Behavioral Insomnia Therapy With Fibromyalgia

描述(由申请人提供)：纤维肌痛(FM)是一种流行的、使人虚弱的疾病，其特征是慢性广泛性疼痛、持续的白天疲劳、睡眠障碍、情绪低落、耐力丧失以及由此导致的残疾。到目前为止，研究已经记录了药物治疗(抗抑郁药)对管理FM相关疼痛和情绪障碍的好处，以及各种非药物干预对减轻压力、增强疾病应对能力和增加健康/耐力的好处。然而，大多数FM患者报告了慢性睡眠障碍(例如，延迟睡眠开始、零碎或不清新的睡眠)，而针对FM症状管理的以睡眠为重点的干预措施的益处相对较少受到研究关注。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策略中增加睡眠卫生(SH)教育可能会提高治疗效果。此外，初步回归分析表明，睡眠障碍措施作为FM疼痛改善的中介和调节剂是有用的。建议的项目旨在通过适度大的FM样本来证实和扩展这些发现。共有111名FM患者将被随机分为CBT/SH常规护理(DC)条件(n=37)、安慰剂对照(PC)治疗UC(n=37)或单独UC(n=37)。在治疗前和治疗8周后进行多导睡眠监测，并在治疗前、治疗后和6个月随访时进行睡眠记录监测和活动描记，以评估睡眠改善情况。疼痛、情绪、白天疲劳和生活质量的自我报告将在治疗前、治疗中、治疗后和随访时获得，以评估其他关键FM症状的变化。标准统计分析和具有临床意义的检验将用于评估CBT/SH干预措施。此外，回归分析将考虑从睡眠记录、多导睡眠图的标准评分和睡眠脑电频谱分析中提取的测量方法，以确定关键的非睡眠FM症状(如疼痛、疲劳)改善的基于睡眠的调节因素和调节因素。这项试验的结果应该为FM的病理生理学和治疗提供洞察力。

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.