Peer-led Trauma Therapy for Re-entry

NCT06019767 | Completed DMC

• 3 other identifiers: 2023-1144Protocol Version 12/02/24SMPH/PSYCHIATRY/PSYCHIATRY
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD

Keywords

Previously incarcerated; Group therapy; Cognitive Processing Therapy

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Change in depression symptom severity

  Baseline to end of follow-up (up to 4.5 months)

• Change in trauma related thoughts and beliefs

  Baseline to end of follow-up (up to 4.5 months)

• Change in aspects of hopelessness

  Baseline to end of follow-up (up to 4.5 months)

• Change in substance use

  Baseline to end of follow-up (up to 4.5 months)

• Change in anxiety symptom severity

  Baseline to end of follow-up (up to 4.5 months)

Study Arms (1)

Cognitive Processing Therapy (CPT)

EXPERIMENTAL

Groups of 6-8 receive CPT to treat PTSD

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Cognitive Processing Therapy (CPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michael Koenigs, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: November 14, 2023
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)