Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial

项目摘要/摘要 相当大比例的酒精使用障碍(AUD)患者也符合创伤后应激障碍的标准 精神障碍(PTSD)。AUD/PTSD并存的特点是症状更严重， 与任何一种障碍相比，功能障碍、自杀风险增加和较差的治疗结果 独自一人。在药物使用干预的同时，提供以创伤为重点的认知行为干预 精神障碍在降低创伤后应激障碍的严重程度和药物使用方面最为有效。认知加工疗法(CPT) 对于创伤后应激障碍和针对AUD的复发预防(RP)是两种最广泛使用和有效的行为 针对这些情况的治疗。研究人员成功地开发并试行了一份治疗手册 将CPT与RP相结合。初步数据显示安全、可行、高保留率(80.0%)和 病人满意度。此外，我们的数据来自最近对一线精神健康提供者的全国调查(N= 76)表明CPT是创伤后应激障碍最常用的创伤重点治疗方法，提供者高度重视 对CPT-RP综合干预感兴趣，在现实世界实践中具有很强的吸收潜力 设置。事实上，由于缺乏可用的、经验性开发的、机械化的CPT-RP治疗，84.0%的 前线提供者报告说，他们试图自己创造这样一种治疗方法，用于他们的患者。今年5月 这将导致高度多变和次优的实施和结果。响应于提供商输入和肯定 初步数据，建议的研究通过评估一种新的综合CPT直接满足这一关键需求-- 对并发AUD和PTSD的个体进行RP治疗。目前只有一家专注于创伤，综合性的 对AUD/PTSD可进行干预，它使用长时间暴露(PE)来减少PTSD症状。在……里面 与PE相比，CPT的应用范围更广，通常是临床医生的首选，在减少创伤后应激障碍方面同样有效 症状，并与较低的辍学率有关。因此，新的CPT-RP干预可能会有更广泛的影响 而且比基于暴露的治疗更容易被接受。治疗的选择与改进的治疗有关 结果，因此，迫切需要增加以证据为基础、以创伤为重点、 AUD/PTSD的综合治疗。这项第二阶段研究的主要目标是检查 与单纯使用RP相比，CPT-RP可减少(1)饮酒次数和饮酒量，(2)减少PTSD症状 目前患有澳大利亚/创伤后应激障碍的个人的严重程度。为了实现这一点，我们将使用一个 临床结果的干预、随机研究设计和标准化重复相关性测量 多个时间点。行为改变的可能机制将通过日常监测进行评估。这个 拟议的研究与NIAAA的使命密切一致，因为它的目标是产生最大限度的有效 对AUD和诸如创伤后应激障碍等共病精神障碍的行为干预。这项研究的发现 将为促进AUD/PTSD共病的科学研究和创新临床实践提供新的信息。

PROJECT SUMMARY/ABSTRACT A substantial proportion of individuals with alcohol use disorder (AUD) also meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of AUD/PTSD is characterized by more severe symptomatology, greater functional impairment, increased suicide risk, and poorer treatment outcomes as compared to either disorder alone. Trauma-focused, cognitive-behavioral interventions delivered alongside interventions for substance use disorders are most effective in reducing PTSD severity and substance use. Cognitive Processing Therapy (CPT) for PTSD and Relapse Prevention (RP) for AUD are two of the most widely used and efficacious behavioral treatments for these conditions. The investigators successfully developed and pilot tested a therapy manual that combines CPT with RP. The preliminary data demonstrate safety, feasibility, high rates of retention (80.0%) and patient satisfaction. Moreover, our data from a recent national survey of frontline mental health providers (N = 76) indicate that CPT is the most commonly used trauma-focused treatment for PTSD and providers are highly interested in an integrative CPT-RP intervention, conferring strong potential for uptake in real-world practice settings. In fact, due to the lack of an available, empirically developed, manualized CPT-RP treatment, 84.0% of frontline providers report attempting on their own to create such a treatment to use with their patients. This may result in highly variable and suboptimal implementation and outcomes. In response to provider input and positive preliminary data, the proposed study directly addresses this critical need by evaluating a new integrative CPT- RP treatment for individuals with co-occurring AUD and PTSD. At present, only one trauma-focused, integrative intervention is available for AUD/PTSD and it uses Prolonged Exposure (PE) to reduce PTSD symptoms. In comparison to PE, CPT is more widely used, often preferred by clinicians, equally as effective in reducing PTSD symptoms, and associated with lower dropout rates. Thus, the new CPT-RP intervention could have wider reach and greater acceptability than exposure-based treatments. Treatment choice is related to improved treatment outcomes, and therefore, there is an immediate need to add to the portfolio of evidence-based, trauma-focused, integrative treatments for AUD/PTSD. The primary objective of this Stage II study is to examine the efficacy of CPT-RP, as compared to RP alone, in reducing (1) alcohol use frequency and quantity and (2) PTSD symptom severity among individuals with current AUD/PTSD. To accomplish this, we will employ a manualized intervention, randomized study design, and standardized repeated dependent measures of clinical outcomes at multiple time points. Putative mechanisms of behavior change will be evaluated via daily monitoring. The proposed study aligns closely with the mission of NIAAA in that it aims to produce maximally efficacious behavioral interventions for AUD and comorbid psychiatric disorders such as PTSD. The findings from this study will provide new information to advance the science of AUD/PTSD comorbidity and innovate clinical practice.