Formerly Incarcerated Adults
Conditions
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
Interventions
BEHAVIORALWellbeing skills for reentry
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.
DEVICEHealthy Minds Program
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The groups will be randomized to one of two groups in a 1:1 ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological distress | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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 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. |
| Change in Purpose | 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. |
Countries
United States
Contacts
CONTACTStudy Team
PRINCIPAL_INVESTIGATORDan Grupe, PhD
University of Wisconsin, Madison
Outcome results
None listed