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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA059549 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
Incarcerated participants (N = 640; 50% female) will be enrolled from ~10 prisons in ~5 states, ensuring variability in population and setting characteristics. They will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Cognitive Processing Therapy (CPT) | Active Comparator | 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). |
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| Individual trauma focused self-help via workbook | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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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):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa J Zielinski, PhD | Contact | 501-526-8229 | MJZielinski@uams.edu | |
| Mollee K Smith Steely, PhD | Contact | 501-320-7271 | MKSteelysmith@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melissa J Zielinski, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Not yet recruiting | Little Rock | Arkansas | 72205 | United States |
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| 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. |
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| 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 |
| Northeast Arkansas Community Corrections Center (NEACC) | Recruiting | Osceola | Arkansas | 72370 | United States |
| Southwest Arkansas Community Correction Center | Recruiting | Texarkana | Arkansas | 71854 | United States |
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| East Central Arkansas Community Correction Center | Recruiting | West Memphis | Arkansas | 72301 | United States |
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| North Dakota State Penitentiary (NDSP) | Recruiting | Bismarck | North Dakota | 58501 | United States |
| Heart River Correctional Center (HRCC) | Recruiting | Bismarck | North Dakota | 58502 | United States |
| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| D014947 | Wounds and Injuries |
| D040921 | Stress Disorders, Traumatic |
| D000075665 | Recidivism |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
| D000066479 | Criminal Behavior |
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