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经历失眠。老年人是催眠药物最常见的使用者。尽管更安全，但即使是最新的“安眠药”也会导致认知障碍和福尔斯跌倒的风险。因此，失眠症的非药物治疗被作为药物治疗的替代品也就不足为奇了，有些人认为它们应该是“第一线治疗”。“我们提出了一项随机临床试验，以评估CBT-I特定成分的相对疗效和有效性：与SR和CT（SR+CT）相结合相比，睡眠限制（SR）和认知疗法（CT）。我们假设，由于CT与SR的拟议作用机制有很大不同，它们的组合可能具有累加效应。尽管SR和CT的作用机制可能不同，但没有数据证明将一种药物加到另一种药物中比单独使用任何一种药物可提供更多的总体临床获益。 最后，为了更好地了解SR和CT是如何工作的，以及在谁身上工作的，我们计划正式评估选定的调解人和主持人的临床效果，包括焦虑和唤醒的认知和生理措施。将在一项采用平行组设计的随机临床试验中比较三种治疗（SR、CT和SR+CT）。将在治疗开始前、治疗6周后和6个月随访结束时收集疗效和有效性数据。这项为期五年的申请最终将包括150名受试者（三组，每组50人），他们至少60岁。数据将包括睡眠日志，多导睡眠图，中介和调节措施，以及生活质量的措施，在每个组中的所有受试者。这些努力遵循国家精神卫生研究所战略计划战略3.1，为干预研究开发创新干预措施和设计，在这种情况下，促进新的干预试验，重点是治疗反应的调解人和调解人。

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.