Investigating non-inferiority and additional benefits of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial

失眠的主要特征是难以开始和/或维持睡眠，并伴有高度痛苦或日常活动受损。全球失眠症患病率约为6-10%。失眠对患者来说是一个沉重的负担，因为它损害了他们的社会、家庭和职业生活，并对生活质量产生了严重的负面影响。就残疾调整生命年而言，失眠是第九大最重要的脑部疾病。此外，失眠也是抑郁症、焦虑症、心血管疾病和糖尿病的主要风险因素。最后，失眠是一个沉重的社会经济负担，特别是由于生产力损失。两种最常用的失眠治疗方法是苯二氮卓受体激动剂（BZRA）和失眠认知行为疗法（CBT-I）。BZRA短期治疗可改善睡眠连续性，但耐受性和依赖性是重要的副作用。相比之下，cbt - 1是安全有效的，对失眠严重程度有很大的影响。临床指南一致推荐CBT-I作为一线治疗。然而，健康保险数据表明，CBT-I在常规护理中并未广泛使用，主要在少数专业研究机构中提供。因此，失眠患者在临床实践中获得一线治疗的机会有限。最近，越来越多的证据表明，互联网提供的CBT-I （iCBT-I）非常有效，其效果似乎与面对面的CBT-I相当。因此，iCBT-I被认为是一个很有希望的解决方案，因为它可以大规模传播，使更多的患者获得有效的治疗。此外，它可以随时随地轻松访问，适应日益数字化的生活方式。iCBT-I更高的灵活性可能会提供更多的便利，患者节省一些时间和看治疗师的费用。虽然有充分的理由假设iCBT-I是面对面CBT-I的适当替代品，但尚未建立结论性证据。事实上，对iCBT-I作为额外一线治疗的乐观态度是否合理尚未得到证实。计划中的非劣效性研究将首次调查患者是否能从iCBT-I中获得与面对面干预相同程度的益处。到目前为止，iCBT-I和面对面CBT-I尚未在设计充分的非劣效性研究中进行评估。在证实非劣效性的情况下，患者可以确信两种形式的CBT-I同样可能降低失眠严重程度。同样，这项研究将为普通医学和睡眠医学从业者以及心理治疗师提供坚实的证据，拓宽他们的治疗选择。决策者将获得有助于在常规护理中实施iCBT-I的信息。

Difficulties in initiating and/or maintaining sleep in combination with a high degree of suffering or impaired daily activities are the main characteristics of insomnia. The worldwide prevalence of insomnia is around 6-10%. Insomnia is a heavy burden for patients as it impairs their social, family, and occupational life, and has a highly negative impact on quality of life. In terms of disability-adjusted life years, insomnia is the 9th most important brain disorder. Moreover, insomnia is also a major risk factor for depression and anxiety disorders as well as for cardiovascular diseases and diabetes. Finally, insomnia represents a heavy socioeconomic burden, especially due to productivity losses. The two most commonly used treatments for insomnia are benzodiazepine receptor agonists (BZRA) and cognitive-behavioural therapy for insomnia (CBT-I). BZRA improve sleep continuity in short-term treatment, but tolerance and dependence are important side effects. CBT-I, by contrast, is safe and effective with large effect sizes on insomnia severity. Clinical guidelines unanimously recommend CBT-I as the first-line treatment. However, health insurance data suggests that CBT-I is not widely available in routine care and mainly offered in a few specialised research settings. As a result, patients with insomnia have limited access to first-line treatment in clinical practice. Recently, there has been growing evidence that internet-delivered CBT-I (iCBT-I) is highly effective with effects appearing to be comparable to those of face-to-face CBT-I. Consequently, iCBT-I has been suggested as a promising solution since it can be disseminated on a large scale, giving more patients access to effective treatment. In addition, it is easily accessible anytime and anywhere, fitting in with an increasingly digital lifestyle. The higher flexibility of iCBT-I may provide more convenience, patients save some of the time and costs of seeing therapists. Although there are good reasons to hypothesize that iCBT-I is an adequate alternative to face-to-face CBT-I, conclusive evidence has not yet been established. In fact, it has not been proven whether the optimism about iCBT-I as an additional first-line treatment is justified. For the first time, the planned non-inferiority study will investigate whether patients would benefit from iCBT-I to the same degree as from face-to-face interventions. So far, iCBT-I and face-to-face CBT-I have not yet been evaluated in an adequately designed non-inferiority study. In case non-inferiority is confirmed, patients can be confident that both formats of CBT-I are equally likely to reduce insomnia severity. Similarly, the study will provide solid evidence for general and sleep medicine practitioners and psychotherapists, broadening their therapeutic options. Policy-makers will gain information useful for implementing iCBT-I into routine care.