Group Cognitive Processing Therapy for people in prison with PTSD and substance use
Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons
This trial tests whether group Cognitive Processing Therapy (CPT) delivered in prison helps adults with PTSD and recent drug problems reduce trauma symptoms, substance use, and re-offending after release.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 640 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arkansas Academic / other |
| Locations | 6 sites (Little Rock, Arkansas and 5 other locations) |
| Trial ID | NCT06923423 on ClinicalTrials.gov |
What this trial studies
Adults incarcerated at participating Arkansas prisons who have a recent drug use disorder, trauma history, and elevated posttraumatic stress symptoms are enrolled and assigned to either group CPT delivered in custody or to an individual trauma-focused workbook control. Treatment is delivered while incarcerated and participants are followed through release to measure posttraumatic stress symptoms, drug use, and criminal justice outcomes. The trial also collects data on how CPT is implemented in prison settings and the costs of providing the intervention. Outcomes will inform whether in-prison CPT can be scaled and whether it affects relapse and recidivism.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults incarcerated at one of the partnered Arkansas sites who used drugs shortly before incarceration, met criteria for a past-year drug use disorder, have trauma exposure with clinically significant PTSD symptoms, and expect to be in custody long enough to complete the program and be released within about 12–15 months.
Not a fit: People without significant posttraumatic stress symptoms, who are not English-speaking, who are incarcerated at non-participating facilities, or who cannot participate in group sessions due to severe behavioral or psychiatric instability are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, providing CPT in prison could lower PTSD symptoms, reduce substance use and relapse, and decrease rates of re-arrest after release.
How similar studies have performed: Cognitive Processing Therapy has proven effective for PTSD in community and veteran populations, but delivering CPT in prison settings and measuring effects on substance use and recidivism is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Able to understand and speak English * Able to give informed consent * All items listed in "Inclusion criteria for all participants" * Be currently incarcerated in one of the prisons that have partnered as study sites * Have met criteria for a drug use disorder in the year prior to their current incarceration (≥ 2 symptoms on a DSM-5 drug use disorder checklist) * Have used drugs in the 30 days prior to their current incarceration * Have a history of traumatic event exposure * Endorse clinically significant posttraumatic stress symptoms (score ≥ 4 on the Primary Care PTSD Screen for DSM-5; PC-PTSD-5) * Expect to be incarcerated for at least long enough to complete CPT-CJ as it is being implemented at the particular site (i.e., anticipated to be \~3 months, but will depend on dates associated with next available intervention group) * Expect to be released from prison within 12 months following the end of treatment (i.e., within \~15 months of the pre-treatment assessment) * Willing to consent to randomization to treatment condition Exclusion criteria for prisoners (additional requirements assessed during pre-treatment assessments or indicated by prison staff; will result in being withdrawn from the study prior to randomization by the PI): * Unable to provide any locator information for post-release assessments * Determined to be releasing sooner than would allow the individual to complete CPT-CJ * Determined to have an unavoidable scheduling conflict or facility restriction (e.g., disciplinary, medical) that would prevent participation in CPT-CJ. Of note, if the scheduling conflict or facility restriction is expected to resolve following the next round of randomization at the study site, the participant may be put on "hold for next round" status rather than withdrawn unless other exclusionary criteria would be met by that time (e.g., release).
Where this trial is running
Little Rock, Arkansas and 5 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Not_yet_recruiting)
- Northeast Arkansas Community Corrections Center (NEACC) — Osceola, Arkansas, United States (Recruiting)
- Southwest Arkansas Community Correction Center — Texarkana, Arkansas, United States (Recruiting)
- East Central Arkansas Community Correction Center — West Memphis, Arkansas, United States (Recruiting)
- North Dakota State Penitentiary (NDSP) — Bismarck, North Dakota, United States (Recruiting)
- Heart River Correctional Center (HRCC) — Bismarck, North Dakota, United States (Recruiting)
Study contacts
- Principal investigator: Melissa J Zielinski, PhD — University of Arkansas
- Study coordinator: Melissa J Zielinski, PhD
- Email: MJZielinski@uams.edu
- Phone: 501-526-8229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.