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

Обзор

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.

Вмешательства

• Поведенческое Group Cognitive Processing Therapy (CPT)
  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.
• Поведенческое Control Group Individual trauma focused self-help via workbook
  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.

Первичные конечные точки

• Drug Use Frequency (Count) [Срок оценки: 3- and 6-month post-release from prison]
• Drug use (Binary) [Срок оценки: 3- and 6-month post-release from prison]
• Posttraumatic Stress Symptom Severity (Sum) [Срок оценки: 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) [Срок оценки: 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.]

Вторичные конечные точки (12)

• Drug Use Disorder Symptom Severity (Count) [Срок оценки: 3- and 6-months post-release from prison]
• Drug Use Disorder (Binary) [Срок оценки: 3- and 6-months post-release from prison]
• Depressive Symptom Severity (Sum) [Срок оценки: 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) [Срок оценки: 3- and 6-months post-release from prison]
• Alcohol Use (Binary) [Срок оценки: 3- and 6-months post-release from prison]
• Alcohol Use Disorder Symptom Severity (Count) [Срок оценки: 3- and 6-months post-release from prison]
• Alcohol Use Disorder (Binary) [Срок оценки: 3- and 6-months post-release from prison]
• Drug-Related Crime Frequency (Count) [Срок оценки: 6-months post-release from prison]
• Drug Related Crime (Binary) [Срок оценки: 6-months post-release from prison]
• Substance-Related Disciplinary Violations (Count) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 3- and 6-months post-release from prison]

Критерии участия

Критерии включения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 6 центров

• University of Arkansas for Medical Sciences — Little Rock
• Northeast Arkansas Community Corrections Center (NEACC) — Osceola
• Southwest Arkansas Community Correction Center — Texarkana
• East Central Arkansas Community Correction Center — West Memphis
• North Dakota State Penitentiary (NDSP) — Bismarck
• Heart River Correctional Center (HRCC) — Bismarck

Идентификаторы

NCT: NCT06923423 · 297770 · R01DA059549

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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