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Completed

NCT Number: 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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility: Participation

    Time frame: Study duration (up to 2 years)

    Will be measured as the percentage of invited, eligible individuals who elect to participate.

  2. 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

  3. 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.

  4. Feasibility: Compliance through homework

    Time frame: Study duration (up to 2 years)

    Will be measured by percentage of participants completing homework assignments each week.

  5. 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.

  6. 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.

  7. Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist

    Time frame: Study duration (up to 2 years)

    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.

  8. Change in suicide and self-harm ideation

    Time frame: Baseline to end of follow-up (up to 4.5 months)

    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.

  9. Participant satisfaction

    Time frame: One week post-treatment (up to 7 weeks)

    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.

  10. Change in PTSD symptom severity

    Time frame: Baseline to end of follow-up (up to 4.5 months)

    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.

Secondary outcomes

  1. 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.

  2. Change in trauma related thoughts and beliefs

    Time frame: Baseline to end of follow-up (up to 4.5 months)

    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.

  3. Change in aspects of hopelessness

    Time frame: Baseline to end of follow-up (up to 4.5 months)

    Beck Hopelessness Scale is a 20-item questionnaire, which participants answer true or false.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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