NCT05432817

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

June 20, 2022

Last Update Submit

April 23, 2026

Conditions

Keywords

Group therapyIncarcerated Individuals

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD Checklist for DSM-5 (PCL-5) severity score

    PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy

    baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)

Secondary Outcomes (5)

  • Change in score on the Beck Depression Inventory 2 (BDI-II)

    baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)

  • Change in score on the Beck Anxiety Inventory (BAI)

    baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)

  • Percentage of participants endorsing 2 or higher on Q9 of BDI-II

    baseline (two weeks prior to intervention), up to 6 weeks (mid-intervention), up to 13 weeks (one week post-intervention), up to 18 weeks (one month post-treatment), and up to 26 weeks (three months post-treatment)

  • 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)

  • 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)

Study Arms (2)

Cognitive Processing Therapy (CPT) group

EXPERIMENTAL

Participant groups to receive CPT to treat PTSD

Behavioral: Cognitive Processing Therapy

Waitlist Control

NO INTERVENTION

Participant groups will provide data as a control group first, and will then receive CPT to treat PTSD

Interventions

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 25757522BACKGROUND
  • 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: 25697197BACKGROUND
  • 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: 12182270BACKGROUND
  • 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: 12150085BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Michael R Koenigs, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two therapy-intervention groups: CPT or active waitlit control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 27, 2022

Study Start

January 4, 2024

Primary Completion

January 30, 2026

Study Completion

April 24, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations