NCT05336123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 12, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

March 31, 2022

Results QC Date

April 24, 2024

Last Update Submit

September 11, 2024

Conditions

Keywords

YogaHealth EducationAggressionAngerIncarceration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Program Credibility

    Assessed at beginning of the program at week 1

  • Program Expectancy

    Assessed at beginning of the program at week 1

  • Class Attendance

    Assessed at each weekly class for 10 weeks

  • Novaco Anger Scale

    Change from baseline to the 10 week follow-up

Study Arms (2)

Hatha Yoga

EXPERIMENTAL

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

Health Education

ACTIVE COMPARATOR

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

Interventions

Hatha YogaBEHAVIORAL

Weekly hatha yoga classes lasting 10 weeks.

Hatha Yoga

Weekly health education classes lasting 10 weeks.

Health Education

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Department of Corrections

Cranston, Rhode Island, 02920, United States

Location

Related Publications (1)

  • Uebelacker LA, Stevens L, Graves H, Braun TD, Foster R, Johnson JE, Tremont G, Weinstock LM. Pilot Randomized Controlled Trial of a Yoga-Based Intervention Targeting Anger Management for People Who Are Incarcerated. J Integr Complement Med. 2025 Feb;31(2):183-195. doi: 10.1089/jicm.2024.0308. Epub 2024 Oct 7.

MeSH Terms

Conditions

AggressionHealth Education

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Results Point of Contact

Title
Dr. Lauren Weinstock
Organization
Brown University

Study Officials

  • Lauren M Weinstock, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
One of the study MPIs and all but one of the Co-Investigators will be blind to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either a 10 week hatha yoga class or health education class.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 20, 2022

Study Start

March 12, 2022

Primary Completion

April 12, 2023

Study Completion

June 29, 2023

Last Updated

September 26, 2024

Results First Posted

June 12, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations