Clinical trial NCT06923423: Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons
Official title: Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
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
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-11
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Drug Use Frequency (Count)
timeFrame: 3- and 6-month post-release from prison
measure: Drug use (Binary)
timeFrame: 3- and 6-month post-release from prison
measure: Posttraumatic Stress Symptom Severity (Sum)
timeFrame: 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
measure: Treatment fidelity (ratio)
timeFrame: 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:
measure: Drug Use Disorder Symptom Severity (Count)
timeFrame: 3- and 6-months post-release from prison
measure: Drug Use Disorder (Binary)
timeFrame: 3- and 6-months post-release from prison
measure: Depressive Symptom Severity (Sum)
timeFrame: 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
measure: Alcohol Use Frequency (Count)
timeFrame: 3- and 6-months post-release from prison
measure: Alcohol Use (Binary)
timeFrame: 3- and 6-months post-release from prison
measure: Alcohol Use Disorder Symptom Severity (Count)
timeFrame: 3- and 6-months post-release from prison
measure: Alcohol Use Disorder (Binary)
timeFrame: 3- and 6-months post-release from prison
measure: Drug-Related Crime Frequency (Count)
timeFrame: 6-months post-release from prison
measure: Drug Related Crime (Binary)
timeFrame: 6-months post-release from prison
measure: Substance-Related Disciplinary Violations (Count)
timeFrame: Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years
measure: Substance-Related Disciplinary Violations (Binary)
timeFrame: Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years
measure: Positive Urine Drug Screens (Binary)
timeFrame: 3- and 6-months post-release from prison
measure: Treatment Acceptability (mean)
timeFrame: Post-treatment assessments will be completed 2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)
measure: Treatment Acceptability (sum)
timeFrame: Administered at post-treatment assessment, which will be completed ~2 weeks after treatment ends
measure: Treatment appropriateness (mean)
timeFrame: Post-treatment assessments will be completed ~2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)
measure: Treatment feasibility (mean)
timeFrame: Immediately and 12-months post-implementation
measure: Treatment adoption (ratio)
timeFrame: 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
measure: Treatment sustainability (ratio)
timeFrame: 1-year post-implementation
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Melissa J Zielinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: