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NCT Number: NCT06975657

Well-being Skills for Reentry

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:

* Does mindfulness skills training improve symptoms of anxiety and depression? * Do participants find this mindfulness program to be acceptable and feasible to participate in?

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:

* Complete an initial intake visit, consisting of an interview and questionnaires * Randomly be assigned to a mindfulness group or a waitlist control group * Participate in weekly mindfulness classes for 6 weeks (mindfulness group only) * Complete a set of questionnaires after the conclusion of the mindfulness classes * Complete a set of questionnaires and an interview 2 months after the conclusion of the mindfulness classes

Recruiting

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Key information

Conditions

Formerly Incarcerated Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53703, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Formerly incarcerated in a local jail, state or federal prison
  • Can read, speak and understand English
  • Able to provide informed consent

Exclusion criteria

  • Suicidal ideation with some intent to act or with a specific plan and intent
  • Active psychosis
  • Daily or nearly daily use (over the past 3 months) of the following substances: cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids

Treatment and study plan

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.

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.

Primary outcomes

  1. Psychological distress

    Time frame: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)

    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.

  2. Feasibility based on Theoretical Framework of Acceptability (TFA) questionnaire

    Time frame: Following week 8 of intervention period (approximately 10 weeks)

    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.

Secondary outcomes

  1. Change in Awareness

    Time frame: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)

    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.

  2. Change in Connection

    Time frame: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)

    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.

  3. Change in Insight

    Time frame: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)

    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.

  4. Change in Purpose

    Time frame: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team

CONTACT

[email protected]

(608) 228-1709

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Community-engaged Research to Promote Mental Health and Successful Reentry Outcomes Following Incarceration

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 16, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.