- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283757
PTSD Treatment for Incarcerated Men and Women: AV
PTSD Treatment for Incarcerated Men and Women: Arnold Ventures (AV)
Study Overview
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael R Koenigs, PhD
- Phone Number: (608) 263-1679
- Email: mrkoenigs@wisc.edu
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53719
- Recruiting
- Psychiatric Institute and Clinic
-
Contact:
- Michael R Koenigs, PhD
- Phone Number: 608-263-1679
- Email: mrkoenigs@wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
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 |
|---|---|
|
No Intervention: Waitlist Control
Participant groups will provide data as a control group first, and will then receive CPT to treat PTSD
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Experimental: Cognitive Processing Therapy (CPT) group
Participant groups of 6-10 people to receive CPT to treat PTSD over 6 weeks or 12 weeks, depending on session frequency.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Conduct Reports
Time Frame: Up to 26 weeks on study
|
Effectiveness of group CPT in reducing conduct reports measured by number of violations of prison rules such assaults and substance use.
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Up to 26 weeks on study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PTSD Checklist for DSM-5 (PCL-5) severity score
Time Frame: baseline (pre-intervention), up to 12 weeks (post-intervention), and up to 24 weeks (three months follow up)
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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.
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baseline (pre-intervention), up to 12 weeks (post-intervention), and up to 24 weeks (three months follow up)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael R Koenigs, PhD, University of Wisconsin, Madison
Publications and helpful links
General Publications
- James, D.J. and L.E. Glaze, Mental health problems of prison and jail inmates, U.S.D.o. Justice, Editor. 2006: Bureau of Justice Statistics Special Report.
- Egeressy A, Butler T, Hunter M. 'Traumatisers or traumatised': Trauma experiences and personality characteristics of Australian prisoners. Int J Prison Health. 2009;5(4):212-22. doi: 10.1080/17449200903343209.
- Campbell CA, Albert I, Jarrett M, Byrne M, Roberts A, Phillip P, Huddy V, Valmaggia L. Treating Multiple Incident Post-Traumatic Stress Disorder (PTSD) in an Inner City London Prison: The Need for an Evidence Base. Behav Cogn Psychother. 2016 Jan;44(1):112-7. doi: 10.1017/S135246581500003X. Epub 2015 Feb 20.
- Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.
- Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.
- Morgan RD, Winterowd CL. Interpersonal process-oriented group psychotherapy with offender populations. Int J Offender Ther Comp Criminol. 2002 Aug;46(4):466-82. doi: 10.1177/0306624X02464008.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0630: AV
- A538900 (Other Identifier: UW Madison)
- Protocol Version 1/23/2026 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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