Department of Sleep and Cognition, Netherlands Institute for Neuroscience (NIN), an institute of the Royal Netherlands Academy of Arts and Sciences, Meibergdreef 47, 1105, BA, Amsterdam, The Netherlands.
Department of Integrative Neurophysiology, Center for Neurogenomics and Cognitive Research (CNCR), Amsterdam Neuroscience, VU University Amsterdam, Amsterdam, The Netherlands.
BMC Psychiatry. 2020 Apr 15;20(1):163. doi: 10.1186/s12888-020-02554-8.
Major depressive disorder is among the most burdening and costly chronic health hazards. Since its prognosis is poor and treatment effectiveness is moderate at best, prevention would be the strategy of first choice. Insomnia may be the best modifiable risk factor. Insomnia is highly prevalent (4-10%) and meta-analysis estimates ±13% of people with insomnia to develop depression within a year. Among people with insomnia, recent work identified three subtypes with a particularly high lifetime risk of depression. The current randomized controlled trial (RCT) evaluates the effects of internet-guided Cognitive Behavioral Therapy for Insomnia (CBT-I), Chronobiological Therapy (CT), and their combination on insomnia and the development of depressive symptoms.
We aim to include 120 participants with Insomnia Disorder (ID) of one of the three subtypes that are more prone to develop depression. In a two by two factorial repeated measures design, participants will be randomized to CBT-I, CT, CBT-I + CT or treatment as usual, and followed up for one year. The primary outcome is the change, relative to baseline, of the severity of depressive symptoms integrated over four follow-ups spanning one year. Secondary outcome measures include a diagnosis of major depressive disorder, insomnia severity, sleep diaries, actigraphy, cost-effectiveness, and brain structure and function.
Pre-selection of three high-risk insomnia subtypes allows for a sensitive assessment of the possibility to prevent the development and worsening of depressive symptoms through interventions targeting insomnia.
Netherlands Trial Register (NL7359). Registered on 19 October 2018.
重度抑郁症是最具负担和代价高昂的慢性健康危害之一。由于其预后较差，治疗效果充其量也只是中等，因此预防将是首选策略。失眠可能是最可改变的风险因素。失眠的患病率很高（4-10%），荟萃分析估计，失眠患者中有±13%在一年内会发展为抑郁症。在失眠患者中，最近的研究确定了三种亚型，这些亚型具有特别高的终生抑郁风险。目前这项随机对照试验（RCT）评估了互联网指导的认知行为疗法治疗失眠（CBT-I）、时间生物学疗法（CT）及其组合对失眠和抑郁症状发展的影响。
我们旨在纳入 120 名患有失眠症障碍（ID）的患者，这些患者属于三种更易发展为抑郁症的亚型之一。采用两因素两水平重复测量设计，参与者将被随机分配到 CBT-I、CT、CBT-I+CT 或常规治疗组，并随访一年。主要结局是相对于基线，在跨越一年的四次随访中，抑郁症状严重程度的变化。次要结局包括重度抑郁症的诊断、失眠严重程度、睡眠日记、活动记录仪、成本效益以及大脑结构和功能。
对三种高风险失眠亚型的预先选择，使得通过针对失眠的干预措施来预防抑郁症状的发展和恶化的可能性得到了更敏感的评估。
荷兰试验注册库（NL7359）。于 2018 年 10 月 19 日注册。
