The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults
Phase: NA
Conditions: Anger, Aggression
Sponsor: Brown University

The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in 
Incarcerated Adults 
Signature Page 
____________________________________ 
__________01/09/2023____________
Lauren Weinstock, Ph.D., MPI 
Date 
____________________________________ 
__________01/09/2023____________
Lisa Uebelacker, Ph.D., MPI 
Date 

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CLINICAL INTERVENTION STUDY 
PROTOCOL  
 
 

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The Peace of Mind and Body Project: Treatment development of  
yoga for anger management in incarcerated adults 
 
Principal Investigators:   
Lauren Weinstock, Ph.D. 
Associate Professor, Brown University 
 
 
Lisa Uebelacker, Ph.D. 
Professor, Brown University 
Assistant Director of Psychosocial Research, Butler Hospital 
 
 
Supported by:  
 
The National Center for Complementary and Integrative Health, R34AT010172 
 
 
 
 
 
 

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Tool Revision History 
Version Number: 1.9 
Version Date: 12/15/2022 
Summary of Revisions Made:  
Version 
Number 
Version 
Date 
Summary of the Revision 
1.1 
6/10/19 
Update recruitment procedures (location of announcements and 
individually approaching inmates to assess interest)  
1.2 
07/05/19 The following changes are in response to NCCIH’s requested edits to 
our protocol:  
• 
Adding the length of time each participant will be in the study 
• 
Added information about randomization in section 3, study 
design 
• 
Added more information on minimum group size 
• 
Added in the number of interventionists, yoga teachers and 
health education teachers 
• 
Added details on percent adherence in section 5.4 
• 
Added more information on randomization in section 6.2.5, 
blinding 
• 
Clarified primary and exploratory outcomes  
• 
Clarified where to find Table 4 in the hypothesis section  
• 
Corrected errors found in Table 3 
• 
Added data collection completion rates as a feasibility 
outcome 
The following change is per the RIDOC’s Medical Director’s request to 
decrease the burden on their staff/facilities: 
• 
Changed the exclusion criterion from “any endorsed item on the 
Physical Activity Readiness Questionnaire (PAR-Q) combined 
with lack of medical clearance lack of medical clearance from 
prison healthcare staff to participate in the study interventions” 
to “any endorsed item on the Physical Activity Readiness 
Questionnaire (PAR-Q).” 
1.3 
10/18/19 Corrected a typographical error found in Table 3, Schedule of 
Evaluations, Phase 2.  
1.4 
12/20/19 The following changes have been made per our completion of Phase 1 
of this pilot study, guided by focus groups and key informant 
interviews: 
• 
Removed restriction on sex of yoga and Health Education 
teachers.  
• 
Updated Health Education teacher qualifications.  
• 
Changed our inclusion criterion to include sentenced and 
unsentenced inmates serving 90 days or more 

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• 
Updated our PAR-Q exclusion criterion to exclude item 6 (relating 
to hypertension medications) from the exclusion criterion.  
• 
Specified we will run classes in men’s medium (n=20) and 
women’s facilities (n=20). We will not run classes in men’s 
minimum security facility.  
• 
Indicated that the length of classes will be 60-75 minutes. 
• 
Typographical errors 
1.5 
02/27/20 Per NCCIH request, we clarified wording that the populations being 
studied are Men’s medium security prison and Women’s combined 
minimum and medium security prisons. 
1.6 
03/31/22 Addition of qualitative interview for participants in the yoga 
intervention at 14 weeks post enrollment.  
1.7 
06/09/22 Updated RIDOC personnel per NCCIH request. 
1.8 
07/27/22 Increase the number of participants that could be enrolled in the pilot 
RCT in order to reach the study’s randomization goal.  
1.9 
12/15/22 Increase the number of participants that could be enrolled in the pilot 
RCT in order to reach the study’s randomization goal. 
 
 
 
 

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TABLE OF CONTENTS 
Page 
Clinical Intervention Study Protocol .............................................................................................. 1 
Tool Revision History ..................................................................................................................................... 3 
TABLE OF CONTENTS ........................................................................................................................... 5 
STUDY TEAM ROSTER .................................................................................................................................... 8 
PARTICIPATING STUDY SITES .................................................................................................................... 9 
PRÉCIS ............................................................................................................................................................... 10 
1. STUDY OBJECTIVES ........................................................................................................................ 12 
1.1 Primary Objective .................................................................................................................................. 12 
2. BACKGROUND AND RATIONALE ................................................................................................ 13 
2.1 Background on Condition, Disease, or Other Primary Study Focus ................................... 13 
2.2 Study Rationale ....................................................................................................................................... 14 
3. STUDY DESIGN ................................................................................................................................. 15 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................................ 16 
4.1 Inclusion and Exclusion Criteria, Prisoners, Phase 1. .............................................................. 16 
4.2 Inclusion and Exclusion Criteria, Stakeholders, Phase 1. ....................................................... 16 
4.3 Inclusion and Exclusion Criteria, Prisoners, Phase 2. .............................................................. 17 
4.4 Study Enrollment Procedures ........................................................................................................... 17 
4.4.1. Recruitment and Screening – Prisoner Participants. ...................................................... 18 
4.4.2. Recruitment and Screening – Stakeholder Participants. ............................................... 18 
4.4.3. Informed Consent Procedures – Prisoner Participants. ................................................ 19 
4.4.4. Informed Consent Procedures – Stakeholder Participants. ......................................... 20 
4.4.5. Enrollment and Randomization. ............................................................................................. 20 
4.4.6. Documentation of Reasons for Ineligibility. ....................................................................... 20 
5. STUDY INTERVENTIONS ............................................................................................................... 21 
5.1 Interventions, Administration, and Duration ............................................................................. 21 
5.2 Handling of Study Interventions ...................................................................................................... 21 
5.2.1. Hatha Yoga Intervention. ........................................................................................................... 21 
5.2.2. Health Education Control Group. ........................................................................................... 22 
5.3 Concomitant Interventions ................................................................................................................ 23 
5.3.1 Allowed Interventions. ................................................................................................................ 23 
5.3.2 Required Interventions. .............................................................................................................. 23 

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5.3.3 Prohibited Interventions. ........................................................................................................... 23 
5.4 Adherence Assessment ........................................................................................................................ 23 
6. STUDY PROCEDURES ..................................................................................................................... 24 
6.1 Schedule of Evaluations ....................................................................................................................... 24 
6.2 Description of Evaluations ................................................................................................................. 27 
6.2.1 Baseline Visit and Focus Group --Prisoners – Phase 1. ................................................... 27 
6.2.2 Screening and Focus Group -- Stakeholders – Phase 1 ................................................... 27 
6.2.3 Focus Group Procedures and Study Material Revision................................................... 28 
6.2.4 Baseline Visit -- Prisoners – Phase 2. ..................................................................................... 28 
6.2.5 Blinding – Phase 2. ........................................................................................................................ 29 
6.2.6 Follow-up Visits – Phase 2. ........................................................................................................ 30 
6.2.7 Completion/Final Evaluation – Phase 2 ............................................................................... 30 
6.3 Audiorecording ....................................................................................................................................... 30 
6.4.  Material Inducements ........................................................................................................................ 31 
7. SAFETY ASSESSMENTS .................................................................................................................. 32 
7.1.  Human Subjects .................................................................................................................................... 32 
7.2 Specification of Safety Parameters .................................................................................................. 36 
7.3 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ..... 37 
7.4 Adverse Events and Serious Adverse Events .............................................................................. 37 
7.5 Reporting Procedures .......................................................................................................................... 38 
7.6 Follow-up for Adverse Events ........................................................................................................... 39 
7.7 Safety Monitoring................................................................................................................................... 39 
8. INTERVENTION DISCONTINUATION ........................................................................................ 40 
9. STATISTICAL CONSIDERATIONS................................................................................................ 41 
9.1 General Design Issues .......................................................................................................................... 41 
9.1.1. Summary of Aims, Endpoints, and Data Analytic Strategy. .......................................... 41 
9.1.2. Description of Assessment Instruments. ............................................................................. 43 
9.2 Sample Size and Randomization ...................................................................................................... 44 
9.2.1. Sample Size. .................................................................................................................................... 44 
9.2.2. Treatment Assignment Procedures. ...................................................................................... 44 
9.3 Definition of Populations .................................................................................................................... 45 
9.4 Interim Analyses and Stopping Rules ............................................................................................ 45 
9.4.1 Interim analysis. ............................................................................................................................. 45 
9.4.2 Halting Rules. .................................................................................................................................. 45 
9.5 Outcomes ................................................................................................................................................... 45 

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9.5.1 Primary Outcome. .......................................................................................................................... 45 
9.5.2 Secondary/ Exploratory Outcomes. ....................................................................................... 46 
9.6 Data Analyses .......................................................................................................................................... 47 
10. DATA COLLECTION AND QUALITY ASSURANCE................................................................. 48 
10.1 Data Collection Forms ....................................................................................................................... 48 
10.2 Data Management ............................................................................................................................... 48 
10.3 Quality Assurance ............................................................................................................................... 49 
10.3.1 Training .......................................................................................................................................... 49 
10.3.2 Quality Control Committee ..................................................................................................... 49 
10.3.3 Metrics ............................................................................................................................................. 49 
10.3.4 Protocol Deviations .................................................................................................................... 49 
10.3.5 Monitoring ..................................................................................................................................... 49 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................................ 50 
11.1 Institutional Review Board (IRB) Review ................................................................................. 50 
11.2 Informed Consent Forms.................................................................................................................. 50 
11.3 Participant Confidentiality .............................................................................................................. 50 
11.4 Study Discontinuation ....................................................................................................................... 50 
11.5 Inclusion of Special Classes, Women and Minorities, and Children ................................ 50 
12. COMMITTEES ................................................................................................................................. 51 
13. PUBLICATION OF RESEARCH FINDINGS ............................................................................... 53 
15. SUPPLEMENTS/APPENDICES ................................................................................................... 58 
 
 
 

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STUDY TEAM ROSTER  
Lauren Weinstock, PhD.  
Role: MPI 
Associate Professor, Brown University 
Address: Brown University, Box G-BH, Providence, RI 02912 
Tel: 401-455-6304; Fax: 401-455-6235; Email: lauren_weinstock@brown.edu 
 
Lisa Uebelacker, Ph.D. 
Role: MPI 
Professor, Brown University 
Assistant Director of Psychosocial Research, Butler Hospital 
Address: Butler Hospital, 345 Blackstone Blvd., Providence, RI, 02906 
Tel: 401-455-6381; Fax: 401-455-6235; Email: luebelacker@butler.org 
 
Leslie Brick, Ph.D.  
Role: Study Statistician 
Assistant Professor, Brown University 
Address: Brown University, Box G-BH, Providence, RI 02912 
Tel: 401-444-1958; Fax: 401-444-1911; Email: leslie_brick@brown.edu 
 
Hannah Graves, Sc.M. 
Role: Study Coordinator 
Project Coordinator, Brown University 
Address: Brown University, Box G-BH, Providence, RI 02912 
Tel: 401-444-1953; Fax 401-444-1904; Email: hannah_graves@brown.edu 
 
Jennifer Johnson, Ph.D. 
Role: Co-Investigator 
C. S. Mott Endowed Professor of Public Health, Professor of OBGYN, Professor of 
Psychiatry and Behavioral Medicine, Michigan State University 
Address: 200 East 1st St, Flint, MI 48502 
Tel: (810) 600-5669; Fax: 810-600-5609; Email: Jennifer.Johnson@hc.msu.edu 
 
Tracie Shea, Ph.D. 
Role: Co-Investigator 
Professor, Brown University 
Address: Veterans Affairs Medical center, 830 Chalkstone Avenue, Bldg 32,  
Providence, RI 02903 
Tel: 401-273-7100 x6248; Fax: 401-457-3311; Email: m_shea@brown.edu 
 
Geoffrey Tremont, Ph.D. 
Role: Co-Investigator 
Director, Neuropsychology, Rhode Island Hospital and The Miriam Hospital  
Address: 593 Eddy Street, Providence, RI 02803 
Tel: 401-444-4500; Fax: 401-444-6643; Email: gtremont@lifespan.org 

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PARTICIPATING STUDY SITES 
Brown University: 164 Angell Street, Providence, RI 02912 
Contact: Lauren Weinstock, Ph.D. 
 
Butler Hospital: 345 Blackstone Boulevard, Providence, RI 02906 
Contact: Lisa Uebelacker, Ph.D. 
 
Lifespan: 593 Eddy Street, Providence, RI 02903 
Contact: Geoffrey Tremont, Ph.D. 
 
Michigan State University: 200 East 1st St, Flint, MI 48502 
Contact: Jennifer Johnson, Ph.D.  
 
Rhode Island Department of Corrections: 40 Howard Ave, Cranston, RI 02920 
Contact: Erin Boyar 
 
 

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PRÉCIS 
Study Title  
The Peace of Mind and Body Project: Treatment development of yoga for anger 
management in incarcerated adults 
 
Objectives  
Our proposed project will have two phases. Specific Aims for each phase include:  
 
1. Phase 1: To refine our current manualized hatha yoga intervention and health 
education intervention to target high levels of anger dysregulation in prisoners. 
a. To conduct focus groups with prisoners and criminal justice stakeholders 
(separately) to understand ways of increasing feasibility, acceptability, and 
efficacy of yoga for anger management as well as feasibility and acceptability of 
our control arm (health education); 
b. To solicit feedback from experts in correctional mental health, addiction, and 
yoga; and 
c. To modify our existing yoga treatment manual, health education manual, and 
instructor fidelity scales. 
 
2. Phase 2: To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a 
health education group (attention control) for prisoners high in self-reported anger 
dysregulation. Participants will be enrolled in the active intervention for 10 weeks, 
and then be followed for 8 weeks. 
a. To assess feasibility and acceptability of both the yoga class and the health 
education control group. We will assess credibility of the assigned intervention 
and expectancy for improvement for both groups at baseline, program 
satisfaction following program participation, participant adherence, ability to 
hold group classes (with a certain number of participants), and instructor fidelity 
to the manuals. We will conduct structured interviews following program 
participation to further understand and develop strategies to improve 
acceptability and feasibility. 
b. To assess safety, we will track all adverse events in a structured fashion. We do 
not expect to see any serious adverse events definitely or probably related to 
study participation. 
c. To assess feasibility of research procedures, we have benchmarks for 
recruitment rate, retention for study assessments, and reliability of instructor 
fidelity measures. 
 
If successful, this project will provide us with materials, experience, and pilot data needed 
for the next step in this research, namely, a fully powered randomized clinical trial with 
anger dysregulation as the primary outcome. 
 
Design and Outcomes   

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In Phase 1, we will conduct focus groups with prisoners and representatives from 
important criminal justice stakeholder groups (separately). We will also conduct individual 
interviews with prison administrators as key informants. 
 
 
 
In Phase 2, we will conduct a pilot randomized clinical trial (n = 40) of hatha yoga 
vs. a health education group (attention control) for prisoners high in self-reported anger 
dysregulation. Participants will be enrolled in the active intervention for 10 weeks, and 
then be followed for 8 weeks. We will assess feasibility and acceptability of both the yoga 
class and the health education control arm, safety, and feasibility of research procedures.  
 
In both programs, participants be involved in the study for approximately 15 hours over 18 
weeks.  
  
Interventions and Duration  
Yoga classes. The manualized hatha yoga program will begin with an initial 
individual session with a yoga teacher to increase motivation for class attendance and self-
efficacy for yoga practice between classes. Subsequently, participants will be asked to 
attend one 60-75 minute class per week for 10 weeks.  
 
Health education. The program consists of information about general health topics. 
Participants will be asked to attend one 60-75 minute class per week for 10 weeks. Each 
week will cover a different topic. 
 
Sample Size and Population  
Phase 1 of the proposed project will include up to 18 prisoners and 6 
representatives from important criminal justice stakeholder groups in focus groups. Also in 
Phase 1, we will conduct interviews with 3 separate prison administrators as key 
informants.  Because RIDOC administrators may have a supervisory role over other RIDOC 
stakeholders, we believe it may not be prudent to have them participate in focus groups 
with other staff. Thus, prison administrators will be interviewed individually and 
separately as key informants (which are not considered to be human subjects, per the 
Brown University IRB). 
Phase 2 of the proposed project will include 40 prisoners in the pilot.  All prisoners 
will be high in self-reported anger dysregulation. Participants will be prisoners aged 18 to 
70. We will recruit 20 men and 20 women to participate.  
 
 

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1. STUDY OBJECTIVES 
1.1 Primary Objective 
 
The primary aim of this treatment development research is to develop and 
establish the feasibility, acceptability, and safety of a hatha yoga intervention for prisoners 
with anger dysregulation and aggression. Development of the yoga intervention (and the 
health education control condition) will be informed by our prior experiences conducting 
research on yoga for depression, bipolar disorder, and chronic pain in community settings 
and by our prior experiences evaluating behavioral interventions for mental health 
outcomes in the criminal justice context.   
 
The Specific Aims of this treatment development research are: 
 
1. Phase 1: To refine our current manualized hatha yoga intervention and health 
education intervention to target high levels of anger dysregulation in prisoners. 
a. To conduct focus groups with prisoners and criminal justice stakeholders 
(separately) to understand ways of increasing feasibility, acceptability, and 
efficacy of yoga for anger management as well as feasibility and acceptability of 
our control arm (health education); 
b. To solicit feedback from experts in correctional mental health, addiction, and 
yoga; and 
c. To modify our existing yoga treatment manual, health education manual, and 
instructor fidelity scales. 
 
2. Phase 2: To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a 
health education group (attention control) for prisoners high in self-reported anger 
dysregulation. Participants will be enrolled in the active intervention for 10 weeks, 
and then be followed for 8 weeks. 
a. To assess feasibility and acceptability of both the yoga class and the health 
education control group. We will assess credibility of the assigned intervention 
and expectancy for improvement for both groups at baseline, program 
satisfaction following program participation, participant adherence, ability to 
hold group classes (with a certain number of participants), and instructor fidelity to 
the manuals. We will conduct structured interviews following program 
participation to further understand and develop strategies to improve 
acceptability and feasibility. 
b. To assess safety, we will track all adverse events in a structured fashion. We do 
not expect to see any serious adverse events definitely or probably related to 
study participation. 
c. To assess feasibility of research procedures, we have benchmarks for 
recruitment rate, retention for study assessments, and reliability of instructor 
fidelity measures. 
 
We hypothesize that we will hit all benchmarks in table 4 on page 38.  If successful, this 
project will provide us with materials, experience, and pilot data needed for the next step 

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in this research, namely, a fully powered randomized clinical trial with anger dysregulation 
as the primary outcome. 
 2. BACKGROUND AND RATIONALE 
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Prisoner mental health is an area of high public health significance. The United 
States (US) has the highest rates of incarceration and criminal justice (CJ) involvement in 
the world.1 Nearly 7 million people pass through the US CJ system each year, and 1.6 
million people are housed in US prisons at any given time.2 In addition to the well 
documented and significant racial, ethnic, and socioeconomic disparities encountered in 
the CJ system,3 there is a disproportionately high mental health burden among those who 
are incarcerated. Indeed, the US CJ system has been described, by proxy, as the largest 
mental healthcare system in the United States.4 Roughly 50% of prisoners report a history 
of one or more psychiatric diagnoses,5 most commonly depressive and anxiety disorders, 
trauma-related disorders, psychotic-spectrum illnesses, and disorders of impulse control.6 
Prisoners also report a disproportionately high rate of lifetime substance use disorders, 
ranging in prevalence from 25-58%,6–8 and as high as 74% among those with a history of 
psychiatric illness.5 Following from this substantial psychiatric and substance use 
morbidity, and further complicated by the high medical burden also documented in this 
population,9 prisoners are at significantly heightened risk for suicide and premature all-
cause mortality, both in prison10 and upon community re-entry.11  
 
Of particular interest has been a focus on anger dysregulation. With significant 
transdiagnostic relevance, anger is a negative affective state of variable duration, ranging in 
intensity from “mild irritation or annoyance to intense fury and rage.”12 In addition to being 
an affective experience, anger involves cognition and physiological arousal. Anger is 
typically associated with negative cognitions surrounding a triggering event, particularly 
those focused on themes of perceived injustice and attributions of blame.13 Anger is also 
typically marked by activation of the neuroendocrine system and autonomic arousal, 
consistent with a fight-or-flight response, with corresponding elevations in heart rate, 
muscle tension, skin flushing, and shortness of breath.14 Anger is frequently – though not 
always – paired with aggression, marked by behaviors that aim to “warn, intimidate, 
control, or attack, or gain retribution,”13 such as verbal or behavioral intimidation or 
punishment (i.e., in the form of interpersonal confrontation or violence) toward others.  
 
Together, anger dysregulation and aggression are frequently encountered in the CJ 
setting, and in fact, may contribute to the very offenses that result in initial CJ involvement 
and incarceration.15 While incarcerated, anger dysregulation may contribute to affective 
distress and exacerbation of underlying mental health problems. Overt aggression further 
increases risk of disciplinary action,16,17 such as placement in restraints or prison 
seclusion,18 and may delay parole or release decisions.19 After prison release, anger 
dysregulation and aggression may precipitate clinical deterioration, and contribute to risk 
for reoffending and recidivism.20,21 

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2.2 Study Rationale 
 
In the criminal justice (CJ) system in the US, there are high rates of mental health 
and substance use disorders. Although prisons must provide treatment, the CJ system is 
resource-poor and the presenting problems of prisoners are diverse. To maximize 
efficiency in the CJ context, recent efforts focus adjunctive interventions on symptoms that 
are most detrimental to prisoners, and that are shared across diverse conditions. Of 
particular interest has been anger dysregulation, as this is prevalent in CJ-involved 
populations, contributing not only to distress and exacerbation of other mental health 
problems, but also to risk of aggression. Overt aggression further increases risk for prison 
behavioral infractions or placement in restraints or seclusion, and may delay parole or 
release decisions.  
There are many limitations to existing approaches to anger management in prison. 
We propose that hatha yoga could serve as a useful adjunctive treatment for anger within 
prisons. In addition to preliminary research showing that yoga programs may improve 
anger regulation, research has also demonstrated benefits of yoga for related symptoms of 
depression, anxiety, and trauma-related emotion reactivity and arousal. Yoga may be 
delivered in a relatively low-cost fashion. Finally, prisoners may view yoga as less 
stigmatizing than more traditional anger management interventions, particularly given its 
focus on physical body awareness/movement and on overall wellness.  
Despite a recent proliferation of yoga programs for various problems in prisons, 
empirical research on this topic is minimal, with a small number of studies limited by 
significant methodological concerns. We propose to conduct systematic treatment 
development research that would prepare us to study whether yoga (vs. a health education 
control group) is an effective adjunctive treatment for prisoners with anger dysregulation.  
 
 

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3. STUDY DESIGN 
 
In Phase 1, we will conduct 4 focus groups, composed of approximately 6 
individuals each (N=24). To achieve this number, we will consent up to 72 individuals to 
achieve our enrollment goals. The first 3 focus groups will be compromised of 18 prisoners 
in each of the 3 RIDOC facilities where we plan to conduct the next phase of this research 
project (men’s minimum, n=6; men’s medium, n=6; women’s combined minimum/medium 
n=6). The fourth focus group will consist of 6 representatives from important criminal 
justice stakeholder groups, including correctional officers, prison treatment staff, and 
justice-focused members of the public. To complement the focus groups, we will conduct 
separate interviews (n=3) of prison administrators as key informants. Enrollment period 
for this phase will last approximately 4 months.   
 
In Phase 2, we will consent up to 175 prisoners in order to achieve our enrollment 
goal of 40 prisoners who meet study inclusion for randomization to conditions in the pilot 
RCT. Participants will be recruited from the Rhode Island Department of Corrections 
(RIDOC) in Cranston, RI.  They will be randomized to either the yoga intervention or the 
health education group. The study research assistant will randomize participants in the 
prison using small opaque envelopes labeled with a number and the strata (for example, 
male medium 1, male medium 2, etc.).  Depending on group assignment, participants will 
be invited to participate in 10 weekly sessions of yoga or the health education group, to be 
held in the facility where they reside.  Group classes will be held in relevant spaces in the 
facilities at RIDOC (i.e. classrooms, chapels, library, etc.). The hatha yoga intervention will 
involve an initial individual session with a yoga teacher, designed to increase motivation 
for yoga class attendance and self-efficacy for adapted yoga practice between classes. 
Following the initial individual session, participants will be invited to attend one 60-75 
minute yoga class for 10 weeks in the prison facility where they reside. Registered yoga 
teachers will deliver the intervention.  The Health education control group will be a 10-
week program that consists of weekly 60-75 minute group classes in the prison facility 
where the participants reside. In classes, instructors will provide information about 
general health topics through a variety of means such as slides, handouts, and/or audio and 
video clips. This class will be taught by instructors with experience working in correctional 
settings and post-baccalaureate experiences or certification in a relevant health care field. 
In addition to the baseline assessment, outcome assessments will occur at 5 weeks (mid-
intervention), 10 weeks (post-intervention), 14 weeks (qualitative interview for yoga 
participants only), and at 8 week follow-up, for a total length of participation of each 
individual participant of 4.5 months. Enrollment period for this phase will last 
approximately 7 months.  
 
 
 
 

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4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion and Exclusion Criteria, Prisoners, Phase 1. 
 
Participants must meet all of the relevant inclusion criteria to participate in the 
study.  Inclusion/exclusion criteria for prisoners in Phase 1 will be similar to those 
proposed for the pilot RCT (see Phase 2):  
 
Phase 1 (Focus Group) Inclusion Criteria – Prisoners 
 
1. Sentenced prisoners who are incarcerated in the women’s and men’s minimum and 
medium security prison facilities at the RI Department of Corrections (RIDOC) in 
Cranston, RI. 
2. Ages 18-70;  
3. Clinically significant anger dysregulation, as evidenced by a score ≥ 86 on the 
Novaco Anger Scale (NAS);  
4. Ability and willingness to provide informed consent; and  
5. Willingness to be audio recorded in the focus group meeting. 
 
Phase 1 (Focus Group) Exclusion Criteria – Prisoners 
 
1. Presence of current manic or psychotic symptoms, or suicide risk (warranting 
referral to prison mental health clinical staff);  
2. Any endorsed item on the Physical Activity Readiness Questionnaire (PAR-Q);  
3. Current weekly yoga practice or current participation in mindfulness- based 
programming;  
4. Pregnancy; and  
5. Inability to understand English sufficiently well to understand the consent form or 
assessments when they are read aloud 
 
4.2 Inclusion and Exclusion Criteria, Stakeholders, Phase 1. 
Participants must meet all of the relevant inclusion criteria to participate in the 
study.  
 
Phase 1 (Focus Group) Inclusion Criteria – Stakeholders 
 
The fourth focus group will consist of 6 representatives from important criminal 
justice stakeholder groups, including correctional officers, prison treatment staff, and 
justice-focused members of the public.  
 
1. 18 years or older;  
2. Currently employed in one of the stakeholder settings described above 
3. Able to speak English sufficiently well to participate in the interview 
4. Willing to be audio recorded during the focus group meeting, and  

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5. Willing to consent to participate in the focus group.  
 
Because prison administrators operate in a supervisory role over the stakeholder groups 
described above, we will conduct separate, individual interviews with up to 3 prison 
administrators, who will serve as key informants for purposes of conducting the proposed 
research. As content experts, it has been determined by the Brown University IRB that 
prison administrators as key informants are not considered to be human subjects 
participants for purposes of the proposed research. 
 
Phase 1 (Focus Group) Exclusion Criteria – Stakeholders 
 
None.  
 
4.3 Inclusion and Exclusion Criteria, Prisoners, Phase 2. 
 
Participants must meet all of the relevant inclusion criteria to participate in the study.  
 
Phase 2 Inclusion Criteria – Prisoners 
 
1. Age 18-70;  
2. Clinically significant anger dysregulation, as evidenced by a score ≥ 86 on the 
Novaco Anger Scale (NAS);  
3. Prisoner or jail detainee, with anticipated duration of remaining time incarcerated 
of 90 days or more, allowing for participation in the 10 week intervention;  
4. Ability and willingness to provide informed consent; and  
5. Willingness to be audio recorded in the intervention condition sessions (e.g., yoga or 
health education groups).  
 
Phase 2 Exclusion Criteria – Prisoners 
 
1. Presence of current manic or psychotic symptoms, or suicide risk (warranting 
referral to prison mental health clinical staff);  
2. Any endorsed item on the Physical Activity Readiness Questionnaire (PAR-Q) except 
for item 6 (i.e., participants can be included even if they endorse item 6);  
3. Current weekly yoga practice or current participation in mindfulness- based 
programming;  
4. Pregnancy; and  
5. Inability to understand English sufficiently well to understand the consent form or 
assessment instruments when read aloud. 
 
4.4 Study Enrollment Procedures  
 

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4.4.1. Recruitment and Screening – Prisoner Participants.   
 
Recruitment will follow procedures successfully used to recruit prisoners into our 
completed and ongoing trials at the study site over the past decade. Participants will be 
recruited from the women’s combined minimum and medium security prison and the 
men’s medium security prison facilities of the RIDOC in Cranston, RI (see letter of support). 
Recruitment will occur in one of four ways. First, with permission from prison treatment 
staff and security personnel, research staff will make announcements to inmates to briefly 
explain the study (i.e. in housing units, medical units, etc.).  Research staff will either 
individually approach inmates to assess their level of interest in the study, or hand out 
“interest slips” of paper, on which participants can confidentially indicate interest or lack of 
interest in learning more about the study. We request that all prisoners complete the 
“interest slip,” regardless of interest in participation, to ensure privacy of responses. 
Second, we will identify potentially eligible participants based on their time in prison and 
release dates from prison records and approach them privately. This information is already 
publicly available (http://www.doc.ri. Gov/inmate_search/search.php), but is often 
provided to us in list form by the Deputy or his/her assistant for greater ease in identifying 
individuals who are not anticipated to be released within 90 days. Third, with the 
assistance of behavioral health leadership at the RIDOC, with whom we have a long history 
of collaboration, we will provide an in-service to prison psychiatrists and mental health 
counselors, and distribute study brochures so that they may refer potentially eligible 
participants to the study. Brochures will contain study details and guidance regarding how 
a participant can confidentially request more information about the study. To further 
minimize risk of coercion, we will not solicit direct referrals from prison mental health or 
other staff. Fourth, we will post flyers in each recruitment facility indicating that interested 
prisoners should submit an “interest slip” to learn more about our study.    
Participants who indicate potential interest in the study are approached privately in 
a confidential setting.  To meet with an inmate at the RIDOC, research staff will notify 
RIDOC personnel of the name/prison ID of the inmate we wish to approach. We will 
emphasize that this initial meeting with the RA is completely voluntary, and that refusal to 
meet with a member of our study team for this initial meeting will have no impact (positive 
or negative) on their status in the prison. If the inmate agrees to meet with the RA, the 
research staff will meet with the inmate in as private of an area as possible (i.e. classroom, 
mod, chapel, library, attorney’s room when not in use by attorneys, etc.). If the research 
staff meets with an inmate in a more public area (i.e. visiting room), they will move to an 
area as far away from others as possible and speak in hushed tones to avoid being 
overheard. 
 
4.4.2. Recruitment and Screening – Stakeholder Participants.   
 
For stakeholder participants: Our RIDOC partners have agreed to give us their 
directories and to let their staff know about the study and that we may be approaching 
them. Using the staff directory, we will individually and confidentially reach out to 
stakeholders internal to the RIDOC. We are using this strategy in our current IRB-approved 

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protocol for the Project CARE study, and have used this strategy successfully to enroll and 
interview stakeholders for Dr. Johnson’s prison depression implementation treatment 
study (R01 MH095230). Community stakeholders will be recruited through the RI-based 
Center for Prisoner Health and Human Rights, of which Drs. Weinstock and Johnson are 
members. Prison counselors and staff who indicate potential interest in focus group 
participation will be approached privately. 
 
Prison administrators as key informants: Because RIDOC administrators may have a 
supervisory role over other RIDOC stakeholders, we believe it may not be prudent to have 
them participate in focus groups with other staff. Thus, prison administrators will be 
interviewed individually and separately as key informants. As with the stakeholders, we 
will recruit administrators through the RIDOC staff directory, and will emphasize that that 
participation has no impact on their employment or affiliation with the RIDOC. All key 
informants will be reminded that there is no penalty if they choose to not participate in the 
key informant interview and that they may terminate the interview at any time. 
 
4.4.3. Informed Consent Procedures – Prisoner Participants.  
 
 
Research staff will carefully explain all aspects of the study to a potential 
participant, including its voluntary nature, risks and benefits, the schedule of visits, and the 
expected duration of participation, and will elicit and answer any questions the participant 
may have. Potential participants will also be informed that: (1) a decision to not participate 
in the research will have no impact on their status, access to treatment, or length of stay at 
the prison; (2) the study has a Certificate of Confidentiality; and (3) the study information 
will be kept confidential from prison staff, officers of the court, parole officers, or others in 
the criminal justice system. Study staff will also carefully review the limits to 
confidentiality, including the prison’s mandatory reporting procedures for suicidal ideation 
and homicidal ideation (see below). We will ask participants if they would like us to read 
the consent forms aloud.  
Participants who give their consent will sign a copy of the document and will be given a 
signed copy of the informed consent document.  Informed consent procedures have been 
developed to comply with the Code of Federal Regulations 45 CFR 46.116, General 
Requirements for Informed Consent and 46.117 Documentation of Informed Consent, and are 
subject to oversight and approval of Brown University’s Institutional Review Board and the 
Medical Research Advisory Group of the RIDOC. Freedom to refuse to participate or to 
discontinue participation at any time without penalty will be emphasized.  
It is possible that some participants will be released from prison prior to study 
completion. For that reason, participants will be asked to provide written permission for us 
to try to locate them through significant others, their appointed parole/probation officer, 
and/or post-release treatment program, but will not be excluded if they are unwilling to do 
so.  Participants will be able to refuse or revoke locator consent. Once a participant has 
agreed to participate in the research and signed the informed consent, s/he will undergo 
the baseline assessment phase. 
 

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4.4.4. Informed Consent Procedures – Stakeholder Participants.  
 
 
Study staff will fully explain the study procedures, risks and benefits, and 
alternatives to participation. We will emphasize that participation has no impact on their 
employment or affiliation with the RIDOC. All participants will be reminded that there is no 
penalty for participants who choose to not participate or to withdraw from the study. 
 
4.4.5. Enrollment and Randomization.  
 
 
 In Phase 1, for prisoners, if a participant is determined to be eligible following the 
baseline assessment, s/he will be enrolled.   For stakeholders, enrollment occurs when they 
sign the informed consent form at the focus group meeting.  
 
 
In Phase Two (pilot RCT), if a participant is determined to be eligible following the 
baseline assessment, s/he will be enrolled and randomized to either the yoga intervention 
or the health education group.  
 
 
Recruitment will be rolling. If we ever have more than 10 people enrolled in a class, 
we will halt recruitment until there is room in both classes for new participants (maximum 
class size = 10).  
 
4.4.6. Documentation of Reasons for Ineligibility.  
 
 
All potential participants who are approached for the study (i.e., express interest in 
the study) will be tracked on paper and in REDCap along with the status of their 
participation.  Potential participants will have a study record documenting which inclusion 
criteria were assessed and the outcome of that assessment.  A study RA will complete an 
inclusion/exclusion form for each potential participant indicating their eligibility status.  
This form will be signed by the RA and the PC/MPI.  The paper version of the study record 
is linked to the participant’s name and other personal identifiers only by the study ID 
number.  A separate form will be used to link the potential participant’s name to ID.  Both 
study data and identifiable data are entered into REDCap and paper copies are locked 
separately in file cabinets in locked offices at Brown University.  REDCap has the ability to 
restrict identifiable data access to only necessary study personnel.  Those without access to 
identifiable data, will only be able to see the participant’s identification number and de-
identified data in REDCap.     
 
 

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5. STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
Hatha yoga intervention. The yoga intervention will involve an initial individual 
session with a yoga teacher, designed to increase motivation for yoga class attendance and 
self-efficacy for adapted yoga practice (see below) between classes. Following the initial 
individual session, participants will be invited to attend one 60-75 minute yoga class for 10 
weeks in the prison facility where they reside. Class length must be flexible as research 
staff do not control exactly when all participants will be able to arrive at the designated 
classroom. Registered yoga teachers will deliver the intervention. Potential risks include 
loss of privacy or breach of confidentiality, and mild physical injury. 
Health education control group. To match for attention, the control condition will be 
a 10-week program that consists of weekly 60-75 minute group classes in the prison 
facility where the participants reside. In classes, instructors will provide information about 
general health topics through a variety of means such as slides, handouts, and/or audio and 
video clips. This class will be taught by instructors with experience working in correctional 
settings and post-baccalaureate experiences or certification in a relevant health care field. 
Potential risks include loss of privacy or breach of confidentiality. 
 
5.2 Handling of Study Interventions  
5.2.1. Hatha Yoga Intervention.  
 
The yoga intervention will involve an initial individual session with a yoga teacher, 
designed to increase motivation for yoga class attendance and self-efficacy for adapted 
yoga practice (see below) between classes. Following the initial individual session, 
participants will be invited to attend one 60-75 minute yoga class for 10 weeks in the 
prison facility where they reside. Each class will consist of: breathing exercises, brief 
guided centering meditation, warm-ups, standing postures, floor postures, an inversion, 
relaxation, and between-class practice assignments. Classes will emphasize mindfulness, 
including noticing emotions, thoughts, and physical sensations related to anger, and 
moderate physical activity. Classes will include some teaching of a relevant yoga theme, 
such as nonviolence (ahimsa). We will plan themes with input from prisoners and other 
stakeholders prior to starting classes and rotate through themes. Themes may be 
introduced via a brief meditation at the beginning of class, and mentioned briefly through 
class. Between-class practice assignments will be tailored to the prison setting. With input 
from our stakeholders, we will design a series of brief yoga practices that prisoners can 
engage in either a) on a daily basis, such as when they wake up or before bed; and b) when 
they notice that they need to cope with angry or other difficult feelings. Practices may 
include breathing exercises, brief meditation, and simple poses. We will provide 
participants with written descriptions and diagrams to assist them with yoga practice. 
Because each participant will have an individual introduction session with a yoga teacher 
before beginning the classes, and because sessions are not cumulative, participants can 

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enter the group at any time (i.e., rolling enrollment). Minimum class size is 1, maximum is 
10. We prefer to have a group of at least 4 participants for a group effect, with larger 
groups (i.e, 8-10) being more cost-effective, of 8-10, but recognize that there will be times 
that not all participants can attend; thus, we will run the classes as long as 1 participant 
attends. 
Yoga teachers. The Yoga Alliance is a professional organization which sets standards 
for yoga teacher training. One can be a Registered Yoga Teacher (RYT) at the 200- or 500-
hour level. Experienced Registered Yoga Teachers (E-RYT) at the 500-hour level have at 
least 4 years of experience and 2000 hours of teaching, and are qualified to train teachers 
and provide continuing education. All study yoga teachers will be RYTs. We will hire and 
train 2-4 yoga teachers. Male or female instructors will teach classes in both the RIDOC 
men’s and women’s facilities. Teachers will also have study-specific training on research 
methods, anger and emotion dysregulation, and adverse events with the PIs, and on the 
yoga manual with our local yoga expert consultant, Mr. Tom Gillette (E-RYT) and Co-I Dr. 
Tremont (RYT). Yoga instructor supervision will include the following: Dr. Tremont, with 
Mr. Gillette’s assistance, will oversee delivery of yoga classes to ensure adherence to the 
manual and to maintain good quality of instruction. Once trained, teachers will meet twice 
monthly with Mr. Gillette and/or Dr. Tremont for supervision. If an instructor falls below 
80% adherence in 3 consecutive classes, we will implement remediation measures, such as 
observing classes and providing direct instruction to the teacher. Continued non-adherence 
may be grounds for replacement. 
 
Instructor adherence. We will develop an adherence measure in order to evaluate 
whether yoga teachers can reliably deliver the manualized program. This adherence 
measure will have two components: a) a checklist corresponding to the manual to ensure 
that instructors lead each major component of the class; and b) scales regarding the degree 
to which the instructor adheres to the style of the class outlined in the manual. (For 
example, does he/ she repeatedly direct participants to attend to physical sensation in their 
bodies?). Dr. Tremont and Dr. Uebelacker will train an RA to conduct adherence ratings on 
audio-recorded yoga classes, as video will not be allowed in the RIDOC. Once Dr. Tremont 
and the RA have achieved an acceptable degree of reliability (r > .80), the RA will conduct 
adherence ratings of 20% of classes. Dr. Tremont and Mr. Gillette will review ratings with 
teachers. Dr. Tremont and/or Dr. Uebelacker will rate classes on a monthly basis to test RA 
reliability against a “gold standard” in an ongoing fashion. 
 
5.2.2. Health Education Control Group. 
To match for attention, the control condition will be a 10-week program that 
consists of weekly 60-75 minute group classes. In classes, instructors will provide 
information about general health topics through a variety of means such as slides, 
handouts, and/or audio and video clips. There will be an emphasis on group discussion of 
relevant topics; instructors do not just lecture. The core rationale for this course is that 
good physical health is important for good mental health. In prior research, we have 
developed and successfully used a manual for teaching this class; the manual will be 
modified based on feedback from prisoners and prison staff in Phase 1 of this study. 
Sample class topics are: What to Eat; What Not to Eat; Protecting Your Heart; Physical 
Activity Guidelines; Diabetes; Cancer Prevention; and Getting a Good Night’s Sleep. In 

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modifying the manual, we will pay attention to making sure that any health-related 
recommendations are feasible both within prison and for a person on a limited budget in 
the community. Instructors provide will information and encourage questions but avoid 
psychotherapeutic techniques or personalized goal-setting. Instructors will give 
participants readings to explore on their own. Because each week covers a different topic 
and sessions are not cumulative, participants can enter the group at any time (i.e., rolling 
enrollment), further providing equipoise with the yoga group. Minimum class size is 1, 
maximum is 10.  
Health education instructors. This class will be taught by health education instructors 
who have experience working in correctional settings and post-baccalaureate experiences 
or certification in a relevant health care field.  We will hire and train 2 health education 
instructors.  Training procedures will be similar to those used for yoga teachers, with 
training from Drs. Weinstock and Uebelacker, and additional input from Co-I Dr. Johnson. 
To enhance equipoise, similar to the yoga arm, male or female instructors will teach HE 
classes in the participating RIDOC men’s and women’s facilities. Although it may be difficult 
to conceal the fact that this is a control group from instructors, we will encourage 
instructors to do their best work.  
Instructor adherence. Health education instructor supervision, adherence, and 
adherence rating procedures will be the same as those used for the yoga instructors, with 
Dr. Uebelacker as the supervisor, and Dr. Uebelacker training the RA in adherence ratings 
and serving as the gold standard rater. 
5.3 Concomitant Interventions  
5.3.1 Allowed Interventions. 
Once a participant is enrolled in the study, participants will not be excluded for any 
concomitant intervention.  
 
5.3.2 Required Interventions. 
None.  
 
5.3.3 Prohibited Interventions. 
None.  
5.4 Adherence Assessment  
Yoga participant adherence.  To be considered adherent, a participant must attend 
6/10 classes. Our target is for 70% of all participants to complete 6/10 classes in the RCT. 
 
Health education participant adherence. To be considered adherent, a participant 
must attend 6/10 classes. Our target is for 70% of all participants to complete 6/10 classes 
in the RCT. 
 
 

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6. STUDY PROCEDURES  
6.1 Schedule of Evaluations 
 
Table 1. Schedule of Evaluations, Phase 1, Prisoners.  
 
Assessment 
Baseline and 
Enrollment: 
(Day-30 to Day -1) 
Focus Group 
Visit 1 (Day 0) 
Inclusion/ Exclusion 
X 
 
Informed consent form 
X 
 
Demographics  
X 
 
Novaco Anger Scale – Provocation Inventory 
X 
 
MINI (screening) 
X 
 
Physical Activity Readiness Questionnaire 
X 
 
Payment  
 
$20 
 
 
 
Table 2. Schedule of Evaluations, Phase 1, Stakeholders.  
 
Assessment 
Baseline and 
Enrollment: 
(Day-30 to Day -1) 
Baseline, 
Enrollment,  
Visit 1 (Day 0) 
Inclusion/ Exclusion 
X 
 
Informed consent form 
 
X 
Demographics  
 
X 
Payment  
 
$20 

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Table 3, Schedule of Evaluations, Phase 2.  
 
Assessment 
Type of 
Assessment 
Baseline1, 
Visit 1 
(Day 0) 
After 
initial 
class 
After each 
class 
Wk 5 
Wk 10 
Wk 14 
Wk 18 
Inclusion/ Exclusion   
Interview, pre-
randomize 
X 
 
 
 
 
 
 
Informed Consent Form  
Pre-randomize 
X 
 
 
 
 
 
 
Enrollment/ 
Randomization  
Interview 
 
X 
 
 
 
 
 
 
CEQ  
Self-report 
 
X 
 
 
 
 
 
CSQ-8 
Self-report 
 
 
 
 
X 
 
 
Qualitative Interview  
Interview 
 
 
 
 
X 
X 
(yoga 
only) 
 
Homework Questionnaire  
Self-report 
 
 
X 
 
 
 
 
Injuries due to yoga  
Self-report 
 
 
X 
 
 
 
 
SAFTEE- GI 
Interview 
X 
 
 
X 
X 
 
X 
Novaco Anger Scale- 
Provocation Inventory 
Self-report 
X 
 
 
X 
X 
 
X 
Aggression 
Questionnaire- Short 
Form 
Self-report 
X 
 
 
X 
X 
 
X 
Behavioral Infractions in 
Prison 
Record Review 
X 
 
 
X 
X 
 
X 
Patient Health 
Questionnaire-9 
Self-report 
X 
 
 
X 
X 
 
X 
PROMIS Anxiety 
Self-report 
X 
 
 
X 
X 
 
X 
SF-12 from RAND 
Medical Outcomes Study 
Self-report 
X 
 
 
X 
X 
 
X 
Anger Rumination Scale 
Self-report 
X 
 
 
X 
X 
 
X 
Experiences 
Questionnaire 
Self-report 
X 
 
 
X 
X 
 
X 
Stroop Color and Word 
Test 
Task 
X 
 
 
X 
X 
 
X 
MINI (screening) 
Interview 
X 
 
 
 
 
 
 

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Assessment 
Type of 
Assessment 
Baseline1, 
Visit 1 
(Day 0) 
After 
initial 
class 
After each 
class 
Wk 5 
Wk 10 
Wk 14 
Wk 18 
Physical Activity 
Readiness Questionnaire 
Self-report 
X 
 
 
 
 
 
 
 Life Events 
Checklist/PTSD Checklist 
Self-report 
X 
 
 
 
 
 
 
Treatment History 
Interview 
Interview 
X 
 
 
X 
X 
 
X 
International Physical 
Activity Questionnaire 
Self-report 
X 
 
 
X 
X 
 
X 
Payment  
 
 
 
 
$20 
$20 
$20 
$20 
Abbreviations: timepoints: Wk5, Wk10, Wk18 = Week 5, Week 10, Week 18. 

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6.2 Description of Evaluations  
Assessments will be administered by research assistants (RAs) trained in procedures to 
ensure confidentiality and proper management of research data.  
 
6.2.1 Baseline Visit and Focus Group --Prisoners – Phase 1.  
Consenting Procedure—Prisoners Phase 1 
Written informed consent will be obtained at the baseline visit. Please see section 4.4 for 
more information about the consent procedures. 
Screening—Prisoners Phase 1 
Following informed consent, all participants will complete an initial demographics 
questionnaire. In phase 1, prisoner participants will also complete a baseline interview 
consisting of only those measures (see Table 1) that will be used to determine eligibility for 
participation in the focus groups. Study eligibility will be determined and documented on the 
prisoner focus group inclusion/exclusion sheet.  
For purposes of assessment of certain inclusion/exclusion criteria, a brief diagnostic 
interview will be used to assess current mania, psychosis, or active suicide risk (warranting 
referral to prison mental health treatment staff). 
List of measures used to assess inclusion/ exclusion criteria:  
• Novaco Anger Scale – Provocation Inventory 
• MINI (Screening) 
• Physical Activity Readiness Questionnaire 
Additional assessments—Prisoners Phase 1 
There will be no additional assessment of participants in phase 1. We will conduct focus 
groups as described in section 6.2.3. 
 
Payment—Prisoners Phase 1 
Payment to prisoners for participation in the focus group is $20.  
 
6.2.2 Screening and Focus Group -- Stakeholders – Phase 1 
Screening – Stakeholders Phase 1 
Stakeholders will be screened only for age, position at the RIDOC or other role in the 
criminal justice system (e.g., community advocate), and ability to speak English sufficiently well 
to participate in the focus groups. Screening will occur prior to the signing of consent in the focus 
groups. Study eligibility will be determined and documented on the stakeholder 
inclusion/exclusion sheet.   
Consenting Procedure– Stakeholders Phase 1 
Written informed consent will be obtained at the time of the focus group.  Please see 
section 4.4 for more information about the consent procedures. 

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Additional assessments– Stakeholders Phase 1 
There will be no additional assessment of participants in phase 1. We will conduct focus 
groups as described in section 6.2.3. 
Payment—Stakeholders Phase 1 
 
Payment to stakeholders for participation in the focus group is $20.  
 
6.2.3 Focus Group Procedures and Study Material Revision 
In Phase 1 of the study, participants who provide informed consent and are 
determined to be eligible for participation will be enrolled in one of 4 focus groups. Eligible 
prisoner participants will be invited to attend a single-session focus group. Focus groups will 
be recruited and convened one at a time, sequentially across the three RIDOC prison facilities 
where prisoners reside (i.e., men’s minimum, men’s medium, and women’s minimum/ 
medium). The stakeholder focus group will be held at our Brown University offices on the 
Butler Hospital campus. We anticipate all focus groups will last between 60-75 minutes each.   
Focus groups will be designed to solicit feedback re: 1) yoga classes; 2) health 
education classes; and 3) general study design. We will ask participants for feedback on each 
of these aspects of the study, with a particular focus on 1) tailoring that may be needed to 
make interventions more feasible or acceptable, safe, and efficacious for addressing anger 
management needs in this population, and 2) how to discuss and market the study to so that 
the procedures are accurately portrayed, and stigma and barriers to participation are 
minimized.  
Focus group leaders. MPIs Weinstock and Uebelacker, and/or named study Co-
Investigators will conduct focus groups and individual interview with key informants. As 
content experts and developers of the research interventions and protocols, and with prior 
experiences leading focus groups and analyzing qualitative data, study MPIs and Co-Is are 
well equipped and have the expertise to perform this study role. 
Study Material Revision. Themes derived from focus group will then be shared with 
and discussed with the entire scientific team and staff at RIDOC. Following this 
comprehensive review of focus group data, Drs. Weinstock and Uebelacker will make initial 
modifications to the study materials, in an effort to maximize acceptability, feasibility, and 
safety of the study procedures and conditions. The revised materials will then be circulated to 
the scientific team, consultants, and other key informants for additional comment. This 
feedback will then be reviewed by Drs. Weinstock and Uebelacker, and integrated into the 
study materials in an iterative manner.  
 
6.2.4 Baseline Visit -- Prisoners – Phase 2.   
Consenting Procedure—Phase 2 
Written informed consent will be obtained at the baseline visit. Please see section 4.4 for 
more information about the consent procedures. 
Screening—Phase 2 
Following informed consent, all participants will complete an initial demographics 
questionnaire. In phase 2, prisoner participants will also complete an interview consisting of 
those measures that will be used to determine eligibility for participation. 
 
For purposes of assessment of certain inclusion/exclusion criteria, a brief diagnostic 
interview will be used to assess current mania, psychosis, or active suicide risk (warranting 
referral to prison mental health treatment staff). A brief questionnaire (PARQ) will be used to 
determine whether a participant can safely engage in a moderate level of physical activity. If the 

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participant endorses an item of this measure (except for item 6 which refers to hypertension 
medications, which are permissible in this study), they will be ruled ineligible.  
List of measures used to assess inclusion/ exclusion criteria:  
• Physical Activity Readiness Questionnaire 
• Novaco Anger Scale – Provocation Inventory 
• MINI (Screening) 
Enrollment—Phase 2 
 
If a participant meets all inclusion/ exclusion criteria, he/she will be enrolled in the study 
at this baseline visit. Study eligibility will be determined and documented on the RCT 
inclusion/exclusion sheet.   
Baseline assessments—Phase 2 
Remaining baseline assessments are detailed in Table 3.  
Randomization—Phase 2 
Randomization will occur at the baseline visit after all assessments are completed. 
Participants may begin study classes within one week of randomization.  
 
6.2.5 Blinding – Phase 2. 
The following individuals will be blinded during the course of the study: Dr. Lauren 
Weinstock, MPI; Dr. Leslie Brick, Statistician; Dr. Jennifer Johnson, Co-I; Dr. Tracie Shea, Co-I. 
The following individuals will not be blinded during the course of the study: Dr. Lisa 
Uebelacker, MPI; Dr. Geoffrey Tremont, Co-I; Hannah Graves, Project Coordinator; study 
interventionists; study RA. Randomization will be conducted by the study RA and overseen by 
Hannah Graves, Project Coordinator (see section 9.2.2 for more information on randomization). 
Dr. Uebelacker will be the non-blind PI and will primarily be responsible for supervision 
of the interventionists and ensuring therapist/ yoga instructor adherence. Dr. Weinstock will be 
the blind PI and will be primarily responsible for the supervision of the research assistants. Dr. 
Brick, the study statistician, will be blind to group assignment (and will have no contact with 
participants.)  When there is a question about whether a participant meets inclusion criteria, Dr. 
Weinstock will make a decision about inclusion. Drs. Uebelacker, Ms. Graves, and study RAs will 
meet separately to discuss intervention-specific concerns (e.g., need to cancel class due to lack of 
participants). 
To ensure that blindness will be maintained, there will be a separate data collection 
instrument in REDCap to enter randomization assignment. Only non-blind study personnel will 
have access to this section of REDCap.  We will also have a separate section in REDCap for 
intervention specific data (e.g., dates of sessions attended, yoga homework) that only the non-
blinded staff will have access to.  
In reporting adverse events to the Safety Monitoring Committee, determination of “causal 
relationship” will be made by the non-blind PI only, as it may require knowledge of which 
intervention arm the participant is in. The standard Adverse Events Reporting Form of our IRB 
does not ask for intervention arm; thus risk of unblinding from AE reporting is minimal.  
The non-blind PI will meet with yoga instructors and HE instructors for supervision. The 
instructor/ therapist adherence ratings will be conducted by the non-blind PI and RA. 
We will keep a record of any instances of unblinding. This record will be used to improve 
procedures for a larger clinical trial. After all data are collected and the database is locked, the 
blind PI may be unblinded so as to contribute to data interpretation.  

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Participants cannot be blind to study intervention. However, we will present both 
interventions (Yoga or HE) with equipoise to all participants in written materials and orally.  
 
 
6.2.6 Follow-up Visits – Phase 2. 
For all follow-up assessments, research staff will make every effort to conduct the 
assessment within one week before or one week after the exact due date of the assessment. 
However, because all data can be analyzed with modern statistical methods regardless of 
whether it was collected inside that window, RAs will still collect data if possible even if it is later 
than that two-week window. We will record optimum date for the assessment as well as the 
actual date of the assessment.  
 
Participants will complete a brief assessment after each class that they attend.  
  
In addition, all participants will be assessed at: baseline, 5 weeks (mid-intervention), 10 
weeks (post-intervention), 14 weeks (yoga group participants only), and at 8 week follow-up. In 
addition to demographics, we will assess acceptability of the intervention conditions, safety of 
the yoga condition, anger and aggression, secondary outcomes (depression and anxiety 
symptoms, general functioning), potential intervention mechanisms of action (anger rumination, 
decentering, impulsivity), and other descriptive characteristics (trauma history, treatment 
utilization, physical activity levels).  
 
In the event that a participant is released back into the community before they complete 
all of their study assessments, we will complete them in the community. We will aim to complete 
all of these follow-up assessments by telephone. However, there may be some circumstances that 
might make it difficult for a participant to complete the follow-up assessment by telephone (e.g., 
limited phone minutes, enrollment in a residential treatment program). In such cases, we will 
complete the follow-up assessment in person in our offices at Brown University or in the facility 
where the participant is located (e.g., residential treatment facility, with facility approval). 
Additionally, if a participant is transferred to another facility at RIDOC, we will complete their 
assessments at the other facility (e.g., Men’s Maximum Security) with RIDOC approval.   
 
Please see table 3 for a list of all assessments to be completed at each visit.  
 
6.2.7 Completion/Final Evaluation – Phase 2 
Even if prisoners drop out of study treatment, we will attempt to collect data at all 
assessment points if prisoners agree to it.    
 
6.3 Audiorecording 
We will audio record all focus groups for purposes of transcription and assessment of 
data for qualitative analysis. This will be a requirement for participation in the focus groups. We 
will audio record assessment interviews in order to perform reliability checks. Participants may 
refuse audio recording of assessments but still participate in the study. We will audio record all 
classes (yoga and health education) for purposes of instructor supervision and to monitor 
instructor adherence to the intervention protocols. Because the interventions will be delivered in 
group format, and because it is imperative that we provide supervision and monitor adherence 

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of the instructors, participants may not refuse audio recording of classes in this study (e.g., if one 
participant refused audio recording of classes, we would not have these recordings for the group 
as a whole). 
6.4.  Material Inducements 
In phase 1 (focus groups), we will compensate participants $20 for completion of the 
focus groups. For prisoner participants, this compensation will be in the form of money paid 
directly into their commissary account at the RIDOC. For stakeholder participants, this 
compensation will be in the form of a money order or gift card, paid to them directly upon 
completion of the focus group.  
In phase 2 (pilot RCT), we will compensate participants $20 for each of the  follow-up 
assessments (mid-intervention, post-intervention, 4 week follow-up (yoga participants only) and 
8 week follow-up). In total, participants may receive up to $80 compensation. Similar to our 
procedures for prisoner participant compensation in phase 1, the compensation will be in the 
form of money paid directly into their commissary account at the RIDOC. If a participant is 
released from the RIDOC while still enrolled in the study, and completes any follow-up 
assessment in the community, this compensation will be provided in the form of a money order 
or gift card.  Additionally, a participant may also choose to have us mail their compensation to a 
family member or significant other of their choosing. 
 
 

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7. SAFETY ASSESSMENTS  
7.1.  Human Subjects 
 
For yoga, the only expected adverse event is:  
• Physical injury (mild) 
 
For group HE, there are no expected adverse events.   
 
Drs. Weinstock and Uebelacker will be responsible for overseeing the safety of all 
participants. Drs. Tremont, Shea, and Johnson (who maintains a clinical license in RI) will be 
available to serve as clinical back-up for the MPIs, when required. Participant safety will 
monitored in two ways: (a) during the intake or ongoing assessments by the research staff, and 
(b) during intervention sessions. Research assessments will be conducted at study intake, 5 
weeks (mid-intervention), 10 weeks (post-intervention), 14 weeks (yoga group participants 
only) and at 8 week follow-up. For those randomized to the yoga condition, yoga instructors will 
carefully monitor participants for any physical injury during each class. We will carefully 
monitor all participants for significant suicidal ideation (SI), homicidal ideation (HI), and for 
adverse events and serious adverse events at each time point. 
 
There are five major sources of low to moderate risk associated with participation in the 
proposed study. 
1. Potential coercion. It is possible that individuals may feel coerced into participating. This is 
a particularly important risk to minimize with incarcerated individuals. This is also an 
important risk to minimize with stakeholders (i.e., prison staff or other RIDOC employees).  
2. Potential suicidal or homicidal ideation. Given that prisoner participants will have risk  
factors for suicide or homicide (e.g., a mental health diagnosis, incarceration), some  
participants may experience suicide ideation or behavior or homicidal ideation in the  
course of study participation. 
3. Increased distress due to assessment procedures. It is possible that some participants will   
experience increased intrapersonal or interpersonal psychological distress as a result of 
participating in focus groups (prisoner and stakeholder participants), and yoga and health 
education groups. In the vast majority of cases, we believe that any increased distress 
experiences will be mild and transitory in nature. 
4. Confidentiality and loss of privacy. The greatest potential risks to those participating in the 
research are legal or social, caused by the inadvertent loss of confidential information 
obtained during the data collection process. That is, a participant’s identity may be 
inadvertently exposed or questionnaire material may be released or disclosed to 
unauthorized persons. In the case of such a breach, serious personal and social 
consequences could conceivably occur. However, such risks can be minimized by 
instituting the proper procedures to protect confidentiality and by having resources in 
place to provide counseling and referrals. We have extensive experience taking 
appropriate measures to safeguard confidential information in research with criminal 
justice populations. These measures are described below. 
6. Potential physical injury (phase 2 only). Because yoga is a physical activity, there is a 
small risk of physical injury for those participants who are in study yoga classes. 

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Protection Against Risks 
All research materials collected or received by the Butler Hospital research team will be 
covered by HIPAA regulations according to hospital policy. Data and safety monitoring will take 
place to assure the safety of subjects (see below). All participants will be reminded that their 
participation is voluntary and that they can withdraw at any time without penalty. Additionally, 
the risks described above will be minimized by the following procedures: 
1. We will minimize the risk of potential coercion by following standard procedures for 
obtaining informed consent. Prior to enrolling prisoner participants in the research, we will fully 
explain the study procedures, risks, benefits, and alternatives to participants, emphasizing that 
participation has no impact on the other services they receive at the prison, the terms or length 
of their confinement, or any other community services that they receive post-release.  Also, 
participants who do not consent or who withdraw will receive appropriate referrals (e.g., for 
mental health treatment), if needed. For stakeholder participants, we will also fully explain the 
study procedures, risks and benefits, and alternatives to participation. We will emphasize that 
participation has no impact on their employment or affiliation with the RIDOC. All participants 
will be reminded that there is no penalty for participants who choose to not participate or to 
withdraw from the study. 
2. We will minimize the risk of potential suicidal or homicidal ideation by instituting the 
proper procedures for protecting the safety of participants and others, which we have applied 
extensively in our prior and ongoing research at the RIDOC. During incarceration, Per RIDOC 
policy, their standards for mandatory reporting of suicide risk (i.e., breaking confidentiality to 
report suicide risk) specify that we are required to report anyone who has had suicidal ideation 
within the past 24 hours (as determined through query and follow-up for an endorsement of any 
score > 0 on item 9 of the PHQ-9 or reporting of any current desire to hurt oneself to any 
member of the research staff). We will follow this RIDOC policy, per their requirements for 
researchers conducting human subjects research with any of their facilities. If the participant 
reports this level of SI within the past 2 weeks, but not in the 24 hours prior to the assessment, 
the RA will notify one of the PIs (both of who are licensed psychologists) or their covering 
licensed clinician who will make a clinical determination if further referral or action is needed, 
and a voluntary referral will be offered. Participants meeting the prison’s SI mandatory reporting 
criteria (or those who elect the voluntary referral) will be referred to a prison mental health 
clinician for evaluation, who will follow prison procedures. When confidentiality must be broken 
due to a RIDOC mandatory report, the research staff member will report the information to a 
social worker, a nurse, and/or the highest ranking person available (i.e. Captain, Lieutenant, 
Correctional Officer, etc.). We will prioritize reporting to a medical staff member first, but will 
report to the highest ranking person available if a medical staff member is unavailable at the 
time of the report. Standard prison procedures include: (1) checking with the prison’s behavioral 
health department to see if the person has already been flagged as having SI; (2) having a 
licensed mental health clinician check in with the person and do a suicide risk evaluation; and/or 
(3) if needed, putting the person on psychiatric observation within the prison. If the prison 
mental health professional determines that someone’s risk has gone down, that person will leave 
psychiatric observation and return to the general population. All of these procedures are set and 
executed by the prison, which follows its own ethical and legal requirements. We will clearly 
describe this in our consent form. Homicidal risk will be defined by reporting any desire to hurt 
another person, including any member of the study staff. Standard mandatory reporting 
procedures (e.g., contact prison mental health staff), per RIDOC policy, will be followed.  

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Given study inclusion criteria, we think it unlikely that anyone will be released into the 
community while participating in the study. However, we do have procedures in place for people 
post-release. During the post-release period, definitions of suicide risk, and homicide risk will be 
the same those described above; however, we will rely upon our standard study procedures (vs. 
RIDOC mandatory/ voluntary reporting criteria) to facilitate clinician referral and safety 
assessment, as needed. If any study staff member identifies an individual who reports any 
suicidal or homicidal ideation in the course of standard assessment procedures, the staff member 
will immediately contact Dr. Weinstock or Dr. Uebelacker (or the licensed covering clinician). 
The covering clinician will evaluate the participant over the telephone or in person. First, they 
will conduct a suicide and homicide risk assessment to determine whether it is necessary to take 
immediate action to prevent the participant from causing harm to self or others. If needed, 
actions that the covering clinician may take include escorting the person to the emergency 
Patient Assessment Service (PAS) at Butler Hospital (if the person is in our offices), having a 
family member transport the person to Butler Hospital or another hospital, or sending an 
ambulance so that the individual may be evaluated for inpatient psychiatric hospitalization.  
A participant who has undergone a suicide or homicide risk assessment may continue to 
participate in the study unless the study PIs, in concert with the participant’s healthcare 
providers, deem study participation to increase risk for this particular participant.  
3. We will minimize the risk of distress by informing all participants that they do not have to 
answer questions that they find too distressing and will be reminded that they can discontinue 
participation at any time. Focus groups will be led by a licensed clinician (Drs. Weinstock, 
Uebelacker, and/or one of the study Co-Is) to help facilitate the stabilization and referral process 
if participants who decompensate during study procedures. In the pilot RCT, clinical backup will 
be provided during all assessments and intervention sessions by a licensed clinician to help 
facilitate the stabilization and referral process for participants who decompensate during study 
procedures. The need for additional services will also be monitored during each clinical 
(assessment or intervention) contact. Participants will be formally assessed at 4 time points 
(baseline, 5 weeks, 10 weeks, 18 weeks). Incarcerated participants who manifest significant 
psychiatric symptomatology (i.e., psychosis or mania per the MINI Neuropsychiatric Interview) 
will be referred to appropriate clinical prison staff for evaluation, per RIDOC policy, following the 
same procedures for participants who report significant homicidal ideation or suicide risk (as 
described above). For any assessments in the community (in the rare event that a participant is 
released from prison prior to study completion), a licensed clinician (the MPIs or their covering 
clinician) will be available at all times to provide clinical coverage. Research staff will notify the 
licensed clinician if there are any safety concerns 
4. We will minimize potential risks due to loss of confidentiality of research data by 
instituting the proper procedures to protect confidentiality and by having resources in place to 
provide counseling and referrals. We have extensive experience taking appropriate measures to 
safeguard confidential information in research with criminal justice populations. We will 
minimize potential risks due to loss of confidentiality of research data by having all information 
collected and handled by research staff trained to deal appropriately with sensitive clinical 
issues.  All participants will be informed about the limits of confidentiality concerning suicidal 
intent, homicidal intent, suspected child abuse, suspected elder abuse, and other prison-required 
mandatory reporting issues (i.e., sexual contact within the prison, weapons in the prison, prison 
escape plans). All information will be treated as confidential material and will be available only 
to research staff. All information will be kept in locked file cabinets at Brown University. 
Computer data files will be kept on Brown’s secure research servers and Care New England’s 
REDCap system, will be available only to authorized personnel, and no names or obvious 
identifying information will be stored in data files. No participant will be identified in any report 

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of the project. To further protect participants, there will be a Federal Certificate of 
Confidentiality for this project, which is now automatically awarded by NIH when a proposal is 
funded. Potential subjects will be informed that a Certificate of Confidentiality has been obtained 
for this project and that this certificate will protect the investigators from being forced to release 
any research data in which participants can be identified, even under court order or subpoena, 
although this protection is not absolute. Potential participants will be informed of the situations 
during the informed consent process (and as documented in the informed consent document) in 
which they may not be protected under the Certificate of Confidentiality. No information about 
participants will be released without their permission or where required by law.  
Audio recording is necessary to: a) obtain and transcribe focus group data and b) conduct 
supervision and adherence ratings for interventionists. Audio recording of assessments is also 
important, but not mandatory, for measurement of assessment reliability (i.e., because only a 
random selection of recordings will be used for this purpose, it is not necessary that every 
participant or every session be recorded). 
As in our past 10 years of prison research, audio recording is accomplished through the use 
of credit-card size digital audio recorders, which have password-protection and encryption 
capabilities thereby protecting their contents during transport between the RIDOC and our 
research offices. These digital recordings are regularly transferred to Brown’s secure computer 
server (designed to hold and protect digital audio and video recordings for clinical trials) via USB 
connection and secure file transfer to Brown’s secure audio server, and the recorders are wiped. 
This is the same procedure that has been used in our completed and ongoing intervention 
studies with prisoners and jail detainees at the recruitment site. Participants will be asked to 
give informed written consent to audio recording at the time of intervention study entry. To 
assure the confidentiality and protection of participants with respect to audio taping, the 
following steps will be taken: a) each recording will be labeled with the following: focus groups- 
focus group number, the interviewer’s name, and the focus group date; group classes- the type of 
class, the interventionist’s name, and the date; assessments- the participant’s ID number, the 
interviewer’s name, and the date of the assessment; b) all recordings will be stored on a secured 
computer server designed to hold and protect research data; and c) access to the audio 
recordings will be limited to only those research staff who need access to the recordings to 
perform their duties.   
Although group discussion will be kept to a minimum in the yoga class, a participant’s 
confidential statements during any of the study group sessions (e.g., focus group, yoga class, 
health education group) may be disclosed by another member of their corresponding group. To 
minimize risk, we will remind all participants that: a) any group discussion should be kept 
confidential; and b) because we cannot guarantee confidentiality due to the group nature of the 
discussion, all participants should be careful about disclosing anything that they want kept 
private.  Finally, we will ask all participants not to disclose the names of prisoners in their group 
to others outside the group.  
5. We will minimize potential risk for physical injury by: a) requiring all participants in yoga 
classes to be medically appropriate for moderate physical activity; and b) requiring all 
instructors to be registered yoga teachers with experience in directing people in how to achieve 
yoga postures without physical injury. Class content will be designed to accommodate the needs 
of yoga-naïve students who are not currently physically active. By presenting modifications of all 
postures, and by using props (e.g., chairs, blankets), the risk for injury will be minimized.  
Injuries due to yoga will be monitored at frequent intervals during this part of the study and 
patients will be followed for a sufficient period of time (2 months) after completing yoga classes 
to ensure stabilization of injuries.  
 

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Benefits of the proposed research to the subjects and others. 
The potential risks associated with participation in this study appear to be mild to moderate. 
Although there is a risk for distress, the procedures proposed for monitoring distress should 
ensure that participants who require a higher level of care receive it. Participants assigned to 
yoga may benefit from improved anger regulation and associated behaviors. The study provides 
additional screening, assessment, and referral to emergency services, as needed, for all study 
participants, and in no way restricts or limits the treatment individuals would have received had 
they not participated in the study.  Moreover, participants are helping other incarcerated 
individuals with high levels of anger dysregulation by providing information that will improve 
treatments for this population. Thus, the potential benefits outweigh the potential risks of the 
study. 
 
Importance of knowledge to be gained. 
To our knowledge, this current R34 proposal represents the first attempt to systematically 
develop and pilot a yoga intervention for anger dysregulation in incarcerated individuals. This 
pilot study will lay the groundwork for a larger, stage II clinical trial (R01) to evaluate the 
effectiveness of yoga for anger management, and for improvement in associated behaviors, other 
mental health symptoms, and functioning in prison. The risks involved in the study are minimal 
compared to the need for treatments for this population. 
 
Risk-Benefit Ratio.  
We believe that most serious risks (e.g., loss of confidentiality, major psychological distress 
due to study participation, or serious physical injury due to yoga participation) to subjects are 
very unlikely. We have attempted to minimize these risks (described above). While some risks 
may be more likely to occur (e.g., minor, transient psychological distress), these risks are much 
less serious. The risk of ineffective treatment is a serious risk, but one which: 1) is minimized 
through safeguards described above; 2) is common to any treatment as usual for emotional 
disturbance in the prison or community setting. Therefore, the potential benefits of the proposed 
study seem to outweigh the potential risks of this study for the individual participants. 
 
7.2 Specification of Safety Parameters 
Safety issues will be minimal in Phase 1 given that participation involves only a single 
focus group, no yoga classes, and no formal assessment of suicidality. However, should an issue 
arise (e.g., a voluntary report of suicide ideation), staff would manage it in the same way that 
they would manage it in Phase 2.  
 
Please see Table 4 for a summary of safety issues, how they are assessed, when they are 
assessed, and relevant staff actions. 
 
 
 

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Table 4. Assessment and Management of Safety Issues, Summary, Phase 2 
Safety Issue 
How assessed 
When Assessed in Phase 2 
Relevant Research Staff 
Actions 
Suicide or 
homicidal 
ideation 
PHQ-9 
Participant report to 
research staff 
BL, wk5, wk10, wk18 
Any point 
Immediate clinical 
assessment as described 
in DSMP 
Injuries due to 
yoga 
Structured self-report 
Weekly during first 10 
weeks 
Follow until resolution; 
may result in changes to 
yoga instructor manual 
Other AEs 
SAFTEE 
Participant report to 
research staff 
 
BL, wk5, wk10, wk18 
Any point 
If related to study 
participation, follow 
resolution;  potential 
changes to procedures 
particularly if AE is also 
unexpected 
7.3 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
See Table 3.  
7.4 Adverse Events and Serious Adverse Events  
An adverse event (AE) is any untoward medical occurrence in a subject during participation 
in the clinical study or with use of the experimental agent being studied. An adverse finding can 
include a sign, symptom, abnormal assessment (laboratory test value, vital signs, 
electrocardiogram finding, etc.), or any combination of these regardless of relationship to 
participation in the study.  
 
Unanticipated problems. The Office for Human Research Protections (OHRP) considers 
unanticipated problems involving risks to subjects or others to include, in general, any incident, 
experience, or outcome that meets all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved research 
protocol and informed consent document; and (b) the characteristics of the subject 
population being studied; 
• Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and 
• Suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
 
Serious adverse events (SAEs). A serious adverse event (SAE) is one that meets one or more o 
the following criteria: 
• Results in death 
• Is life-threatening (places the subject at immediate risk of death from the event as it 
occurred; includes a suicide attempt or drug overdose) 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect   
 

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An important medical event that may not result in death, be life threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, the 
event may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. 
Unanticipated problems will be recorded in the data collection system throughout the study.  
Study staff will record all reportable events with start dates occurring any time after informed 
consent is obtained until 8 weeks (i.e., follow-up assessment after the last day of class 
participation).  Each time participants attend classes, we will inquire about injuries due to study 
participation. At midpoint, endpoint, and at week 8 follow-up, study staff will administer the 
SAFTEE in order to inquire about the occurrence of AE/SAEs during the previous 8-10 weeks.  
SAEs related study participation will be followed for outcome information until resolution or 
stabilization. 
 
Characteristics of an adverse event will include: a) relationship to study intervention, b) 
expectedness of SAEs, and c) event severity. 
 
Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are used: 
1. Related (Possible, Probable, Definite) 
a. The event is known to occur with the study intervention. 
b. There is a temporal relationship between the intervention and event onset. 
c. The event abates when the intervention is discontinued. 
d. The event reappears upon a re-challenge with the intervention. 
2. Not Related (Unlikely, Not Related) 
a. There is no temporal relationship between the intervention and event onset. 
b. An alternate etiology has been established. 
 
Relatedness of SAEs 
The Study PI and Independent Monitoring Committee will be responsible for determining 
whether an SAE is expected or unexpected.  An adverse event will be considered unexpected if 
the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the intervention.  The risk information to assess expectedness can be 
obtained from preclinical studies, the investigator’s brochure, published medical literature, the 
protocol, or the informed consent document. 
Expected AEs for this study include:  
• Any event that may be reasonably anticipated to occur as a result of the study procedure 
(i.e., mild aches or pains following a yoga class) 
 
Severity of Event 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on 
ADL 
3. Severe: significant symptoms requiring invasive intervention; subject seeks medical 
attention, needs major assistance with ADL 
7.5 Reporting Procedures 
Unanticipated Problem Reporting  

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Incidents or events that meet the OHRP criteria for unanticipated problems require the creation 
and completion of an unanticipated problem report form.  OHRP recommends that investigators 
include the following information when reporting an adverse event, or any other incident, 
experience, or outcome as an unanticipated problem to the IRB: 
• Appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• A detailed description of the adverse event, incident, experience, or outcome;  
• An explanation of the basis for determining that the adverse event, incident, experience, 
or outcome represents an unanticipated problem;  
• A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the unanticipated problem. 
 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported using 
the following timeline:   
• Unanticipated problems that are serious adverse events will be reported to the IRB, SMC, 
and NCCIH within 7 days of the investigator becoming aware of the event.  
• Any other unanticipated problem will be reported to the IRB, SMC, and NCCIH within 14 
days of the investigator becoming aware of the problem.  
 
All unanticipated problems should be reported to appropriate institutional officials (as required 
by an institution’s written reporting procedures), the supporting agency head (or designee), and 
OHRP within one month of the IRB’s receipt of the report of the problem from the investigator. 
 
Adverse event reporting 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the Data Safety and Monitoring Board (DSMB), IRB, and NCCIH in accordance with 
requirements.  
• Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Officer and DSMB within 3 days of the investigator becoming aware of the 
event.  Other serious and unexpected AEs related to the intervention will be reported 
within 7 days. 
• Anticipated or unrelated SAEs will be handled in a less urgent manner but will be 
reported to the SMC, IRB, and other oversight organizations in accordance with their 
requirements, and will be reported to NCCIH on an annual basis.    
• All other AEs documented during the course of the trial will be reported to NCCIH on an 
annual basis by way of inclusion in the annual report and in the annual AE summary 
which will be provided to NCCIH and to the DSMB.  The DSMB Report will state that all 
AEs have been reviewed. 
7.6 Follow-up for Adverse Events 
Any SAEs related study participation will be followed for outcome information until 
resolution or stabilization. Follow-up reports will be submitted to the IRB, SMC, or NCCIH as 
required in each specific instance.  
7.7 Safety Monitoring  
The NCCIH requires that all Human Subjects research studies undergo independent 
monitoring, and NCCIH Program Officials will provide specific guidelines to the PI for the study.   

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8. INTERVENTION DISCONTINUATION  
Prisoners will be discontinued from an intervention in the following circumstances:  
• If the prisoner or prison staff does not believe it is in the best interest of the 
prisoner to continue. As soon as an MPI is informed of this, study staff will speak 
with the participant about discontinuation, if possible.  
• If a prisoner chooses to discontinue attendance.  
• If one of the MPIs, in consultation with the relevant instructor, finds the prisoner to 
be so disruptive to the rest of the class that he/she has a repeated and substantive 
negative impact on the other participants. 
• If a prisoner is released from prison unexpectedly.  
• If a prisoner exhibits inappropriate behavior towards study staff. 
Participants will continue with subsequent assessments if they are willing to do so.  
Assessment schedule and assessments used will not change.  
 
 

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9. STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
For this pilot treatment development trial, assessment of feasibility, acceptability, and safety 
of the intervention and research procedures is the primary goal. Nonetheless, pilot data can be 
used to demonstrate whether the effects of treatment look promising across a set of outcome 
variables, to begin to examine the distribution of outcome variables to inform future analytic 
strategies, and to suggest, in concert with results from larger scale clinical trials in related fields, 
the range of effect sizes that would be reasonable to expect in a future trial. 
Because this is a treatment development study, we have chosen our sample sizes as being 
sufficient to assess feasibility and acceptability. This study is not powered to assess differences 
between treatments.  
 
9.1.1. Summary of Aims, Endpoints, and Data Analytic Strategy.   
Table 5 summarizes each aim, the target endpoint, and the data analysis strategy, where 
applicable.  
 
 

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Table 5. Summary of Aims, endpoints, and analyses. 
Aim/ Objective 
Endpoint 
Analyses 
Phase 1 – Focus Groups 
To conduct focus groups with 
prisoners and criminal justice 
stakeholder groups 
(separately) to understand 
ways of increasing feasibility, 
acceptability, and efficacy of 
yoga for anger management as 
well as feasibility and 
acceptability of our control 
arm (health education); 
 
Conduct 4 focus groups, composed 
of approximately 6 individuals 
each.   
Qualitative analysis – see 
description below.  
To solicit feedback from experts in 
correctional mental health, 
addiction, and yoga 
Feedback received from experts in 
relevant areas 
Qualitative analysis– see 
description below. 
To modify our existing yoga 
treatment manual, health 
education manual, and instructor 
fidelity scales. 
 
Draft of yoga manual, health 
education manual, and instructor 
fidelity scales 
N/A 
Phase 2 – Pilot RCT 
To conduct a pilot RCT of hatha 
yoga vs. health education   
40 prisoners enrolled & follow up 
assessments completed  
N/A 
To assess feasibility and 
acceptability of both the yoga class 
and the health education control 
group. ** This is primary.** 
See Table 6 for a complete list  
 
Descriptive statistics (see Table 6) 
and qualitative data analysis  
To assess safety, we will track all 
adverse events in a structured 
fashion. 
See Table 6 for a complete list 
Descriptive statistics (see Table 6) 
To assess feasibility of research 
procedures, 
See Table 6 for a complete list 
Descriptive statistics (see Table 6) 
To assess within-group changes 
on outcomes. The primary clinical 
target (and primary outcome for a 
subsequent efficacy trial) will be 
anger dysregulation assessed by 
the NAS at post-intervention 
(wk10). Secondary targets (and 
secondary outcomes for a 
subsequent efficacy trial) include 
Aggression (AQ-SF); behavioral 
infractions, depression (PHQ-9), 
anxiety (PROMIS Anxiety), and 
functional impairment (SF-12).  
We will assess these changes from 
pre-intervention to post-
intervention (wk10), and pre-
intervention to follow-up (wk18). 
** This is exploratory.** 
Endpoint = post-intervention 
(wk10); follow-up (wk18) 
Within-subjects t-tests (e.g., from 
pre-intervention to post-
intervention/wk10, and pre-
intervention to wk18). We will 
conduct analyses separately by 
treatment group. We will calculate 
effect sizes (Cohen’s d) from pre- 
to post- treatment/wk10, with 
corresponding confidence 
intervals. 
Assess within-group changes on 
anger rumination, decentering, 
and impulsivity.  
** This is exploratory.** 
Endpoint = post-intervention 
(wk10).  
Within-subjects t-tests (e.g., from 
pre-intervention to wk10). We will 
conduct analyses separately by 
treatment group. 
 

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9.1.2. Description of Assessment Instruments. 
All interview and self-report assessment measures were chosen because they have strong 
psychometric properties for measurement of constructs of interest to the study, and have been 
used in other NIH-funded clinical trials and prospective studies. With signed releases of 
information (ROIs) obtained at the baseline assessment, we will supplement interview and self-
report data with criminal justice records review to assess for rates of behavioral infractions in 
prison. 
Acceptability and Feasibility. Intervention credibility and patient expectations for 
intervention success at baseline will be measured with the Credibility Expectancy Questionnaire 
(CEQ)23; this is administered after their initial class.  The Client Satisfaction Questionnaire (CSQ-
8)24 will be used post-treatment to assess satisfaction with treatment. We will also use 
qualitative responses to a detailed post-treatment interview to gain participants’ feedback about 
intervention components and research procedures. Finally, it is critical that the amount of yoga 
practice at home be measured as accurately as possible. Participants will complete a yoga 
homework questionnaire on a weekly basis. The tool will yield three indices of home practice: 
frequency of extended home practice, minutes of extended home practice, and frequency of 
micro home practice.  
Participant safety. After each homework questionnaire, we will ask participants in the 
yoga arm only whether they experienced any injuries as a result of yoga practice. At each follow-
up, we will administer the Systematic Assessment of Treatment-Emergent Events – General 
Inquiry (SAFTEE)25 to all participants. This allows us to systematically assess number of adverse 
events, severity, and resulting impairment. Finally, any time a participant reports an adverse 
event to any staff member, a research assistant will talk with the participant to ascertain 
information for recording of the adverse event. For adverse events ascertained by any of these 
three possible methods, the research assistant gets information on what happened, start and 
stop dates, severity, functional impact, interactions with healthcare professionals, perceived 
cause, and possible relation to study participation.  For more information and details on coding 
of AEs, please see DSMP.  
Anger and aggression. We will use the two-part Novaco Anger Scale and Provocation 
Inventory (NAS-PI)26,27 to measure anger. The first part of the measure, the Novaco Anger Scale 
(NAS) will be used to measure the primary outcome of anger dysregulation. The NAS is a 48-item 
scale that yields a total score reflecting the likelihood and severity of experiencing anger 
reactions across cognitive, arousal, and behavioral, domains of anger. Each of these domains has 
a corresponding subscale that can be evaluated separately. The Novaco Provocation Inventory 
(PI), contains 25 items that assess anger reactivity to a variety of provocations (e.g., annoyances, 
disrespect, frustration, perceived injustice). This will be a secondary outcome. The NAS-PI is 
among the most widely used measures of anger,,28 and has demonstrated strong reliability and 
validity (including concurrent validity with other measures of anger,29–32) across many different 
samples,33–35 including incarcerated30–32,36 and other CJ-involved36–38 individuals. To measure 
aggression, we will use the Aggression Questionnaire-Short Form (AQ-SF).39,40 The AQ-SF is a 
widely used scale that measures self-reported physical and verbal aggression. It has been 
validated for use across range of populations,40,41  including those who are CJ-involved.42,43 
Finally, we will assess frequency of behavioral infractions in prison, and receipt of disciplinary 
action through review of local criminal justice records, as well as through self-report. 
Other Secondary Outcomes. The Patient Health Questionnaire (PHQ-9)44 will be used to 
assess depression via self-report. The PHQ-9 has established reliability and validity. We will use 
the self-report PROMIS anxiety45 8-item scale (short form 8A) to assess , anxiety severity. 
Functional impairment will be assessed via the SF-12,46 a brief, widely used self-report measure 

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of physical and mental health functioning.  
Potential Mechanisms of Action. The Anger Rumination Scale (ARS)47,48 is a 19-item self-
report questionnaire that measures the tendency to focus and perseverate on angry affect and 
past anger experiences. Unlike the cognitive subscale of the NAS, this scale measures a cognitive 
process, rather than the content of cognitions, per se. We will use the Experiences Questionnaire 
(EQ)49,50 to assess decentering. Decentering is a process of distancing from and observing 
cognitive content, without judgment or reactivity.51 The EQ consists of 20 items and two 
subscales: decentering and rumination. Finally, the Stroop Color Word Test52–54 will be 
administered as a task-based measure of disinhibition and impulsivity. 
Other Measures. Subjects will be asked for demographic information and, number of prior 
arrests and incarcerations, and length of time spent incarcerated. For purposes of determining 
inclusion/ exclusion criteria, the mood and psychosis modules of the brief MINI 
Neuropsychiatric Interview55 will be used to assess for current mania, psychosis, or active 
suicide risk (see section 4.7.1). The Physical Activity Readiness Questionnaire56 (PAR-Q) will be 
used to determine whether a participant is able to safely engage in a moderate level of physical 
activity. As noted in section 4.7.1, if someone answers “yes” to any of the 7 items on the scale 
they will be ruled ineligible for the study. For descriptive purposes, the Life Events 
Checklist/PTSD Checklist57,58 (LEC/PCL) will be used to assess for lifetime history of trauma 
exposure and severity of PTSD symptoms. The Treatment History Interview59 (THI) will be used 
to assess mental health treatment (i.e., pharmacotherapy, psychotherapy, group therapy, 12-step 
participation) received over the course of study participation. Finally, we will use the 
International Physical Activity Questionnaire22 (IPAQ), a self-report measure of physical activity. 
We have adapted this scale to measure amount of yoga practice engaged in during the follow-up 
time period, as well as other physical activity. The Qualitative Interview - Intersectional Stigma 
(for yoga participants only) will be conducted to assess intersectional stigma or multilevel 
resiliency in the context of incarceration among people participating in a yoga program.  
9.2 Sample Size and Randomization 
9.2.1. Sample Size. 
This project consists of three phases:  In Phase 1, we will conduct focus groups with up to 
18 prisoners and 6 prison stakeholders.  In Phase 2, we will consent up to 175 prisoners in order 
to achieve our enrollment goal of 40 prisoners who meet study inclusion for randomization to 
conditions in the pilot RCT. We will assess feasibility, acceptability, and safety of the 
interventions and research design, and examine key outcomes within relevant confidence 
intervals. This phase of the study is not designed to be adequately powered to assess efficacy; 
rather, it is focused on feasibility, acceptability, and safety.   
 
9.2.2. Treatment Assignment Procedures. 
Participants in Phase 2 will undergo randomization. Randomization will be conducted 
using a blocked stratified randomization scheme. We will stratify patients based on gender and 
facility (i.e., men’s medium security [n= 20], and women’s combined minimum and medium 
security [n=20]). Randomization sequences will be generated by computer. Because we cannot 
bring computers into the prison, we will have someone not associated with the study conceal the 
group assignments within small opaque envelopes labeled with a number and the strata (for 
example, male medium 1, male medium 2, etc.).  Research assistants will then take the envelopes 
to the prison, and open them when randomization occurs.  

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9.3 Definition of Populations 
All data analysis will use the intent to treat population and use all available data. There is 
no per protocol analysis planned.  
 
9.4 Interim Analyses and Stopping Rules 
9.4.1 Interim analysis. 
There is no interim data analysis plan.  
Data analysis of Phase 1 qualitative data will occur during and immediately after data 
collection in Phase 1.  
Data analysis of Phase 2 data will occur after enrolling 10, 20, and 40 participants (for 
feasibility and acceptability outcomes). 
 
9.4.2 Halting Rules. 
If there are any SAEs judged related to the study intervention, we will halt the study 
intervention until an ad hoc safety review is convened with the DSMB, MPIs, site PI, and other 
relevant study staff. The safety review will determine whether the study should continue per 
protocol, proceed with enhanced monitoring, be further investigated, be discontinued, or be 
modified and then proceed. Subsequent review of serious, unexpected, and related AEs by the 
DSMB, IRB, the sponsor(s), or relevant local regulatory authorities may also result in suspension 
of further study interventions. The study sponsor(s) retain the authority to suspend additional 
enrollment and study interventions/ administration of study product for the entire study, as 
applicable. 
 
9.5 Outcomes  
9.5.1 Primary Outcome.   
The primary outcomes are acceptability, feasibility, and safety.  
 
Target treatment development outcomes. We monitor treatment development outcomes 
(see Table 6) throughout the trial. Target outcomes were chosen on face validity, clinical 
experience, and, when available, relevant clinical literature. At 3 time points throughout the RCT 
(i.e., after enrolling 10, 20, and 40 participants), the scientific team will convene to discuss how 
our actual procedural outcomes compare to the target outcomes. Discrepancies will result in: 1) 
investigation (using qualitative or other data) of the reason for the failure to meet this outcome; 
and 2) discussion amongst the research team. Depending on the nature of the discrepancy, we 
may modify recruitment procedures, assessment procedures, instructions to participants, 
instructor training procedures, or other aspects of the trial. Ultimately, failure to meet these 
outcomes could result in a decision not to write a grant proposal for a large-scale RCT; in other 
cases, it may inform the design of a subsequent RCT.  
Primary data analyses will be focused on feasibility and acceptability (see Table 6) using 
intent-to-treat population. Study measures and endpoints will continue to be collected for all 
enrolled participants if they are willing, even in the event of premature discontinuation of the 
study intervention.  

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9.5.2 Secondary/ Exploratory Outcomes. 
In Phase 2, we will also examine change in key variables over time. This is an exploratory 
analysis.  
 
Specifically, we will look at change over time the in the following variables. The primary 
outcome in a subsequent efficacy study is in bold and underlined. Secondary outcomes are in 
standard text. Potential mechanisms are in italics.  
 
• NAS-Provocation Inventory from BL to wk10; BL to wk18.  
• Aggression Questionnaire – Short Form, BL to wk10; BL to wk18.  
• Number of behavioral infractions in Prison, BL to wk10; BL to wk18 
• PHQ-9, BL to wk10; BL to wk18 
• PROMIS Anxiety, BL to wk10; BL to wk18 
• SF-12 physical health composite score, BL to wk10; BL to wk18 
• SF-12 mental health composite score, BL to wk10; BL to wk18 
• Anger rumination scale, BL to wk10; BL to wk18 
• Experiences Questionnaire, BL to wk10; BL to wk18 
Table 2.  Target Outcomes  
 
Description  
(Assessment method) 
Target 
Feasibility and Acceptability--  Hatha yoga, Health education 
Acceptability  (qualitative 
interview) 
Most feedback positive; few substantive negative comments.  
Negative comments used to enhance procedures. 
Credibility at baseline 
(CEQ) 
Average > 50 (i.e., midpoint score between low and high 
credibility) on subscale 
Expectancy at baseline 
(CEQ) 
Average > 50 (i.e., midpoint score) on subscale 
Program satisfaction 
(CSQ-8) 
Average total score > 24 
Home practice 
(homework 
questionnaire) 
70% of yoga participants engage in practice at least 2 times 
per week for 6/10 weeks. 
Class attendance 
70% of all participants complete 6/10 classes in the RCT 
Instructor adherence 
(Adherence measures) 
Yoga instructors and HE instructors achieve at least 80% 
adherence on a random subset of classes taught 
Class size 
70% of classes have 4 or more participants.  
Safety 
Adverse events (SAFTEE; 
injuries due to yoga) 
No serious adverse events or injuries that are possibly, 
probably, or definitely related to study participation. 
Feasibility and Acceptability—Research Procedures 
Recruitment rate 
Average of 6 enrolled per month 
Retention rate 
80% complete week 10 assessment; 70% complete wk. 18 
assessment 
Completion of items on 
assessment instruments 
At least 90% of items are completed on each assessment 
instrument (so each will be valid).  

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• Stroop Color and Word Test, BL to wk10; BL to wk18 
 
9.6 Data Analyses  
Qualitative Data Analysis.  We will identify themes through team-level review of 
transcripts and group discussions.  
Quantitative Data Analysis.  In the past, researchers have used pilot data to estimate an 
effect size for future power calculations. Kraemer et al.60 emphasized the limitations of this 
practice due to the likelihood of large standard errors surrounding effect size estimates, and the 
concern that ultimately, large-scale RCTs should be powered to detect between-group 
differences considered to be minimally clinically significant. 
Using data from the pilot RCT, we will examine differences in means and SDs (or 
frequencies) of key variables (e.g.,NAS total score, NAS subscale scores, secondary outcomes, and 
possible mechanisms) across time points using repeated-measures ANOVA. We will use effect 
size estimates to characterize differences between groups at each timepoint and will calculate 
associated 95% confidence intervals of these estimates in order to understand the precision, or 
lack thereof, of our estimates. We recognize that, due to the likely size of these CIs, these analyses 
may not permit definitive conclusions. 
 
 

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10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Participants will answer self-report data on standardized paper forms.  Data will be 
entered in REDCap and double checked for accuracy.  For the RCT (Phase 2), there will be a 
separate data collection instrument in REDCap to enter randomization assignment (yoga or 
health education).  Additionally, we will have section of REDCap for intervention specific data 
(e.g., dates of sessions attended, yoga homework).  Only non-blinded study personnel will have 
access to this section of REDCap. Blind personnel will be restricted.   
Data and audio recordings will be identified with a participant ID number and identifying 
information will not be attached to paper data forms.  All data (identifiable and non-identifiable) 
will be entered and tracked in REDCap.  REDCap has the ability to restrict identifiable data access 
to only necessary study personnel.  Those without access to identifiable data, will only be able to 
see the participant’s identification number and de-identified data in REDCap.  Care New 
England’s instance of REDCap has been deemed HIPAA compliant by CNE Information 
Technology.   
All paper records will be kept in a locked file cabinet.  Any identifying information will be 
stored in a separate locked file cabinet from non-identifiable data at our offices at Brown 
University.  All audio recorders are password-protected and encrypted for purposes of safe 
transport between the RIDOC facilities and Brown University offices. Digital recordings will be 
regularly transferred to Brown’s secure computer server (designed to hold and protect digital 
audio and video recordings for clinical trials) via USB connection and secure file transfer to 
Brown’s secure audio server, and the recorders are wiped. 
 
 10.2 Data Management  
All Data will be collected using standardized paper forms or (if collected by telephone) 
will be directly entered into the Care New England REDCap database.  Data from paper forms 
will be entered into REDCap and double checked for accuracy.  Data entered directly into 
REDCap (if collected by telephone) will be reviewed by the Project Coordinator for completion 
and discrepancies.  Any discrepancies will be resolved by the Project Coordinator in consultation 
with the MPIs as needed.   
Care New England’s REDCap is a secure, web application designed to support data 
capture for research studies, providing user-friendly web-based case report forms, real-time 
data entry validation (e.g. for data types and range checks), audit trails, and a de-identified data 
export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). The system was 
developed by a multi-institutional consortium and was initiated at Vanderbilt University. 
Network transmissions (data entry, survey submission, web browsing, etc.) in REDCap are 
protected via Secure Sockets Layer (SSL) encryption.  Access to REDCap can be restricted at 
different levels (e.g., research assistant, PI, and Co-Investigators).  Exported data from REDCap 
will be stored on a secure password-protected server at Brown University.   
 
Please see also “Data Handling and Record Keeping” in the DSMP.  

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10.3 Quality Assurance  
10.3.1 Training 
All research personnel will have formal training in research with human subjects (e.g., 
CITI training, GCP training). Drs. Weinstock and Uebelacker will provide training to and 
supervise the research assistants. RAs will have a bachelor’s or master’s degree, and will receive 
training in the informed consent process and their ethical responsibilities when conducting 
research, with a particular focus on the ethics involved with research with prisoner populations. 
All interviewers will receive specific training in the assessment instruments to be administered 
and in all study-related safety protocols. With assistance from the PIs, study Co-I Dr. Tremont 
and study consultant Mr. Gillette will supervise yoga instructors. Drs. Weinstock and Uebelacker 
will supervise the health education instructors, with additional assistance from Co-I Dr. Johnson. 
10.3.2 Quality Control Committee  
Drs. Uebelacker and Weinstock will be responsible for quality control of this study. They 
review recruitment and retention reports, and AE reports, on weekly basis.  
10.3.3 Metrics 
None of the outcome data include interview-administered questionnaires, so there are no 
relevant inter-rater reliability requirements.  
 
10.3.4 Protocol Deviations 
During weekly study meetings, protocol deviations will be discussed with the MPIs, 
including plans for corrective action. Protocol deviations will be logged on the protocol deviation 
tracking sheet and filed in the regulatory binder. 
10.3.5 Monitoring 
The investigators are responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported.  All source documents will be completed in a neat, legible 
manner to ensure accurate interpretation of data. Specific instructions for each step of the data 
management process, from acquisition to storage, will be included in a manual of procedures 
(MOP).  
Data quality will be monitored by random inspection of the completed forms by one of the 
research assistants and any problems detected will be discussed with the PI. Standard data 
checking procedures will include checking forms for missing data, double entry with discrepancy 
resolution, daily back-up copies of computer files, and examination of key variables for 
skewness, variability, missing data, and outliers. Data and materials will be collected specifically 
for the proposed project.  
Data collection and accurate documentation are the responsibility of the study staff under 
the supervision of MPIs.  All source documents must be reviewed by the study team to ensure 
that they are accurate and complete.  
 
 
 

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11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol and the informed consent documents and any subsequent modifications 
will be reviewed and approved by the IRB or ethics committee responsible for oversight of the 
study. The consent form should be separate from the protocol document.  
11.2 Informed Consent Forms 
A signed consent form will be obtained from each participant. The consent forms will 
describe the purpose of the study, the procedures to be followed, and the risks and benefits of 
participation. A copy will be given to each participant and this fact will be documented in the 
participant’s record.  
11.3 Participant Confidentiality  
Data will be collected using standardized paper forms or (if collected by telephone) will be 
directly entered into the Care New England REDCap database, and will only be identified with 
the study’s ID of the participant. Identifiable data will be restricted to only necessary study 
personnel (both paper forms and in REDCap).  Collected forms will be transported to Dr. 
Weinstock’s data entry center hosted by Brown University.   
The computer systems used for data entry and analysis are protected by passwords and 
secure logon and data communications procedures to minimize the potential for disclosure of 
research information either inadvertently or as a result of external attack. Within each computer 
system, only those users authorized to access the data for a given study are able to do so. 
Research records are stored in areas that are locked when staff is not present.   
All research data will be entered into Care New England’s REDCap. Please see section 10.2 
Data Management for more information. . 
All paper forms will be referenced to a participant ID number and will be kept in locked 
file cabinets. The participant’s ID number can be connected to the participant’s name only 
through a single master file, accessible only to research staff. Consent forms and other 
documentation with personal identifiers will be kept in a separate file from other data. We will 
use encrypted, password-protected audio recorders and a locked transport box for 
transportation of paper files from RIDOC to Brown University offices at Butler Hospital.  
Information will not be released without written permission of the participant, except as 
necessary for monitoring by IRB, the FDA, the NCCIH, and the OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
 
11.5 Inclusion of Special Classes, Women and Minorities, and Children 
Special classes. Because the purpose of this study is to develop and evaluate the feasibility 
and acceptability of yoga and the health education control condition for prisoners with anger 
dysregulation, it is necessary to sample a prison population. Prisoners are an understudied 
population with complex treatment needs; hence the urgency for more research attending to the 
emotional and behavioral needs of this population. Because the target population is constituted 

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by sentenced prisoners, the Prisoner Checklist for research has been included as an appendix to 
this application. Incarcerated children 18-21 will be eligible. 
 
Inclusion of Women and Minorities. Because the purpose of this application is to develop 
and pilot a Hatha yoga intervention for prisoners with anger dysregulation, the study population 
will consist of sentenced male and female inmates.  
Extant data from prisoners at participating facilities in Rhode Island have been used to 
estimate the racial and ethnic distribution of the prisoner participants in the focus groups (n=18) 
and in the pilot randomized trial (n=40) phases of the proposed research. For females, the 
overall racial distribution will be approximately 66% White, 17% African American, 2% Asian, 
4% American Indian or Alaska Native, and 11% other. The overall ethnic distribution for women 
will be approximately 17% Hispanic or Latina and 83% Non-Hispanic or Latina. For males, the 
overall racial distribution will be 48% White, 28% African American, 2% Asian, 4% American 
Indian or Alaska Native, and 18% other. The overall ethnic distribution for men will be 
approximately 24% Hispanic or Latino and 76% Non-Hispanic or Latino. 
If the minority distribution of our participants falls below the targeted minority distribution 
(i.e., if halfway through the study, the proportions of African Americans or Hispanics recruited 
are less than two thirds of the proportion of that minority distribution for the RIDOC), then we 
will conduct additional outreach to the group that fell below their targeted enrollment numbers. 
We will also attempt to obtain feedback on why individuals for that group may refuse to 
participate in the study. Based on the feedback, we will take corrective action. All subjects will be 
asked to identify their race and ethnicity separately, by self-report, at the time of study entry, 
when demographic information is collected. We plan to conduct analysis to determine whether 
minority status is associated with any of the treatment utilization or clinical outcome data 
collected as part of this investigation. The Targeted/Planned Enrollment Table displays the 
expected racial and ethnic distribution of participants for this study. 
 
Inclusion of Children.  Individuals aged 18-21 who meet our inclusion criteria will be 
included in this study. Individuals younger than 18 will not be included. Stakeholder focus group 
participants will be employees of the RIDOC, and therefore over the age of 18. However, children 
18-21 will be included. This study will not include anyone under 18 years of age (the age of 
emancipation in Rhode Island) because individuals younger than age 18 are supervised by the RI 
Juvenile Corrections Division (not the RIDOC) and because adolescent developmental issues 
would confound outcomes of interest to the study and because incarcerated individuals. 
Additional instruments and study methods would also be required to assess the unique mental 
health needs of a younger population. Thus, the current research is not applicable to children 
under the age of 18. 
Because children ages 18-21 are of legal age, they will be treated as adults and will be able to 
consent and agree to participate in the study themselves. Our consent procedures are conducted 
face-to-face, with trained interviewers guiding eligible subjects step-by-step; materials are 
written at a Grade 7 level and the interviewers ensure that each element is understood. In 
addition, consent forms will be read aloud. 
12. COMMITTEES 
 
An external local SMC will be assembled to evaluate the data and safety to participants 
enrolled in the study. We will recruit 3 non-Brown-affiliated board members who have 
experience in clinical trials and/or yoga research and/or anger dysregulation research and/or 
research with criminal justice samples as well as the ethical issues involved with a randomized 

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control study. No member of the SMC will have co-published with the MPIs within the past three 
years, and they will not collaborate with the MPIs on any other studies.  
 
 
RIDOC.  We have a letter of support from the RI Department of Corrections (RIDOC) for 
this project. We have submitted this protocol to the RIDOC Medical Research Advisory Group 
(MRAG) for their review and approval prior to beginning any human subjects research at their 
site. We have contacts at RIDOC from years of conducting research in their facilities. This includes 
our point person, the Associate Director for Planning and Research, as well as contacts in each facility, 
including Deputies and the Programs Coordinator. 
 
 
OHRP.  In addition, the Brown University IRB submitted this protocol to the US Office of 
Human Research Protections (OHRP) and received their certification of this research protocol. 
 
 
 

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13. PUBLICATION OF RESEARCH FINDINGS  
Drs. Weinstock and Uebelacker will be responsible for oversight and approval of any 
publications or presentations that arise from this research.  
 
As is required, we will also provide draft materials (to include presentations, 
publications) based on this research to the attention of the Associate Director of Planning and 
Research at RIDOC, prior to dissemination. The purpose of the review is to allow the opportunity 
to ensure that the Department specific data is being accurately interpreted, not to edit the 
content of the work.

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Mills JF, Kroner DG, Forth AE. Novaco anger scale: Reliability and validity within an adult 
criminal sample. Assessment. 1998;5:237-248.  
32.  
Baker MT, Van Hasselt VB, Sellers AH. Validation of the Novaco Anger Scale in an incarcerated 
offender population. Crim Justice Behav. 2008;35:741-754.  
33.  
Jones JP, Thomas-Peter BA, Trout A. Normative data for the Novaco Anger Scale from a non-

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Novaco RW, Chemtob CM. Anger and combat-related posttraumatic stress disorder. J Trauma 
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Chemtob CM, Novaco RW, Hamada RS, Gross DM. Cognitive-behavioral treatment for severe 
anger in posttraumatic stress disorder. J Consult Clin Psychol. 1997;65:184-189.  
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Moeller SB, Novaco RW, Heinola-Nielsen V, Hougaard H. Validation of the Novaco Anger 
Scale–Provocation Inventory with nonclinical, clinical, and offender samples. Assessment. 
2016;23:624-636.  
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Novaco RW, Taylor JL. Anger and assaultiveness of male forensic patients with developmental 
disabilities: Links to volatile parents. Aggress Behav. 2008;34:380-393.  
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Novaco RW, Taylor JL. Assessment of anger and aggression in male offenders with 
developmental disabilities. Psychol Assess. 2004;16:42-50.  
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Buss AH, Perry M. The Aggression Questionnaire. J Pers Soc Psychol. 1992;63:452-459.  
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Bryant FB, Smith BD. Refining the architecture of aggression: A measurement model for the 
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Webster GD, Dewall CN, Pond RS, et al. The brief aggression questionnaire: Psychometric and 
behavioral evidence for an efficient measure of trait aggression. Aggress Behav. 2014;40:120-
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Wolff N, Morgan RD, Shi J, Huening J, Fisher WH. Thinking styles and emotional states of male 
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Diamond PM, Magaletta PR. The Short-Form Buss-Perry Aggression Questionnaire (BPAQ-SF): 
A validation study with federal offenders. Assessment. 2006;13:227-240.  
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Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: Validity of a brief depression severity 
measure. J Gen Intern Med. 2001;16:606-613.  
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Schalet BD, Pilkonis PA, Yu L, et al. Clinical validity of PROMIS Depression, Anxiety, and Anger 
across diverse clinical samples. J Clin Epidemiol. 2016;73:119-127.  
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Burdine JN, Felix MRJ, Abel AL, Wiltraut CJ, Musselman YJ. The SF-12 as a population health 
measure: An exploratory examination of potential for application. Health Serv Res. 
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Sukhodolsky DG, Golub A, Cromwell EN. Development and validation of the anger rumination 
scale. Pers Individ Dif. 2001;31:689-700.  
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Anestis MD, Anestis JC, Selby EA, Joiner TE. Anger rumination across forms of aggression. Pers 
Individ Dif. 2009;46:192-196.  
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McCracken LM, Gutieŕrez-Martínez O, Smyth C. “Decentering” reflects psychological flexibility 
in people with chronic pain and correlates with their quality of functioning. Heal Psychol. 

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Fresco DM, Moore MT, van Dulmen MHM, et al. Initial psychometric properties of the 
Experiences Questionnaire: Validation of a self-report measure of decentering. Behav Ther. 
2007;38:234-246.  
51.  
Bernstein A, Hadash Y, Lichtash Y, Tanay G, Shepherd K, Fresco DM. Decentering and related 
constructs: A critical review and metacognitive processes model. Perspect Psychol Sci. 
2015;10:599-617. 
52.  
Strauss GP, Allen DN, Jorgensen ML, Cramer SL. Test-retest reliability of standard and 
emotional Stroop tasks: An investigation of color-word and picture-word versions. 
Assessment. 2005;12:330-337.  
53.  
Golden CJ. Stroop Color and Word Test: A manual for clinical and experimental uses. Chicago: 
Stoelting. 1978:1-46.  
54.  
Sharma L, Markon KE, Clark LA. Toward a theory of distinct types of “impulsive” behaviors: A 
meta-analysis of self-report and behavioral measures. Psychol Bull. 2014;140:374-408.  
55.  
Sheehan D V., Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric 
Interview (M.I.N.I.): The development and validation of a structured diagnostic psychiatric 
interview for DSM-IV and ICD-10. Journal of Clinical Psychiatry. 1998;59:22-33.  
56.  
Thomas S, Reading J, Shephard RJ. Revision of the Physical Activity Readiness Questionnaire 
(PAR-Q). Can J Sport Sci. 1992;17:338-345. 
57.  
Gray MJ, Litz BT, Hsu JL, Lombardo TW. Psychometric properties of the life events checklist. 
Assessment. 2004;11:330-341.  
58.  
McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD Checklist: A critical review. 
Clin Psychol Rev. 2010;30:976-987.  
59.  
Linehan MM, Heard HL. Treatment History Interview-4 (THI-4). Seattle,WA: University of 
Washington; 1996. 
60.  
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot 
studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63:484-
489 
 
 
 

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15. SUPPLEMENTS/APPENDICES 
None.  
 

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Name of Sponsor: National Center for Complementary and 
Integrative Health 
Grant Number: 
Version Date: December 20, 2019 
Version Number: 1.2 
Data and Safety Monitoring Plan (DSMP) 
Treatment Development of Yoga for Anger Management in Incarcerated adults 

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1 STUDY OVERVIEW 
 
 
1.1 
Purpose of Study 
 
The overall goal of this project is to conduct treatment development research that would prepare 
us to study whether hatha yoga (vs. a health education control group) might be an effective 
adjunctive treatment to target anger dysregulation in people in prison. We will conduct focus 
groups (n = 24) to gain feedback from men and women in prison, and from prison 
administrators. We will then conduct a pilot randomized controlled trial (n = 40) of hatha yoga 
vs. health education for anger dysregulation. In total, the sample will be 58 incarcerated 
individuals and 6 prison administrators, ages 18-70 years, who meet the study’s inclusion 
criteria and sign the consent form. The sample will be recruited from the women’s and men’s 
medium security prison facilities at the RI Department of Corrections (RIDOC) in Cranston, RI. 
 
1.2 
Adherence Statement 
 
The Data Safety Monitoring Plan (DSMP) outlined below will adhere to the protocol approved by 
the Brown University IRB. 
 
2 PROTOCOL AMENDMENTS 
 
All protocol amendments, other than minor administrative changes as defined by the NCCIH 
Guidance on Changes in Clinical Studies in Active Awards will be submitted in a prospective 
manner to NCCIH except when necessary to protect the safety, rights, or welfare of subjects. 
Prior to submission to NCCIH the proposed changes will be reviewed and approved by the 
Independent Monitor(s). IRB-approval will not be sought until after NCCIH approval of the 
protocol amendment has been obtained. 
 
3 MULTI-SITE STUDIES 
 
Not applicable. 
 
4 
CONFIDENTIALITY 
 
4.1 
Protection of Subject Privacy 
Subject confidentiality is strictly held in trust by the investigators, study staff, and the sponsor(s) 
and their agents. This confidentiality is extended to cover testing of biological samples in 
addition to any study information relating to subjects. 
 
The study protocol, documentation, data, and all other information generated will be held in 
strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the sponsor. 
 
 
 
 
 
 

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The study monitor or other authorized representatives of the sponsor may inspect all study 
documents and records required to be maintained by the investigator, including but not limited 
to, medical records (office, clinic, or hospital) for the study subjects. The clinical study site will 
permit access to such records. 
 
4.2 
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 identification code. 
 
5 EXPECTED RISKS 
 
Expected risks to the subject are as follows: 
 
Potential coercion. It is possible that individuals may feel coerced into participating. This is 
an especially important risk to minimize with incarcerated individuals. We will minimize the risk 
of potential coercion by following standard procedures for obtaining informed consent (see 
section 9). We will begin this process during the intake where we will clarify the nature of the 
study and possible alternatives upfront. Prior to enrolling participants in the research, we will 
fully explain the study procedures, risks, benefits, and alternatives to participants, emphasizing 
that participation has no impact on the other services they receive at the prison, the terms or 
length of their confinement, or any other community services that they receive post-release. 
Also, participants who do not consent or who withdraw will receive appropriate referrals (e.g., for 
mental health treatment), if needed. All participants will be reminded that there is no penalty for 
participants who choose to not participate or to withdraw from the study. All reimbursements for 
participating will be commensurate with participants’ time required for participating in the 
research. 
 
Physical injury. Because yoga is a physical activity, there is a small risk of physical injury 
for those participants who are in study yoga classes. The risk of physical injury will be minimized 
by: a) requiring all participants in yoga classes to be medically appropriate for moderate 
physical activity; and b) requiring all instructors to be registered yoga teachers with experience 
in directing people in how to achieve yoga postures without physical injury. Class content will be 
designed to accommodate the needs of yoga-naïve students who are not currently physically 
active. By presenting modifications of all postures, and by using props (e.g., folding chairs, 
blocks, and blankets), the risk for injury will be minimized. Injuries due to yoga will be monitored 
at frequent intervals during this part of the study and patients will be followed for a sufficient 
period of time (2 months) after completing yoga classes to ensure stabilization of injuries. 
 
Suicide or homicide ideation. Given that participants will have risk factors for suicide or 
homicide (e.g., a mental health diagnosis, incarceration), some participants may experience 
suicide ideation or behavior in the course of study participation. During incarceration the RIDOC 
standards for mandatory reporting of suicide risk specify that we are required to report anyone 
who has had suicidal ideation within the past 24 hours (as determined by participant reporting of 
any current desire to hurt oneself to any member of the research staff). If the participant reports 
this level of SI within the past 2 weeks, but not in the 24 hours prior to the assessment, a 
voluntary referral will be offered. Participants meeting the prison’s SI mandatory reporting 
criteria (or those who elect the voluntary referral) will be referred to a prison mental health 
clinician for evaluation, who will follow prison procedures. Standard prison procedures include: 
 

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(1) checking in the prison’s electronic medical record to see if the person has already been 
flagged as having SI; (2) having a licensed mental health clinician check in with the person and 
do a suicide risk evaluation; and/or (3) if needed, putting the person on psychiatric observation 
within the prison. If the prison mental health professional determines that someone’s risk has 
gone down, that person will leave psychiatric observation and return to the general population. 
All of these procedures are set and executed by the prison, which follows its own ethical and 
legal requirements. We will clearly describe this in our consent form. Homicidal risk will be 
defined by reporting any desire to hurt another person, including any member of the study staff. 
Standard mandatory reporting procedures (e.g., contact prison mental health staff) will be 
followed. 
 
Given study inclusion criteria, we think it unlikely that anyone will be released into the 
community while participating in the study. However, we do have procedures in place for people 
post-release. During the post-release period, definitions of suicide risk, and homicide risk will be 
the same those described above; however, we will rely upon our standard study procedures (vs. 
RIDOC mandatory/voluntary reporting criteria) to facilitate clinician referral and safety 
assessment, as needed. If any study staff member identifies an individual with significant clinical 
deterioration or who report any suicidal or homicidal ideation in the course of standard 
assessment procedures, the staff member will immediately contact Dr. Weinstock or Dr. 
Uebelacker (or the licensed covering clinician). The covering clinician will evaluate the 
participant over the telephone or in person. First, they will conduct a suicide and homicide risk 
assessment to determine whether it is necessary to take immediate action to prevent the 
participant from causing harm to self or others. If needed, actions that the covering clinician may 
take include escorting the person to the emergency Patient Assessment Service (PAS) at Butler 
Hospital (if the person is in our offices), having a family member transport the person to Butler 
Hospital or another hospital, or sending an ambulance so that the individual may be evaluated 
for inpatient psychiatric hospitalization. 
 
A participant who has undergone a suicide or homicide risk assessment may continue to 
participate in the study unless the study PIs, in concert with the participant’s healthcare 
providers, deem study participation to increase risk for this particular participant. Participants 
who are hospitalized due to concerns about suicidality will be discontinued from the study. 
 
Distress due to assessment or intervention procedures. It is possible that some 
participants will experience increased intrapersonal or interpersonal psychological distress as a 
result of participating in assessment or intervention. In the vast majority of cases, we believe 
that any increased distress experiences will be mild and transitory in nature. We will minimize 
the risk of distress by informing all participants that they do not have to answer questions that 
they find too distressing and will be reminded that they can discontinue participation at any time. 
Moreover, clinical backup will be provided during all assessments and intervention sessions by 
a licensed clinician to help facilitate the stabilization and referral process for participants who 
decompensate during study procedures. The need for additional services will also be monitored 
during each clinical (assessment or intervention) contact. Participants will be formally assessed 
at 4 time points (baseline, 5 weeks, 10 weeks, 18 weeks). Incarcerated participants who 
manifest significant psychiatric symptomatology (i.e., psychosis or mania per the MINI 
Neuropsychiatric Interview) will be referred to appropriate clinical prison staff for evaluation, per 
RIDOC policy.  As noted above, we will follow these same procedures for participants who 
report significant homicidal ideation or suicide risk. For assessments in the community, a 
licensed clinician (the MPIs or their covering clinician) will be available at all times to provide 
clinical coverage. Research staff will notify the licensed clinician if there are any safety concerns 
 
   

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Confidentiality and loss of privacy. The greatest potential risks to those participating in 
the research are legal or social, caused by the inadvertent loss of confidential information 
obtained during the data collection process. That is, a participant’s identity may be inadvertently 
exposed or questionnaire material may be released or disclosed to unauthorized persons. In the 
case of such a breach, serious personal and social consequences could conceivably occur. 
However, such risks can be minimized by instituting the proper procedures to protect 
confidentiality and by having resources in place to provide counseling and referrals. We have 
extensive experience taking appropriate measures to safeguard confidential information in 
research with criminal justice populations. We will minimize potential risks due to loss of 
confidentiality of research data by having all information collected and handled by research 
staff, including study interventionists, trained to deal appropriately with sensitive clinical issues. 
All participants will be informed about the limits of confidentiality concerning suicidal intent, 
homicidal intent, suspected child abuse, suspected elder abuse, and other prison-required 
mandatory reporting issues (i.e., sexual contact within the prison, weapons in the prison, prison 
escape plans). All information will be treated as confidential material and will be available only to 
research staff. All information will be kept in locked file cabinets at Brown University. Computer 
data files will be kept on Brown’s secure research servers, will be available only to authorized 
personnel, and no names or obvious identifying information will be stored in data files. No 
participant will be identified in any report of the project. Written consent will be obtained to 
contact other persons for the purpose of locating the participant for follow-up and participants 
can refuse or revoke such requests. Participants will update their contact information and 
contact person (in the unanticipated event of a reduced sentence and release prior to study 
completion) at each assessment point to ensure that this information remains appropriate. To 
further protect participants, there will be a Federal Certificate of Confidentiality for this 
project, which is now automatically awarded by NIH when a proposal is funded. Potential 
subjects will be informed that a Certificate of Confidentiality has been obtained for this project 
and that this certificate will protect the investigators from being forced to release any research 
data in which participants can be identified, even under court order or subpoena, although this 
protection is not absolute. Potential participants will be informed of the situations during the 
informed consent process (and as documented in the informed consent document) in which 
they may not be protected under the Certificate of Confidentiality. No information about 
participants will be released without their permission or where required by law. 
Audio recording is necessary to rate reliability of the interview assessments and also study 
interventionists’ fidelity to the treatment. As in our past 10 years of prison research, audio 
recording is accomplished through the use of credit-card size digital audio recorders, which 
have password-protection and encryption capabilities thereby protecting their contents during 
transport between the RIDOC and our research offices. These digital recordings are regularly 
transferred to Brown’s secure computer server (designed to hold and protect digital audio and 
video recordings for clinical trials) via USB connection and secure file transfer to Brown’s secure 
audio server, and the recorders are wiped. This is the same procedure that has been used in 
our completed and ongoing intervention studies with prisoners and jail detainees at the 
recruitment site. Participants will be asked to give informed written consent to audio recording at 
the time of intervention study entry. To assure the confidentiality and protection of participants 
with respect to audio taping, the following steps will be taken: a) each recording will be labeled 
with the participant’s study identification number, the intervention provider’s/interviewer’s name, 
and the session/interview date; b) all recordings will be stored on a secured computer server 
designed to hold and protect research data; and c) access to the audio recordings will be limited 
to only those research staff who need access to the recordings to perform their duties. 
 
 

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Finally, a participant’s confidential statements during a focus group or a treatment group 
may be repeated by another member of the group. To minimize risk, we will remind all 
participants that: a) group discussion should be kept confidential; and b) because we cannot 
guarantee confidentiality due to the group nature of the discussion, all participants should be 
careful about disclosing anything that they want kept private. Finally, we will ask all 
participants not to disclose the names of prisoners in their focus group or treatment 
group to others outside the group. 
 
 
 
3 ADVERSE EVENT/ UNANTICIPATED PROBLEMS 
 
3.1 
Definitions 
 
3.1.1 
Adverse Event (AE) 
 
An adverse event (AE) is any untoward medical occurrence in a subject during participation in 
the clinical study or with use of the experimental agent being studied. An adverse finding can 
include a sign, symptom, abnormal assessment (laboratory test value, vital signs, 
electrocardiogram finding, etc.), or any combination of these regardless of relationship to 
participation in the study. 
 
3.1.2 
Unanticipated Problems (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or outcome 
that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB-approved 
research protocol and informed consent document; and (b) the characteristics of the 
subject population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
 
3.1.3 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
 
• 
Results in death 
• 
Is life-threatening (places the subject at immediate risk of death from the event as it 
occurred; includes a suicide attempt or drug overdose) 
 
 
 

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• 
Results in inpatient hospitalization or prolongation of existing hospitalization 
• 
Results in a persistent or significant disability or incapacity 
• 
Results in a congenital anomaly or birth defect 
An important medical event that may not result in death, be life threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, 
the event may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. 
 
3.2 
Time Period and Frequency for Event Assessment and Follow-Up 
Unanticipated problems will be recorded in the data collection system throughout the study. 
 
Study staff will record all reportable events with start dates occurring any time after informed 
consent is obtained until 8 weeks (i.e., follow-up assessment after the last day of class 
participation). Each time participants attend classes, we will inquire about injuries due to study 
participation. At midpoint, endpoint, and at week 8 follow-up, study staff will administer the 
SAFTEE in order to inquire about the occurrence of AE/SAEs during the previous 8-10 weeks. 
SAEs related study participation will be followed for outcome information until resolution or 
stabilization. 
 
3.3 
Characteristics of an Adverse Event 
 
3.3.1 
Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are used: 
 
1. Related (Possible, Probable, Definite) 
 
a. The event is known to occur with the study intervention. 
 
b. There is a temporal relationship between the intervention and event onset. 
 
c. The event abates when the intervention is discontinued. 
 
d. The event reappears upon a re-challenge with the intervention. 
 
2. Not Related (Unlikely, Not Related) 
 
a. There is no temporal relationship between the intervention and event onset. 
 
b. An alternate etiology has been established. 
 
3.3.2 
Expectedness of SAEs 
The Study PI and Independent Monitoring Committee will be responsible for determining 
whether an SAE is expected or unexpected. An adverse event will be considered unexpected if 
the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the intervention. The risk information to assess expectedness can be 
 
 
 

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obtained from preclinical studies, the investigator’s brochure, published medical literature, the 
protocol, or the informed consent document. 
 
Expected AEs for this study include: 
 
• 
Any event that may be reasonably anticipated to occur as a result of the study procedure 
(i.e., mild aches or pains following a yoga class) 
 
 
3.3.3 
Severity of Event 
The following scale will be used to grade adverse events: 
 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on 
ADL 
 
3. Severe: significant symptoms requiring invasive intervention; subject seeks medical 
attention, needs major assistance with ADL 
 
 
3.4 
Reporting Procedures 
 
3.4.1 
Reporting for Multi-Center Trials 
 
Not applicable. 
 
 
3.4.2 
Unanticipated Problem Reporting 
Incidents or events that meet the OHRP criteria for unanticipated problems require the creation 
and completion of an unanticipated problem report form. OHRP recommends that investigators 
include the following information when reporting an adverse event, or any other incident, 
experience, or outcome as an unanticipated problem to the IRB: 
 
• 
Appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• 
A detailed description of the adverse event, incident, experience, or outcome; 
• 
An explanation of the basis for determining that the adverse event, incident, experience, 
or outcome represents an unanticipated problem; 
• 
A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the unanticipated problem. 
 
 
 
 
 
 

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To satisfy the requirement for prompt reporting, unanticipated problems will be reported using 
the following timeline: 
 
• 
Unanticipated problems that are serious adverse events will be reported to the IRB, 
SMC, and NCCIH within 7 days of the investigator becoming aware of the event. 
• 
Any other unanticipated problem will be reported to the IRB, SMC, and NCCIH within 14 
days of the investigator becoming aware of the problem. 
All unanticipated problems should be reported to appropriate institutional officials (as required 
by an institution’s written reporting procedures), the supporting agency head (or designee), and 
OHRP within one month of the IRB’s receipt of the report of the problem from the investigator. 
 
 
3.4.3 
Adverse Event Reporting of Non-IND Studies 
 
 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the Safety Monitoring Committee (SMC), IRB, and NCCIH in accordance with 
requirements. 
 
• 
Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Officer and SMC within 3 days of the investigator becoming aware of 
the event. Other serious and unexpected AEs related to the intervention will be reported 
within 7 days. 
• 
Anticipated or unrelated SAEs will be handled in a less urgent manner but will be 
reported to the SMC, IRB, and other oversight organizations in accordance with their 
requirements, and will be reported to NCCIH on an annual basis. 
• 
All other AEs documented during the course of the trial will be reported to NCCIH on an 
annual basis by way of inclusion in the annual report and in the annual AE summary 
which will be provided to NCCIH and to the SMC. The SMC Report will state that all 
AEs have been reviewed. 
 
3.4.4 
Adverse Event Reporting for IND Studies 
Not applicable. 
 
3.4.5 
Events of Special Interest (if applicable) 
None. 
 
3.4.6 
Reporting of Pregnancy 
Because prenatal yoga is considered safe and is recommended for pregnant women, and the 
yoga intervention that we intend to provide will not be strenuous, we have no reason to believe 
that it will be harmful to pregnant women. However, if a woman becomes pregnant during the 
course of the study, we will ask her to stop participating in the yoga intervention. With her 
permission, we will continue assessments with her on the usual assessment schedule. 
 
 
 
   

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3.5 
Halting Rules 
If there are any SAEs judged related to the study intervention, we will halt the study intervention 
until an ad hoc safety review is convened with the SMC, MPIs, site PI, and other relevant study 
staff. The safety review will determine whether the study should continue per protocol, proceed 
with enhanced monitoring, be further investigated, be discontinued, or be modified and then 
proceed. 
 
Subsequent review of serious, unexpected, and related AEs by the SMC, IRB, the sponsor(s), 
or relevant local regulatory authorities may also result in suspension of further study 
interventions. The study sponsor(s) retain the authority to suspend additional enrollment and 
study interventions/administration of study product for the entire study, as applicable. 
 
7 QUALITY CONTROL AND QUALITY ASSURANCE 
 
7.1 
Subject Accrual and Compliance 
 
7.1.1 
Measurement and Reporting of Subject Accrual 
 
Review of the rate of subject accrual and compliance with inclusion/exclusion criteria will occur 
at least monthly during the recruitment phase to ensure that a sufficient number of participants 
is being enrolled, in keeping with proposed recruitment projections, and that they meet eligibility 
criteria as outlined in the grant proposal. We will submit accrual reports to NCCIH as required. 
 
 
7.1.2 
Measurement and Reporting of Participant Adherence to Treatment 
Protocol 
Data on adherence to the treatment protocol will be collected weekly by research staff and 
reviewed at least monthly by the MPIs. Adherence of participants will be evaluated by rates of 
class attendance (adherence to intervention) and rates of follow-up assessment completion 
(adherence to assessments). There is very limited preliminary data on the adherence rate of this 
population to weekly yoga classes; one of the aims of this study is to assess that adherence 
rate. During the study, the MPIs and study staff will continually discuss ways to enhance 
adherence. 
 
 
7.2 
Justification of Sample Size 
 
This project consists of two phases: Phase 1 – Focus Groups (N=24), and Phase 2– Feasibility 
and Pilot Testing (n=40). In phase 1, we will conduct 4 focus groups with a total of 24 
participants. This should provide sufficient feedback to modify our current yoga manual 
specifically for anger dysregulation in prison. In Phase 2, we will conduct a pilot RCT (n = 40), in 
which participants will be assigned to either weekly hatha yoga or health education classes for 
10 weeks (on a 1:1 basis). We will assess feasibility, acceptability, and safety of the 
interventions and research design, and examine key outcomes (anger dysregulation, 
aggression) within relevant confidence intervals. This phase of the study is not designed to be 
 
 
 

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Version Date: 12/20/19 
 
adequately powered to assess efficacy; rather, it is focused on feasibility, acceptability, and 
safety. 
 
7.3 
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. 
 
 
7.4 
Designation of a Monitoring Committee 
 
An external local Safety Monitoring Committee (SMC) will be assembled to evaluate the data 
and safety to participants enrolled in the study. We will recruit 3 non-Brown-affiliated board 
members who have experience in clinical trials and/or yoga research and/or anger dysregulation 
research and/or research with criminal justice samples as well as the ethical issues involved 
with a randomized control study. No member of the Committee will have co-published with the 
MPIs within the past three years, and they will not collaborate with the MPIs on any other 
studies. 
 
 
7.5 
Safety Review Plan 
 
MPIs will review study progress and safety at least monthly and typically on a weekly basis. 
Progress reports, including patient recruitment, retention/attrition, and AEs will be provided to 
the SMC twice per year (see description of content in section 7.4). 
 
After review by the SMC, reports will be forwarded to the IRB and NCCIH. The IRB and other 
applicable recipients will review progress of this study on an annual basis. 
 
 
7.6 
Study Report Outline for the SMC (Interim or Annual Reports) 
 
The study team will generate Study Reports twice per year. Reports will include: 
• 
Interim CONSORT document (number screened, number consented, reasons not 
eligible, status of all participants enrolled in the study, number completed the study vs. 
withdrawn) 
• 
Actual vs. expected enrollment numbers 
• 
Gender, age, race, and ethnicity of enrolled participants; whether all participants met 
inclusion/ exclusion criteria 
• 
Reasons for any study withdrawals 
• 
List and description of deaths, unanticipated problems, and SAEs 
• 
Summary table of AEs 
• 
Analysis of whether AE rates are inconsistent with pre-study expectations. 
• 
List of protocol deviations, if any 
• 
Ongoing quality assurance and quality control procedures and findings. 
 
 
 

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Data and Safety Monitoring Plan 
 
 
 
 
 
 
 
NCCIH DSMP Template  
Version Date: 12/20/19 
 
• 
Whether continuation of the study is justified on the basis that additional data are 
needed to accomplish the stated aims of the study 
No PHI will be included in this report. 
 
7.7 
Submission of On-Site Monitoring/Audit and Inspection Reports 
 
The IRB, IMC, and NCCIH Program Officials will receive copies of all study monitoring/audit or 
inspection reports within 14 days of PI receipt. For example, the NCCIH (Westat) monitoring 
report will be submitted to the IRB and SMC (NCCIH does not require copies of Westat 
monitoring reports). 
 
 
 
7.8 
Table A 
 
Data type 
Frequency of review 
Reviewer 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Monthly or more often 
MPIs 
Semi-annually 
SMC 
Annually 
IRB, NCCIH 
Status of all enrolled subjects, as 
of date of reporting 
Monthly or more often 
MPIs 
Semi-annually 
SMC 
Annually 
IRB, NCCIH 
Data entry quality control checks 
on 20% of charts 
Monthly 
QA Reviewer, MPIs 
Adherence data regarding study 
visits and intervention 
Monthly or more often 
MPIs 
Semi-annually 
SMC 
Annually 
IRB, NCCIH 
AEs and rates 
Monthly or more often 
MPIs 
Semi-annually 
SMC 
Annually 
IRB, NCCIH 
SAEs (unexpected and related) 
Per occurrence 
MPIs, SMC, NCCIH 
SAEs (expected or unrelated) 
Per Occurrence 
MPIs 
Semi-annually 
SMC 
Annually 
NIH/NCCIH 
Unanticipated Problems 
Monthly 
MPIs 
Per Policy 
SMC, IRB, NCCIH 
 
 
 
 
 
 
 
 
 

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Data and Safety Monitoring Plan 
 
 
 
 
 
 
 
NCCIH DSMP Template  
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8 DATA HANDLING AND RECORD KEEPING 
 
The investigators are responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. All source documents will be completed in a neat, legible 
manner to ensure accurate interpretation of data. The investigators will maintain adequate case 
histories of study subjects, including accurate case report forms (CRFs), and source 
documentation. 
 
Specific instructions for each step of the data management process, from acquisition to storage, 
will be included in a manual of procedures (MOP). 
 
Data will be collected using standardized paper forms or (if collected by telephone) will be 
directly entered into the REDCap database, and will only be identified with the study’s ID of the 
participant. The codes that link the name of the participant and the study ID will be kept 
confidential in a separate database on a secure server. Collected forms will be transported to 
Dr. Weinstock’s data entry center hosted by Brown University. Data quality will be monitored by 
random inspection of the completed forms by one of the research assistants and any problems 
detected will be discussed with the PI. Standard data checking procedures will include checking 
forms for missing data, double entry with discrepancy resolution, daily back-up copies of 
computer files, and examination of key variables for skewness, variability, missing data, and 
outliers. Data and materials will be collected specifically for the proposed project. 
 
The computer systems used for data entry and analysis are protected by passwords and secure 
logon and data communications procedures to minimize the potential for disclosure of research 
information either inadvertently or as a result of external attack. Within each computer system, 
only those users authorized to access the data for a given study are able to do so. Research 
records are stored in areas that are locked when staff is not present. 
 
8.1 
Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff under the 
supervision of MPIs. All source documents must be reviewed by the study team to ensure that 
they are accurate and complete. Unanticipated problems and adverse events must be reviewed 
by the MPIs or designee. 
 
8.2 
Database Protection 
 
All research data (with the exception of HIPAA-defined personal identifiers) will be entered into 
REDCap. REDCap is a secure, web application designed to support data capture for research 
studies, providing user-friendly web-based case report forms, real-time data entry validation 
(e.g. for data types and range checks), audit trails, and a de-identified data export mechanism to 
common statistical packages (SPSS, SAS, Stata, R/S-Plus). The system was developed by a 
multi-institutional consortium and was initiated at Vanderbilt University. Network transmissions 
(data entry, survey submission, web browsing, etc.) in REDCap are protected via Secure 
Sockets Layer (SSL) encryption. Access to REDCap can be restricted at different levels (e.g., 
research assistant, PI, and Co-Investigators). Exported data from REDCap will be stored on a 
secure password-protected server at Brown University. 
 
 
 
 

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Data and Safety Monitoring Plan 
 
 
 
 
 
 
 
NCCIH DSMP Template  
Version Date: 12/20/19 
 
8.3 
Source Document Protection 
 
All paper CRFs will be referenced to a participant ID number and will be kept in locked file 
cabinets. The participant’s ID number can be connected to the participant’s name only through a 
single master file, accessible only to senior research staff. Consent forms and other 
documentation with personal identifiers will be kept in a separate file from other data. We will 
use encrypted, password-protected audio recorders and a locked transport box for 
transportation of paper files from RIDOC to Brown University offices at Butler Hospital. 
 
See also 8.2. Database protection. 
 
 
8.4 
Schedule and Content of Reports 
Report Type 
Frequency of Review 
Reviewer 
Recruitment, enrollment, 
adherence and retention 
Monthly or more often 
MPIs, research staff 
SMC Report 
Twice per year (with additional 
per-event reports as detailed 
above) 
SMC 
IRB Annual review 
Once per year (with additional 
per-event reports as detailed 
above 
IRB 
 
There is no interim data analysis plan. 
Data analysis of Phase 1 qualitative data will occur during and immediately after data collection 
in Phase 1. 
Data analysis of Phase 2 data will occur after 10, 20, and 40 participants have completed Phase 
2. There are no masked data. 
 
9 INFORMED CONSENT 
 
Informed consent is a process that is initiated prior to the individual agreeing to participate in the 
study and continues throughout study participation. Informed consent procedures have been 
developed to comply with the Code of Federal Regulations 45 CFR 46.116, General 
Requirements for Informed Consent and 46.117, Documentation of Informed Consent, and 
contain all required elements. Extensive discussion of risks and possible benefits of study 
participation will be provided to subjects and their families, if applicable. Freedom to refuse to 
participate or to discontinue participation at any time without penalty will be emphasized. A 
consent form describing in detail the study procedures and risks will be given to the subject. 
Consent forms will be IRB-approved, and the subject is required to read and review the 
document or have the document read to him or her. The investigator or designee will explain 
the research study to the subject and answer any questions that may arise. The subject will 
 
 
 

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Data and Safety Monitoring Plan 
 
 
 
 
 
 
 
NCCIH DSMP Template  
Version Date: 12/20/19 
 
sign the informed consent document prior to any study-related assessments or procedures. 
Subjects will be given the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate. They may withdraw consent at any time throughout the course 
of the study. A copy of the signed informed consent document will be given to subjects for their 
records. The rights and welfare of the subjects will be protected by emphasizing to them: (1) 
that a decision not to participate in the research will have no impact on their status or expected 
length of stay at the prison; (2) that the quality of their clinical care in the prison will not be 
adversely affected if they decline to participate in this study; (3) the study has a NIH Certificate 
of Confidentiality; (4) the confidentiality of study information from jail staff, officers of the court, 
parole officers or others in the criminal justice system; and (5) and limits of confidentiality, 
including the jail’s mandatory reporting procedures for suicide ideation (see Section 4.2). 
 
We have utilized these procedures for informed consent in our current and completed research 
at the RIDOC for over 12 years. As a function of the strong history of research partnership 
between the RIDOC and our research group, in addition to RIDOC partnerships with other local 
investigators and institutions conducting human subjects research, RIDOC staff are familiar with 
and have fully cooperated with the procedures and policies to minimize coercion and protect 
participant confidentiality, as described above. 
 
The consent process will be documented in the research record. 
 
10 REPORTING CHANGES IN STUDY STATUS 
 
During the funding of this study, any action by an IRB, the SMC, 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 3 business days of notification. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Contact PD/PI: Weinstock, Lauren M 
 
Data and Safety Monitoring Plan 
 
 
 
 
 
 
 
NCCIH DSMP Template  
Version Date: 12/20/19