Behavioral Treatment of Menopausal Insomnia; Sleep, Depression, Daytime Outcomes

描述（由申请人提供）：失眠被认为是最普遍和最昂贵的睡眠障碍之一，与相当高的发病率相关，包括显著降低生活质量，损害工作表现，增加患重度抑郁症的风险。1-4失眠是更年期过渡的一个关键症状，40-50%的绝经后妇女（约1700万）患有失眠与更年期相关的失眠症有一种睡眠障碍模式，其主要特征是睡眠维持困难，包括频繁醒来和唤醒，睡眠效率降低和整体睡眠碎片化。最近的研究表明，这种睡眠障碍的模式，即难以维持睡眠，会随着绝经期的进展而增加我们最近发现，更年期的睡眠维持问题与工作表现下降、医疗保健利用率增加和生活质量下降有关从历史上看，包括睡眠障碍在内的更年期症状都是用激素替代疗法（HRT）治疗的。然而，将激素替代疗法与心脏病和癌症风险增加联系起来的证据导致绝经后妇女使用性类固醇激素减少了40%，并强调了替代治疗方法的必要性重要的是，由于缺乏这方面的研究成果，美国临床内分泌学家协会的更年期管理指南没有涉及更年期相关失眠的治疗认知行为疗法治疗失眠症（CBT-I）具有与药物治疗失眠症相同的短期疗效和优越的长期持久性。然而，认知行为疗法对绝经期失眠合并症（本研究的主要焦点之一）的疗效尚未得到验证。然而，传统的CBT-I有缺点，包括需要训练有素的治疗师和患者的大量时间投入。因此，多组分CBT- i的广泛可用性受到CBT睡眠专家数量相对较少、治疗复杂性和患者负担的限制。因此，该项目的另一个目的是测试单一成分行为疗法对更年期相关失眠的急性和长期疗效。考虑到失眠与更年期合并症中存在显著的日间损害，包括抑郁、生活质量和疲劳，本提案的最终目的是确定cbt - 1对更年期相关失眠妇女的这些措施的有效性。

DESCRIPTION (provided by applicant): Insomnia is recognized as one of the most prevalent and costly sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition with 40-50% of postmenopausal women (> 17 million) having insomnia.5,6 Insomnia associated with menopause has a pattern of sleep disturbance predominantly characterized by sleep maintenance difficulties including frequent awakenings and arousals, reduced sleep efficiency, and overall fragmented sleep. It has recently been demonstrated that this pattern of sleep disturbance, difficulty maintaining sleep, increases throughout the progression of menopause.7 We have recently found sleep maintenance problems in menopause are associated with reduced work performance, increased healthcare utilization, and impaired quality of life.8 Historically, menopausal symptoms including sleep disturbance, were treated using hormone replacement therapy (HRT). However, evidence linking HRT to increased risks of heart disease and cancer have led to a 40% reduction in the use of sex steroid hormones by postmenopausal women and highlight the need for alternative approaches to treatment.9 Importantly, the American Association of Clinical Endocrinologists guidelines for management of menopause do not address treatment of menopausal-related insomnia due to the absence of research findings in this area.10 Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. However, the efficacy of cognitive behavioral therapy for insomnia comorbid with menopause, one of the primary focuses of the present proposal, has not been tested. Traditional CBT-I has disadvantages however, including the need for a trained therapist and significant time commitment on the part of the patient. Therefore, widespread availability of multicomponent CBT-I is limited by the relatively low number of CBT sleep specialists, complexity of therapy, and patient burden. Thus, another aim of this project is to test the acute and long-term efficacy of a single component behavioral therapy for menopausal-related insomnia. Given the significant daytime impairment present in insomnia comorbid with menopause including depression, quality of life, and fatigue, a final aim of this proposal is to determine the efficacyof CBT-I on these measures in women with menopausal-related insomnia.