Study Objectives Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity. Methods Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33. Results Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2. Conclusions At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.

中文翻译：

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失眠认知行为疗法的实施方式：数字和面对面治疗的随机对照非劣效性试验


研究目标 失眠数字认知行为疗法 (dCBT-I) 已在自我参考和社区样本中证明可以有效降低失眠严重程度。然而，对于转诊至临床二级服务的个人来说，dCBT-I 与个人面对面 (FtF) CBT-I 相比如何，目前尚不清楚。我们进行了一项随机对照试验，以测试全自动 dCBT-I 在降低失眠严重程度方面是否不劣于个体 FtF CBT-I。方法 合格的参与者是从挪威公共心理健康服务提供的睡眠诊所招募的被诊断为失眠症的成年患者。失眠严重程度指数（ISI）是主要结果指标。非劣效性界值预先定义为第 33 周时 ISI 2.0 分。 结果 个体被随机分配至 FtF CBT-I (n = 52) 或 dCBT-I (n = 49)；平均基线 ISI 评分分别为 18.4 (SD 3.7) 和 19.4 (SD 4.1)。第 33 周时，平均得分分别为 8.9 (SD 6.0) 和 12.3 (SD 6.9)。两种干预措施均存在显着的时间效应 (p < 0.001)；第 33 周时 ISI 的平均差异为 -2.8（95% CI：-4.8 至 -0.8；p = 0.007，Cohen's d = 0.7），第 9 周时为 -4.6（95% CI -6.6 至 -2.7；p = 0.007） < 0.001)，科恩 d = 1.2。结论 在第 33 周的主要终点，估计治疗差异的 95% CI 包括非劣效性界限，并且完全位于零左侧。因此，关于 dCBT-I 是否优于 FtF CBT-I，该结果尚无定论，但 dCBT-I 的表现明显差于 FtF CBT-I。第 9 周时，dCBT-I 劣于 FtF CBT-I，因为 95% CI 完全超出非劣效性界限。 这些发现强调需要更多的临床研究来阐明 dCBT-I 的最佳应用、传播和实施。 ClinicalTrials.gov：NCT02044263：由治疗师或在互联网上提供的失眠认知行为疗法：随机对照非劣效性试验。