Combination Treatment for PTSD After the WTC Attack

描述（由申请人提供）：创伤后应激障碍（PTSD）是一种流行的疾病，残疾和合并症的发生率很高。最近在大纽约地区进行的调查表明，由于严重暴露于世贸中心袭击事件，仍有数千例与9/11有关的创伤后应激障碍病例。以前的研究表明，行为疗法（长期暴露）和最近的血清素再摄取抑制剂（SSRIs）对高度慢性PTSD有效。然而，由于这种规模的恐怖行为，人们对PTSD患者的治疗反应知之甚少。此外，没有研究专门研究这些治疗在PTSD患者中的组合。来自行为疗法和药物研究的对照试验表明，相当一部分慢性PTSD患者从治疗中获益，但仍有症状和功能受损。迄今为止，还没有研究系统地研究药物治疗与行为疗法的结合，尽管这种方法在临床实践中被广泛推荐。因此，本研究将探讨SSRI治疗与行为疗法同时提供的价值。总体目标是研究慢性PTSD成人的治疗反应最大化。 参与者将是100名患有世贸中心袭击相关PTSD的成年人。所有患者将被随机分配接受10次暴露治疗加帕罗西汀或10次暴露治疗加安慰剂。将在基线、第5周和第10周由不了解随机化状态的独立评价者进行主要评估。治疗应答者将继续服用药丸/安慰剂额外12周，并在第14周、第18周和第22周进行评估。评估将集中在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。它研究了两种具有成本效益的，经过验证的，补充性治疗方法在慢性PTSD（大规模恐怖袭击的受害者）的新人群中的组合。然后，它检查是否仍然存在，甚至继续通过维护阶段积累的好处。研究结果可能会通过对这种严重和常见的精神疾病的最大化治疗反应的研究来加强公共卫生。

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.