改善夜间睡眠能带来更美好的白天吗？针对患有一系列心理健康问题的人群，基于互联网的失眠症认知行为疗法指南：一项实用随机临床试验方案。

Do better nights lead to better days? Guided internet-based cognitive behavioral therapy for insomnia in people suffering from a range of mental health problems: Protocol of a pragmatic randomized clinical trial.

作者信息

Reesen J E, van der Zweerde T, Batelaan N M, Fris E, Hoogendoorn A W, Ikelaar S, Lakbila-Kamal O, Lancee J, Leerssen J, van Marle H J F, van Nassau F, van Oppen P, van Straten A, van Trigt S, van der Wal S J, van Someren E J W

机构信息

Department of Sleep and Cognition, Netherlands Institute for Neuroscience, Royal Netherlands Academy of Arts and Sciences, Amsterdam, the Netherlands; Department of Integrative Neurophysiology, Center for Neurogenomics and Cognitive Research, Amsterdam Neuroscience, Vrije Universiteit University Amsterdam, Amsterdam, the Netherlands.

Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Psychiatry, Amsterdam, the Netherlands; GGZ inGeest Mental Health Care, Amsterdam, the Netherlands.

出版信息

Contemp Clin Trials. 2023 Apr;127:107122. doi: 10.1016/j.cct.2023.107122. Epub 2023 Feb 20.

DOI:10.1016/j.cct.2023.107122

PMID:36813085

Abstract

BACKGROUND

Insomnia is the transdiagnostically shared most common complaint in disorders of anxiety, stress and emotion regulation. Current cognitive behavioral therapies (CBT) for these disorders do not address sleep, while good sleep is essential for regulating emotions and learning new cognitions and behaviours: the core fundaments of CBT. This transdiagnostic randomized control trial (RCT) evaluates whether guided internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) (1) improves sleep, (2) affects the progression of emotional distress and (3) enhances the effectiveness of regular treatment of people with clinically relevant symptoms of emotional disorders across all mental health care (MHC) echelons.

METHODS

We aim for 576 completers with clinically relevant symptoms of insomnia as well as at least one of the dimensions of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), posttraumatic stress disorder (PTSD) or borderline personality disorder (BPD). Participants are either pre-clinical, unattended, or referred to general- or specialized MHC. Using covariate-adaptive randomization, participants will be assigned to a 5 to 8-week iCBT-I (i-Sleep) or a control condition (sleep diary only) and assessed at baseline, and after two and eight months. The primary outcome is insomnia severity. Secondary outcomes address sleep, severity of mental health symptoms, daytime functioning, mental health protective lifestyles, well-being, and process evaluation measures. Analyses use linear mixed-effect regression models.

DISCUSSION

This study can reveal for whom, and at which stage of disease progression, better nights could mean substantially better days.

TRIAL REGISTRATION

International Clinical Trial Registry Platform (NL9776). Registered on 2021-10-07.

摘要

背景

失眠是焦虑、压力和情绪调节障碍中最常见的跨诊断共同症状。目前针对这些障碍的认知行为疗法（CBT）并未涉及睡眠问题，而良好的睡眠对于调节情绪以及学习新的认知和行为至关重要，这些都是CBT的核心基础。这项跨诊断随机对照试验（RCT）评估了通过互联网提供的失眠症指导性认知行为疗法（iCBT-I）是否（1）改善睡眠，（2）影响情绪困扰的进展，以及（3）提高各级精神卫生保健（MHC）中患有情绪障碍临床相关症状的患者接受常规治疗的效果。

方法

我们的目标是招募576名具有失眠临床相关症状以及广泛性焦虑症（GAD）、社交焦虑症（SAD）、恐慌症（PD）、创伤后应激障碍（PTSD）或边缘性人格障碍（BPD）至少一个维度症状的受试者。参与者要么处于临床前阶段、无人照料，要么被转介至普通或专科MHC。采用协变量适应性随机化方法，将参与者分配至为期5至8周的iCBT-I（i-Sleep）组或对照组（仅睡眠日记），并在基线、两个月和八个月后进行评估。主要结局是失眠严重程度。次要结局涉及睡眠、心理健康症状严重程度、日间功能、心理健康保护性生活方式、幸福感以及过程评估指标。分析采用线性混合效应回归模型。