Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder

描述（由申请人提供）：失眠是接受创伤后应激障碍（PTSD）治疗的患者最常见的主诉（超过90%的患病率）。药物治疗无法有效治疗失眠，而且关于行为疗法治疗PTSD患者睡眠问题的有效性的信息也不足。最近的研究已经证明了失眠认知行为治疗（CBT-I）对多种伴发失眠的疾病的疗效，包括抑郁症、癌症、酒精中毒、创伤性脑损伤和慢性疼痛。本应用程序将检查在原发性失眠症患者中开发的失眠认知行为疗法（CBT-I）是否会改善患有慢性创伤后应激障碍（PTSD）的男性和女性的睡眠质量，这些患者接受了创伤后应激障碍（PTSD）的一线治疗，但符合失眠研究诊断标准（RDC）定义的持续性失眠。这个应用程序将检验CBT-I是否会改善PTSD患者的睡眠质量，并收集初步数据，以确定这种治疗是否具有超出改善睡眠障碍范围的临床效果。我们将获得试点数据，以产生CBT-I治疗PTSD的效应大小估计，并将制定在更大的随机临床试验中应用这种治疗的程序。本研究的主要目的是检验与单纯监测相比，8周的CBT-I治疗是否能显著减少PTSD受试者的主观失眠主诉和改善多导睡眠图睡眠连续性，并测试失眠的改善是否持久。次要目的是检查CBT-I与监测仪条件相比是否在其他临床结果（包括噩梦、非睡眠PTSD症状、情绪、白天活力、警觉性测试表现和社会适应）方面产生显著的前后改善。所有受试者将接受为期1周的监测，包括睡眠日记、活动记录仪、每日疲劳测量和精神运动警觉性，随后在8周治疗前后进行2晚的多导睡眠描记仪或仅监测期。随机分配到CBT-I的受试者将在治疗后6个月和12个月进行重复评估和程序（多导睡眠图除外），以测试治疗效果的持久性。

DESCRIPTION (provided by applicant): Insomnia is the most commonly reported complaint (over 90% prevalence) of patients receiving treatment for Posttraumatic Stress Disorder (PTSD). Insomnia is not effectively treated with pharmacologic treatments and there is insufficient information on the effectiveness of behavioral therapy for sleep problems in PTSD. Recent studies have demonstrated the efficacy of Cognitive Behavior Treatment of Insomnia (CBT-I) in a variety of disorders with comorbid insomnia, which include depression, cancer, alcoholism, traumatic brain injury, and chronic pain. This application will examine if Cognitive Behavioral Therapy for Insomnia (CBT-I), developed in subjects with Primary Insomnia, will improve sleep quality in men and women with chronic Posttraumatic Stress Disorder (PTSD) who have received a first line treatment for PTSD but have persistent insomnia as defined by meeting Research Diagnostic Criteria (RDC) for Insomnia Disorder. This application will examine if CBT-I will improve sleep quality in men and women with PTSD and will gather preliminary data on whether such treatment has clinical effects that extend beyond the amelioration of sleep disturbances. We will obtain pilot data to produce an effect size estimate for CBT-I in PTSD and will develop procedures for applying this treatment in a larger randomized clinical trial. The primary objectives are to examine whether an 8 week course of CBT-I compared to a Monitor Only condition produces a significant pre-post decrease in subjective insomnia complaints and improvement in polysomnography sleep continuity in PTSD subjects and to test if the improvement in insomnia is durable. The secondary objectives are to examine whether CBT-I compared to the Monitor Only condition produces a significant pre-post improvement in other clinical outcomes including nightmares, non-sleep PTSD symptoms, mood, daytime vigor, performance on the vigilance testing, and social adjustment. All subjects will be monitored for 1 week with sleep diary, actigraphy, daily measures of fatigue and psychomotor vigilance followed by 2 nights of polysomnography before and after the 8 week treatment or monitor only period. Subjects randomized to CBT-I will have repeat assessments and procedures (except polysomnography) at 6 and 12 months post treatment to test for durability of treatment gains.