Cognitive Behavioral Treatment of Insomnia in Posttraumatic Stress Disorder

创伤后应激障碍失眠的认知行为治疗

• 批准号: 7576886
• 负责人: Thomas C Neylan
• 金额: $ 24.82万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7576886
• 关键词: Aftercare; Alcoholism; Behavior Therapy; Chronic; Clinical; Cognitive; Comorbid Insomnia; Control Groups; Data; Diagnostics Research; Disease; Effectiveness; Fatigue; Malignant Neoplasms; Measures; Modification; Monitor; Moods; Nightmare; Outcome; Patients; Performance; Polysomnography; Post-Traumatic Stress Disorders; Prevalence; Primary Insomnia; Procedures; Randomized; Randomized Clinical Trials; Reporting; Risk; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Social Adjustment; Stress; Symptoms; Testing; Time; Traumatic Brain Injury; Woman; actigraphy; chronic pain; clinical effect; cognitive behavior therapy; coping; depression; diaries; follow-up; improved; meetings; men; physical conditioning; sleep onset; vigilance

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.

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投诉（超过90％的患病率）。失眠不能有效地接受药理治疗，并且在PTSD中行为疗法对睡眠问题的有效性不足。最近的研究表明，失眠（CBT-I）认知行为治疗在多种合并症失眠症中的疗效，包括抑郁症，癌症，酒精中毒，创伤性脑损伤和慢性疼痛。该应用将检查在主要失眠受试者中开发的失眠症（CBT-I）的认知行为治疗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，这些男性和女性已接受PTSD的第一线治疗，但持续的失眠症患者持续诊断诊断诊断诊断症状（RITENICAINIA）（RESOMNIA）（RESOM NISOMNIA）。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，并会收集有关此类治疗是否具有临床作用的初步数据，超出了睡眠障碍的改善。我们将获得PILOT数据，以产生PTSD中CBT-I的效果大小估计，并将在更大的随机临床试验中开发用于应用此治疗的程序。主要目标是检查仅与监视器相比，CBT-I为8周的课程是否会导致主观失眠的投诉前显着下降，并改善PTSD受试者的多症仪表睡眠连续性，并测试失眠症的改善是否持久。次要目标是检查CBT-I与监视器相比仅在其他临床结局中会显着改善，包括噩梦，非睡眠PTSD症状，情绪，白天活力，警惕性测试的表现和社交调整。所有受试者将通过睡眠日记，表演，疲劳和精神运动警惕性进行1周监测1周，然后在8周治疗之前和之后进行2晚的多症术或仅监测期。在治疗后6和12个月时，随机分解为CBT-I的受试者将进行重复评估和程序（多聚术），以测试治疗的持久性。