subject 
might have. 
2. Patients who scored less than 90% on the informed consent assessment will meet 
individually with the Research Coordinator or other approved study personnel who will 
administer the Rapid Estimate of Adult Literacy in Medicine—Short Form (REALM-SF) 
form[7] to assess patient literacy levels.  This is a 7-item word recognition test, which takes 
about 2 minutes, offers a valid quick assessment of patient health literacy and has excellent 
agreement with the 66-item REALM instrument in terms of grade-level assignments. Patients 
are instructed to read seven words aloud for a member of the study team.  Patients who 
pronounce fewer than four of the words correctly read at a literacy level of 4th to 6th grade. 
Patients with less than a 7th grade reading level in English will be excluded from initial 
groups and from experimental fMRI pilot.  
3. The Research Coordinator and other approved study personnel will be present during the 
Informed Consent Session if patients have any questions during the consent process or the 
consent assessment. After completion, participants will be provided an additional copy of the 
signed informed consent form for their own records. Once the participant demonstrates 
understanding of the study and agrees to participate in the study, the consent will be signed in 
the presence of the doctoral level member of the study team and a witness.  Participants must 

 
69 
 
give written, informed consent in order to participate in the study.  Participation in the study 
is voluntary.  All participants will be notified that they are free to discontinue from 
participating in the study at any time.  All participants will be asked to complete and sign a 
section acknowledging that sessions will be audio-recorded for research purposes. No study-
specific procedures or investigations will be performed before the participant has signed and 
dated the Informed Consent Form.   
 
4. The NIH Common Fund Science of Behavior Change Initiative and NCCIH will be listed as 
co-sponsors of this study in the overall initial consent document signed prior to the 
Mindfulness Orientation Visit for all participants.  If the MINDFUL-PC study continues after 
the NIH Common Fund/NCCIH grant ends, then references to NIH Common Fund and 
NCCIH as study sponsors will be removed from the overall consent document.  No other 
intervention materials will mention NIH Common Fund and NCCIH other than the overall 
initial consent document and the neuroimaging pilot study consent document.   
 
D.5.c. Consent for Patients for experimental fMRI pilot study: 
After completion of the MINDFUL-PC consent form, the orientation session, and after being 
randomized to the mindfulness group, interested participants will be phone-screened by the 
Research Coordinator or other trained study staff based on the experimental fMRI inclusion and 
exclusion criteria during the group-scheduling phone call. Those who screened into the optional 
study are asked about any questions regarding the information sheet, flyer, and study in general. 
At the imaging session, participants are given enough time to study the informed consent and ask 
any question regarding the fMRI pilot study. Participants will then sign the informed consent 
before any other questionnaires or neuroimaging will be administered. It will be emphasized that 
any refusal to participate will not impact current or future treatment, nor participation in the 
broader study. 
 
D.5.d.  Consent for Patients for HEART pilot study:  
Participants are first notified of the opportunity to enroll in the HEART study during the 
MINDFUL-PC confirmation phone call to attend MINDFUL-PC orientation. Following this, at 
the in-person orientation, participants will be led through the verbal and written consent process 
for MINDFUL-PC.  Once they have signed their MINDFUL-PC consent forms, they are eligible 
for the HEART study and will be given the HEART study information packet, as well as the 
HEART study informed consent form. A doctoral level member of the research staff will then 
guide participants through a verbal introduction of the HEART study, informing them of the 
invitation to voluntarily participate, reviewing study inclusion and exclusion criteria, and 
providing a chance to ask any questions. If after this in-person review, interested participants will 
be invited to sign the HEART study consent form.  If an interested participant does not 
understand or agree to study requirements after the verbal introduction and a chance to ask 
questions, the doctoral level research staff member conducting the orientation session will decide 
to exclude the participant from the HEART study.   
 
Upon completion of the HEART study informed consent form, participants will be given an 
additional copy of the signed informed consent form for their own records.  The signed informed 
consent forms will be stored in a binder in a double-locked cabinet at the Center for Mindfulness 
and Compassion.  Only IRB-approved study staff will have access to this cabinet 

 
70 
 
 
 
D.6. Reporting Changes in Study Status: 
During the funding of this study, any action by the IRB or one of the study investigators that 
results in a temporary or permanent suspension of the study will be reported to the NCCIH 
Program Official within 1 business day of notification. 
D.7. Participant Reimbursement: 
 
Participants will incur no fees as a result of participation in this study.  All study-related visits 
and will be provided to the participants at no cost; however, given this is an implementation 
project and group visits will be offered as group psychotherapy, patient visits will be billed to 
their insurance companies and a co-pay may be involved. If a patient’s insurance will not cover 
their participation in the group despite PCP referral, then the principal investigator will consider 
their inclusion individually on a case-by-case basis.  
 
Patient participants will receive up to $140 in total compensation in the form of prepaid cards or 
cash cards for participating in the MINDFUL-PC study.    
 Baseline:  Up to $20  
o Patient participants will receive one $20 prepaid card after their first session of 
surveys. 
 Week 8:  Up to $40 
o They will receive a $20 card payment after their post-study week 8 session of 
surveys.   
o Participants will receive a $20 prepaid card at Study Week 8 for completing both 
the Weekly Mindfulness Practice Diaries and Weekly Mindfulness Resource Use 
Surveys every week during Study Weeks 1-8.  If participants only complete 6 of 8 
of the Weekly Mindfulness Practice Diaries or 6 of 8 of the Weekly Mindfulness 
Resource Use Surveys, they will receive a $15 prepaid card instead of a $20 
prepaid card.  If participants complete fewer than 6 of either of the weekly diaries, 
they will not receive compensation for this aspect of the study.    
 Week 26:  Up to $80 
o $20 for the 6-month follow-up session 
o $15 for the Action Plan Study Session 
o $15 total ($5 each) for the Week 9, Week 10, and Week 16 APIS-5 sessions 
o $30 completion bonus if all study participation items have been completed.   
 Post Study: $15 
o They will receive $15 if they choose to do the Action Plan Interview 
 
Participant Reimbursement for the HEART Pilot Study: 
 
Patients will not be reimbursed for data plan usage relevant to this study. The Argus app and 
similar smartphone applications do not transmit data continuously, so the amount of data use is 
not high and will have a small impact on data usage.  
 
 
 
Concurrent Cohort:   Up to $195 

 
71 
 
$30 
Behavioral Measures (pre) 
$21 
Part 0:   
 $1/day each, for  
o Mindfulness tracking for 1 week ($7 total) 
o Smartphone/Accelerometer-based activity tracking for 1 week ($7) 
 $1/day for Food, Activity, and Sleep Tracking (FAST) Questionnaire for 1 week ($7) 
$84 
Part 1 & 2   
 $1/day each, for  
o Mindfulness tracking for 4 weeks ($28 total) 
o Smartphone/Accelerometer-based activity tracking for 4 weeks ($28) 
 $1/day for Food, Activity, and Sleep Tracking (FAST) Questionnaire for 4 weeks ($28) 
$30 
Behavioral Measures (post) 
 
 
$30 High Completion Bonus:  If action plan paperwork is fully submitted and use of daily 
tracking on > 90% of the days for each activity above, participants will receive a $50 dollar 
bonus. 
 
$20 Mid Completion Bonus:  If action plan paperwork is fully submitted and use of daily 
tracking on 75-89% of the days for each activity above, participants will receive a $20 dollar 
bonus. 
 
$ 
 
To be disbursed in 3 payments:  
 
Payment 1:  $30 after pre-Behavioral Measures visit 
Payment 2:  Up to $105 after completing Part 2  
Payment 3: $60 after completing post-Behavioral measures visit, including the high 
completion bonus. If the participant has been given any devices (e.g. wristband sensor), 
then this payment will be disbursed only after the device is returned in working 
condition.   
 
 
D.7.a. PCP Participant Reimbursement: 
PCP Participants will incur no fees as a result of participation in this study.  All study-related 
visits and procedures will be provided to the participants at no cost.  
 
Reimbursement for transportation will not be provided to or from the study location; however, a 
van may be available for transportation for the day of silent practice day depending on location. 
 
D.7.b. Experimental fMRI Pilot Participant Reimbursement: 
Participants in the fMRI experiment will be paid $5 for completing the screening and informed 
consent and providing toxicology and pregnancy screenings if applicable at the pre-fMRI 
session, and $5 for completing the toxicology and pregnancy screenings at the post-fMRI 
session. Participants will be paid $50 after completion of each fMRI session. The total 
reimbursement for 2 fMRI visits and the screenings and informed consent will be $110. 
Participants will also receive free parking or $10 towards public transport or taxi costs for every 
fMRI visit. All payments for the fMRI study will be in cash. 

 
72 
 
 
D.8. MTPC Session Quality and Protocol Adherence: 
 
Mindfulness group leaders will report on the quality of the sessions and the adherence to the 
protocol to the Program Manager or the Principal Investigator after each session. Every MTPC 
group will have an embedded unbiased observer who will rate group leader adherence and 
fidelity to the manual. In addition, all groups will be audio recorded. A trained rater will review 
10% of group sessions for adherence, fidelity and competency. In order to prevent therapist drift, 
the program manager and/or principal investigator will review group adherence and fidelity 
ratings weekly. All MTPC group leaders will be asked to participate in weekly group supervision 
until they have successfully completed four 8-week sessions.   
 
D.9. New Information: 
 
Any pertinent new information will be communicated to study participants.  In light of new 
information, participants may elect to discontinue their participation in the study. 
 
D.10. Sources of Research Materials:  
 
D.10.a. Sources of Research Materials for Patients: 
The following research material will be obtained: 
1.  Responses to surveys 
2.  EPIC electronic medical records to assess for health outcomes 
3.  Audio tapes of MTPC sessions for fidelity ratings 
 
The following data will be recorded: 
1.  Assessment measuring socio-demographic characteristics, depression, anxiety, stress, 
mindfulness, self-compassion, relationship with primary care provider, consumption of alcohol, 
and record of substance abuse.  
2.  Medical history for the year before and year after the study, including patient alcohol use, 
body mass index (BMI), patient health questionnaire (PHQ-2), HgAlc, LDL-C, smoking 
cessation attempts and cigarettes per day, frequency of meat eating, blood pressure, risky sexual 
behaviors, quantity of prescribed opioids and sedatives, and illicit drug use. 
3.  Attendance of medical visits, including number of visits with the patient’s PCP, number of 
outpatient medical visits, number of inpatient medical visits, number of visits to the emergency 
department (ED), and no-show rates for the year before and the six months after randomization. 
4.  Patient action plan, created by a patient and his or her primary care provider at the PCP visit 
and reported in EPIC electronic medical records. 
 
D.10.b. Sources of Research Materials for Patients in fMRI study: 
The following research material will be obtained: 
1. Toxicology testing (oral fluids) 
2. Pregnancy testing (urine, females only, will be offered to female patients with childbearing 
potential) 
3. Self-report measures as administered through a secure REDCap link 
4. fMRI 
5. Autonomic monitoring: heart rate, breathing rate, and skin conductance 
 

 
73 
 
The following data will be recorded: 
1.  Toxicology results for alcohol and illicit drugs.   
2.  Qualitative HCG result 
3.  Edinburgh Handedness Inventory 
4.  fMRI BOLD signal 
5.  Recordings of heart rate, breathing rate, and skin conductance during the full fMRI session 
 
D.10.c. Sources of Research Materials for PCPs: 
The following research material will be obtained: 
1.  Responses to surveys 
 
The following data will be recorded: 
1.  Assessment measuring depression, anxiety, stress, mindfulness, self-compassion, and 
burnout. 
 
D.10.d. Data Linkage to subjects and access to data: 
The secure web application REDCap will be used for data collection.  Data will be entered 
directly into REDCap by participants.  Any data entry not conducted by participants will be 
conducted only by members of the research team.  All data collection will take place under the 
supervision of the Principal Investigator (Dr. Schuman-Olivier, MD), the Project and Data 
Manager (Richa Gawande, PhD), or the Research Coordinator, Elizabeth Pine. All fMRI data 
collection will take place under the supervision of a doctoral-level neuroimaging collaborator, 
including the Neuroimaging Consultant and Director of the Center for Integrative Pain 
Neuroimaging (Vitaly Napadow, PhD), Neuroimaging Consultant in Department of Radiology 
(Gaelle Desbordes, PhD), or the neuroimaging postdoctoral fellow (Jacqueline Lutz, PhD). 
Substitute codes will be used to label all sources of subject information and access to identifiable 
data will be limited to researchers directly involved in the study. The Project and Data Manager, 
Richa Gawande, PhD, will be responsible for coding data and exporting coded data from 
REDCap to SAS 9.3. All identifiable data will be destroyed 10 years after study completion and 
will not be maintained for future uses not specified in this research plan.  
 
D.11. Personnel: 
D.11.a. Personnel present during study procedure: 
At least one of the following personnel will be present during study procedures: 
Zev Schuman-Olivier, MD, Principal Investigator; Richa Gawande, PhD, Program and Data 
Manager; Elizabeth Pine, BA, Research Coordinator; Angela Lozada, BA and Andrea Chen, MA 
Research Assistants  and additional Research Assistants; CHA Behavioral Health Specialists. 
 
D.11.b. Study team members responsible for the following activities: 
At least one of the following personnel will be responsible for obtaining and documenting 
informed consent/parent or guardian permission/minor assent/legally authorized representative 
permission:  Zev Schuman-Olivier, MD, Principal Investigator; Richa Gawande, PhD, Program 
and Data Manager; Elizabeth Pine, BA, Research Coordinator; and additional Research 
Assistants. 
 
The following personnel will be responsible for providing on-going information to the study 
sponsor and the IRB:  Zev Schuman-Olivier, MD, Principal Investigator. 

 
74 
 
 
At least one of the following personnel will be responsible for maintaining participant's research 
records:  Zev Schuman-Olivier, MD, Principal Investigator; Richa Gawande, PhD, Program and 
Data Manager; Elizabeth Pine, BA, Research Coordinator;  and additional Research Assistants. 
 
In addition, the experimental fMRI pilot study will be conducted through collaboration with the 
following people: Gaelle Desbordes, PhD, Neuroimaging Consultant; Vitaly Napadow, PhD, 
Neuroimaging Consultant, Director of Center for Integrative Pain Neuroimaging; and Jacqueline 
Lutz, PhD, neuroimaging post-doctoral fellow. 
 
D.11.c. Inclusion of study personnel:  
This project is a research study built on top of an implementation pilot program. The senior 
MBSR teachers, CMC faculty, and mindfulness-trained behaviorists are all part of the underlying 
implementation program and they will not have access to study data or randomization codes. 
While behavioral health clinicians will provide some data which will be included in the 
screening and referral process, it will be MINDFUL-PC study staff under supervision from the 
principal investigator who will actually apply inclusion and exclusion criteria and send 
invitations for the study. 
 
The MINDFUL-PC study staff will include Zev Schuman-Olivier, MD (Principal Investigator); 
Todd Griswold, MD (CMC Medical Director and MINDFUL-PC Clinical Implementation 
Supervisor); Richa Gawande, PhD (Program and Data Manager); Elizabeth Pine, BA 
(MINDFUL-PC Research Coordinator); Gaelle Desbordes, PhD, (Neuroimaging Consultant); 
Vitaly Napadow, PhD, (Neuroimaging Consultant); Jacqueline Lutz, PhD, neuroimaging post-
doctoral fellow and additional Research Assistants. 

 
75 
 
 

 
76 
 
Table 3. Study Visit and Assessment Schedule for Patient Participants 
  
 Screen 
Visit 
Consent 
Session 
Pre-Treatment 
Surveys 
Group 
Orientation 
Week 
1-5 
Week 
 6- 7 
Action 
Plan 
Week 
 8 
Patient Screening 
 
 
 
  
Patient Eligibility Questionnaire 
X 
  
 
  
  
  
 
  
  
MINDFUL-PC Patient Screening 
Form# 
X 
  
 
  
  
  
 
  
Informed Consent 
  
 
  
  
  
  
 
  
  
Informed Consent Form 
  
X 
 
  
  
  
 
  
  
Consent Quiz 
  
X 
 
  
  
  
 
  
REALM-SF% 
X 
 
 
Baseline Battery 
  
 
  
  
  
 
  
  
Demographics Survey# 
  
 
X 
  
  
  
 
  
  
SMME# 
  
 
X 
  
  
  
 
  
  
FTND# 
  
 
X 
  
  
  
 
  
Mindfulness Self-Report Battery 
  
 
  
  
  
 
  
  
FFMQ# 
  
 
X 
  
  
  
 
  
  
SCS-SF# 
  
 
X 
  
  
  
 
  
DERS# 
  
 
X 
  
  
  
 
  
MAIA# 
  
 
X 
  
  
  
 
  
Clinical Assessment Battery 
  
 
  
  
  
 
  
  
DASS-21# 
  
 
X 
  
  
  
 
  
PHQ-2# 
 
X 
 
  
PSS# 
  
 
X 
  
  
  
 
  
  
AUDIT-C# 
  
 
X 
  
  
  
 
  
  
DSM-V SSU# 
  
 
X 
  
  
  
 
  
PROMIS-ASF# 
  
 
X 
  
  
  
 
  
PROMIS-DSF# 
  
 
X 
  
  
  
 
  
Self-Management Battery 
  
 
  
  
  
 
  
  
SECD-6# 
  
 
X 
  
  
  
 
  
  
PAM# 
  
 
X 
  
  
  
 
  
  
PCQ# 
  
 
X 
  
  
  
 
  
APA-10# 
 
 
X 
APIS-5# 
  
 
  
 
  
  
 
  
Action Plan Worksheet 
 
 
X 
 
TFEQ-R18 
 
 
X 
 
 
 
 
 
Weekly Mindfulness Practice 
  
 
  
 
  
  
 
  
  
Weekly Mindfulness Practice 
Diary  
  
 
  
X 
X 
 
X 
Weekly Mindfulness Resources 
Use Survey 
 
 
X 
X 
 
X 
MTPC Satisfaction Survey 
 
 
 
 
Satisfaction survey# 
  
 
  
  
  
  
 
  
Engagement and Adverse Event 
Reporting  
 
 
 
Adverse Event Reporting Form 
  
 
  
  
  
  
 
  
Participant Engagement Phone 
Call 
 
 
X 
X 
 
X 
Patient Study Visits 
 
 
 
60-minute Group Orientation 
  
 
  
X 
  
  
 
  
2-hour MTPC Sessions 
  
 
  
X^ 
X^ 
 
X^ 
Action Plan Study Session 
  
 
  
  
  
X 
  
7-hour Full-Day Session 
  
 
  
  
  
X^ 
 
  
 
Action Plan Interview  
 
 
 
 
 
 
 
 
Visit Duration (min) 
10 
32 
83 
60 
660^ 
684^ 
20 
132^ 
Payments at study visits ($) 
  
 
20 
  
  
  
 
  
^ Represents surveys, events, and time durations that only apply to MTPC group participants   
% Represents surveys administered only to patients who score below 90% on the ICF assessment 
# Represents surveys and/or instruments administered through REDCap 
* Represents surveys, events, and time durations that only apply to 6-month waitlist participants   

 
77 
 
 
Table 3 (Cont’d). Study Visit and Assessment Schedule for Patient Participants 
Post-
Treatment 
Surveys 
Week 
9 
Week
10 
Week 
16 
Follow-up 
Surveys 
Optional 
Action Plan 
Interview 
Item 
Duration 
(min) 
Patient Screening 
  
Patient Eligibility Questionnaire 
 
  
 
 
 
 
  
5 
  
MINDFUL-PC Patient Screening 
Form# 
 
  
 
 
 
 
  
5 
Informed Consent  
  
Informed Consent Form 
 
  
 
 
 
 
  
20 
  
Consent Quiz 
 
  
 
 
 
 
  
10 
REALM-SF% 
 
 
 
 
 
2 
Baseline Battery   
  
Demographics Survey# 
 
  
 
 
 
 
  
5 
  
SMME# 
 
  
 
 
 
 
  
5 
  
FTND# 
 
  
 
 
 
 
  
3 
Mindfulness Self-Report Batter  
  
FFMQ# 
 
X 
 
 
 
X 
 
8 
  
SCS-SF# 
 
X 
 
 
 
X 
 
4 
DERS# 
 
X 
 
 
 
X 
 
5 
MAIA# 
 
X 
 
 
 
X 
 
5 
Clinical Assessment Batter  
  
DASS-21# 
 
X 
 
 
 
X 
 
3 
PHQ-2# 
 
 
 
 
 
 
1 
  
PSS# 
 
X 
 
 
 
X 
 
3 
  
AUDIT-C# 
 
X 
 
 
 
X 
 
1 
  
DSM-V SSU# 
 
X 
 
 
 
X 
 
3 
PROMIS-ASF# 
 
X 
 
 
 
X 
 
3 
PROMIS-DSF# 
 
X 
 
 
 
X 
 
3 
Self-Management Battery  
  
SECD-6# 
 
X 
 
 
 
X 
 
3 
  
PAM# 
 
X 
 
 
 
X 
 
4 
  
PCQ# 
 
X 
 
 
 
X 
 
3 
APA-10# 
 
 
 
 
 
 
4 
APIS-5# 
 
X 
X 
X 
X 
X 
 
3 
Action Plan Worksheet 
 
 
 
 
 
 
 
TFEQ-R18 
 
X 
 
 
 
X 
 
5 
Weekly Mindfulness Practice  
  
Weekly Mindfulness Practice Diary  
 
X 
 
 
 
X 
 
6 
Weekly Mindfulness Resources Use 
Survey 
 
X 
 
 
 
X 
 
6 
MTPC Satisfaction Survey 
Satisfaction survey# 
 
X^ 
 
 
 
 
 
5 
Engagement and Adverse Event Reporting  
Adverse Event Reporting Form 
 
X 
 
 
 
X 
 
2 
Participant Engagement Phone Call 
 
 
 
 
 
5 
Patient Study Visits 
60-minute Group Orientation 
 
  
 
 
 
 
  
 60 
2-hour MTPC Sessions 
 
  
 
 
 
 
  
960^ 
Action Plan Study Session 
 
  
 
 
 
 
  
20 
7-hour Full-Day Session 
 
  
 
 
 
 
  
420^ 
 
Action Plan Interview  
 
 
 
 
 
 
X 
 
Visit Duration (min) 
85 
3 
3 
3 
92 
30 
Payments at study visits ($) 
40 
 
 
 
80 
15 
  
^ Represents surveys, events, and time durations that only apply to MTPC group participants   
% Represents surveys administered only to patients who score below 90% on the ICF assessment 
# Represents surveys and/or instruments administered through REDCap 

 
78 
 
 
 
Table 4. Study Visit and Assessment Schedule for HEART pilot study participants 
 
Concurrent Cohort: 
 
 
 
Infomed 
Consent 
 
1st 
Behavioral 
Visit (Wk 0) 
 
Part 0 
(Wk 0)  
 
Part 1 
(Wks 5 & 6)  
 
Part 2 
(Wks 7 & 8) 
2nd 
Behavioral 
Visit (Wks 
8-9) 
Item 
Duration 
(min) 
Informed Consent 
Session 
x 
 
 
 
 
 
30 
Smartphone 
app/accelerometer-
based daily activity 
tracking 
 
 
daily 
daily 
daily 
 
2 
FAST Questionnaire 
 
 
daily 
daily 
daily 
 
10 
Daily mindfulness 
practice diary 
 
 
daily 
daily 
daily 
 
3 
Daily mindfulness 
resource use diary 
 
 
daily 
daily 
daily 
 
2 
Behavioral 
Measures 
 
x 
 
 
 
x 
20 
Visit Duration (min) 
45 
45 
15/day 
15/day 
15/day 
45 
 
Payments at study 
visits ($) 
 
$30 
 
 
$105 
$60 
$195 
 
 
Table 5. Study Visit and Assessment Schedule for fMRI Pilot Study Participants 
 
 
  
 
Screening  
 
fMRI 
session 1 
 
fMRI 
session 2 
 
Item 
Duration 
(min) 
Group Scheduling phone screen 
call 
 
  
  
fMRI pilot screening form 
x 
  
  
5 
 
Edinburgh Handedness 
Questionnaire 
x 
 
 
5 
fMRI appointment 
 
  
  
  
  
Informed Consent Form 
 
 x 
20 
 
Toxicology/Pregnancy 
screening 
 
x 
x 
10 
 
Autonomic measures 
electrodes/belt set-up 
 
x 
x 
10 
  
fMRI scan 
 
 X  
 X  
90 
* Represents surveys, events, and time durations that only apply to 6-month waitlist participants   

 
79 
 
fMRI questionnaire 
 
X 
X 
5 
Visit Duration (min) 
10 
110 
110 
Payments at study visits ($)  
5 + 50 
5 + 50 
  
Travel Expenses ($) 
 
10 or 
parking 
10 or 
parking 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
80 
 
 
 
Choice of Smartphone Applications and Tracking Devices 
 
The HEART Pilot study is intended to test the feasibility of using commercial behavior tracking 
smartphone applications and devices in the context of the action planning and initiation process 
of the MINDFUL-PC study, as well as to validate with objective behavioral measures, the self-
report action plan initiation survey. We are not pilot testing the devices and applications 
themselves but are pilot testing their use in our studies. Due to the rapid innovations in the 
consumer market, we have left open the possibility of using other, improved but similar 
applications for activity, sleep, and diet tracking.  The Argus App is among the current best 
possible apps for this purpose.  Below is a list of similar alternatives.   
 
We are considering the following smartphone activity tracking applications for inclusion in the 
study as alternatives to the Argus App:  
 Pedometer for Android 
 Stepz for IOS.  
 Activ8 by 2M Engineering 
We are considering use of the following activity tracking devices for inclusion in the study: 
- 
Fitbit  
- 
Moov 
- 
Jawbone 
- 
Withings 
- 
MD2K Cerebrum 
- 
Garmin Vivosmart 
 
 

 
81 
 
 
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