NCT Number: NCT06923423
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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):
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
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.
Time frame: 3- and 6-month post-release from prison
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
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: 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
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: 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.
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: 3- and 6-months post-release from prison
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
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: 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
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: 3- and 6-months post-release from prison
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
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.
Time frame: 3- and 6-months post-release from prison
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.
Time frame: 3- and 6-months post-release from prison
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).
Time frame: 6-months post-release from prison
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.
Time frame: 6-months post-release from prison
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.
Time frame: Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years
Sum of substance-related disciplinary violations received while incarcerated per administrative records
Time frame: Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years
Presence or absence of any substance-related disciplinary violations received while incarcerated per administrative records.
Time frame: 3- and 6-months post-release from prison
Presence or absence of any positive urine drug screens following release from prison per department of corrections administrative records.
Time frame: Post-treatment assessments will be completed 2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)
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.
Time frame: Administered at post-treatment assessment, which will be completed ~2 weeks after treatment ends
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.
Time frame: Post-treatment assessments will be completed ~2 weeks after treatment ends (for residents). Immediately and 12-months post-implementation (for prison stakeholders)
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.
Time frame: Immediately and 12-months post-implementation
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.
Time frame: 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
Ratio of patients who completed CPT-CJ to the number who were randomized
Time frame: 1-year post-implementation
The number of sites of total that are maintaining or increasing in CPT-CJ provision with high fidelity after implementation facilitation support is withdrawn.
Contact information is provided by the study sponsor or research team.
Melissa J Zielinski, PhD
CONTACT
Mollee K Smith Steely, PhD
CONTACT
University of Arkansas
Other
Acronym: STRIDES2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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