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

Aggression Clinical Trial

— POMB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336123
• Other study ID #: 1811002261
• Secondary ID: 5R34AT010172
• Status: Completed
• Phase: N/A
• Start date: March 12, 2022
• Est. completion date: June 29, 2023

Study information

• Verified date: May 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 29, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Anger

Intervention

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

Locations

Country	Name	City	State
United States	Rhode Island Department of Corrections	Cranston	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Brown University	Butler Hospital, National Center for Complementary and Integrative Health (NCCIH), The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program Satisfaction	Program Satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) total score. The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale. Items are summed, with a total score range from 8-32. Higher scores indicate greater client satisfaction.	Assessed at the end of the program (hatha yoga or health education) at week 10
Secondary	Program Credibility	Credibility as assessed by Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ consists of 3 items from the 6 item CEQ. The 3 items are scored on a range of 0-1, and the mean of these is used in analysis. Higher scores indicate greater intervention credibility.	Assessed at beginning of the program at week 1
Secondary	Program Expectancy	Expectancy assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. The 3 items are each scored on a range of 0-1, and the mean of of this is used in analysis. Higher scores indicate greater expectations that the intervention will be beneficial.	Assessed at beginning of the program at week 1
Secondary	Class Attendance	Number of participants who met class attendance target (6/10 classes total) as assessed through weekly attendance ratings.	Assessed at each weekly class for 10 weeks
Secondary	Novaco Anger Scale	Anger severity was assessed using the Novaco Anger Scale (NAS) from the Novaco Anger Scale and Provocation Inventory (NAS-PI). The NAS is a 48 item measure with each item rated from 1-3. Items are summed, with scores that range from 48-144. Higher scores are indicative of greater experiences of anger. For this study, we report average change in scores from the baseline to the 10 week-follow-up, upon completion of the study intervention. Hence, a positive (vs. negative) change score reflects a reduction in anger from baseline to 10 week follow-up. Higher change scores reflect larger reductions in anger severity.	Change from baseline to the 10 week follow-up