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

NCT06923423 | Recruiting DMC

• 2 other identifiers: 297770R01DA059549
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 6

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

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

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

Outcome Measures

Primary Outcomes (4)

• Drug Use Frequency (Count)

  Participants complete a Timeline Follow Back Interview assessment of illicit drug use during the previous 30 days at 3- \& 6-months post-release from prison. The total number of days of drug use will be summed to represent drug use frequency.

  3- and 6-month post-release from prison

• Drug use (Binary)

  Participants complete a Timeline Follow Back Interview assessment of illicit drug use during the previous 30 days at 3- \& 6-months post-release from prison. The total number of days of drug use will be dichotomized to indicate presence or absence of drug use since release.

  3- and 6-month post-release from prison

• Posttraumatic Stress Symptom Severity (Sum)

  Participants complete the PTSD Checklist for DSM-5 (PCL-5) at all assessments to examine change the effectiveness of the intervention and control groups on posttraumatic stress symptom severity. Scores range from 0-80 with higher scores indicating more severe PTSD symptoms.

  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)

  The ratio of the number of CPT-CJ components delivered to the number of CPT-CJ components planned per completed fidelity monitoring templates.

  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.

Secondary Outcomes (18)

• Drug Use Disorder Symptom Severity (Count)

  3- and 6-months post-release from prison

• Drug Use Disorder (Binary)

  3- and 6-months post-release from prison

• Depressive Symptom Severity (Sum)

  Pre-treatment assessments will be done ~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 exit

• Alcohol Use Frequency (Count)

  3- and 6-months post-release from prison

• Alcohol Use (Binary)

  3- and 6-months post-release from prison

Study Arms (2)

Group Cognitive Processing Therapy (CPT)

ACTIVE COMPARATOR

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).

Behavioral: Group Cognitive Processing Therapy (CPT)

Individual trauma focused self-help via workbook

ACTIVE COMPARATOR

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.

Behavioral: Control Group Individual trauma focused self-help via workbook

Interventions

Group Cognitive Processing Therapy (CPT) 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.

Also known as: CPT-CJ

Group Cognitive Processing Therapy (CPT)

Control Group Individual trauma focused self-help via workbook 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.

Individual trauma focused self-help via workbook

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to understand and speak English
• Able to give informed consent
• 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

You may not qualify if:

• Unable to provide any locator information for post-release assessments
• Determined to be releasing sooner than would allow the individual to complete CPT-CJ

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (6)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

NOT YET RECRUITING

Northeast Arkansas Community Corrections Center (NEACC)

Osceola, Arkansas, 72370, United States

RECRUITING

Southwest Arkansas Community Correction Center

Texarkana, Arkansas, 71854, United States

RECRUITING

East Central Arkansas Community Correction Center

West Memphis, Arkansas, 72301, United States

RECRUITING

North Dakota State Penitentiary (NDSP)

Bismarck, North Dakota, 58501, United States

RECRUITING

Heart River Correctional Center (HRCC)

Bismarck, North Dakota, 58502, United States

RECRUITING

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Alcoholism; Substance-Related Disorders; Depression; Psychological Well-Being; Wounds and Injuries; Stress Disorders, Traumatic; Recidivism

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Chemically-Induced Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Criminal Behavior

Study Officials

• Melissa J Zielinski, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa J Zielinski, PhD

CONTACT

501-526-8229; MJZielinski@uams.edu

Mollee K Smith Steely, PhD

CONTACT

501-320-7271; MKSteelysmith@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: April 11, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (6)