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

认知处理疗法与酒精使用障碍和并发 PTSD 复发预防的整合：一项随机临床试验

• 批准号: 10934633
• 负责人: SUDIE E BACK
• 金额: $ 71.15万
• 依托单位: TEXAS A&M UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10934633
• 关键词: Address; Aftercare; Age; Alcohol consumption; Alcohols; Area; Back; Behavior; Behavior Therapy; Behavioral Mechanisms; Biological Markers; Client satisfaction; Clinical; Cognition; Cognitive; Cognitive Therapy; Collaborations; Combined Modality Therapy; Complex; Data; Disease; Dropout; Ecological momentary assessment; Event; Evidence based treatment; Expenditure; Exposure to; Feeling hopeless; Feeling suicidal; Frequencies; Guilt; Health Personnel; Individual; Integrative Therapy; Intervention; Intoxication; Investigation; Manuals; Measures; Memory; Mental Health; Mental disorders; Mission; Monitor; National Institute on Alcohol Abuse and Alcoholism; Outcome; Participant; Patient Self-Report; Patient-Focused Outcomes; Patients; Post-Traumatic Stress Disorders; Protocols documentation; Provider; Public Health; Qualifying; Randomized; Reporting; Research; Research Design; Research Personnel; Safety; Science; Severities; Standardization; Strategic Planning; Substance Use Disorder; Surveys; Symptoms; Testing; Time; Trauma; Treatment outcome; Visit; Work; alcohol use disorder; behavior change; clinical outcome measures; clinical practice; combat injury; comorbidity; design; distress tolerance; drinking; effective therapy; efficacy evaluation; efficacy testing; evidence base; experience; follow-up; functional disability; implementation outcomes; improved; innovation; interest; intervention effect; negative emotional state; novel; pilot test; practice setting; preventive intervention; psychiatric comorbidity; randomized, clinical trials; reduce symptoms; reduced alcohol use; relapse prevention; response; retention rate; substance use; suicidal risk; symptomatology; targeted treatment; timeline; trauma exposure; traumatic event; treatment choice; uptake

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.

项目摘要/摘要 相当一部分酒精使用障碍（AUD）患者也符合创伤后应激障碍的标准 PTSD（PTSD）。AUD/PTSD的共同发生的特征是更严重的精神病学，更大的 功能障碍、自杀风险增加和治疗结果较差 一个人以创伤为重点的认知行为干预措施与物质使用干预措施一起提供 在降低PTSD严重程度和物质使用方面最有效。认知加工疗法（CPT） PTSD和AUD的复发预防（RP）是两种最广泛使用和有效的行为治疗方法， 治疗这些条件。研究人员成功地开发和试点测试了治疗手册， 结合CPT和RP。初步数据证明了安全性、可行性、高保留率（80.0%）和 患者满意度。此外，我们最近对一线心理健康提供者进行的全国性调查的数据（N = 100）表明， 76)表明CPT是最常用的创伤为重点的治疗PTSD和供应商高度 对综合CPT-RP干预感兴趣，在现实世界的实践中具有很强的吸收潜力 设置.事实上，由于缺乏可用的，经验开发的，手动CPT-RP治疗，84.0%的 一线提供者报告说，他们自己试图创造这样的治疗方法来用于他们的病人。这可能 导致执行和结果高度可变和次优。根据供应商的输入和积极的 初步数据，拟议的研究直接解决了这一关键需求，通过评估一个新的综合CPT- RP治疗合并AUD和PTSD的个体。目前，只有一种以创伤为重点的、综合的 对AUD/PTSD进行干预，并使用延长暴露（PE）来减少PTSD症状。在 与PE相比，CPT使用更广泛，通常被临床医生首选，在减少PTSD方面同样有效 症状，并与较低的辍学率。因此，新的CPT-RP干预措施可能会有更广泛的影响， 和更大的可接受性。治疗选择与改善治疗有关 结果，因此，迫切需要增加以证据为基础，以创伤为重点， AUD/PTSD的综合治疗第二阶段研究的主要目的是研究 CPT-RP与RP单独使用相比，减少（1）酒精使用频率和数量以及（2）PTSD症状 目前患有AUD/PTSD的个体的严重程度。为了实现这一目标，我们将采用手动 干预、随机研究设计和临床结局的标准化重复依赖性测量， 多个时间点。将通过日常监测评价行为变化的假定机制。的 拟议的研究与NIAAA的使命密切相关，因为它的目的是产生最有效的 行为干预AUD和共病精神障碍如PTSD。这项研究的结果 将为推进AUD/PTSD共病科学和创新临床实践提供新的信息。