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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arkansas

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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"

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

640 Participants
are divided into 2 treatment groups
Group A: Group Cognitive Processing Therapy (CPT)Active comparator 1 intervention
Group B: Individual trauma focused self-help via workbookActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3- and 6-month post-release from prison
2

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.

Time frame
3- and 6-month post-release from prison
3

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.

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
4

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.

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.

Secondary outcomes

1

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.

Time frame
3- and 6-months post-release from prison
2

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).

Time frame
3- and 6-months post-release from prison
3

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.

Time frame
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
4

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.

Time frame
3- and 6-months post-release from prison

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator