Mind-Body Skills Groups for Incarcerated Men and Women

Resilience Clinical Trial

Official title:

Mind-Body Skills Groups for Incarcerated Men and Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05948917
• Other study ID #: CMBMIndianaPrisons002
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: The Center for Mind-Body Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. Do the mind-body skills groups increase resilience?

2. Do the mind-body skills groups decrease depression, anxiety and/or stress?

3. Do the mind-body skills groups increase participants' belief that they have improved coping skills?

4. Do the mind-body skills groups increase a sense of meaning in life?

5. Do the mind-body skills groups increase a sense of life purpose?

6. Do the mind-body skills groups increase self-esteem in women?

7. Do the mind-body skills groups decrease aggressive responses in men?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 104
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

1. a sentence that will end,

2. a scheduled change in security level to a minimum-security prison or,

3. 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

Related Conditions & MeSH terms

• Resilience

Intervention

Behavioral:
• Mind-Body Skills Groups
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.

Locations

Country	Name	City	State
United States	Indiana Women's Prison	Indianapolis	Indiana
United States	Plainfield Correctional Facility	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Mind-Body Medicine	Herbert Simon Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	How the Mind-Body Medicine Skills Groups have Affected the Participants by using Focus Group Interviews	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.	11 weeks
Primary	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.	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	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.	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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	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.	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