Trial Outcomes & Findings for Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2) (NCT NCT03265600)

NCT ID: NCT03265600

Last Updated: 2020-11-25

Results Overview

The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable). For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 136 participants
• Primary outcome timeframe: Weeks 8-10
• Results posted on: 2020-11-25

Participant Flow

Participants were recruited from 11 metro-north Boston primary care Patient Centered Medical Homes via print and digital flyers, as well as referrals from primary and mental health care settings confirmed by a primary care provider. 465 participants were recruited.

All participants received a 60-minute introduction to mindfulness led by an MTPC group leader prior to randomization. The session included a conceptual/experiential mindfulness introduction, inquiry, and digital and print resources. Participants were able to decline study continuation after the 60-minute introduction and before randomization.

Participant milestones

Measure	Mindfulness Training for Primary Care Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Overall Study STARTED	92	44
Overall Study COMPLETED	68	32
Overall Study NOT COMPLETED	24	12

Reasons for withdrawal

Measure	Mindfulness Training for Primary Care Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Overall Study Lost to Follow-up	17	5
Overall Study Withdrawal by Subject	4	2
Overall Study Partially completed 8 wk or 24 wk survey	3	5

Baseline Characteristics

Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 2)

Baseline characteristics by cohort

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.	Total n=136 Participants Total of all reporting groups
Age, Continuous	40.6 years STANDARD_DEVIATION 12.7 • n=5 Participants	40.3 years STANDARD_DEVIATION 12.2 • n=7 Participants	40.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	26 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	18 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	17 Participants n=5 Participants	4 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic	75 Participants n=5 Participants	40 Participants n=7 Participants	115 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	73 Participants n=5 Participants	32 Participants n=7 Participants	105 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
English as second language	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Annual Income <$20,000	31 Participants n=5 Participants	9 Participants n=7 Participants	40 Participants n=5 Participants
Marital Status Single	44 Participants n=5 Participants	23 Participants n=7 Participants	67 Participants n=5 Participants
Marital Status Married/cohabitating	32 Participants n=5 Participants	17 Participants n=7 Participants	49 Participants n=5 Participants
Marital Status Divorced	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants
Marital Status Widowed	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Marital Status Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Education	16.6 years STANDARD_DEVIATION 3.1 • n=5 Participants	15.5 years STANDARD_DEVIATION 4.1 • n=7 Participants	16.2 years STANDARD_DEVIATION 3.4 • n=5 Participants
Insurance Medicaid or Medicare	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Insurance Subsidized	39 Participants n=5 Participants	12 Participants n=7 Participants	51 Participants n=5 Participants
Insurance Private	39 Participants n=5 Participants	22 Participants n=7 Participants	61 Participants n=5 Participants
Insurance Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Have practiced meditation before	56 Participants n=5 Participants	22 Participants n=7 Participants	78 Participants n=5 Participants
Baseline meditation practice	6.8 minutes/day STANDARD_DEVIATION 10.5 • n=5 Participants	4.1 minutes/day STANDARD_DEVIATION 6.5 • n=7 Participants	5.9 minutes/day STANDARD_DEVIATION 9.4 • n=5 Participants
DSM-V diagnosis Single DSM-V diagnosis	59 Participants n=5 Participants	30 Participants n=7 Participants	89 Participants n=5 Participants
DSM-V diagnosis 2+ DSM-V diagnosis	33 Participants n=5 Participants	14 Participants n=7 Participants	47 Participants n=5 Participants
Primary DSM-V diagnosis Major depressive disorder	27 Participants n=5 Participants	10 Participants n=7 Participants	37 Participants n=5 Participants
Primary DSM-V diagnosis Generalized anxiety disorder	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Primary DSM-V diagnosis Anxiety NOS	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Primary DSM-V diagnosis Adjustment disorder	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Primary DSM-V diagnosis Other depressive disorder	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Primary DSM-V diagnosis Other	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Any PTSD diagnosis	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Any depression diagnosis	48 Participants n=5 Participants	19 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 8-10

Population: Using mixed effects intent-to-treat analysis, we defined non-initiator status as participants who never endorsed greater than 4 or who did not complete the API survey. by week 9. The APIS-5 is analyzed using an intent to treat analysis and missing APIS is considered incomplete action plan initiation.

The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable).

For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Action Plan Initiation Survey (APIS-5)	53 Participants	14 Participants

PRIMARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Perceived Stress Scale (PSS) (10 items) 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). Scores range from 0-40 with higher scores reflecting worse results (more stress).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Perceived Stress Scale Baseline	25.0 score on a scale Standard Deviation 6.7	24.3 score on a scale Standard Deviation 6.6
Perceived Stress Scale 8 Weeks	19.9 score on a scale Standard Deviation 6.3	20.9 score on a scale Standard Deviation 6.3

PRIMARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) 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 Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) Baseline	63.9 score on a scale Standard Deviation 6.9	61.9 score on a scale Standard Deviation 6.6
Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) 8 Weeks	58.5 score on a scale Standard Deviation 6.6	58.9 score on a scale Standard Deviation 6.9

PRIMARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) 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 Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) Baseline	59.2 score on a scale Standard Deviation 8.6	58.0 score on a scale Standard Deviation 8.6
Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) 8 Weeks	53.9 score on a scale Standard Deviation 7.9	55.6 score on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Five Facet Mindfulness Questionnaire (FFMQ) 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." 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). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Five Facet Mindfulness Questionnaire (FFMQ) Baseline	115.8 score on a scale Standard Deviation 18.2	115.6 score on a scale Standard Deviation 24.5
Five Facet Mindfulness Questionnaire (FFMQ) 8 Weeks	132.0 score on a scale Standard Deviation 16.9	119.4 score on a scale Standard Deviation 26.4

SECONDARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion.

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Self-Compassion Scale-Short Form (SCS-SF) Baseline	2.6 score on a scale Standard Deviation 0.67	2.6 score on a scale Standard Deviation 0.73
Self-Compassion Scale-Short Form (SCS-SF) 8 Weeks	3.1 score on a scale Standard Deviation 0.65	2.8 score on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) 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). Higher scores indicate better results (higher levels of self-efficacy).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Change in Self-Efficacy for Managing Chronic Disease (SECD-6) Baseline	6.1 score on a scale Standard Deviation 1.9	6.2 score on a scale Standard Deviation 2.0
Change in Self-Efficacy for Managing Chronic Disease (SECD-6) 8 Weeks	6.7 score on a scale Standard Deviation 1.6	6.5 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Perceived Control Questionnaire (PCQ) Baseline	23.5 score on a scale Standard Deviation 4.4	23.0 score on a scale Standard Deviation 4.4
Perceived Control Questionnaire (PCQ) 8 Weeks	25.3 score on a scale Standard Deviation 4.2	23.8 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Difficulty in Emotion Regulation Scale (DERS) Baseline	76.1 score on a scale Standard Deviation 23.0	72.2 score on a scale Standard Deviation 23.2
Difficulty in Emotion Regulation Scale (DERS) 8 Weeks	60.2 score on a scale Standard Deviation 21.8	68.8 score on a scale Standard Deviation 21.8

SECONDARY outcome

Timeframe: Baseline and week 8 (pre to post Intervention)

Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).

Outcome measures

Measure	Mindfulness Training for Primary Care n=92 Participants Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 Participants Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Multidimensional Assessment of Interoceptive Awareness (MAIA) Baseline	2.4 score on a scale Standard Deviation 0.73	2.5 score on a scale Standard Deviation 0.73
Multidimensional Assessment of Interoceptive Awareness (MAIA) 8 Weeks	3.1 score on a scale Standard Deviation 0.64	2.6 score on a scale Standard Deviation 0.69

Adverse Events

Mindfulness Training for Primary Care

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Low-dose Comparator

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mindfulness Training for Primary Care n=92 participants at risk Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 participants at risk Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Gastrointestinal disorders Diagnosed with colon cancer	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Psychiatric disorders Psychiatric hospitalization, hypomanic episode	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Psychiatric disorders Psychiatric hospitalization, increased PTSD symptoms	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Psychiatric disorders Psychiatric hospitalization, suicidal ideation	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.

Other adverse events

Measure	Mindfulness Training for Primary Care n=92 participants at risk Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers. Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.	Low-dose Comparator n=44 participants at risk Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7. 60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Injury, poisoning and procedural complications Back injury	2.2% 2/92 • Number of events 2 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	2.3% 1/44 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Psychiatric disorders ED visit for alcohol abuse	1.1% 1/92 • Number of events 2 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Psychiatric disorders Binge drinking	0.00% 0/92 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	2.3% 1/44 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Injury, poisoning and procedural complications Motor vehicle accident	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Social circumstances ED visit after alleged sexual assault	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Psychiatric disorders Flashback during MTPC All-Day Session	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Psychiatric disorders Increased Anxiety during Open Awareness Practice	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Ear and labyrinth disorders ED visit due to hearing loss, ear pain, tinnitus	0.00% 0/92 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	2.3% 1/44 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Eye disorders Corneal abrasion	1.1% 1/92 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	0.00% 0/44 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.
Renal and urinary disorders Admission for flu and UTI	0.00% 0/92 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.	2.3% 1/44 • Number of events 1 • Participants completed a self-reported adverse events form during weeks 8 and 24. Adverse events were further collected during engagement phone calls during weeks 2, 4 6, and 8 using a combination of checklist and open-ended questions. An adverse event 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. AEs will be labeled according to severity based on their impact on the patient on the patient's well-being: "mild" if it does not have major impact, "moderate" if it causes some minor inconvenience, and "severe" if it causes substantial disruption.

Additional Information

Dr. Zev Schuman-Olivier

Cambridge Health Alliance

Phone: 617-591-6132

Email: zschuman@cha.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place