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.

项目概要/摘要 相当一部分患有酒精使用障碍 (AUD) 的人也符合创伤后应激障碍标准 障碍（创伤后应激障碍）。 AUD/PTSD 同时发生的特点是症状更严重、发病率更高 与任何一种疾病相比，功能障碍、自杀风险增加以及治疗结果较差 独自的。以创伤为重点的认知行为干预措施与物质使用干预措施同时进行 疾病对于减轻 PTSD 严重程度和药物使用最有效。认知加工疗法（CPT） PTSD 治疗和 AUD 复发预防 (RP) 是两种最广泛使用和有效的行为治疗方法 针对这些情况的治疗。研究人员成功开发并试点测试了治疗手册 将 CPT 与 RP 结合起来。初步数据表明安全性、可行性、高保留率（80.0%）和 患者满意度。此外，我们的数据来自最近对一线心理健康服务提供者进行的一项全国调查（N = 76) 表明 CPT 是针对 PTSD 最常用的针对创伤的治疗方法，并且提供者高度重视 对综合 CPT-RP 干预感兴趣，赋予其在现实世界实践中采用的强大潜力 设置。事实上，由于缺乏可用的、凭经验开发的手动 CPT-RP 治疗，84.0% 一线医疗服务提供者报告称，他们正在尝试自己创造一种用于患者的治疗方法。这可能 导致实施和结果高度可变且次优。响应提供商的意见和积极的 根据初步数据，拟议的研究通过评估新的综合 CPT- 直接解决了这一关键需求 对同时患有 AUD 和 PTSD 的个体进行 RP 治疗。目前，只有一种以创伤为重点的综合性治疗 可针对 AUD/PTSD 进行干预，并使用长期暴露 (PE) 来减轻 PTSD 症状。在 与 PE 相比，CPT 的应用更为广泛，通常受到临床医生的青睐，在减少 PTSD 方面同样有效 症状，并与较低的辍学率相关。因此，新的 CPT-RP 干预措施可能具有更广泛的影响 比基于暴露的治疗具有更高的可接受性。治疗选择与治疗改善有关 因此，迫切需要增加基于证据的、以创伤为重点的、 AUD/PTSD 的综合治疗。该第二阶段研究的主要目的是检验以下药物的功效： 与单独 RP 相比，CPT-RP 可以减少 (1) 饮酒频率和数量以及 (2) PTSD 症状 当前患有 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、随机研究设计以及临床结果的标准化重复相关测量 多个时间点。行为改变的假定机制将通过日常监测进行评估。这 拟议的研究与 NIAAA 的使命密切相关，因为它旨在产生最有效的 针对 AUD 和共病精神疾病（如 PTSD）的行为干预。这项研究的结果 将提供新信息来推进 AUD/PTSD 合并症的科学发展并创新临床实践。