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Completed

NCT Number: NCT05336123

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Department of Corrections

Cranston, Rhode Island, 02920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hatha yoga

Behavioral

Weekly hatha yoga classes lasting 10 weeks.

Health Education

Behavioral

Weekly health education classes lasting 10 weeks.

Primary outcomes

  1. Program Satisfaction

    Time frame: 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. 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.

Secondary outcomes

  1. Program Credibility

    Time frame: Assessed at beginning of the program at week 1

    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.

  2. Program Expectancy

    Time frame: Assessed at beginning of the program at week 1

    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.

  3. Class Attendance

    Time frame: Assessed at each weekly class for 10 weeks

    Number of participants who met class attendance target (6/10 classes total) as assessed through weekly attendance ratings.

  4. Novaco Anger Scale

    Time frame: Change from baseline to the 10 week follow-up

    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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Butler Hospital
  • National Center for Complementary and Integrative Health (NCCIH)
  • The Miriam Hospital

Registry information

Acronym: POMB

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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