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PTSD Treatment for Incarcerated Men and Women: AV

PTSD Treatment for Incarcerated Men and Women: Arnold Ventures (AV)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07283757
Enrollment
900
Registered
2025-12-16
Start date
2025-12-22
Completion date
2029-12-01
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

Group therapy, Incarcerated Individuals

Brief summary

This research will help identify if a PTSD treatment group, called Cognitive Processing Therapy (CPT), that is used in community settings is helpful in reducing PTSD symptoms among people who are incarcerated. The goal of CPT is to create a space for people to modify unhelpful beliefs related to trauma. A total of 692 participants will be enrolled from 6 locations and can expects to be on study for up to 24 weeks.

Detailed description

The primary objective of this project is to determine the effectiveness of group CPT in reducing conduct reports (violations of prison rules such assaults and substance use), reducing PTSD symptom severity, and address the long-term outcome of recidivism in male and female incarcerated populations. Up to 692 incarcerated individuals will participate in group assignment. To account for potential participant attribution between consent, group assignment, and the waitlist group receiving treatment, enrollment could be up to 900 participants. AV branch of the study involves a waitlist control group; this group will receive the CPT treatment after the treatment group completes the treatment. Participation in the waitlist control group will not affect participation in any other treatments that are available at the facilities. 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 waitlist control group. The CPT group will engage in 8 -12, 90-minute treatment sessions (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 / PHQ-9 at the beginning of each session. As well as pre-treatment testing session prior to the start of treatment. CPT and control group members will complete post-treatment testing within one week after completing week 6 or 12 of treatment. Facilities will have the option to offer one follow up CPT session 6-12 weeks post-treatment. Final follow-up will occur three months after the end of treatment. Procedures will be the same as other timepoint follow-ups. Participants who receive treatment may be selected for a 1on1 interview to hear about their experiences with the group. CPT and control group members will be asked to complete 15-19 sessions in total (pre-treatment, post- treatment, three-month follow-up treatment, 1on1 interview, 12 group sessions and one optional follow-up CPT session).

Interventions

BEHAVIORALCognitive Processing Therapy

CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered in 8 - 12, 90-minute sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER
Arnold Ventures
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The research members performing the assessments will be blind to the group assignment. One study staff will schedule participants according to the randomization, thus minimizing the possibility of systematically biasing the outcome and mediator assessments.

Intervention model description

Participants are assigned to one of two therapy-intervention groups: CPT or active waitlist control group. Participants will be stratified/randomized based on PTSD severity (PCL-5 total score).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be enrolled from the Department of Corrections trauma treatment waitlist who have been screened for: * 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Conduct ReportsUp to 26 weeks on studyEffectiveness of group CPT in reducing conduct reports measured by number of violations of prison rules such assaults and substance use.

Secondary

MeasureTime frameDescription
Change in PTSD Checklist for DSM-5 (PCL-5) severity scorebaseline (pre-intervention), up to 12 weeks (post-intervention), and up to 24 weeks (three months follow up)PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity). Participants will complete the PCL-5 questionnaire during pre-, post-, and three-month follow up timepoints.

Countries

United States

Contacts

CONTACTMichael R Koenigs, PhD
mrkoenigs@wisc.edu(608) 263-1679
PRINCIPAL_INVESTIGATORMichael R Koenigs, PhD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026