Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-27 @ 7:39 AM
Study NCT ID:
NCT06975657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Well-being Skills for Reentry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological distress', 'timeFrame': 'Baseline, following week 6 of intervention period (approximately 8 weeks), 3-month follow-up after intervention period (approximately 20 weeks)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Formerly Incarcerated Adults']}, 'descriptionModule': {'briefSummary': '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:\n\n* Does mindfulness skills training improve symptoms of anxiety and depression?\n* Do participants find this mindfulness program to be acceptable and feasible to participate in?\n\nResearchers 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.\n\nParticipants will:\n\n* Complete an initial intake visit, consisting of an interview and questionnaires\n* Randomly be assigned to a mindfulness group or a waitlist control group\n* Participate in weekly mindfulness classes for 6 weeks (mindfulness group only)\n* Complete a set of questionnaires after the conclusion of the mindfulness classes\n* Complete a set of questionnaires and an interview 3 months after the conclusion of the mindfulness classes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Formerly incarcerated in a local jail, state or federal prison\n* Can speak and understand English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Suicidal ideation with some intent to act or with a specific plan and intent\n* Active psychosis\n* Daily or nearly daily use (over the past 3 months) of the following substances: cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids'}, 'identificationModule': {'nctId': 'NCT06975657', 'briefTitle': 'Well-being Skills for Reentry', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Community-engaged Research to Promote Mental Health and Successful Reentry Outcomes Following Incarceration', 'orgStudyIdInfo': {'id': '2024-1269'}, 'secondaryIdInfos': [{'id': 'A483000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wellbeing skills training', 'interventionNames': ['Behavioral: Wellbeing skills for reentry']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control'}], 'interventions': [{'name': 'Wellbeing skills for reentry', 'type': 'BEHAVIORAL', 'description': 'A 6-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)', 'armGroupLabels': ['Wellbeing skills training']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}