PTSD Treatment for Incarcerated Men and Women: NIMH

NCT05168267 | Completed Results DMC

• 3 other identifiers: 2018-0630: NIMHR34MH118319A538900
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Study examining the feasibility of and 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 CPT in both populations (i.e., 40 participants total; 20F/20M). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.

Conditions

PTSD

Keywords

Group therapy; Incarcerated Individuals

Outcome Measures

Primary Outcomes (3)

• Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions

  Intervention feasibility measured primarily by participant retention

  up to 6 weeks (by the end of 12th session)

• Change in Self-reported PTSD Symptoms (PCL-5)

  PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.

  baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)

• Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)

  Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

  Post (1 week post-intervention, up to 13 weeks on study)

Secondary Outcomes (8)

• Percentage of Individuals That Meet Study Inclusion Criteria

  baseline (one week prior to intervention)

• Percentage of Eligible Individuals Enrolled in the Study

  up to start of intervention

• Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)

  By the end of final treatment session (up to 12 weeks)

• Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets

  By the end of final treatment session (up to 12 weeks)

• Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor

  By the end of final treatment session (up to 12 weeks)

Study Arms (1)

Cognitive Processing Therapy (CPT) group

EXPERIMENTAL

Arm = Cognitive Processing Therapy (CPT) Group = 4 groups of 12 (48 total; 24F/24M) receive CPT to treat PTSD

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Cognitive Processing Therapy (CPT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intelligence quotient (IQ) greater than or equal to 70
• years old or older
• Reading level of 4th grade or higher
• stable medication use (same medication for at least one month)
• able and willing to participate in group therapy
• meet PCL-5 criteria for a current PTSD diagnosis within two months of study enrollment
• no scheduled release date before the end of the treatment group

You may not qualify if:

• currently enrolled in trauma focused treatment that is historical or involves processing of trauma itself
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Psychiatric Institute and Clinic

Madison, Wisconsin, 53719, United States

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  PMID: 25757522 BACKGROUND

• 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.

  PMID: 25697197 BACKGROUND

• Resick, P.A., C.M. Monson, and K.M. Chard, Cognitive Processing Therapy for PTSD: A Comprehensive Manual. 2016: Guilford Press.

  BACKGROUND

• 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.

  PMID: 12182270 BACKGROUND

• 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.

  PMID: 12150085 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Michael Koenigs
• Organization: University of Wisconsin Madison - Incarceration and Mental Health Lab

mrkoenigs@wisc.edu

(608) 263-1679

Study Officials

• Michael R Koenigs, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to CPT therapy-intervention group.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: June 6, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)