PTSD Treatment for Incarcerated Men and Women: WPP

April 23, 2026 updated by: University of Wisconsin, Madison
Study examining the psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of individuals for both CPT and waitlist control in both populations (180 participants total).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overall Study Objectives:

The primary objectives of this project include:

  1. Determine the effectiveness of CPT in reducing PTSD symptom severity;
  2. Identify putative psychological mechanisms of response to CPT through pre-, mid-, and post-intervention measures of PTSD symptom severity as well as measures of hopelessness, self-blame, and negative self-related thoughts.

Prior to beginning any study procedures, informed consent will be obtained orally and in writing. During the informed consent process, eligible participants will be provided with detailed information about the study, including their right to refuse or discontinue participation at any time and the fact that their decision to participate or decline will have no bearing on their standing within the criminal justice system.

Potential participants will be contacted by calling them over the phone system within the prison. When they arrive to the private testing room, they are asked if they would like to learn about the study and potentially participate. If so, participants undergo consent.

Eligible participants will complete the PCL-5 to ascertain current PTSD symptomology and probable diagnosis. This assessment will take approximately 90 minutes.

Participants will be randomly assigned to the CPT or the active control groups. The CPT group will engage in 10 to 12, 90-minute treatment sessions (up to 18 hours total). With the optional opportunity to take 15-20 minutes after each session to de-stress and calm down if necessary. These sessions will take place over 6 to 12 weeks, depending on session frequency. CPT group-members are also asked to complete weekly homework (approximately 12 hours total). A maximum of 10 participants, but no less than 3 will be included in each CPT group. When the waitlist control group reaches the treatment phase, if the participant count fall below 3, additional participants will be enrolled to maintain sufficient numbers. Data collection during treatment will mirror that of the active waitlist control group. Participants will be notified via institutional mail which group they have been enrolled in.

In addition to the treatment groups, CPT and control group members will complete a PCL-5 at the beginning of each session. As well as, pre-treatment testing session two weeks prior to the start of treatment. After treatment session 5, CPT and control group members will complete mid-treatment testing assessments. Participants will be called down individually to complete these assessments in a private room with a research assistant after completing the 5th therapy session, but before completing the 8th therapy session. CPT and control group members will then complete post-treatment testing within one week after completing week 6 of treatment. One month after the treatment is completed, CPT and control group members will complete follow-up testing and interviewing about their experience in the treatment groups and will have one follow up CPT session 6-8 weeks post-treatment. Post-treatment and one-month follow up-testing will follow the same procedure as pre-treatment and mid-treatment testing. Final follow-up will occur three months after the end of treatment. Procedures will be the same as other timepoint follow-ups. CPT and control group members will be asked to complete 18 sessions in total (pre-treatment, mid- treatment, post- treatment, one-month follow up-testing, three-month follow-up treatment, 12 group sessions and one follow-up CPT session).

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53719
        • Psychiatric Institute and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Participants will be selected and screened from the Department of Corrections trauma treatment waitlist.

Inclusion Criteria:

  • 18 years old or older
  • meet PCL-5 criteria for current PTSD diagnosis within 2 months of enrollment
  • no scheduled release date before the end of the treatment group
  • able to understand the consent form as measured by the consent quiz
  • have not participated in the previous CPT groups with UW project
  • No active symptoms of psychosis that would interfere with the individual's ability to participate in the group
  • No active suicidal ideation with intent or plan
  • Able and willing to participate in group therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Processing Therapy (CPT) group
Participant groups to receive CPT to treat PTSD
Behavioral: Cognitive Processing Therapy
CPT: 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.
No Intervention: Waitlist Control
Participant groups will provide data as a control group first, and will then receive CPT to treat PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PTSD Checklist for DSM-5 (PCL-5) severity score
Time Frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy
baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements
Time Frame: Up to 7 weeks (by the end of the 12th session)
Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy. For each 12-session intervention, 2 sessions will be audiotaped and rated.
Up to 7 weeks (by the end of the 12th session)
Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist
Time Frame: Up to 7 weeks (by the end of the 12th session)
Higher ratings indicate higher-quality session element (scores 1-7;1="not satisfactory", 4="satisfactory", 7="excellent") by the clinical supervisors. Competence ratings will be collected for two audiotaped group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention efficacy.
Up to 7 weeks (by the end of the 12th session)
Change in score on the Beck Depression Inventory 2 (BDI-II)
Time Frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Depression level measured by score on BDI-II (between 0 and 63; over 40 = extreme depression); secondary measure of intervention efficacy
baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Change in score on the Beck Anxiety Inventory (BAI)
Time Frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Anxiety level measured by score on BAI (between 0 and 63; over 30 = severe anxiety); secondary measure of intervention efficacy
baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Percentage of participants endorsing 2 or higher on Q9 of BDI-II
Time Frame: baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)
Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution.
baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Wisconsin Partnership Program

Investigators

  • Principal Investigator: Michael R Koenigs, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

April 24, 2026

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0630: WPP
  • A538900 (Other Identifier: UW Madison)
  • Protocol Version 5/21/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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