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

University of Arkansas

Status: Enrolling

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

Treatments: Behavioral: Group Cognitive Processing Therapy (CPT); Behavioral: Control Group Individual trauma focused self-help via workbook

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06923423

297770

R01DA059549 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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640 participants in 2 patient groups

Group Cognitive Processing Therapy (CPT)

Active Comparator group

Description:

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).

Treatment:

Behavioral: Group Cognitive Processing Therapy (CPT)

Individual trauma focused self-help via workbook

Active Comparator group

Description:

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.

Treatment:

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