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Search / Trial NCT06923423

Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons

Launched by UNIVERSITY OF ARKANSAS · Apr 9, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Post Traumatic Stress Disorder Post Traumatic Stress Symptoms Substance Use Substance Use Disorder Cognitive Processing Therapy Cognitive Processing Therapy For Criminal Justice Setting Trauma Focused Self Help Facilitation Implementation Facilitation Implementation Cost Estimation And Offsets Drug Use Disorder Alcohol Use Disorder Trauma Depression Adult Incarcerated Prison Imprisonment Intervention Treatment Comparison Acceptability Feasibility Budget Impact Cost Estimate Implementation Evaluation Recidivism Self Help Workbook Criminal Justice Effectiveness Evidence Based Intervention Cpt Cpt Cj

ClinConnect Summary

This clinical trial is studying a special therapy called Cognitive Processing Therapy (CPT) to see if it can help people in prison who have experienced trauma and struggle with substance use issues. The trial will compare two approaches: one where participants join group therapy sessions led by a therapist and another where they use a self-help workbook at their own pace. By providing this therapy while individuals are incarcerated, the study aims to find out if it can reduce drug and alcohol use, mental health problems, and crime after they are released.

To participate in the trial, individuals must be at least 18 years old, currently in prison, and have a history of drug use and trauma. They will be asked to complete surveys and give urine samples at different times during and after their treatment. The study will include about 640 participants across several prisons, ensuring a diverse range of people are involved. Participants will also have a chance to provide feedback, which will help improve the therapy's implementation in prisons and assess the costs associated with these treatments.

Gender

ALL

Eligibility 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).

About University Of Arkansas

The University of Arkansas is a leading research institution dedicated to advancing healthcare through innovative clinical trials. With a commitment to excellence in research and education, the university facilitates a collaborative environment that encourages interdisciplinary studies and the development of cutting-edge therapies. Its clinical trial programs leverage state-of-the-art facilities and expert faculty, aiming to improve patient outcomes and contribute to the body of medical knowledge. The university fosters partnerships with healthcare providers and industry stakeholders, ensuring rigorous ethical standards and adherence to regulatory requirements in all research endeavors.

Locations

Little Rock, Arkansas, United States

Patients applied

0 patients applied

Trial Officials

Melissa J Zielinski, PhD

Principal Investigator

University of Arkansas

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported