A Randomized, Placebo-Controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-Rich Web Application
A Randomized, Placebo-Controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-Rich Web Application
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DOI：
10.5665/sleep.1872
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发表时间：
2012-06-01
期刊：
影响因子：
5.6
通讯作者：
Brown, June S. L.
中科院分区：
文献类型：
--
作者：
Espie, Colin A.;Kyle, Simon D.;Brown, June S. L.
研究目标：互联网为医疗服务提供了一个无处不在的环境。本研究的目的是确定由自动虚拟治疗师提供的新型基于网络的认知行为治疗（CBT）课程与可信安慰剂相比的有效性；这是一种必要的方法，因为网络产品可能具有内在的吸引力，容易受到安慰剂反应的影响。设计：随机、安慰剂对照试验，包括3组：CBT、意象缓解疗法（IRT：安慰剂）、常规治疗（TAU）。设置：参与者在英国的在线社区。参与者：164名符合DSM-5失眠标准的成年人(120名F:[平均年龄49岁（18-78岁）]，随机分配到CBT （n = 55; 40 F）、IRT安慰剂（n = 55; 42 F）或TAU （n = 54; 38 F）组。干预措施：CBT和IRT各包括6个在线课程，由动画个人治疗师提供，并提供自动网络和电子邮件支持。参与者还可以访问视频库/会议内容的回溯目录和维基百科风格的文章。在线CBT使用者可以访问一个适度的社交网络/用户社区。TAU不包括对日常护理和访问在线睡眠日记的限制。测量和结果：基线、治疗后和治疗后8周随访时的主要评估；通过在线睡眠日记和临床状态评估结果。在睡眠效率的主要终点（SE；总睡眠时间占总卧床时间的百分比），在线CBT与治疗后（+20%）相对于TAU （+6%; d = 0.95）和IRT （+6%: d = 1.06）以及8周（+20%）相对于IRT （+7%: d = 1.00）和TAU （+9%: d = 0.69）的持续改善相关，这些发现反映在一系列睡眠日记测量中。CBT的临床益处被证实为在日间结果上相对于安慰剂有适度的优势（d = 0.23-0.37），并且在睡眠状况指标上显著改善了睡眠-觉醒功能（d = 0.77-1.20）。四分之三的CBT参与者（76% [CBT]对29% [IRT]和18% [TAU]）完成SE >治疗80%，超过一半（55% [CBT]对17% [IRT]和8% [TAU]）完成SE >治疗85%，超过三分之一（38% [CBT]对6% [IRT]和0% [TAU]）完成SE >治疗90%；这些改善在随访期间基本保持。结论：CBT采用富媒体的web应用程序，具有自动支持和社区论坛，可有效改善成人失眠患者的睡眠和相关的日间功能。
Study Objectives: The internet provides a pervasive milieu for healthcare delivery. The purpose of this study was to determine the effectiveness of a novel web-based cognitive behavioral therapy (CBT) course delivered by an automated virtual therapist, when compared with a credible placebo; an approach required because web products may be intrinsically engaging, and vulnerable to placebo response.Design: Randomized, placebo-controlled trial comprising 3 arms: CBT, imagery relief therapy (IRT: placebo), treatment as usual (TAU).Setting: Online community of participants in the UK.Participants: One hundred sixty-four adults (120 F: [mean age 49y (18-78y)] meeting proposed DSM-5 criteria for Insomnia Disorder, randomly assigned to CBT (n = 55; 40 F), IRT placebo (n = 55; 42 F) or TAU (n = 54; 38 F).Interventions: CBT and IRT each comprised 6 online sessions delivered by an animated personal therapist, with automated web and email support. Participants also had access to a video library/back catalogue of session content and Wikipedia style articles. Online CBT users had access to a moderated social network/community of users. TAU comprised no restrictions on usual care and access to an online sleep diary.Measurements and Results: Major assessments at baseline, post-treatment, and at follow-up 8-weeks post-treatment; outcomes appraised by online sleep diaries and clinical status. On the primary endpoint of sleep efficiency (SE; total time asleep expressed as a percentage of the total time spent in bed), online CBT was associated with sustained improvement at post-treatment (+20%) relative to both TAU (+6%; d = 0.95) and IRT (+6%: d = 1.06), and at 8 weeks (+20%) relative to IRT (+7%: d = 1.00) and TAU (+9%: d = 0.69) These findings were mirrored across a range of sleep diary measures. Clinical benefits of CBT were evidenced by modest superiority over placebo on daytime outcomes (d = 0.23-0.37) and by substantial improved sleep-wake functioning on the Sleep Condition Indicator (range of d = 0.77-1.20). Three-quarters of CBT participants (76% [CBT] vs. 29% [IRT] and 18% [TAU]) completed treatment with SE > 80%, more than half (55% [CBT] vs. 17% [IRT] and 8% [TAU]) with SE > 85%, and over one-third (38% [CBT] vs. 6% [IRT] and 0% [TAU]) with SE > 90%; these improvements were largely maintained during follow-up.Conclusion: CBT delivered using a media-rich web application with automated support and a community forum is effective in improving the sleep and associated daytime functioning of adults with insomnia disorder.