Formerly Incarcerated AdultsNCT06975657
Well-being Skills for Reentry
A study testing Wellbeing skills for reentry and Healthy Minds Program in people with Formerly Incarcerated Adults, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Formerly Incarcerated Adults
- What is being tested?
- Wellbeing skills for reentry and Healthy Minds Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53703
About this study
Official title: Community-engaged Research to Promote Mental Health and Successful Reentry Outcomes Following Incarceration
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?
Read more
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
- Being tested
- Wellbeing skills for reentry, Healthy Minds Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellbeing skills for reentryBehavioural
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 ProgramDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wellbeing skills training | Experimental | Not described Receives: Behavioral: Wellbeing skills for reentry; Device: Healthy Minds Program |
| Waitlist control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Following week 8 of intervention period (approximately 10 weeks)
Secondary outcomes (4)
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.
Measured: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start12 Jan 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Formerly Incarcerated AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The groups will be randomized to one of two groups in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Grupe, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975657
- Sponsor's protocol ID
- 2024-1269
- Other IDs
- A483000, Protocol Version 8/20/2026
- Status last verified
- Sep 2026
- First submitted
- 7 May 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-engaged Research to Promote Mental Health and Successful Reentry Outcomes Following Incarceration
- ClinicalTrials.gov ID
- NCT06975657
- Acronym / sponsor ID
- 2024-1269
- Conditions
- Formerly Incarcerated Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The groups will be randomized to one of two groups in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Wellbeing skills training | Experimental | Behavioral: Wellbeing skills for reentry, Device: Healthy Minds Program |
| Waitlist control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellbeing skills for reentryAn 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. | Behavioural | Wellbeing skills training |
| Healthy Minds ProgramA customized version of the Healthy Minds Program app will allow participants to listen to recorded meditation practices in support of the in-person curriculum. | Device | Wellbeing skills training |
Primary outcome
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.
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.
4 secondary outcomes
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 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 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 Purpose
Time frame: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Grupe, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellbeing skills for reentry and Healthy Minds Program in people with Formerly Incarcerated Adults, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Team ((608) 228-1709, mindful-reentry@chm.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: Baseline, following week 8 of intervention period (approximately 10 weeks), 2-month follow-up after intervention period (approximately 18 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.