POMB: The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults

Sponsor

Brown University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05336123

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH), Butler Hospital (Other), The Miriam Hospital (Other)

Enrollment

Location

Arms

9.7

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. The investigators will assess feasibility and acceptability of the yoga program, the health education control group, and research procedures.

Condition or Disease	Intervention/Treatment	Phase
Anger Aggression	Behavioral: Hatha Yoga Behavioral: Health Education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to either a 10 week hatha yoga class or health education class.Participants will be randomly assigned to either a 10 week hatha yoga class or health education class.

Masking:

Single (Investigator)

Masking Description:

One of the study MPIs, the study statistician, and all but one of the Co-Investigators will be blind to group assignment.

Primary Purpose:

Treatment

Official Title:

The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults

Actual Study Start Date :

Mar 12, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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).	Behavioral: Hatha Yoga Weekly hatha yoga classes lasting 10 weeks.
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.	Behavioral: Health Education Weekly health education classes lasting 10 weeks.

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).

Behavioral: Hatha Yoga

Weekly hatha yoga classes lasting 10 weeks.

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.

Behavioral: Health Education

Weekly health education classes lasting 10 weeks.

Outcome Measures

Primary Outcome Measures

Program Satisfaction [Assessed at the end of the program (hatha yoga or health education) at week 10]
Program Satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) total score

Secondary Outcome Measures

Program Acceptability [Assessed at the end of the program at week 10]
Qualitative interview used to assessed the acceptability of the yoga intervention
Program Credibility [Assessed at beginning of the program at week 1]
Credibility as measured by the Credibility Expectancy Questionnaire (CEQ) subscale
Program Expectancy [Assessed at beginning of the program at week 1]
Expectancy as measured by the Credibility Expectancy Questionnaire (CEQ) subscale
Home Practice [Assessed at each weekly class for 10 weeks]
Home practice as assessed by the number of participants who report engaging in home practice on the Homework Questionnaire
Class Attendance [Assessed at each weekly class for 10 weeks]
Attendance will be taken at each class
Instructor Adherence [Adherence assessed within the 10-week class modules]
"POMB Study-Specific Adherence Scale" to be developed over the course of this pilot trial
Class size [Assessed at each weekly class for 10 weeks]
Class size will be assessed by attendance taken at each class

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.