Peer-led Trauma Therapy for Re-entry

Study Overview
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Brief Summary
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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.

Detailed Description
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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 24 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 where they are asked about their experience in the therapy and to provide feedback on the study as a whole.

Official Title
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Peer-led Trauma Therapy for Re-entry

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Cognitive Processing Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Processing Therapy (CPT)<br>Groups of 6-8 receive CPT to treat PTSD | Behavioral: Cognitive Processing Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Participation | Will be measured as the percentage of invited, eligible individuals who elect to participate. | Study duration (up to 2 years) | 
| Feasibility: Rate of retention | 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 | 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 | Will be measured by percentage of participants completing homework assignments each week. | Study duration (up to 2 years) | 
| Feasibility: Compliance through completing assessments | 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 | 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 | 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. | Study duration (up to 2 years) | 
| Change in suicide and self-harm ideation | 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. | Baseline to end of follow-up (up to 4.5 months) | 
| Participant satisfaction | 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. | One week post-treatment (up to 7 weeks) | 
| Change in PTSD symptom severity | 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. | Baseline to end of follow-up (up to 4.5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression symptom severity | 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. | Baseline to end of follow-up (up to 4.5 months) | 
| Change in trauma related thoughts and beliefs | 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. | Baseline to end of follow-up (up to 4.5 months) | 
| Change in aspects of hopelessness | Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false. | Baseline to end of follow-up (up to 4.5 months) | 
| Change in substance use | 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. | Baseline to end of follow-up (up to 4.5 months) | 
| Change in anxiety symptom severity | 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. | Baseline to end of follow-up (up to 4.5 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Previously incarcerated, Group therapy, Cognitive Processing Therapy