PTSD Treatment for Incarcerated Men and Women: WPP

Not Applicable

Recruiting

• Conditions: PTSD

• Registration Number: NCT05432817
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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).

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 Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Study Start: 2024-01-04
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-11
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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
• no serious self-harm within past 6-months
• no disciplinary segregation tim in past 6-months
• have not participated in the previous CPT groups with UW project

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PTSD Checklist for DSM-5 (PCL-5) severity score	baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), up to 12 weeks (one month post-treatment), and up to 20 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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants endorsing 2 or higher on Q9 of BDI-II	baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), up to 12 weeks (one month post-treatment), and up to 20 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.
Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements	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.
Change in score on the Beck Anxiety Inventory (BAI)	baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), up to 12 weeks (one month post-treatment), and up to 20 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
Change in score on the Beck Depression Inventory 2 (BDI-II)	baseline (two weeks prior to intervention), up to 3 weeks (mid-intervention), up to 8 weeks (one week post-intervention), and up to 12 weeks (one month post-treatment)	Depression level measured by score on BDI-II (between 0 and 63; over 40 = extreme depression); secondary measure of intervention efficacy
Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist	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.

Trial Locations

Locations (1)

Psychiatric Institute and Clinic; 🇺🇸 Madison, Wisconsin, United States