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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34AT010172 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Butler Hospital | OTHER |
| The Miriam Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha Yoga | Behavioral | Weekly hatha yoga classes lasting 10 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Program Credibility | 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. | Assessed at beginning of the program at week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren M Weinstock, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Department of Corrections | Cranston | Rhode Island | 02920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39373144 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hatha Yoga | 10 weeks of hatha yoga. Yoga: Hatha yoga for incarcerated adults. |
| FG001 | Health Education | 10 weeks of Heath Education Health Education: Health Education classes for incarcerated adults. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hatha Yoga | 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults |
| BG001 | Health Education | 10 weeks of health education Health Education: Health education classes for incarcerated adults |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Results for this outcome are reported for the 34 participants of 40 randomized who completed this measure. | Posted | Mean | Standard Deviation | score on a scale | Assessed at the end of the program (hatha yoga or health education) at week 10 |
|
The period from baseline to the 10 week follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hatha Yoga | 10 weeks of hatha yoga Yoga: Hatha yoga for incarcerated adults | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious adverse event possibly related to study participation | Musculoskeletal and connective tissue disorders | Systematic Assessment | One participant in the hatha yoga arm reported new back pain; they did not believe it was related to yoga but the investigators judged it to be "possibly" related simply because it occurred during the time period they were taking yoga classes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Weinstock | Brown University | 401-455-6304 | Lauren_Weinstock@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2023 | Apr 24, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2022 | Jul 10, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000374 | Aggression |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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Participants will be randomly assigned to either a 10 week hatha yoga class or health education class.
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One of the study MPIs and all but one of the Co-Investigators will be blind to group assignment.
| Health Education |
| Behavioral |
Weekly health education classes lasting 10 weeks. |
|
| Program Expectancy | 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. | Assessed at beginning of the program at week 1 |
| Class Attendance | Number of participants who met class attendance target (6/10 classes total) as assessed through weekly attendance ratings. | Assessed at each weekly class for 10 weeks |
| Novaco Anger Scale | 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. | Change from baseline to the 10 week follow-up |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
10 weeks of health education
Health Education: Health education classes for incarcerated adults
|
|
| Secondary | Program Credibility | 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. | Results for this outcome are reported for the 37 participants of 40 randomized who completed this measure. | Posted | Mean | Standard Deviation | score on a scale | Assessed at beginning of the program at week 1 |
|
|
|
| Secondary | Program Expectancy | 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. | Results for this outcome are reported for the 37 participants of 40 randomized who completed this measure. | Posted | Mean | Standard Deviation | score on a scale | Assessed at beginning of the program at week 1 |
|
|
|
| Secondary | Class Attendance | Number of participants who met class attendance target (6/10 classes total) as assessed through weekly attendance ratings. | Posted | Count of Participants | Participants | Assessed at each weekly class for 10 weeks |
|
|
|
| Secondary | Novaco Anger Scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to the 10 week follow-up |
|
|
|
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Health Education | 10 weeks of health education Health Education: Health education classes for incarcerated adults | 0 | 20 | 0 | 20 | 0 | 20 |
|
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| D000099060 |
| Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |