PTSD Treatment for Incarcerated Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- PTSD-Checklist-5 (PCL-5)
研究概览
简要总结
There is a particular need for more effective treatments for post-traumatic stress disorder (PTSD) within the incarcerated population. The prevalence of trauma history and PTSD are markedly higher in jail and prison populations than in the general population, with estimates of current PTSD prevalence among prison inmates exceeding 20%, as opposed to 3-6% in the general population. Cognitive Processing Therapy (CPT) is a potentially promising PTSD treatment for the prison setting.
The primary objectives of this project include:
- Establish the feasibility of group CPT delivery in male and female prisons with PTSD by examining participant retention in the 12-week course;
- Obtain preliminary efficacy estimates for reducing PTSD symptom severity, as well as secondary symptoms associated with trauma, including depression, hopelessness, self-blame, and negative self-related thoughts.
详细描述
PTSD is associated with an increased risk for crime-related behaviors, such as violence and substance abuse. There is virtually no research examining the efficacy of empirically-supported therapies for PTSD in incarcerated individuals. Despite the patent need for more effective treatment strategies, there is scant translational research on PTSD in the criminal offender population, and no randomized controlled studies that have tested the efficacy of empirically-supported PTSD treatments in the prison setting. The treatment programs offered to prison inmates (across the United States, but particularly in Wisconsin) target specific, overt criminal behaviors (e.g., alcohol/drug use, violence, sexual offenses), rather than underlying psychopathology. Our program of research could usher a new paradigm of offender rehabilitation, by addressing the traumatic experiences and consequent psychopathology that predispose individuals to certain forms of maladaptive and criminal behavior.
Cognitive Processing Therapy (CPT) is a potentially promising PTSD treatment for the prison setting, primarily due to its cost- and time-effectiveness in the manualized group format. Individual (one-on-one) therapies such as Prolonged Exposure and Eye Movement Desensitization and Reprocessing are less likely to gain widespread implementation in prison systems, where therapist access is a major limitation. In addition, CPT is applicable to a wide range of individuals, such as those with minimal formal education, low intelligence (IQs), or comorbid psychiatric disorders. In studies of non-incarcerated individuals, CPT has been found to be more effective than wait-list control and equivalent to Prolonged Exposure. The majority of non-incarcerated individuals undergoing CPT for PTSD exhibit a clinically significant reduction in symptoms, with over 40% achieving a loss of the diagnosis. However, the generalizability of these findings to the offender population has not yet been determined. This research study will determine whether CPT is indeed an effective and feasible treatment for PTSD in inmates, or whether different treatment strategies need to be developed.
Hypotheses:
Regarding Aim 1, it is predicted that feasibility will be established by obtaining ≥80% participant retention for the CPT course. Additional metrics of feasibility will assess eligibility; participation; compliance; adherence; competence; and safety.
Regarding Aim 2, it is predicted that PTSD symptom reduction will be greater among CPT participants than waitlist control participants. Furthermore, it is predicted that reductions in depression, hopelessness, self-blame, and negative self-related thoughts will also be greater in the CPT group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM 5 criteria for current PTSD diagnosis
- •IQ greater than 70
- •Reading level of 5th grade or higher
- •No history of psychosis or dementia
- •Stable medication use (same medication for at least one month) if using medication
- •No scheduled transfer or release for at least 12 weeks (the duration of the intervention).
排除标准
- •Other vulnerable populations within the prison setting will not be eligible for participation, such as:
- •pregnant women
- •individuals who have English as a second language
- •those with visual or hearing impairments
- •individuals appearing to lack the capacity to provide informed consent
结局指标
主要结局
PTSD-Checklist-5 (PCL-5)
时间窗: 4 months
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Participants rate on a 0 ("not at all") - 4 ("Extremely") scale how bothered they have been by PTSD symptoms in the last month. Total scores range from 0-80.
Eligibility
时间窗: 3 months
Percentage of inmates who meet the full set of inclusion criteria.
Participation
时间窗: 4 months
Percentage of eligible inmates agreeing to participate in randomization into one of the two groups.
Retention
时间窗: 12 weeks
Percentage of inmates attending all 12 sessions.
Safety-Suicidal ideation item on the Beck Depression Inventory-II (BDI-II)
时间窗: 4 months
The BDI-II is a 21-item self-report questionnaire assessing symptoms of depression in the last 2-weeks. Each item is on a 0-3 scale, with higher scores indicative of greater symptom severity. Scores range from 0-63.
Compliance
时间窗: 4 months
Compliance will be measured in three ways: Percentage of retained inmates performing intervention activities during session (e.g., attending to and contributing to the discussion); the percentage of inmates completing the homework assignment each week; and the percentage of inmates fully completing the pre-, mid-, and post-intervention assessment batteries. All three measures of compliance will be reported individually. An overall metric of compliance will be calculated by averaging the three individual measures.
Adherence
时间窗: 12 weeks
Adherence will by measured by the presence or absence of five session elements (scores 0-5) by the clinical supervisors, as in previous CPT studies.
Competence
时间窗: 12 weeks
Ratings of the quality of session elements (scores 1-7; 1="not satisfactory", 4="satisfactory", 7="excellent") by the clinical supervisors, as in previous CPT studies
次要结局
- Posttraumatic Cognition Inventory (PCTI)(4 months)
- Beck Hopelessness Scale (BHS)(4 months)
- Beck Depression Inventory (BDI-II)(4 months)
