PTSD Treatment for Incarcerated Men and Women: WPP

PTSD Clinical Trial

Official title: PTSD Treatment for Incarcerated Men and Women: WPP

Status Recruiting

Clinical Trial 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 10 individuals for both CPT and Therapist-facilitated Support Group in both populations (i.e., 80 participants total; 40F/40M, four CPT groups of 10 (2 Female (F)/2 Male (M)); four Therapist-facilitated Support groups of 10 (2F/2M)). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.

Clinical Trial 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 first complete the Clinician-Administered PTSD Scale for DSM-5 (PCL-5) to ascertain current PTSD symptomology and diagnosis. This assessment will take approximately 90 minutes. Participants will then be assigned to the CPT or Therapist-facilitated Support groups. The CPT and Therapist-facilitated groups will engage in 12, 90-minute treatment sessions (18 hours total). CPT and Therapist-facilitated group-members are also asked to complete weekly homework (approximately 12 hours total). Approximately 10 participants will be included in each CPT or therapist-facilitated session. Participants with PTSD will be randomized to the CPT or therapist-facilitated groups. Participants will be notified via institutional mail when they are starting CPT or therapist-facilitated support. Participants in either group will be able to continue any ongoing treatment/interventions they are engaged in within the institution. All participants will be asked what treatment groups they are currently enrolled in during the initial screening to examine the possibility of attentional bias within the CPT group (i.e., more frequent interaction leading to treatment outcomes).

In addition to the treatment groups, CPT and therapist-facilitated support group members will also complete a pre-treatment testing session two weeks prior to treatment week 1. During treatment week 3, CPT and therapist-facilitated support group members will complete mid-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 7th therapy session. CPT and therapist-facilitated group members will then complete post-testing within one week after completing week 6 of treatment. One and three months after the treatment is completed, CPT and therapist-facilitated group members will complete follow-up testing. Post- and one-month follow up- testing will follow the same procedure as pre- and mid-testing. CPT and therapist-facilitated group members will be asked to complete 17 sessions in total (pre-, mid-, post-, one-month follow up-testing, three-month follow-up testing, and 12 treatment groups). ;

Related Conditions & MeSH terms

• PTSD

• NCT number: NCT05432817
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Contact: Michael R Koenigs, PhD
• Phone: (608) 263-1679
• Email: mrkoenigs@wisc.edu
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2024
• Completion date: August 2025