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Combination Treatment for PTSD After the WTC Attack

世贸中心袭击后 PTSD 的联合治疗

基本信息

批准号：
7426931
负责人：
Franklin R. Schneier
金额：
$ 43.52万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-04-01 至 2010-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7426931
关键词：
Accidents Acute Adult Air Anthrax disease Anxiety Area Behavior Therapy Characteristics Chronic Clinical Clinical Trials Combination Medication Communities Comorbidity Complex Condition Conflict (Psychology)Consensus Controlled Study Data Disasters Disease Domestic Violence Double-Blind Method Exposure to Family member Forcible intercourse Fright Goals Grant Grief reaction Individual Knowledge Maintenance Marshal Measures Mental Depression Mental disorders Middle East New York Numbers Paroxetine Participant Patients Persons Pharmaceutical Preparations Phase Placebos Population Post-Traumatic Stress Disorders Procedures Psychopathology Psychotherapy Public Health Quality of life Randomized Rate Recommendation Refugees Research Schedule Score Selective Serotonin Reuptake Inhibitor Sensitivity and Specificity Severities Silver Subway Surveys Symptoms Syndrome Terrorism Testing Trauma Travel Treatment outcome Violence War Week Work acute stress acute traumatic stress disorder automobile accident base blind capsule clinically significant cost day depressive symptoms design disability experience improved novel pill psychosocial response stress related disorder

项目摘要

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.

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，其致残和合并症的发生率很高。最近在大纽约地区的调查表明，由于世贸中心袭击事件的严重影响，仍有数千起与 9/11 相关的创伤后应激障碍 (PTSD) 病例。先前的研究表明，行为疗法（长期暴露）和最近的血清素再摄取抑制剂（SSRI）对高度慢性 PTSD 有效。然而，由于如此规模的恐怖行为，人们对创伤后应激障碍患者的治疗反应知之甚少。此外，还没有研究专门检验这些治疗方法对 PTSD 患者的联合作用。行为疗法和药物研究的对照试验表明，相当一部分慢性创伤后应激障碍患者从治疗中受益，但仍然存在症状和功能受损。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，本研究将探讨同时提供 SSRI 治疗和行为疗法的价值。总体目标是研究慢性创伤后应激障碍 (PTSD) 成人治疗反应的最大化。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 次暴露疗法加帕罗西汀，或 10 次暴露疗法加安慰剂。不知道随机状态的独立评估员将在基线、第 5 周和第 10 周进行主要评估。对治疗有反应的患者将继续服用药物/安慰剂 12 周，并在第 14 周、第 18 周和第 22 周进行评估。评估将侧重于 PTSD 症状、一般功能、人际关系问题以及共病焦虑和抑郁症状。这项研究有几个优点。它研究了两种具有成本效益、经过验证的补充疗法在患有慢性创伤后应激障碍（PTSD）的新人群（大规模恐怖袭击的受害者）中的组合。然后，它会检查在维护阶段是否仍然存在甚至继续产生效益。通过研究这种严重且常见的精神疾病的治疗反应最大化，研究结果可能会增强公众健康。