Well-being Skills for Reentry

NCT06975657 | Recruiting FDA Device

• 3 other identifiers: 2024-1269A483000Protocol Version 1/20/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Formerly Incarcerated Adults

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Change in Awareness

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

• Change in Connection

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

• Change in Insight

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

• Change in Purpose

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

Study Arms (2)

Wellbeing skills training

EXPERIMENTAL

Behavioral: Wellbeing skills for reentry; Device: Healthy Minds Program

Waitlist control

NO INTERVENTION

Interventions

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.

Wellbeing skills training

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.

Wellbeing skills training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53703, United States

RECRUITING

Study Officials

• Dan Grupe, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

(608) 228-1709; mindful-reentry@chm.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The groups will be randomized to one of two groups in a 1:1 ratio

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 16, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)