Resilience Clinical Trial
Official title:
Mind-Body Medicine Training for Incarcerated Men and Women
Verified date | February 2024 |
Source | The Center for Mind-Body Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana Department of Correction | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
The Center for Mind-Body Medicine | Simon Family Foundation |
United States,
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 |
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