2/2-Optimizing PTSD Treatments

描述（申请人提供）：虽然药物和心理疗法在治疗慢性创伤后应激障碍（PTSD）方面都相对有效，但最近的医学研究所（国际移民组织，2007年）的报告强调了我们目前知识的巨大差距，指出缺乏对影响接受和完成治疗的因素的了解，这些药理学和心理学治疗的组合效果，以及它们在常见亚群（例如，具有诊断共现的那些）。为了解决这些差距，我们提出了第一个大规模的试验，直接集中在个性化的创伤后应激障碍治疗的几个关键参数：治疗的选择，心理治疗和药物治疗的影响，以及共同发生的严重抑郁症的存在。在我们之前关于PTSD治疗的心理治疗和药物治疗试验的基础上，我们将进行一项双重随机偏好试验，其中患有慢性PTSD的女性和男性创伤幸存者将被随机分配到选择或无选择的治疗条件。在选择条件下，患者将在长期暴露（PE）和长期暴露加舍曲林（PE + SER）之间进行选择。在无选择条件下，患者将被随机分配至单独延长暴露（PE）或延长暴露加舍曲林（PE + SER）组。此外，我们将专门招募和检查合并重度抑郁症（MDD）的患者。将在治疗后和24个月随访时评估通过精神病理学和更广泛的功能指标测量的结局。我们还将研究反应的生物心理社会标志物，心理治疗的变化过程，以及这些治疗的成本效益。具体目标是：1）比较PE与PE + SER的短期和长期有效性; 2）系统地比较选择治疗的患者与未选择治疗的患者在治疗依从性、治疗完成情况和有效性方面的差异; 3）比较单独患有PTSD的患者与合并有PTSD和重度抑郁症的患者。根据NIMH的战略计划，该提案侧重于更加个性化的医疗，重点是患者的选择和更好地了解个人的结果轨迹。

DESCRIPTION (provided by applicant): Although it is well established that both pharmacological and psychological therapies are relatively effective in treating chronic posttraumatic stress disorder (PTSD), the recent Institute of Medicine (IOM, 2007) report highlights vast gaps in our current knowledge noting a lack of knowledge regarding factors influencing treatment acceptance and completion, the combined effectiveness of these pharmacological and psychological treatment, and their efficacy in common subpopulations (e.g., those with diagnostic co-occurrence). To address these gaps, we propose the first large-scale trial to directly focus on individualizing PTSD care across several key parameters: choice of treatment, the effects of combined psychotherapy and pharmacological PTSD treatment, and the presence of co-occurring major depression. Building on our previous psychotherapy and pharmacotherapy trial on PTSD treatment, we will conduct a doubly randomized preference trial in which female and male trauma survivors with chronic PTSD will be randomly assigned to either choice or no choice treatment conditions. In the choice condition, patients will choose between prolonged exposure (PE) and prolonged exposure plus sertraline (PE + SER). In the no choice condition, patients will be randomly assigned to either prolonged exposure alone (PE) or prolonged exposure plus sertraline (PE + SER). In addition, we will specifically recruit and examine patients with co-occurring major depressive disorder (MDD). Outcome, as measured by both psychopathology and broader functioning measures, will be assessed at post-treatment and through 24-month follow-up. We will also examine biopsychosocial markers of response, psychotherapy change processes, and cost-effectiveness of these treatments. The Specific Aims are: 1) To compare the short-term and long-term effectiveness of PE to that of PE + SER; 2) To systematically compare patients who have chosen their treatment to those who have not in terms of treatment adherence, treatment completion, and effectiveness; and 3) To compare individuals with PTSD alone to those with PTSD and co-occurring major depression. In line with the NIMH's strategic plan, this proposal focuses on more personalized medicine, focusing on patients' choices and better understanding individual trajectories of outcome.