Clinical trial NCT05336123: The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults
Official title: The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anger
Aggression
Keywords: Yoga
Health Education
Aggression
Anger
Incarceration
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Butler Hospital
name: The Miriam Hospital
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either a 10 week hatha yoga class or health education class.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Program Satisfaction
timeFrame: Assessed at the end of the program (hatha yoga or health education) at week 10
Secondary outcomes:
measure: Program Credibility
timeFrame: Assessed at beginning of the program at week 1
measure: Program Expectancy
timeFrame: Assessed at beginning of the program at week 1
measure: Class Attendance
timeFrame: Assessed at each weekly class for 10 weeks
measure: Novaco Anger Scale
timeFrame: Change from baseline to the 10 week follow-up
Other outcomes:
Locations:
city: Cranston
country: United States
facility: Rhode Island Department of Corrections
state: Rhode Island
Study officials:
affiliation: Brown University
name: Lauren M Weinstock, PhD
role: PRINCIPAL_INVESTIGATOR
References: