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| ID | Type | Description | Link |
|---|---|---|---|
| A483000 | Other Identifier | UW Madison | |
| Protocol Version 1/20/2026 | Other Identifier | UW Madison |
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The goal of this clinical trial is to learn if a mindfulness skills training program has mental health benefits for people returning to the community following incarceration. The main questions it aims to answer are:
Researchers will compare outcomes for participants in the mindfulness training program to those in a waitlist control group who will receive the mindfulness program after the end of the study.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wellbeing skills training | Experimental |
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| Waitlist control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellbeing skills for reentry | Behavioral | An 8-week, in-person meditation training program for formerly incarcerated adults, with practices and concepts grounded in the four pillars of the Healthy Minds Program (awareness, connection, insight, and purpose) that are supported by custom meditation practices presented in the Healthy Minds Program App. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological distress | Standardized composite score of three common data elements: the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Perceived Stress Scale-4 (PSS-4). To generate a composite psychological distress measure, PHQ-9, GAD-7, and PSS-4 scores will be z-transformed and then averaged. Resulting composite distress scores will have a mean of 0 and SD of 1, with higher scores indicating greater distress. | Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks) |
| Feasibility based on Theoretical Framework of Acceptability (TFA) questionnaire | TFA is an 8 item questionnaire, which uses a 5-point Likert scale to assess acceptability of the intervention. Scores range from 8-40, with higher scores indicating greater acceptability. | Following week 8 of intervention period (approximately 10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Awareness | Change in awareness will be measured using the Five Facet Mindfulness Questionnaire (FFMQ) Act with Awareness. The FFMQ is an 8 item questionnaire and is scored on a 5-pooint Likert scale. Scores range from 8-40, with higher scores indicating a lower sense of awareness. | Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | (608) 228-1709 | mindful-reentry@chm.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dan Grupe, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53703 | United States |
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The groups will be randomized to one of two groups in a 1:1 ratio
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| Healthy Minds Program | Device | A customized version of the Healthy Minds Program app will allow participants to listen to recorded meditation practices in support of the in-person curriculum. |
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| Change in Connection | Change in Connection will be measured using the Perceived Isolation questionnaire, which is a 9 item questionnaire. Each of the 9 items is standardized. The standardized scores for the 9 items are then averaged to create a single Perceived Isolation score. A higher average score means the individual experiences more perceived isolation or loneliness. | Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks) |
| Change in Insight | Change in Insight will be measured using scores of Metacognitive Process of Decentering, which is a 15 item questionnaire. It is scored on a 5-point Likert scale, with scores ranging from 15-75. Lower scores indicate lower levels of insight. | Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks) |
| Change in Purpose | Change in purpose will be measured using the NIH Toolbox Meaning & Purpose. The Toolbox is a 4 item questionnaire and is scored on a 5-pooint Likert scale. Scores range from 4-20, with higher scores indicating a greater sense of purpose. | Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks) |