Effectiveness, Implementation, and Cost of Cognitive Processing Therapy in Prisons
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 4
- 主要终点
- Drug Use Frequency (Count)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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 (CPT-CJ).
干预措施: Group Cognitive Processing Therapy (CPT) (Behavioral)
Individual trauma focused self-help via workbook
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.
干预措施: Control Group Individual trauma focused self-help via workbook (Behavioral)
结局指标
主要结局
Drug Use Frequency (Count)
时间窗: 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.
Drug use (Binary)
时间窗: 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.
Posttraumatic Stress Symptom Severity (Sum)
时间窗: 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.
Treatment fidelity (ratio)
时间窗: 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.
次要结局
- Drug-Related Crime Frequency (Count)(6-months post-release from prison)
- Drug Related Crime (Binary)(6-months post-release from prison)
- Substance-Related Disciplinary Violations (Count)(Interval between treatment completion and release from incarceration, which could be as short as 1 day and as long as ~2 years)
- Drug Use Disorder Symptom Severity (Count)(3- and 6-months post-release from prison)
- Drug Use Disorder (Binary)(3- and 6-months post-release from prison)
- Depressive Symptom Severity (Sum)(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)(3- and 6-months post-release from prison)
- Alcohol Use (Binary)(3- and 6-months post-release from prison)
- Alcohol Use Disorder Symptom Severity (Count)(3- and 6-months post-release from prison)
- Alcohol Use Disorder (Binary)(3- and 6-months post-release from prison)
- Substance-Related Disciplinary Violations (Binary)(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)(3- and 6-months post-release from prison)
- Treatment Acceptability (mean)(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)(Administered at post-treatment assessment, which will be completed ~2 weeks after treatment ends)
- Treatment appropriateness (mean)(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)(Immediately and 12-months post-implementation)
- Treatment adoption (ratio)(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)(1-year post-implementation)