Division of Mental Health Care, St. Olavs University Hospital, Trondheim, Norway.
Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.
Sleep. 2021 Dec 10;44(12). doi: 10.1093/sleep/zsab185.
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.
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.
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.
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.
数字化认知行为疗法（dCBT-I）对于自报和社区样本的失眠严重程度具有疗效。然而，对于转诊至临床二级服务的个体，dCBT-I 与个体面对面（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，以检验完全自动化的 dCBT-I 是否在降低失眠严重程度方面不劣于个体 FtF CBT-I。
从挪威公共心理健康服务机构提供的睡眠诊所招募符合条件的成年失眠障碍患者参与研究。失眠严重程度指数（ISI）是主要的结局测量指标。非劣效性边界在第 33 周时预先定义为 ISI 增加 2.0 分。
个体被随机分配至 FtF CBT-I（n = 52）或 dCBT-I（n = 49）组；基线时 ISI 平均得分分别为 18.4（标准差 3.7）和 19.4（标准差 4.1）。在第 33 周时，平均得分分别为 8.9（标准差 6.0）和 12.3（标准差 6.9）。两种干预措施均存在显著的时间效应（p < 0.001）；第 33 周时 ISI 的平均差值为-2.8（95%置信区间：-4.8 至-0.8；p = 0.007，Cohen's d = 0.7），第 9 周时为-4.6（95%置信区间：-6.6 至-2.7；p < 0.001，Cohen's d = 1.2）。
在第 33 周的主要终点时，估计治疗差异的 95%置信区间包含非劣效性边界且完全在零的左侧。因此，这一结果对于 dCBT-I 相对于 FtF CBT-I 的可能劣势或非劣效性尚无定论，但 dCBT-I 的表现明显逊于 FtF CBT-I。在第 9 周时，dCBT-I 劣于 FtF CBT-I，因为 95%置信区间完全超出了非劣效性边界。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：由治疗师或互联网提供的认知行为疗法治疗失眠：一项随机对照非劣效性试验。
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