Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons (STRIDES2)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Trauma; Mental Health; Traumatic Stress Disorder; Traumatic Stress; Trauma Exposure; Substance Use Disorder (SUD); PTSD and Alcohol Use Disorder; Post Traumatic Stress Symptoms; PTSD - Post Traumatic Stress Disorder; PTSD and Trauma-related Symptoms
• Intervention / Treatment: Behavioral: Group Cognitive Processing Therapy (CPT); Behavioral: Control Group Individual trauma focused self-help via workbook

• Study Type: Interventional
• Enrollment (Estimated): 640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mollee K Smith Steely, PhD; Phone Number: 501-320-7271; Email: MKSteelysmith@uams.edu
• Study Contact Backup: Name: Melissa J Zielinski, PhD; Phone Number: 501-526-8229; Email: MJZielinski@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Not yet recruiting
      • University of Arkansas for Medical Sciences
      • Contact: Melissa J Zielinski, PhD; Phone Number: 501-526-8229; Email: MJZielinski@uams.edu
      • Principal Investigator: Melissa J Zielinski, PhD
    • Osceola, Arkansas, United States, 72370
      • Recruiting
      • Northeast Arkansas Community Corrections Center (NEACC)
    • Texarkana, Arkansas, United States, 71854
      • Recruiting
      • Southwest Arkansas Community Correction Center
      • Contact: John Miners
    • West Memphis, Arkansas, United States, 72301
      • Recruiting
      • East Central Arkansas Community Correction Center
      • Contact: Tameka Coleman
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Recruiting
      • North Dakota State Penitentiary (NDSP)
    • Bismarck, North Dakota, United States, 58502
      • Recruiting
      • Heart River Correctional Center (HRCC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: 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.; Other Names: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Use Disorder Symptom Severity (Count)	Participants will complete a DSM-5 checklist of drug use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed.	3- and 6-months post-release from prison
Drug Use Disorder (Binary)	Participants will complete a DSM-5 checklist of drug use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed. Sum score will be used to determine substance use disorder presence (i.e., scores ≥ 2) or absence (scores of 0-1).	3- and 6-months post-release from prison
Depressive Symptom Severity (Sum)	Participants will complete the Patient Health Questionnaire - 8-item (PHQ-8) at all assessments to examine change the effectiveness of the intervention and control groups on depressive symptom severity. Scores range from 0-24 with higher scores indicating more severe depressive symptoms.	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)	Participants will complete a Timeline Follow Back Interview assessment of alcohol use during the previous 30 days at both 3- and 6-months post-release from prison. The total number of days of alcohol use will be summed to represent drug use frequency.	3- and 6-months post-release from prison
Alcohol Use (Binary)	Participants will complete a Timeline Follow Back Interview assessment of alcohol use during the previous 30 days at both 3- and 6-months post-release from prison. The total number of days of alcohol use will be dichotomized to indicate presence or absence of alcohol use since release.	3- and 6-months post-release from prison
Alcohol Use Disorder Symptom Severity (Count)	Participants will complete a DSM-5 checklist of alcohol use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed.	3- and 6-months post-release from prison
Alcohol Use Disorder (Binary)	Participants will complete a DSM-5 checklist of alcohol use disorder diagnostic criteria. The checklist can result in a maximum score of 11, with scores of 2 or greater indicating the presence of symptoms likely to meet diagnostic criteria. Scores will represent the total number of symptoms currently endorsed. Sum score will be used to determine substance use disorder presence (i.e., scores ≥ 2) or absence (scores of 0-1).	3- and 6-months post-release from prison
Drug-Related Crime Frequency (Count)	Sum of new arrests and new convictions for drug charges based on the Criminal and Legal Activities Form and, if sufficient data is available, administrative records.	6-months post-release from prison
Drug Related Crime (Binary)	Presence or absence of any new arrests or new convictions for drug charges based on the Criminal and Legal Activities Form and, if sufficient data is available, administrative records.	6-months post-release from prison
Substance-Related Disciplinary Violations (Count)	Sum of substance-related disciplinary violations received while incarcerated per administrative records	Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years
Substance-Related Disciplinary Violations (Binary)	Presence or absence of any substance-related disciplinary violations received while incarcerated per administrative records.	Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years
Positive Urine Drug Screens (Binary)	Presence or absence of any positive urine drug screens following release from prison per department of corrections administrative records.	3- and 6-months post-release from prison
Treatment Acceptability (mean)	Prison residents and stakeholders will complete the Acceptability of Intervention Measure (AIM) to index treatment acceptability. Mean scores on the AIM range from 1-5, with higher scores indicating greater intervention acceptability.	Post-treatment assessments will be completed 2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)
Treatment Acceptability (sum)	Prison residents will complete the Client Satisfaction Questionnaire (CSQ-8) as an additional index of treatment acceptability. Sum scores on the CSQ-8 range from 8-32, with higher scores indicating greater intervention acceptability.	Administered at post-treatment assessment, which will be completed ~2 weeks after treatment ends
Treatment appropriateness (mean)	The Intervention Appropriateness Measure (IAM) will be completed by both prison residents and prison stakeholders. Mean scores on the IAM range from 1-5, with higher scores indicating greater intervention appropriateness.	Post-treatment assessments will be completed ~2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)
Treatment feasibility (mean)	The Feasibility of Intervention Measure (FIM) will be completed by prison stakeholders to index treatment feasibility. Mean scores on the FIM range from 1-5, with higher scores indicating greater intervention feasibility.	Immediately and 12-months post-implementation
Treatment adoption (ratio)	Ratio of patients who completed CPT-CJ to the number who were randomized	Treatment adoption assessment 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
Treatment sustainability (ratio)	The number of sites of total that are maintaining or increasing in CPT-CJ provision with high fidelity after implementation facilitation support is withdrawn.	1-year post-implementation

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Melissa J Zielinski, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Feasibility; Implementation; Prison; Adult; Intervention; Substance Use; Effectiveness; Substance Use Disorder; Trauma; Acceptability; Alcohol Use Disorder; Cognitive Processing Therapy; Facilitation; Criminal Justice; Evidence Based Intervention; CPT; Incarcerated; Recidivism; Self Help; Drug Use Disorder; Implementation Facilitation; Implementation Evaluation; Post traumatic Stress Disorder; Post traumatic Stress Symptoms; Cognitive Processing Therapy for Criminal Justice Setting; Trauma focused self help; Cost Estimation and Offsets; Imprisonment; Treatment Comparison; Budget Impact; Cost Estimate; Workbook; CPT-CJ
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Chemically-Induced Disorders; Alcohol-Related Disorders; Behavior; Personal Satisfaction; Criminal Behavior; Alcoholism; Depression; Substance-Related Disorders; Wounds and Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders; Psychological Well-Being; Recidivism
• Other Study ID Numbers: 297770; R01DA059549 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No