- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948917
Mind-Body Skills Groups for Incarcerated Men and Women
The goal of this study is to learn about the effectiveness of a Mind-Body Skills Group program for incarcerated participants.The main questions is aims to answer are:
- Do the mind-body skills groups increase resilience?
- Do the mind-body skills groups decrease depression, anxiety and/or stress?
- Do the mind-body skills groups increase participants' belief that they have improved coping skills?
- Do the mind-body skills groups increase a sense of meaning in life?
- Do the mind-body skills groups increase a sense of life purpose?
- Do the mind-body skills groups increase self-esteem in women?
- Do the mind-body skills groups decrease aggressive responses in men?
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46168
- Plainfield Correctional Facility
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Indianapolis, Indiana, United States, 46214
- Indiana Women's Prison
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The inclusion criteria for this study will be English-speaking incarcerated individuals at the Indiana Women's Prison and and at the Plainfield Correctional Facility.
Exclusion Criteria:
1. Having any of the following before the study is completed:
- a sentence that will end,
- a scheduled change in security level to a minimum-security prison or,
- a scheduled work release;
Or 2. Having conduct problems and/or emotional or mental instability that prevents safe and effective participation in the mind-body medicine training program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral: Mind-body Skills Groups
10 mind-body skills groups held once a week.
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The mind-body skills groups consist of supportive small group sessions with about 8-10 participants per group.
Participants of these groups learn and practice mind-body techniques including: meditation, self-expression through drawings, autogenics and biofeedback, guided imagery, body awareness, and genograms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline on resilience using the Connor-Davidson Resilience Scale (CD-RISC) after the 10-session mind-body skills groups and at 3 month follow-up.
Time Frame: Baseline, 11 weeks, and at 3 month follow-up
|
The CD-RISC is a validated, self-report instrument assessing resilience over the last month. The CD-RISC consists of 25 questions that are rated on a 5-point scale with higher scores representing greater resilience. Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 sessions score; and Follow-up Score - Baseline score |
Baseline, 11 weeks, and at 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline on depression, anxiety, and stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 10-session mind-body skills groups and at 3 month follow-up.
Time Frame: Baseline, 11 weeks, and at 3 month follow-up
|
The DASS-21 is a validated, self-report instrument assessing the emotional states of depression, anxiety ans stress over the past week. The DASS-21 consists of 7 questions each for depression anxiety and stress are rated on a 4-point scale with higher scores representing higher levels of depression, anxiety, and stress. Change= After the 10 sessions scores- Baseline scores; Follow-up scores - After the 10 sessions scores; and Follow-up scores - Baseline scores |
Baseline, 11 weeks, and at 3 month follow-up
|
|
Change from Baseline on coping-self efficacy using the Coping Self-Efficacy (CSE) scale after the 10 session mind-body skills groups and at 3 month follow-up
Time Frame: Baseline, 11 weeks, and at 3 month follow-up
|
The CSE Scale is a validated, self-report instrument assessing coping self-efficacy. The CSE scale consists of 26 questions that are rated on scale from 0 "cannot do at all" to 10 "certain can do". Higher scores represent greater levels of coping self-efficacy. Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score. |
Baseline, 11 weeks, and at 3 month follow-up
|
|
Change from Baseline on meaning in life using the Meaning in Life Questionnaire (MLQ) after the 10 session mind-body skills groups and at 3 month follow-up
Time Frame: Baseline, 11 weeks, and at 3 month follow-up
|
The MLQ is a validated, self-report instrument assessing meaning in life. The MLQ consists of 10 questions that are rated on 7- point scale. There are 2 subscales: presence of meaning and search for meaning. Higher scores represent greater levels of these two components of meaning in life. Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score. |
Baseline, 11 weeks, and at 3 month follow-up
|
|
Change from Baseline on purpose in life using the the Life Engagement Test (LET) after the 10 session mind-body skills groups and at 3 month follow-up
Time Frame: Baseline, 11 weeks, and at 3 month follow-up
|
The LET is a 6-item scale made up of items that are framed in half positive and half negative directions. These items are then rated using a 5-point scale that ranges from "1 = strongly disagree" to "5 = strongly agree".Higher scores represent greater levels of purpose in life. Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score. |
Baseline, 11 weeks, and at 3 month follow-up
|
|
Change from Baseline on self-esteem (females only) using the Rosenberg Self-Esteem Scale (RSE) after the 10 session mind-body skills groups and at 3 month follow-up
Time Frame: Baseline, 11 weeks, and at 3 month follow-up
|
The RSE scale consists of 10 items scored on a 4-point scale with responses that range from "not at all like me" to "completely like me". Higher scores represent greater self-esteem. Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score. |
Baseline, 11 weeks, and at 3 month follow-up
|
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Change from Baseline on aggression (males only) using the Aggression Questionnaire (AQ) after the 10 session mind-body skills groups and at 3 month follow-up.
Time Frame: Baseline, 11 weeks, and at 3 month follow-up
|
Improvements in aggression will be measured using the Aggression Questionnaire (AQ) which is a revision of the Buss-Durkee Hostility Inventory that has been widely used to measure aggression.The AQ consists of 34 items scored on a 5-point Likert-type scale with responses ranging from "not at all like me" to "completely like me". The AQ has the following subscales: physical aggression, verbal aggression, anger, hostility, and indirect aggression. Higher scores represent greater aggression according to these components. Change = After the 10 sessions score- Baseline score; Follow-up score - After the 10 session score; and Follow-up score - Baseline score. |
Baseline, 11 weeks, and at 3 month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
How the Mind-Body Medicine Skills Groups have Affected the Participants by using Focus Group Interviews
Time Frame: 11 weeks
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Two focus groups with approximately with approximately 16-20 people each at each of the 2 prisons will be held.
Focus group questions will cover topics such as how the mind-bdy skills groups have affected the participant in terms of relationships, how they view their future, and how they are going to used what they have learned.
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11 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Julie K Staples, PhD, The Center for Mind-Body Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMBMIndianaPrisons002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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