What this study is
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.
What's being tested
- Group Cognitive Processing Therapy (CPT)
Intervention · BEHAVIORAL
Participants in CPT group therapy will learn about trauma and how to change upsetting thoughts related to it. Participants will attend up to a total of 12 sessions held 1-2x/week for 90 minutes. No more than 10 participants will be in a group. In this study, CPT provided is a version that was adapted for prisons.
- Control Group Individual trauma focused self-help via workbook
Intervention · BEHAVIORAL
The self-help therapy is a therapy that people do on their own using a workbook. By reading and doing practice assignments in the workbook, people can learn skills to recover from trauma.
Study details
- Sponsor
- University of Arkansas
- Conditions
- 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
- Enrolling
- 640 people
- Starts
- 2025-07-07
- Est. completion
- 2028-12
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (6)
6 openUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
- Melissa J Zielinski, PhD · Contact501-526-8229MJZielinski@uams.edu
- Melissa J Zielinski, PhD · Principal investigator
Not yet recruitingNortheast Arkansas Community Corrections Center (NEACC)
Osceola, Arkansas, United States
RecruitingSouthwest Arkansas Community Correction Center
Texarkana, Arkansas, United States
- John Miners · Contact
RecruitingEast Central Arkansas Community Correction Center
West Memphis, Arkansas, United States
- Tameka Coleman · Contact
RecruitingNorth Dakota State Penitentiary (NDSP)
Bismarck, North Dakota, United States
RecruitingHeart River Correctional Center (HRCC)
Bismarck, North Dakota, United States
Recruiting
Study team
Sponsor
University of Arkansas
Study ID 297770
Principal investigator
Melissa J Zielinski, PhD
University of Arkansas
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.