- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05336123
The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults (POMB)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. The investigators 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. The investigators 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.
The investigators 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 followed for 8 weeks. The investigators will assess feasibility and acceptability of the yoga program, the health education control group, and research procedures. To assess safety, they will track all adverse events in a structured fashion. The investigators will iteratively revise manuals and materials, making final revisions at the end of the pilot RCT. If successful, this project will provide us with materials, experience, and pilot data needed for the next stage of this line of research, namely, a fully powered RCT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lauren M Weinstock, PhD
- Phone Number: 401-455-6304
- Email: lauren_weinstock@brown.edu
Study Contact Backup
- Name: Lisa A Uebelacker, PhD
- Phone Number: 401-455-6381
- Email: luebelacker@butler.org
Study Locations
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Rhode Island
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Cranston, Rhode Island, United States, 02920
- Rhode Island Department of Corrections
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-70
- Clinically significant anger dysregulation, as evidenced by a score ≥ 86 on the Novaco Anger Scale (NAS)
- Prisoner or jail detainee, with anticipated duration of remaining time incarcerated of 90 days or more, allowing for participation in the 10 week intervention
- Ability and willingness to provide informed consent
- Willingness to be audio recorded in the intervention condition sessions (e.g., yoga or health education groups).
Exclusion Criteria:
- Presence of current manic or psychotic symptoms, or suicide risk (warranting referral to prison mental health clinical staff)
- 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)
- Current weekly yoga practice or current participation in mindfulness- based programming
- Pregnancy
- Inability to understand English sufficiently well to understand the consent form or assessment instruments when read aloud.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hatha Yoga
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).
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Weekly hatha yoga classes lasting 10 weeks.
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Active Comparator: Health Education
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 and handouts.
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.
Instructors will provide information and encourage questions but avoid psychotherapeutic techniques or personalized goal-setting.
Instructors will give participants readings to explore on their own.
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Weekly health education classes lasting 10 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Satisfaction
Time Frame: Assessed at the end of the program (hatha yoga or health education) at week 10
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Program Satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) total score
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Assessed at the end of the program (hatha yoga or health education) at week 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Acceptability
Time Frame: Assessed at the end of the program at week 10
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Qualitative interview used to assessed the acceptability of the yoga intervention
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Assessed at the end of the program at week 10
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Program Credibility
Time Frame: Assessed at beginning of the program at week 1
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Credibility as measured by the Credibility Expectancy Questionnaire (CEQ) subscale
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Assessed at beginning of the program at week 1
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Program Expectancy
Time Frame: Assessed at beginning of the program at week 1
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Expectancy as measured by the Credibility Expectancy Questionnaire (CEQ) subscale
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Assessed at beginning of the program at week 1
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Home Practice
Time Frame: Assessed at each weekly class for 10 weeks
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Home practice as assessed by the number of participants who report engaging in home practice on the Homework Questionnaire
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Assessed at each weekly class for 10 weeks
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Class Attendance
Time Frame: Assessed at each weekly class for 10 weeks
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Attendance will be taken at each class
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Assessed at each weekly class for 10 weeks
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Instructor Adherence
Time Frame: Adherence assessed within the 10-week class modules
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"POMB Study-Specific Adherence Scale" to be developed over the course of this pilot trial
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Adherence assessed within the 10-week class modules
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lauren M Weinstock, PhD, Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1811002261
- 5R34AT010172 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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