Well-being Skills for Reentry

Not Applicable

Not yet recruiting

• Conditions: Formerly Incarcerated Adults

• Registration Number: NCT06975657
• Lead Sponsor: University of Wisconsin, Madison

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 3 months after the conclusion of the mindfulness classes

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2026-01-01
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 or older
• Formerly incarcerated in a local jail, state or federal prison
• Can 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychological distress	Baseline, following week 6 of intervention period (approximately 8 weeks), 3-month follow-up after intervention period (approximately 20 weeks)	Standardized composite score of two common data elements: the Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7). To generate a composite psychological distress measure, PHQ-9 and GAD-7 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.