Behavioral Insomnia Therapy With Fibromyalgia

描述（由申请人提供）：纤维肌痛（FM）是一种普遍的衰弱性疾病，其特征是慢性广泛疼痛、持续的白天疲劳、睡眠障碍、情绪低落、耐力丧失和由此导致的残疾。到目前为止，研究已经证明了药物治疗（抗抑郁药）在管理与fm相关的疼痛和情绪障碍以及各种非药物干预方面的益处，以减轻压力，增强疾病应对能力，并增加健康/耐力。然而，大多数FM患者报告慢性睡眠障碍（例如，睡眠延迟，碎片化或不清醒的睡眠），以睡眠为重点的FM症状管理干预措施的益处得到了相对较少的研究关注。然而，我们最近完成的R21项目表明，认知行为失眠疗法（CBT）是一种有希望的干预措施，可以减少FM患者的睡眠困难和其他关键症状。事后分析表明，在CBT策略中加入睡眠卫生（SH）教育可能会提高治疗效果。此外，试点回归分析表明睡眠障碍测量作为调频疼痛改善的中介和调节因子的有效性。提出的项目是为了在一个中等规模的FM样本中确认和扩展这些发现。共有111名FM患者将被随机分为CBT/SH +常规护理（DC）组（n = 37）、安慰剂对照（PC）治疗+ UC组（n = 37）或单独UC组（n = 37）。在治疗前和治疗后8周进行的多导睡眠描记术以及在治疗前、治疗后和6个月的随访中进行的睡眠日志监测和活动描记术将用于评估睡眠改善情况。在治疗前、治疗期间（治疗中期）、治疗后和随访时，将获得疼痛、情绪、日间疲劳和生活质量的自我报告测量，以评估其他主要FM症状的变化。标准统计分析和临床意义测试将用于评估CBT/SH干预。此外，从睡眠日志、多导睡眠图的标准评分和睡眠脑电图频谱分析中提取的测量值将在回归分析中考虑，以确定关键非睡眠FM症状（如疼痛、疲劳）改善的基于睡眠的调节因子和调节因子。这项试验的结果应该为FM的病理生理学和治疗提供见解。

DESCRIPTION (provided by applicant): Fibromyalgia (FM) is a prevalent and debilitating condition characterized by chronic widespread pain, persistent daytime fatigue, sleep disturbances, low mood, loss of stamina, and resultant disability. To date, research has documented the benefits of pharmacotherapy (antidepressants) to manage FM-related pain and mood disturbances and various nonpharmacologic interventions to reduce stress, bolster illness-coping abilities, and increase fitness/stamina. Whereas, most FM patients report chronic sleep disturbances (e.g., delayed sleep onset, fragmented or un-refreshing sleep), the benefits of sleep-focused interventions for FM symptom management have received relatively little research attention. Nevertheless, our recently completed R21 project showed that a cognitive-behavioral insomnia therapy (CBT) is a promising intervention for reducing sleep difficulties and other key symptoms in FM sufferers. Post-hoc analyses suggested that the addition of sleep hygiene (SH) education to CBT strategies might enhance treatment efficacy. Furthermore, pilot regression analyses suggested the usefulness of sleep disturbance measures of as mediators and moderators of FM pain improvement. The project proposed is designed to confirm and extend these findings in a moderately large FM sample. A total of 111 FM patients will be randomized either to a CBT/SH + usual care (DC) condition (n = 37), a Placebo Control (PC) therapy + UC (n = 37) or UC alone (n = 37). Polysomnography conducted before and after eight weeks of treatment and sleep log monitoring and actigraphy conducted before treatment, after treatment, and at a 6-month follow-up will be used to assess sleep improvements. Self-report measures of pain, mood, daytime fatigue, and quality of life will be obtained before, during (mid-treatment), and after treatment and at follow-up to assess changes in other key FM symptoms. Both standard statistical analyses and tests of clinical significance will be used to evaluate the CBT/SH intervention. Additionally, measures extracted from sleep logs, standard scorings of the polysomnograms, and sleep EEG spectral analyses will be considered in regression analyses to identify sleep-based mediators and moderators of improvements in key non-sleep FM symptoms (e.g., pain, fatigue). Results of this trial should provide insights into the pathophysiology and management of FM.