Investigating non-inferiority and additional benefits of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial
调查互联网提供的失眠认知行为疗法与面对面认知行为疗法 (CBT-I) 的非劣效性和额外益处:一项随机对照试验
基本信息
- 批准号:422022593
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:德国
- 项目类别:Clinical Trials
- 财政年份:
- 资助国家:德国
- 起止时间:
- 项目状态:未结题
- 来源:
- 关键词:
项目摘要
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.
难以启动和/或维持睡眠,加上高度的痛苦或日常活动受损是失眠的主要特征。全球失眠症的患病率约为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,并对生活质量产生高度负面影响。就残疾调整生命年而言,失眠是第九大最重要的大脑疾病。此外,失眠也是抑郁症和焦虑症以及心血管疾病和糖尿病的主要危险因素。最后,失眠是一个沉重的社会经济负担,特别是由于生产力的损失。两种最常用的失眠治疗方法是苯二氮卓类受体激动剂(BZRA)和失眠认知行为疗法(CBT-I)。BZRA在短期治疗中改善睡眠连续性,但耐受性和依赖性是重要的副作用。相比之下,CBT-I是安全有效的,对失眠的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在常规护理中并不广泛,主要在少数专业研究环境中提供。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)是非常有效的,其效果似乎与面对面的CBT-I相当。因此,iCBT-I被认为是一种有前途的解决方案,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,患者可以节省一些时间和费用去看治疗师。虽然有充分的理由假设iCBT-I是面对面CBT-I的适当替代方案,但尚未建立确凿的证据。事实上,尚未证明对iCBT-I作为额外的一线治疗的乐观态度是否合理。计划中的非劣效性研究将首次调查患者是否会从iCBT-I中获益,其程度与面对面干预相同。到目前为止,iCBT-I和面对面CBT-I尚未在充分设计的非劣效性研究中进行评估。如果非劣效性得到证实,患者可以确信两种形式的CBT-I同样有可能降低失眠严重程度。同样,这项研究将为普通和睡眠医学从业者和心理治疗师提供坚实的证据,扩大他们的治疗选择。政策制定者将获得有用的信息,将iCBT-I纳入常规护理。
项目成果
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