Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder

描述（由申请人提供）：创伤后应激障碍（PTSD）是接受治疗的患者最常报告的主诉（患病率超过90%）。药物治疗不能有效地治疗失眠，行为治疗对PTSD睡眠问题的有效性也没有足够的信息。最近的研究已经证明了认知行为治疗失眠症（CBT-I）在多种伴有失眠症的疾病中的疗效，这些疾病包括抑郁症，癌症，酒精中毒，创伤性脑损伤和慢性疼痛。该应用程序将检查在原发性失眠受试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PTSD的一线治疗，但患有持续性失眠，符合失眠症的研究诊断标准（RDC）。该应用程序将检查CBT-I是否会改善患有PTSD的男性和女性的睡眠质量，并将收集有关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PTSD中的效应量估计，并将开发在更大的随机临床试验中应用这种治疗的程序。主要目的是检查与仅监测条件相比，CBT-I的8周疗程是否在PTSD受试者中产生主观失眠投诉的显著前后减少和多导睡眠图睡眠连续性的改善，并测试失眠的改善是否持久。次要目的是检查CBT-I与仅监测条件相比是否在其他临床结果中产生显著的前后改善，包括噩梦，非睡眠PTSD症状，情绪，白天活力，警惕测试的表现和社会适应。所有受试者将通过睡眠日记、活动记录仪、每日疲劳和精神警觉测量进行监测1周，随后在8周治疗或仅监测期之前和之后进行2晚多导睡眠图。随机分配至CBT-I组的受试者将在治疗后6个月和12个月接受重复评估和程序（多导睡眠描记术除外），以检测治疗获益的持久性。

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.