Mind-Body Medicine Training for Incarcerated Men and Women

Resilience Clinical Trial

Official title:

Mind-Body Medicine Training for Incarcerated Men and Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05622799
• Other study ID #: CMBMIndianaPrison001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: February 29, 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 how effective a Mind-Body Medicine Training Program is for prisoners. The main questions it aims to answer are: 1. Does the training program increase resilience? 2. Does the training program reduce depression, anxiety, and/or stress? 3. Does the training program increase optimism? 4. Does the training program increase prisoners' belief that they can have better coping skills? 5. Does the training program increase a sense of meaning in life? 6. Does the training program increase a sense of life purpose? Participants will attend a 2-part mind-body medicine training program (4 days for each part) and will fill out questionnaires before the training, after the training and 6 months after the training. They will also participate in group interviews after the training and 6 months after the training.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 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 Medicine Training Program
A mind-body medicine training program that teaches mind-body skills including meditation, autogenics and biofeedback, guided imagery, body awareness, genograms, and self-expression through writing and drawings. The first 4 day training consists of lectures and small groups where the mind-body techniques are practiced. The second 4 day training allows participants to lead a mind-body skills group and teach the techniques under supervision.

Locations

Country	Name	City	State
United States	Indiana Department of Correction	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Mind-Body Medicine	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 Training has Affected the Participants by using Focus Group Interviews	Two focus group interviews will be conducted with approximately 10 participants each. Focus group questions will cover topics such as practice of the mind-body techniques, how the training has affected the participant in terms of relationships, how they view their future, and how they are going to used what they have learned.	After the 8 day training and at 6-month follow-up
Primary	Change from Baseline on Resilience using the Connor-Davidson Resilience Scale (CD-RISC) after the 8 day training and at 6 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 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up Score - Baseline score	Baseline, after the 8 day training, and at 6 month follow-up
Secondary	Change from Baseline on Depression, Anxiety, and Stress using the Depression Anxiety and Stress Scale -21 (DASS-21) after the 8 day training and at 6 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 8 day training scores- Baseline scores; Follow-up scores - After the 8 day training scores; and Follow-up scores - Baseline scores	Baseline, after the 8 day training, and at 6 month follow-up
Secondary	Change from Baseline on optimism using the Life Orientation Test - Revised (LOT-R) after the 8 day training and at 6 month follow-up	The LOT-R is a validated, self-report instrument assessing optimism. The LOT-R consists of 10 questions that are rated on a 5-point scale. Four of the questions are "filler questions" and are not calculated in the total score. Higher scores represent greater levels of optimism. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.	Baseline, after the 8 day training, and 6 month follow-up
Secondary	Change from Baseline on coping - self efficacy using the Coping Self-Efficacy (CSE) Scale after the 8 day training and 6 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 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.	Baseline, after the 8 day training, at 6 month follow-up
Secondary	Change from Baseline on meaning in life using the Meaning in Life Questionnaire (MLQ) after the 8 day training and 6 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 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.	Baseline, after the 8 day training, and at 6 month follow-up
Secondary	Change from Baseline on purpose in life using the Life Engagement Test (LET) after the 8 day training and 6 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 a greater sense of life purpose. Change = After the 8 day training score- Baseline score; Follow-up score - After the 8 day training score; and Follow-up score - Baseline score.	Baseline, after the 8 day training, and at 6 month follow-up