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

失眠的治疗、调节因素、调节因素和生活质量

• 批准号: 8560917
• 负责人: JEROME A YESAVAGE
• 金额: $ 36.79万
• 依托单位: PALO ALTO VETERANS INSTIT FOR RESEARCH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-20 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8560917
• 关键词: Accounting; Aftercare; Age-Years; Anxiety; Arousal; Beds; Behavioral; Characteristics; Clinical; Clinical Trials Design; Cognition; Cognitive; Cognitive Therapy; Combined Modality Therapy; Data; Detection; Development; Effectiveness; Elderly; Health Surveys; Healthcare Systems; Hygiene; Impaired cognition; Individual; Individual Differences; Intervention; Intervention Studies; Intervention Trial; Lead; Light; Measures; Mediator of activation protein; Middle Insomnia; Monitor; National Institute of Mental Health; Pharmaceutical Preparations; Physiological; Polysomnography; Quality of life; Randomized Clinical Trials; Relative (related person); Relaxation; Signal Transduction; Sleep; Sleeplessness; Staging; Stimulus; Strategic Planning; Techniques; Testing; Time; Treatment Effectiveness; Treatment Efficacy; Work; clinical effect; design; experience; fall risk; follow-up; health related quality of life; hypnotic; improved; indexing; innovation; nondrug therapy; pressure; public health relevance; response; sleep onset; sleep regulation; sleeping pill; therapy design; therapy development; treatment effect; treatment response

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.

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。老年人是最常使用催眠药物的人。尽管更安全，但即使使用最新的“安眠药”也可能导致认知障碍和跌倒的风险。因此，毫不奇怪，人们一直在寻求非药物治疗失眠作为药物的替代方案，一些人建议它们应该成为“一线治疗”。我们提出了一项随机临床试验来评估 CBT-I 特定组成部分的相对功效和有效性：睡眠限制 (SR) 和认知治疗 (CT) 与 SR 和 CT 联合治疗 (SR+CT) 相比。我们假设，由于 CT 与 SR 的作用机制有很大不同，因此它们的组合可能会产生累加效应。尽管 SR 和 CT 的作用机制可能不同，但没有数据证明将其中一种干预措施与另一种干预措施相结合可提供比单独任何一种干预措施更全面的临床益处。 最后，为了更好地了解 SR 和 CT 的作用方式和对象，我们计划正式评估选定的临床效果调节因素和调节因素，包括焦虑和觉醒的认知和生理测量。将在随机临床试验中采用平行组设计对三种治疗方法（SR、CT 和 SR+CT）进行比较。将在治疗开始前、治疗六周后以及六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 名年龄至少 60 岁的受试者（三组，每组 50 人）。数据将包括每组所有受试者的睡眠日志、多导睡眠图、调节器和调节器测量以及生活质量测量。这些努力遵循国家心理健康研究所战略计划战略 3.1，开发创新干预措施和干预研究设计，在本例中，是为了促进一项新的干预试验，重点关注治疗反应的中介因素和调节因素。