Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault

摘要 拟议的以患者为导向的导师研究职业发展奖的总体目标 (K23)是为了支持克里斯汀·哈恩博士获得成为独立调查员所需的技能 有一个研究计划，重点是开发酒精使用障碍(AUD)的干预措施和 精神疾病，特别是创伤后应激障碍(PTSD)。AUD和PTSD频繁发生 在经历过创伤性生活事件(如性侵犯)的人中共同发生。缺少这样一个人 然而，建立了以证据为基础的干预措施，以减少最近受害者中的澳元和创伤后应激障碍。这个 拟议的研究直接解决了这一临床差距，通过测试两种基于证据的、 对AUD和PTSD的认知行为干预将在六周内分五次进行 在性侵犯之后。在第一阶段，我们将使用专家通知的迭代流程调整干预 反馈。在第二阶段，我们将进行一项开放标签试验(n=10)，以最终确定治疗方案。在第三阶段， 我们将在54名最近的性侵犯受害者中使用该治疗方案进行试点随机对照试验 评价AUD在减轻创伤后应激障碍严重程度和PTSD症状方面的可行性和初步疗效。生态 瞬时评估(EMA)将被用来评估在五周的时间里酒精的使用、渴望和影响 治疗阶段。应聘者组建了一支经验丰富的导师团队，他们在澳元、创伤后应激障碍、 性侵犯、心理治疗发展、临床试验和生态瞬时评估。现场 导师(苏迪·贝克博士、凯瑟琳·布雷迪博士、迈克尔·萨拉丁博士)在发展和 对并发的AUD和PTSD进行行为和药物干预的临床试验。Dr。 萨拉丁在成瘾研究的实时数据收集方法方面拥有专业知识。场外导师(芭芭拉博士 埃默里大学的罗斯鲍姆和波士顿大学的布莱恩·马克思博士)将就早期、 为减少性侵犯后的AUD和创伤后应激障碍症状而进行的简短干预。正式的导师关系 K23奖项所提供的课程作业、研讨会和全国会议将确保 应聘者实现以下职业目标：(1)获得AUD机制和干预方面的新知识； (2)培养设计和实施AUD和伴发创伤后应激障碍的临床试验的技能；(3)增加 具有多层次和纵向数据分析的统计技能；(4)加强对研究伦理的理解； 以及(5)通过手稿写作、专业演示和资助来继续专业发展 写作。候选人将在南卡罗来纳医科大学完成拟议的K23活动， 它在致力于推进AUD早期调查人员方面有着良好的记录。这个 拟议的K23活动最终将使哈恩博士做好准备，领导一个严格设计的AUD治疗计划 结果研究。

ABSTRACT The overall objective of the proposed Mentored Patient-Oriented Research Career Development Award (K23) is to support Dr. Christine Hahn in acquiring the skills necessary to become an independent investigator with a program of research focused on the development of interventions for alcohol use disorder (AUD) and comorbid mental health conditions, in particular posttraumatic stress disorder (PTSD). AUD and PTSD frequently co-occur among people who experience traumatic life events, such as sexual assault. There is a lack of established evidence-based interventions, however, to reduce AUD and PTSD among recent victims. The proposed study directly addresses this clinical gap by testing the novel integration of two, evidence-based, cognitive-behavioral interventions for AUD and PTSD to be delivered in five sessions beginning in the six weeks following sexual assault. In Phase 1, we will adapt the intervention using an iterative process informed by expert feedback. In Phase 2, we will conduct an open label trial (n = 10) to finalize the treatment protocol. In Phase 3, we will use the treatment protocol in a pilot randomized controlled trial among 54 recent sexual assault victims to evaluate feasibility and preliminary efficacy in reducing AUD severity and PTSD symptoms. Ecological momentary assessments (EMA) will be used to assess alcohol use, craving, and affect during the five-week treatment phase. The candidate has assembled a team of experienced mentors with expertise in AUD, PTSD, sexual assault, psychotherapy development, clinical trials, and ecological momentary assessment. On-site mentors (Drs. Sudie Back, Kathleen Brady, Michael Saladin) have extensive knowledge in developing and conducting clinical trials of behavioral and pharmacological interventions for co-occurring AUD and PTSD. Dr. Saladin has expertise in real-time data collection methods in addiction research. Off-site mentors (Dr. Barbara Rothbaum at Emory University and Dr. Brian Marx at Boston University) will provide additional guidance on early, brief interventions to reduce AUD and PTSD symptoms following sexual assault. The mentorship, formal coursework, seminars, and national conference attendance afforded by the K23 award will ensure that the candidate achieves the following career goals: (1) Gain new knowledge in AUD mechanisms and interventions; (2) Develop skills in designing and implementing clinical trials for AUD and co-occurring PTSD; (3) Increase statistical skills with multilevel and longitudinal data analyses; (4) Enhance understanding of research ethics; and (5) Continue professional development through manuscript writing, professional presentations, and grant writing. The candidate will complete the proposed K23 activities at the Medical University of South Carolina, which has a strong track record of commitment to the advancement of early stage AUD investigators. The proposed K23 activities will ultimately prepare Dr. Hahn to lead a program of rigorously-designed AUD treatment outcome research.