Behavioral Insomnia Treatment in Chronic Fatigue Syndrome

描述（由申请人提供）：慢性疲劳综合征（CFS）是一种使人衰弱且鲜为人知的疾病，与医疗费用增加和生活质量显著降低有关。迄今为止，慢性疲劳综合症的治疗方法包括药物治疗，以解决疑似致病因素（如病毒或免疫功能障碍）或明显症状（如疲劳、情绪障碍），以及非药物治疗，以增加白天活动或提高疾病特异性应对技能。CFS最普遍的症状之一是失眠（例如，睡眠不清醒或睡眠开始或维持困难），但奇怪的是，对这些个体进行睡眠干预的好处在很大程度上仍未被探索。这种疏忽是值得注意的，因为失眠导致了许多CFS常见的日常症状。此外，失眠对同样的身体系统（例如，神经内分泌和神经免疫系统）也有不利影响，这些系统被认为在机制上对这种综合征很重要。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，测试和完善了一种认知行为疗法（CBT），旨在解决失眠的长期因素。我们最近的试点工作表明，慢性疲劳综合症患者表现出CBT针对的一些持续机制。此外，我们最近的一个临床病例的结果表明，CBT可能是一种有希望的治疗CFS失眠的方法。在目前的项目中，我们将进行一项随机临床试验，以测试CBT作为常规医疗护理的有效性，这些CFS患者也符合失眠的研究诊断标准。50例伴有失眠的慢性疲劳综合症患者将随机分为常规治疗组和辅助CBT组，或常规治疗对照组。客观（活动记录仪）和主观（睡眠日志、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将在治疗前、8周治疗期后立即和1个月随访时获得。本设计允许我们测试CBT-I在该组中的疗效，并探讨失眠是否在CFS中驱动症状的机制。

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.