使用两项大型随机对照试验的个体参与者数据进行分析：采用数字认知行为疗法（Sleepio）治疗失眠是否会改善失眠合并焦虑患者的焦虑症状？

Does treating insomnia with digital cognitive behavioural therapy (Sleepio) mediate improvements in anxiety for those with insomnia and comorbid anxiety? An analysis using individual participant data from two large randomised controlled trials.

机构信息

Big Health Ltd., London, UK/San Francisco, USA; Sir Jules Thorn Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.

出版信息

J Affect Disord. 2023 Oct 15;339:58-63. doi: 10.1016/j.jad.2023.06.053. Epub 2023 Jun 29.

DOI:10.1016/j.jad.2023.06.053

PMID:37390923

Abstract

BACKGROUND

Considerable comorbidity exists between insomnia and anxiety, and evidence shows that the benefits of CBT for insomnia extend to anxiety. Using data from two large trials of digital CBT (dCBT) for insomnia, we evaluated whether improving sleep is an effective treatment target to reduce both insomnia and anxiety symptoms in individuals with insomnia and clinically significant anxiety.

METHODS

This was a controlled sub-analysis combining individual participant data from two previous randomised controlled trials of dCBT for insomnia (Sleepio). Participants (N = 2172) with insomnia disorder and clinically significant anxiety symptoms were included in this sub-analysis and received either dCBT or control (usual care or sleep hygiene education). Assessments were evaluated at baseline, post-intervention (week 8 or 10), and follow-up (week 22 or 24). Mediation was evaluated using structural equation models.

RESULTS

dCBT for insomnia was superior to control at reducing both insomnia (Hedges' g range = 0.77-0.81; both p < 0.001) and anxiety symptoms (Hedges' g range = 0.39-0.44; both p < 0.001) at all time points. Baseline insomnia symptoms moderated the effects of dCBT on insomnia, however no variables moderated treatment effects on anxiety. Reductions in anxiety symptoms at follow-up were mediated by improvements in sleep at post-intervention (% mediated = 84 %), suggesting a causal pathway.

LIMITATIONS

Participants did not have a formal anxiety disorder diagnosis and so the effects of dCBT for insomnia on anxiety may differ by anxiety disorder.

CONCLUSIONS

Addressing sleep using dCBT for insomnia may serve as a treatment target from which to improve anxiety in individuals with insomnia and clinically significant comorbid anxiety.

CLINICAL TRIAL REGISTRATIONS

Digital Insomnia therapy to Assist your Life as well as your Sleep (DIALS) - ISRCTN60530898 http://www.isrctn.com/ISRCTN60530898. Oxford Access for Students Improving Sleep (OASIS) - ISRCTN61272251 http://www.isrctn.com/ISRCTN61272251.

摘要

背景

失眠和焦虑之间存在相当大的共病，有证据表明认知行为疗法（CBT）对失眠的益处扩展到焦虑。利用两项大型失眠数字化认知行为疗法（dCBT）试验的数据，我们评估了改善睡眠是否是治疗失眠和临床显著焦虑共病个体失眠和焦虑症状的有效治疗目标。

方法

这是一项对照性子分析，结合了两项先前失眠数字化认知行为疗法（Sleepio）随机对照试验的个体参与者数据。该子分析纳入了患有失眠障碍和临床显著焦虑症状的参与者（N=2172），他们接受了 dCBT 或对照组（常规护理或睡眠卫生教育）治疗。评估在基线、干预后（第 8 或 10 周）和随访（第 22 或 24 周）进行。使用结构方程模型评估中介作用。

结果

与对照组相比，失眠的 dCBT 在所有时间点都能更有效地降低失眠（Hedges' g 范围为 0.77-0.81；均 p<0.001）和焦虑症状（Hedges' g 范围为 0.39-0.44；均 p<0.001）。基线失眠症状调节了 dCBT 对失眠的影响，但没有变量调节治疗对焦虑的影响。随访时焦虑症状的减轻与干预后睡眠的改善有关（中介百分比为 84%），这表明存在因果关系。