Combination Treatment for PTSD After the WTC Attack

描述（由申请人提供）：创伤后应激障碍（PTSD）是一种具有高致残率和合并症的普遍疾病。最近在大纽约地区进行的调查显示，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（长时间暴露）和最近的血清素再摄取抑制剂（SSRIs）对高度慢性创伤后应激障碍有效。然而，对于这种规模的恐怖主义行为对PTSD患者的治疗效果知之甚少。此外，还没有研究专门检查过这些治疗在PTSD患者身上的结合。行为疗法和药物研究的对照试验表明，很大一部分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。虽然这种方法在临床实践中被广泛推荐，但迄今为止还没有研究系统地调查药物治疗与行为治疗的结合。因此，本研究将检验同时提供SSRI治疗和行为治疗的价值。总体目标是研究成人慢性创伤后应激障碍的治疗反应最大化。

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.