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

Primary Purpose

Anger, Aggression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hatha Yoga
Health Education
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anger focused on measuring Yoga, Health Education, Aggression, Anger, Incarceration

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rhode Island Department of Corrections

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hatha Yoga

Health Education

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Program Satisfaction
Program Satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) total score

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2022
Last Updated
July 12, 2023
Sponsor
Brown University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Butler Hospital, The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05336123
Brief Title
The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults
Acronym
POMB
Official Title
The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2022 (Actual)
Primary Completion Date
April 12, 2023 (Actual)
Study Completion Date
June 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Butler Hospital, The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Aggression
Keywords
Yoga, Health Education, Aggression, Anger, Incarceration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either a 10 week hatha yoga class or health education class.
Masking
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hatha Yoga
Arm Type
Experimental
Arm Description
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).
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hatha Yoga
Intervention Description
Weekly hatha yoga classes lasting 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Weekly health education classes lasting 10 weeks.
Primary Outcome Measure Information:
Title
Program Satisfaction
Description
Program Satisfaction as measured by the Client Satisfaction Questionnaire (CSQ-8) total score
Time Frame
Assessed at the end of the program (hatha yoga or health education) at week 10
Secondary Outcome Measure Information:
Title
Program Acceptability
Description
Qualitative interview used to assessed the acceptability of the yoga intervention
Time Frame
Assessed at the end of the program at week 10
Title
Program Credibility
Description
Credibility as measured by the Credibility Expectancy Questionnaire (CEQ) subscale
Time Frame
Assessed at beginning of the program at week 1
Title
Program Expectancy
Description
Expectancy as measured by the Credibility Expectancy Questionnaire (CEQ) subscale
Time Frame
Assessed at beginning of the program at week 1
Title
Home Practice
Description
Home practice as assessed by the number of participants who report engaging in home practice on the Homework Questionnaire
Time Frame
Assessed at each weekly class for 10 weeks
Title
Class Attendance
Description
Attendance will be taken at each class
Time Frame
Assessed at each weekly class for 10 weeks
Title
Instructor Adherence
Description
"POMB Study-Specific Adherence Scale" to be developed over the course of this pilot trial
Time Frame
Adherence assessed within the 10-week class modules
Title
Class size
Description
Class size will be assessed by attendance taken at each class
Time Frame
Assessed at each weekly class for 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren M Weinstock, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Department of Corrections
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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