RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Addiction and trauma exposure are common among the 5.5 million people (1 in 47 adults) in the U.S. who are in prison or under supervision. About 85% of people in prison have a substance use disorder or are there for a drug-related crime, and many have experienced serious trauma before being incarcerated. Posttraumatic stress symptoms (PTSS) are often a result of trauma and are linked to more severe drug use, higher rates of relapse, and increased crime. PTSS and substance use disorder (SUD) each raise the chances of new arrests for people who are justice-involved, showing that addressing trauma and addiction could help reduce repeat offenses and the costs of incarceration. However, treatments for PTSS are rarely available in prisons, and there is little research on whether providing therapy for PTSS in prison can lower drug use, PTSS, or crime after release. The goal of this clinical trial is to see if trauma-focused group therapy (CPT) provided while in prison, can help people after release from prison. The therapy has been adapted for use in prisons (CPT-CJ) and will be compared to trauma focused therapy delivered via a self-help workbook This study will: * test whether a trauma-focused group therapy (CPT-CJ) can reduce post-incarceration drug and alcohol use, mental health issues, and drug-related crime, compared to trauma-focused self-help, * evaluate a strategy called implementation facilitation, which helps support the use of this therapy in prisons, and * measure the cost of the therapies and support strategies to help plan for future expansion. Incarcerated participants (N = 640; 50% female) will be enrolled from \~10 prisons in \~5 states, ensuring variability in population and setting characteristics. They will: * take surveys and answer questions up to 5 times (before starting treatment, right after getting treatment, right before leaving prison, 3 months after leaving prison and 6 months after leaving prison) * complete CPT group therapy or self-help therapy * provide urine samples 3 months and 6 months after leaving prison Prison stakeholders (e.g., prison staff, prison leadership, governmental officials; N = \~15 per site) who will be purposively sampled based on their role in CPT-CJ implementation will also participate in some surveys.

Official Title

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

Quick Facts

Study Start:2025-07-07
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06923423

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Able to understand and speak English
  3. * Able to give informed consent
  4. * All items listed in "Inclusion criteria for all participants"
  5. * Be currently incarcerated in one of the prisons that have partnered as study sites
  6. * 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)
  7. * Have used drugs in the 30 days prior to their current incarceration
  8. * Have a history of traumatic event exposure
  9. * Endorse clinically significant posttraumatic stress symptoms (score ≥ 4 on the Primary Care PTSD Screen for DSM-5; PC-PTSD-5)
  10. * 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)
  11. * Expect to be released from prison within 12 months following the end of treatment (i.e., within \~15 months of the pre-treatment assessment)
  12. * Willing to consent to randomization to treatment condition
  13. * Unable to provide any locator information for post-release assessments
  14. * Determined to be releasing sooner than would allow the individual to complete CPT-CJ
  15. * 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).
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Stephanie A Hauge, MS
CONTACT
206-295-2549
shauge@uams.edu
Mollee K Smith Steely, PhD
CONTACT
501-320-7271
MKSteelysmith@uams.edu

Principal Investigator

Melissa J Zielinski, PhD
PRINCIPAL_INVESTIGATOR
University of Arkansas

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Northeast Arkansas Community Corrections Center (NEACC)
Osceola, Arkansas, 72370
United States
North Dakota State Penitentiary (NDSP)
Bismarck, North Dakota, 58501
United States
Heart River Correctional Center (HRCC)
Bismarck, North Dakota, 58502
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Melissa J Zielinski, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-07
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-07-07
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • PTSD - Post Traumatic Stress Disorder
  • PTSD and Alcohol Use Disorder
  • PTSD and Trauma-related Symptoms
  • Substance Use Disorder (SUD)
  • Depression
  • Mental Health
  • Trauma
  • Trauma Exposure
  • Traumatic Stress Disorder
  • Traumatic Stress
  • Post Traumatic Stress Symptoms