Kyle Simon D, Hurry Madeleine E D, Emsley Richard, Luik Annemarie I, Omlin Ximena, Spiegelhalder Kai, Espie Colin A, Sexton Claire E
Nuffield Department of Clinical Neurosciences, Sleep and Circadian Neuroscience Institute, University of Oxford, Sir William Dunn School of Pathology, South Parks Road, Oxford, OX1 3RE, UK.
Oxford Nuffield Department of Clinical Neurosciences, Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB Centre), University of Oxford, Oxford, UK.
Trials. 2017 Jun 17;18(1):281. doi: 10.1186/s13063-017-2012-6.
The daytime effects of insomnia pose a significant burden to patients and drive treatment seeking. In addition to subjective deficits, meta-analytic data show that patients experience reliable objective impairments across several cognitive domains. While Cognitive Behavioural Therapy for Insomnia (CBT-I) is an effective and scalable treatment, we know little about its impact upon cognitive function. Trials of CBT-I have typically used proxy measures for cognitive functioning, such as fatigue or work performance scales, and no study has assessed self-reported impairment in cognitive function as a primary outcome. Moreover, only a small number of studies have assessed objective cognitive performance, pre-to-post CBT-I, with mixed results. This study specifically aims to (1) investigate the impact of CBT-I on cognitive functioning, assessed through both self-reported impairment and objective performance measures, and (2) examine whether change in sleep mediates this impact.
METHODS/DESIGN: We propose a randomised controlled trial of 404 community participants meeting criteria for Insomnia Disorder. In the DISCO trial (D efining the I mpact of improved S leep on CO gnitive function (DISCO)) participants will be randomised to digital automated CBT-I delivered by a web and/or mobile platform (in addition to treatment as usual (TAU)) or to a wait-list control (in addition to TAU). Online assessments will take place at 0 (baseline), 10 (post-treatment), and 24 (follow-up) weeks. At week 25, all participants allocated to the wait-list group will be offered digital CBT-I, at which point the controlled element of the trial will be complete. The primary outcome is self-reported cognitive impairment at post-treatment (10 weeks). Secondary outcomes include objective cognitive performance, insomnia severity, sleepiness, fatigue, and self-reported cognitive failures and emotional distress. All main analyses will be carried out on completion of follow-up assessments and will be based on the intention-to-treat principle. Further analyses will determine to what extent observed changes in self-reported cognitive impairment and objective cognitive performance are mediated by changes in sleep. The trial is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) based at Oxford University Hospitals NHS Trust and University of Oxford, and by the NIHR Oxford Health BRC.
This study will be the first large-scale examination of the impact of digital CBT-I on self-reported cognitive impairment and objective cognitive performance.
ISRCTN, ID: ISRCTN89237370 . Registered on 17 October 2016.
失眠的日间影响给患者带来了沉重负担，并促使他们寻求治疗。除了主观缺陷外，荟萃分析数据显示，患者在多个认知领域存在可靠的客观损害。虽然失眠认知行为疗法（CBT-I）是一种有效且可扩展的治疗方法，但我们对其对认知功能的影响知之甚少。CBT-I试验通常使用认知功能的替代指标，如疲劳或工作表现量表，尚无研究将自我报告的认知功能损害作为主要结局进行评估。此外，只有少数研究在CBT-I治疗前后评估了客观认知表现，结果不一。本研究的具体目的是：（1）通过自我报告的损害和客观表现指标，研究CBT-I对认知功能的影响；（2）检验睡眠变化是否介导了这种影响。
方法/设计：我们提议对404名符合失眠障碍标准的社区参与者进行一项随机对照试验。在DISCO试验（定义改善睡眠对认知功能的影响（DISCO））中，参与者将被随机分配至通过网络和/或移动平台提供的数字自动化CBT-I组（除常规治疗（TAU）外）或等待名单对照组（除TAU外）。将在第0周（基线）、第10周（治疗后）和第24周（随访）进行在线评估。在第25周，所有分配至等待名单组的参与者将接受数字CBT-I治疗，届时试验的对照部分将结束。主要结局是治疗后（10周）自我报告的认知损害。次要结局包括客观认知表现、失眠严重程度、嗜睡、疲劳以及自我报告的认知失误和情绪困扰。所有主要分析将在随访评估完成后进行，并将基于意向性分析原则。进一步的分析将确定自我报告的认知损害和客观认知表现的观察变化在多大程度上由睡眠变化介导。该试验由牛津大学医院国民保健服务信托基金和牛津大学的英国国家卫生研究院（NIHR）牛津生物医学研究中心（BRC）以及NIHR牛津健康BRC资助。
本研究将是对数字CBT-I对自我报告的认知损害和客观认知表现影响的首次大规模研究。
ISRCTN，编号：ISRCTN89237370。于2016年10月17日注册。
