- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06019767
Peer-led Trauma Therapy for Re-entry
The purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in reducing PTSD symptoms among people who have been directly impacted by incarceration.
Participants will complete an interview to determine whether they are experiencing PTSD, and if so, will participate in a 6-week therapy group treatment.
Study Overview
Detailed Description
Two community Certified Peer Specialists (CPSs) who have experienced incarceration and re-entry from prison, and who have experienced trauma will be trained on delivering group Cognitive Processing Therapy (CPT).
Working with the Wisconsin Department of Health Services (DHS) and community organizations serving formerly incarcerated individuals, researchers will screen individuals for PTSD treatment need, and invite 48 eligible individuals to participate in group CPT co-led by one of the trained CPSs and a trained community therapist or provider.
Eligible participants who are enrolled in the study will be invited to complete a 6-week (12 sessions total) group CPT therapy treatment for PTSD. Participants will also complete pre-, mid-, and post-treatment mental health surveys. Participants will also complete a post-treatment focus group or post-treatment individual interview where they are asked about their experience in the therapy and to provide feedback on the study as a whole.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- completed a prison or jail sentence
- no current psychosis symptoms
- no active self-harm or active suicidal intent
- able and willing to participate in group therapy
- meet criteria for PTSD treatment need
Exclusion Criteria:
- current and active psychosis
- current and active self-harm and suicidality
- no PTSD diagnosis
- current substance use dependence (not including those used as prescribed for medical reasons) on alcohol, cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Processing Therapy (CPT)
Groups of 6-8 receive CPT to treat PTSD
|
CPT is a type of cognitive behavioral therapy recommended for the treatment of PTSD.
Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs.
Includes homework assignments.
For this study, CPT will be conducted in groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Participation
Time Frame: Study duration (up to 2 years)
|
Will be measured as the percentage of invited, eligible individuals who elect to participate.
|
Study duration (up to 2 years)
|
|
Feasibility: Rate of retention
Time Frame: Study duration (up to 2 years)
|
Will be measured by percentage of participants who complete at least 9 of the 12 study sessions
|
Study duration (up to 2 years)
|
|
Feasibility: Compliance through participation
Time Frame: Study duration (up to 2 years)
|
Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.
|
Study duration (up to 2 years)
|
|
Feasibility: Compliance through homework
Time Frame: Study duration (up to 2 years)
|
Will be measured by percentage of participants completing homework assignments each week.
|
Study duration (up to 2 years)
|
|
Feasibility: Compliance through completing assessments
Time Frame: Study duration (up to 2 years)
|
Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.
|
Study duration (up to 2 years)
|
|
Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
Time Frame: Study duration (up to 2 years)
|
Higher ratings indicate better adherence to session elements.
Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy.
|
Study duration (up to 2 years)
|
|
Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
Time Frame: Study duration (up to 2 years)
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Higher ratings indicate higher-quality session element (scores 1-7; 1=not satisfactory, 4= satisfactory, 7=excellent) by the clinical supervisor.
Assesses for therapist compliance as secondary measure of intervention efficacy.
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Study duration (up to 2 years)
|
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Change in suicide and self-harm ideation
Time Frame: Baseline to end of follow-up (up to 4.5 months)
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Beck Depression Inventory-II (BDI-II), item 9. Participants will answer the item on a scale of 0-3, where a score of 2 or 3 indicates higher ideation.
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Baseline to end of follow-up (up to 4.5 months)
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Participant satisfaction
Time Frame: One week post-treatment (up to 7 weeks)
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Using the 8 item Client Satisfaction Questionnaire (CSQ-8), participants will rate their satisfaction with their experience.
Scale ranges from 1-4, with total potential scores of 8 to 32 with higher scores indicating greater satisfaction.
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One week post-treatment (up to 7 weeks)
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Change in PTSD symptom severity
Time Frame: Baseline to end of follow-up (up to 4.5 months)
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Using the PTSD Checklist for DSM-5 (PCL-5), which is a 20-item self-report measure, symptoms of PTSD will be assessed.
Participants will answer items on a scale of 0-4, where 0=Not at all and 4=Extremely.
Higher scores indicate higher symptom severity.
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Baseline to end of follow-up (up to 4.5 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression symptom severity
Time Frame: Baseline to end of follow-up (up to 4.5 months)
|
Beck Depression Inventory-II (BDI-II), which is a 21-item self-report measure to assess depression severity.
Participants will answer items on a scale of 0-3, where lower scores indicate lower severity.
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Baseline to end of follow-up (up to 4.5 months)
|
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Change in trauma related thoughts and beliefs
Time Frame: Baseline to end of follow-up (up to 4.5 months)
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Posttraumatic Cognitions Inventory (PTCI) is a 33-item measure of negative cognition about the world, negative self-related thoughts, and self-blame.
Participants rate each item on a scale of 1-7, 1=totally disagree, 4=neutral, 7=totally agree.
Higher scores indicate greater levels of trauma.
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Baseline to end of follow-up (up to 4.5 months)
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Change in aspects of hopelessness
Time Frame: Baseline to end of follow-up (up to 4.5 months)
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Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.
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Baseline to end of follow-up (up to 4.5 months)
|
|
Change in substance use
Time Frame: Baseline to end of follow-up (up to 4.5 months)
|
Tobacco, Alcohol, Prescription Medication, and other Substance Use Tool (TAPS) screens for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year, as well as the past 3 months.
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Baseline to end of follow-up (up to 4.5 months)
|
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Change in anxiety symptom severity
Time Frame: Baseline to end of follow-up (up to 4.5 months)
|
Beck Anxiety Inventory (BAI), which is a 21-item self-report measure to assess anxiety severity.
Participants will rate how much items bothered them as: Not at all; Mildly but it didn't bother me much; Moderately - it wasn't pleasant at times; or, Severely - it bothered me a lot.
More symptoms that caused moderate or severe bother indicate higher severity of anxiety.
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Baseline to end of follow-up (up to 4.5 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Koenigs, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-1144
- SMPH/PSYCHIATRY/PSYCHIATRY (Other Identifier: UW Madison)
- Protocol Version 12/02/24 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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