Behavioral Insomnia Treatment in Chronic Fatigue Syndrome

描述(申请人提供)：慢性疲劳综合症(CFS)是一种虚弱和知之甚少的疾病，与增加的医疗费用和显著降低的生活质量有关。到目前为止，CFS的治疗方法包括针对可疑致病因素(例如，病毒或免疫功能障碍)或明显症状(例如，疲劳、情绪功能障碍)的药物治疗，以及增加白天活动或增强疾病特异性应对技能的非药物方法。CFS最普遍的症状之一是失眠(例如，令人不快的睡眠或睡眠开始或维持困难)，但奇怪的是，以睡眠为重点的干预措施对这些人的好处在很大程度上仍未被探索。这一疏忽是值得注意的，因为失眠会导致许多CFS常见的日间症状。此外，失眠对被认为对这种综合征具有机械重要性的相同的身体系统(例如，神经内分泌和神经免疫系统)产生不利影响。因此，失眠可能是CFS的一个关键病因，或者，失眠可能起到中介作用。我们已经开发、测试和改进了一种认知行为疗法(CBT)，旨在解决失眠的持久因素。我们最近的试点工作表明，CFS患者表现出CBT靶向的一些永久化机制。此外，我们最近的一个临床病例的结果表明，CBT可能是治疗CFS失眠的一种有前途的疗法。在目前的项目中，我们将进行一项随机临床试验，在符合失眠研究诊断标准的CFS患者中测试CBT作为常规医疗辅助治疗的疗效。50名CFS失眠患者的样本将被随机分配到常规医疗和辅助CBT，或常规护理对照条件下。在治疗前、治疗8周后立即和1个月的随访中，将获得客观(活动记录)和主观(睡眠记录、问卷)睡眠测量，以及疲劳、清醒活动、情绪、生活质量和治疗有效性的测量。这一设计使我们能够测试CBT-I在这一组中的疗效，并探索失眠是否与CFS的驾驶症状有关。

DESCRIPTION (provided by applicant): Chronic Fatigue Syndrome (CFS) is a debilitating and poorly understood condition associated with increased healthcare costs and markedly reduced quality of life. To date, treatment approaches for CFS have included pharmacotherapy to address suspected pathogenic factors (e.g., a virus or immune dysfunction) or overt symptoms (e.g. fatigue, mood dysfunction), and nonpharmacological approaches to increase daytime activity or enhance disease-specific coping skills. One of the most universal symptoms of CFS is insomnia (e.g., unrefreshing sleep or sleep onset or maintenance difficulties), but curiously, the benefits of sleep-focused interventions for such individuals remains largely unexplored. This oversight is notable because insomnia results in many of the diurnal symptoms common to CFS. In addition, insomnia adversely affects the same bodily systems (e.g., neuroendocrine and neuroimmune systems) thought to be mechanistically important to this syndrome. Thus, insomnia may be a key etiological factor in CFS, or alternately, insomnia may play a mediational role. We have developed, tested and refined a cognitive-behavioral therapy (CBT) designed to address perpetuating factors in insomnia. Our recent pilot work suggests that CFS patients display some of the perpetuating mechanisms targeted by CBT. Moreover, results from one of our recent clinical cases suggest CBT may be a promising therapy for the insomnia in CFS. In the current project, we will conduct a randomized clinical trial to test the efficacy of CBT as an adjunct to usual medical care among CFS patients who also meet Research Diagnostic Criteria for insomnia. A sample of 50 CFS patients with insomnia will be randomized to usual medical care and adjunctive CBT, or a usual care control condition. Objective (actigraphy) and subjective (sleep log, questionnaire) sleep measures, and measures of fatigue, waking activity, mood, quality of life, and treatment validity will be obtained before therapy, immediately after an 8-week treatment phase, and at a 1-month follow-up. This design allows us to test the efficacy of CBT-I in this group, and explore whether insomnia is mechanistic in driving symptoms in CFS.