Trial Outcomes & Findings for The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults (NCT NCT05336123)

Last Updated: 2024-09-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Assessed at the end of the program (hatha yoga or health education) at week 10

Results posted on

2024-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Hatha Yoga 10 weeks of hatha yoga. Yoga: Hatha yoga for incarcerated adults.	Health Education 10 weeks of Heath Education Health Education: Health Education classes for incarcerated adults.
Overall Study STARTED	20	20
Overall Study COMPLETED	18	19
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hatha Yoga n=20 Participants 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults	Health Education n=20 Participants 10 weeks of health education Health Education: Health education classes for incarcerated adults	Total n=40 Participants Total of all reporting groups
Age, Continuous	30.85 years STANDARD_DEVIATION 6.52 • n=5 Participants	33.35 years STANDARD_DEVIATION 8.88 • n=7 Participants	32.10 years STANDARD_DEVIATION 7.80 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at the end of the program (hatha yoga or health education) at week 10

Population: Results for this outcome are reported for the 34 participants of 40 randomized who completed this measure.

Outcome measures

Outcome measures
Measure	Hatha Yoga n=17 Participants 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults	Health Education n=17 Participants 10 weeks of health education Health Education: Health education classes for incarcerated adults
Program Satisfaction	29.76 score on a scale Standard Deviation 3.09	26.69 score on a scale Standard Deviation 4.01

SECONDARY outcome

Timeframe: Assessed at beginning of the program at week 1

Population: Results for this outcome are reported for the 37 participants of 40 randomized who completed this measure.

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.

Outcome measures

Outcome measures
Measure	Hatha Yoga n=19 Participants 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults	Health Education n=18 Participants 10 weeks of health education Health Education: Health education classes for incarcerated adults
Program Credibility	0.86 score on a scale Standard Deviation 0.13	0.81 score on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: Assessed at beginning of the program at week 1

Population: Results for this outcome are reported for the 37 participants of 40 randomized who completed this measure.

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.

Outcome measures

Outcome measures
Measure	Hatha Yoga n=19 Participants 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults	Health Education n=18 Participants 10 weeks of health education Health Education: Health education classes for incarcerated adults
Program Expectancy	0.76 score on a scale Standard Deviation 0.18	0.67 score on a scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hatha Yoga n=20 Participants 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults	Health Education n=20 Participants 10 weeks of health education Health Education: Health education classes for incarcerated adults
Class Attendance	10 Participants	12 Participants

SECONDARY outcome

Timeframe: Change from baseline to the 10 week follow-up

Population: Of the 40 participants randomized, 31 (n=15 in Hatha Yoga; n=16 in Health Education) completed the NAS at the follow-up assessment time point.

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.

Outcome measures

Outcome measures
Measure	Hatha Yoga n=15 Participants 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults	Health Education n=16 Participants 10 weeks of health education Health Education: Health education classes for incarcerated adults
Novaco Anger Scale	11.87 score on a scale Standard Deviation 14.32	5.94 score on a scale Standard Deviation 9.84

Adverse Events

Hatha Yoga

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hatha Yoga n=20 participants at risk 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults	Health Education n=20 participants at risk 10 weeks of health education Health Education: Health education classes for incarcerated adults
Musculoskeletal and connective tissue disorders Non-serious adverse event possibly related to study participation	5.0% 1/20 • Number of events 1 • The period from baseline to the 10 week follow-up	0.00% 0/20 • The period from baseline to the 10 week follow-up

Additional Information

Dr. Lauren Weinstock

Brown University

Phone: 401-455-6304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place