A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

创伤后应激障碍 (PTSD) 和药物依赖同时治疗的随机试验

• 批准号: 8099421
• 负责人: DENISE AIMEE HIEN
• 金额: $ 55.17万
• 依托单位: CITY COLLEGE OF NEW YORK
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8099421
• 关键词: Address; Adult; Aftercare; Alcohol or Other Drugs use; Area; Arousal; Behavior Therapy; Childhood; Clinical; Clinical Research; Clinical Trials; Cognitive Therapy; Comorbidity; Complex; Crime; Data; Development; Diagnosis; Dose; Dropout; Epidemiologic Studies; Fright; Future; High Prevalence; Hospitals; Individual; Investigation; Knowledge; Lead; Measures; Mediator of activation protein; Modality; Modeling; Nature; Neurobiology; New York City; Outcome; Participant; Pathway interactions; Patient Self-Report; Patients; Physiological; Physiological Processes; Population; Population Study; Post-Traumatic Stress Disorders; Procedures; Qualifying; Randomized; Randomized Clinical Trials; Recruitment Activity; Relapse; Relative (related person); Research; Severities; Sexual abuse; Skin; Staging; Substance Addiction; Substance Use Disorder; Substance abuse problem; Symptoms; Techniques; Testing; Trauma; Treatment outcome; United States; Victimization; Violence; Work; active method; arm; base; comparison group; craving; design; disorder later incidence prevention; emotion regulation; experience; improved; meetings; physical assault; primary outcome; psychologic; randomized trial; response; secondary outcome; sexual assault; therapy development; treatment trial

DESCRIPTION (provided by applicant): Nearly two decades of epidemiological and clinical studies have documented the staggering rates of comorbidity between trauma exposure and substance use, as well as the high rates of PTSD comorbidity. However, treatments which effectively address these complex symptoms are still at an early stage of development. This study will enhance the knowledge and understanding of concurrently treating individuals with substance use disorders and PTSD in hopes of facilitating treatment retention and increasing the likelihood for more positive treatment outcomes. Following NIDA's stage model for behavior therapies development, this study will take the next step building upon promising findings from Stage IA work with an exposure-based therapy modified to use safely with substance dependent individuals. The first aim of this Stage1B clinical trial is to modify and test an exposure-based treatment for individuals with substance use disorder and comorbid PTSD. Using a two-armed randomized design, the proposed clinical trial will assess the relative efficacy of: 1) Concurrent Treatment of PTSD and Substance Dependence (CTPSD) which incorporates exposure techniques with CBT, and 2) Relapse Prevention Treatment (RPT). Participants will be recruited from the greater New York City area, with study procedures taking place at St. Luke's\Roosevelt Hospital Center. Treatment will consist of 12 individual sessions with repeated measures at baseline, end of treatment, and 1-, 2- and 3-months post-treatment. The primary outcome is PTSD symptom severity. Secondary outcomes are (2a) substance abuse severity, (2b) global psychiatric symptom severity, and (2c) treatment retention and compliance. The third exploratory aim of the proposed trial is to test the potential mechanisms of action in the respective treatments. Based on findings regarding the neurobiology of trauma, we hypothesize that emotion regulation and related physiological processes are predictive of treatment outcome. We will test for mediator and moderator effects using both subjective (self-report) and objective (electrodermal skin fluctuation) measures. The fourth exploratory aim of the proposed trial is to explore pathways between the comorbid PTSD and SUD diagnoses and how they may change through the course of treatment. The proposed study has the particular advantages of building directly on positive preliminary Stage IA empirical findings by (1) further testing exposure therapy in individuals with PTSD and SUDs using a randomized design with an active treatment comparison group, (2) measuring emotion regulation and physiological arousal with both subjective and objective measures, as well as measuring PTSD and SUD outcomes, and (3) utilizing a multi-disciplinary team of experts who have successfully collaborated in the past and are uniquely qualified to design and implement this type of investigation.

描述（由申请人提供）：将近二十年的流行病学和临床研究证明了创伤暴露与使用物质之间的合并症的惊人率以及PTSD合并症的高率。但是，有效解决这些复杂症状的治疗仍处于发展的早期阶段。这项研究将增强对使用药物使用障碍和PTSD同时治疗个体的知识和理解，以期促进治疗保留率并增加更大的阳性治疗结果的可能性。遵循NIDA的行为疗法开发模型，本研究将在IA阶段工作的有希望的发现中进行下一步的基础，并通过基于暴露的治疗进行了修改以安全地与依赖物质的人一起使用。该阶段1b临床试验的第一个目的是修改和测试针对具有药物使用障碍和合并症患者的基于暴露的治疗方法。使用两臂随机设计，拟议的临床试验将评估以下方面的相对疗效：1）同时处理PTSD和物质依赖性（CTPSD），该依赖性（CTPSD）与CBT结合了暴露技术，以及2）预防复发治疗（RPT）。参与者将从大纽约地区招募，并在圣卢克\罗斯福医院中心进行学习程序。治疗将包括12个单独的课程，并在基线，治疗结束以及1个月和3个月后进行重复测量。主要结果是PTSD症状严重程度。次要结果是（2a）药物滥用严重程度，（2B）全球精神病症状严重程度以及（2C）治疗保留和依从性。该试验的第三个探索目的是测试各自处理中的潜在作用机理。根据有关创伤神经生物学的发现，我们假设情绪调节和相关的生理过程可以预测治疗结果。我们将使用主观（自我报告）和客观（电皮肤波动）措施来测试调解人和主持人效应。拟议试验的第四个探索目的是探索合并症PTSD和SUD诊断之间的途径，以及它们在治疗过程中如何改变。拟议的研究具有直接基于积极初步初步IA经验发现的特殊优势，该发现通过（1）使用随机设计进行了PTSD和SUD的进一步测试暴露疗法，并使用积极的治疗比较组进行随机设计，（2）测量情绪调节和生理学的良好和客观测量和客观测量，以及衡量PTSD和SUD UPI，以及SUD-upi-upi-auti and auti andicl and auti-upi and auti-upi and auti andicl and auti-upi andim andi andi comecoms，以及33），以及33的范围，以及33的范围，以及3个），以及（3）。过去成功合作并且具有设计和实施此类调查的专家。