Combination Treatment for PTSD After the WTC Attack

描述(由申请人提供)：创伤后应激障碍(PTSD)是一种普遍存在的疾病，具有很高的致残率和共患率。最近在大纽约地区的调查表明，由于严重暴露在世贸中心袭击事件中，仍有数千例与9/11有关的创伤后应激障碍病例。先前的研究表明，行为疗法(长期暴露)和最近的5-羟色胺再摄取抑制剂(SSRI)对高度慢性PTSD都有效。然而，由于这种规模的恐怖行为，人们对创伤后应激障碍患者的治疗反应知之甚少。此外，还没有研究具体检查这些治疗方法在创伤后应激障碍患者中的组合。来自行为治疗和药物研究的对照试验表明，相当大比例的慢性创伤后应激障碍患者从治疗中受益，但仍有症状和功能受损。到目前为止，还没有系统地研究药物治疗与行为治疗相结合的研究，尽管这种方法在临床实践中被广泛推荐。因此，这项研究将检验在行为治疗的同时提供SSRI治疗的价值。首要目标是研究成人慢性创伤后应激障碍的治疗反应最大化。 参与者将是100名患有与世贸中心袭击相关的创伤后应激障碍的成年人。所有患者将被随机分配到接受暴露治疗10次加帕罗西汀，或暴露治疗10次加安慰剂。对随机状态视而不见的独立评估者将在基线、第5周和第10周进行主要评估。接受治疗的应答者将继续服用避孕药/安慰剂12周，在第14周、第18周和第22周进行评估。评估的重点将是创伤后应激障碍症状、一般功能、人际关系问题以及共病的焦虑和抑郁症状。 这项研究有几个优点。它研究了在患有慢性创伤后应激障碍(大规模恐怖袭击的受害者)的新人群中，两种具有成本效益的、有效的、互补的治疗方法的组合。然后，它检查福利是否仍然存在，甚至在维护阶段是否继续积累。研究结果可能会通过最大化治疗这种严重和常见的精神疾病的反应来促进公众健康。

DESCRIPTION (provided by applicant): Posttraumatic Stress Disorder (PTSD) is a prevalent condition with high rates of disability and comorbidity. Recent surveys in the greater New York area suggest that there still thousands of 9/11-related cases of PTSD due to the severe exposure to the World Trade Center Attack. Previous research has shown that both behavior therapy (prolonged exposure) and, more recently, serotonin reuptake inhibitors (SSRIs), are effective for highly chronic PTSD. However, very little is known about treatment response in individuals with PTSD due to a terrorist act of this scale. In addition, no study has specifically examined the combination of these treatments in individuals with PTSD. Controlled trials from both behavior therapy and medication studies suggest that a substantial proportion of individuals with chronic PTSD benefit from treatment but remain symptomatic and functionally impaired. There are no studies to date that systematically investigate the combination of medication treatment with behavior therapy, although this approach is widely recommended in clinical practice. This study would therefore examine the value of providing SSRI treatment simultaneously with behavior therapy. The overarching goal is the study of maximization of treatment response for adults with chronic PTSD. Participants will be 100 adults with World Trade Center Attack related PTSD. All patients will be randomly assigned to receive either 10 sessions of exposure therapy plus paroxetine, or 10 sessions of exposure therapy plus placebo. Major assessments by an independent evaluator blind to randomization status will be conducted at baseline, week 5, and week 10. Responders to treatment will be continued on pill/placebo for an additional 12 weeks with assessments at week 14, week 18, and week 22. Assessments will focus on PTSD symptoms, general functioning, interpersonal problems, and comorbid anxiety and depressive symptoms. This study possesses several strengths. It examines the combination of two cost-effective, validated, complementary treatments in a new population with chronic PTSD (victims of a large scale terrorist attack). It then examines whether benefits remain or even continue to accrue through a maintenance phase. Findings may enhance public health through the study of maximization of treatment response for this serious and common psychiatric disorder.