Abstract: Background　Digital cognitive behavioral therapy for insomnia（dCBT-I） has been increasingly used worldwide. dCBT-I developed in China is unique in its cultural and medical background，however，its effect on insomnia remains to be examined. Objective　To evaluate the effect of dCBT-I in Chinese adults，thereby providing further evidence for the management of insomnia. Methods　A systematic search was performed in 10 electronic databases，including CNKI，Wanfang，VIP，SinoMed，PubMed，EMBase，CINAHL，Web of Science，Cochrane，and PsyINFO from inception to December 2020. Only randomized controlled trials（RCTs） conducted in Chinese adults with insomnia were included. The involved patients receiving dCBT-I（experimental group） were compared to those receiving non-dCBT-I（control group）. Primary outcomes included sleep quality，Insomnia Severity Index（ISI），sleep duration，sleep efficiency，and sleep onset latency. Secondary outcomes included beliefs and attitudes about sleep，anxiety，and depression. Two investigators performed the study selection，data extraction，and quality appraisal separately. Version 2 of the Cochrane risk-of-bias tool for randomized trials（ROB2） was used for quality appraisal. Revman 5.4 was used for Meta-analysis. Results　Seven RCTs consisting of 957 participants were included. One had moderate risk of bias and six had high risk. Based on the meta-analysis，compared to medication treatment，dCBT-I resulted in better sleep efficiency〔WMD=4.63，95%CI（0.63，8.63），P=0.02〕，sleep onset latency〔WMD=-12.18，95%CI（ -20.48，-3.88），P=0.004〕，and wake after sleep onset〔WMD=-17.18，95%CI（-30.29，-4.08），P=0.01〕. Similarly，compared to those receiving non-active treatment，those receiving dCBT-I showed better sleep efficiency〔WMD=8.94，95%CI（1.64，16.24），P=0.02〕，sleep onset latency〔WMD=-14.71，95%CI（-27.61，-1.81），P=0.03〕，insomnia severity（assessed using the ISI）〔WMD=-3.73，95%CI（ -6.57，-0.88），P=0.01〕，and overall sleep quality（assessed using the PSQI score）〔WMD= -2.21，95%CI（ -3.04，1.38），P<0.000 01〕. In addition，compared to routine sleep education，dCBT-I improved overall sleep quality（assessed using the PSQI score）（t=3.231，P=0.002）. dCBT-I and medication treatment resulted in similar improvements in anxiety and depression （pre-post treatment comparison，P<0.05）. dCBT-I also improved beliefs and attitudes about sleep （pre-post treatment comparison，P<0.05） and showed greater improvements than non-active treatment（P<0.01）.Conclusion　Currently，dCBT-I is delivered via various forms and platforms in China，without a consistent and standardized protocol. Overall，dCBT-I could improve short-term sleep quality among Chinese adults with insomnia. Larger studies using both objective and subjective measurements of sleep are warranted to examine the long-term effect of dCBT-I.

Key words: Sleep initiation and maintenance disorders, Insomnia, Cognitive behavioral therapy, Digital, Sleep quality, Systematic review, Meta-analysis

摘要： 背景　电子化认知行为疗法（dCBT-I）正在得到广泛应用，我国dCBT-I独具文化和医疗特色，但其效果仍有待明确。目的　对dCBT-I在中国失眠人群中的应用效果进行系统评价，为优化现阶段治疗方案提供证据。方法　计算机检索中国知网、万方数据知识服务平台、维普网、SinoMed、PubMed、EMBase、CINAHL、Web of Science、Cochrane、PsyINFO，检索年限为建库至2020年12月。仅纳入开展于中国失眠成人的随机对照试验。试验组接受dCBT-I干预，对照组接受非dCBT-I干预（空白对照、传统面对面CBT-I或药物治疗）。主要观察指标包括睡眠质量〔匹兹堡睡眠指数（PSQI）〕、失眠严重程度〔失眠严重程度指数量表（ISI）〕、睡眠时间、睡眠效率、睡眠潜伏期；次要观察指标包括睡眠信念与态度、焦虑、抑郁。由两位研究者独立进行文献筛选、数据提取、质量评价，采用Cochrane的Risk of Bias 2（ROB2）进行质量评价，采用Revman 5.4进行Meta分析。结果　纳入7篇文献，共计957例患者。1项研究被评为存在一定偏倚风险，6项研究被评为高偏倚风险。Meta分析：dCBT-I组睡眠效率高于药物治疗组〔WMD=4.63，95%CI（0.63，8.63），P=0.02〕，dCBT-I组睡眠潜伏期〔WMD=-12.18，95%CI（-20.48，-3.88），P=0.004〕、入睡后觉醒时间〔WMD=-17.18，95%CI（-30.29，-4.08），P=0.01〕短于药物治疗组。dCBT-I组睡眠效率高于空白对照组〔WMD=8.94，95%CI（1.64，16.24），P=0.02〕，dCBT-I组睡眠潜伏期短于空白对照组〔WMD=-14.71，95%CI（-27.61，-1.81），P=0.03〕，dCBT-I组减轻失眠严重程度（ISI得分）优于空白对照组〔WMD=-3.73，95%CI（-6.57，-0.88），P=0.01〕，dCBT-I组改善睡眠质量（PSQI得分）优于空白对照组〔WMD=-2.21，95%CI（-3.04，1.38），P<0.000 01〕。此外，dCBT-I在改善整体睡眠质量（PSQI得分）方面优于常规睡眠相关健康教育（t=3.231，P=0.002）。dCBT-I和药物治疗均能改善患者的焦虑、抑郁情况（治疗后数据与基线相比P<0.05）；dCBT-I还可改善研究对象的睡眠信念和态度（治疗后数据与基线相比P<0.05）；dCBT-I较空白对照组改善睡眠信念和态度更优（P<0.01）。结论　我国dCBT-I实施平台和形式多样，但尚未有统一、标准化方案。dCBT-I在改善中国失眠患者的睡眠方面具有短期作用，但仍需结合主客观测量方法，在大样本研究中验证dCBT-I的长期应用效果。

关键词: 入睡和睡眠障碍, 失眠, 认知行为疗法, 电子化, 睡眠质量, 系统评价, Meta分析