Recruiting

CPT-CJ & Self-Help

Sponsor:

University of Arkansas

Code:

NCT06923423

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD and Alcohol Use Disorder

PTSD and Trauma-related Symptoms

Substance Use Disorder (SUD)

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group Cognitive Processing Therapy (CPT)

Control Group Individual trauma focused self-help via workbook

Study Details

Brief summary:

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.

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD and Alcohol Use Disorder

PTSD and Trauma-related Symptoms

Substance Use Disorder (SUD)

Depression

Study ID

NCT06923423

Start date

Jul 7, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

640 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group Cognitive Processing Therapy (CPT)

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 (CPT-CJ).

active comparator: Individual trauma focused self-help via workbook

Participants in the trauma-focused self-help therapy will independently read and do practice assignments in a workbook to learn skills to recover from trauma.

Interventions

Group Cognitive Processing Therapy (CPT)

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

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.

Primary outcome measure

  • Drug Use Frequency (Count) [ Time Frame: 3- and 6-month post-release from prison ]
  • Drug use (Binary) [ Time Frame: 3- and 6-month post-release from prison ]
  • Posttraumatic Stress Symptom Severity (Sum) [ Time Frame: Pre-treatment assessments will be ~2 wks before tx starts; post-treatment will be ~2 wks after tx ends; pre-release will be ~3 days before release; post-release follow-ups will be 3- and 6-mo after prison exist ]
  • Treatment fidelity (ratio) [ Time Frame: Fidelity assessments will be done during the active treatment period which can be as short as 6 weeks to as long as 3 months for participants. The active treatment period is expected to span 1.5 years at each site. ]

Central Contacts and Locations

Central contacts

Melissa J Zielinski, PhD

501-526-8229MJZielinski@uams.edu

Mollee K Smith Steely, PhD

501-320-7271MKSteelysmith@uams.edu

Locations

Northeast Arkansas Community Corrections Center (NEACC)

Recruiting

Osceola, Arkansas, United States, 72370

Southwest Arkansas Community Correction Center

Recruiting

Texarkana, Arkansas, United States, 71854

East Central Arkansas Community Correction Center

Recruiting

West Memphis, Arkansas, United States, 72301

North Dakota State Penitentiary (NDSP)

Recruiting

Bismarck, North Dakota, United States, 58501

Heart River Correctional Center (HRCC)

Recruiting

Bismarck, North Dakota, United States, 58502

More Information

Sponsor

University of Arkansas

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-01-21.