Group Cognitive Processing Therapy for people in prison with PTSD and substance use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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(additional requirements assessed during pre-treatment assessments or indicated by prison staff; will result in being withdrawn from the study prior to randomization by the PI):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 it's running

• 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
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.