Treatments for Insomnia, Mediators, Moderators, and Quality of Life

描述（由申请人提供）：多达三分之一的老年人可能会失眠。老年人是最常使用催眠药物的人。虽然更安全，但即使是使用最新的“安眠药”也会导致认知障碍和跌倒的风险。因此，对失眠的非药物治疗已经成为药物治疗的替代品，这并不奇怪，一些人建议它们应该是“第一线治疗”。我们提出了一项随机临床试验，以评估CBT-I的特定组成部分：睡眠限制（SR）和认知治疗（CT）的相对疗效和有效性，并与SR和CT联合治疗（SR+CT）进行比较。我们假设，由于所提出的CT和SR的作用机制存在很大差异，它们的组合可能具有叠加效应。尽管SR和CT的作用机制可能不同，但没有数据证明其中一种与另一种相结合比单独使用任何一种干预能提供更多的整体临床益处。

DESCRIPTION (provided by applicant): As many as one in three older adults may experience insomnia. Older adults are the most frequent users of hypnotic medications. Although safer, use of even the latest "sleeping pills" can lead to cognitive impairment and risk of falls. Thus, it isnot surprising that non-pharmacological treatments for insomnia have been pursued as alternatives to medications, with some suggesting they should be the "first line of therapy." We propose a randomized clinical trial to evaluate the relative efficacy and effectiveness of specific components of CBT-I: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT). We hypothesize that because the proposed mechanisms of action of CT versus SR substantially differ, their combination may have additive effects. Even though the mechanisms of action of SR and CT may differ, no data exists to document that the addition of one to the other provides more overall clinical benefit than either intervention alone. Finally, to better understand how and in whom SR and CT work, we plan to formally evaluate selected mediators and moderators of the clinical effect including cognitive and physiological measures of anxiety and arousal. Three treatments (SR, CT, and SR+CT) will be compared in a randomized clinical trial with a parallel groups design. Efficacy and effectiveness data will be collected prior to the beginning of treatment, after six weeks of treatment, and at the end of a six-month follow-up. This five-year application will ultimately include 150 subjects (three groups of 50 each) who are at least 60 years of age. Data will include a sleep log, polysomnography, mediator and moderator measures, and quality of life measures on all subjects in each group. These efforts follow the National Institute of Mental Health Strategic Plan Strategy 3.1 to develop innovative interventions and designs for intervention studies, in this case, to promote a new intervention trial that focuses on the mediators and moderators of treatment response.