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)治疗的患者中最常见的主诉(90%以上)。失眠不能通过药物治疗有效治疗，而且关于行为疗法对创伤后应激障碍患者睡眠问题的有效性的信息不足。最近的研究表明，认知行为治疗失眠症(CBT-I)对多种失眠障碍的疗效，包括抑郁症、癌症、酒精中毒、创伤性脑损伤和慢性疼痛。该应用程序将检验在原发性失眠症患者中开发的认知行为疗法(CBT-I)是否会改善慢性创伤后应激障碍(PTSD)患者的睡眠质量，这些患者已经接受了PTSD的一线治疗，但符合失眠障碍研究诊断标准(RDC)定义的持续性失眠。这项应用将检验CBT-I是否将改善患有创伤后应激障碍的男性和女性的睡眠质量，并将收集关于这种治疗是否具有超出改善睡眠障碍的临床效果的初步数据。我们将获得试点数据，以产生CBT-I在创伤后应激障碍中的效果大小估计，并将开发程序，在更大的随机临床试验中应用这种治疗方法。主要目的是检验与只接受监测的情况相比，8周的CBT-I疗程是否在PTSD受试者的主观失眠主诉和多导睡眠图睡眠连续性改善方面产生显著减少，并测试失眠的改善是否持久。第二个目标是检验CBT-I与仅使用Monitor的情况相比，是否在治疗前显著改善了其他临床结果，包括噩梦、非睡眠创伤后应激障碍症状、情绪、白天活力、警觉性测试和社会适应方面的表现。所有受试者将在8周治疗前和8周后接受为期1周的睡眠日记、活动监测、每日疲劳测量和精神运动警觉监测，然后进行2晚多导睡眠监测。随机接受CBT-I试验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)，以测试治疗成果的持久性。

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.