N/A
N=69
PTSD Treatment for Incarcerated Men and Women: NIMH
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT05168267 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions — 31; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Processing Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions |
31; 32 | — |
| PRIMARY Change in Self-reported PTSD Symptoms (PCL-5) |
-19.07; -12.94 | — |
| PRIMARY Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire) |
28.48; 25.7 | — |
| SECONDARY Percentage of Individuals That Meet Study Inclusion Criteria |
43; 36 | — |
| SECONDARY Percentage of Eligible Individuals Enrolled in the Study |
35; 34 | — |
| SECONDARY Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance) |
31; 30 | — |
| SECONDARY Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets |
21; 22 | — |
| SECONDARY Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor |
87.72; 85.96 | — |
| SECONDARY Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist |
4.67; 4.35; 4.77; 4.36 | — |
| SECONDARY Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II) |
0; 2 | — |
| SECONDARY Reasons for Participant Discontinuation |
1; 0; 1; 0; 1; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Intelligence quotient (IQ) greater than or equal to 70
- 18 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05168267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.