Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy

Håvard Kallestad, Jan Scott, Øystein Vedaa, Stian Lydersen, Daniel Vethe, Gunnar Morken, Tore Charles Stiles, Børge Sivertsen, Knut Langsrud, Håvard Kallestad, Jan Scott, Øystein Vedaa, Stian Lydersen, Daniel Vethe, Gunnar Morken, Tore Charles Stiles, Børge Sivertsen, Knut Langsrud

Abstract

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.

Keywords: Cognitive Behavioral Therapy for Insomnia; digital; face-to-face; insomnia disorder; non-inferiority; randomized controlled trial.

© Sleep Research Society 2021. Published by Oxford University Press on behalf of the Sleep Research Society.

Figures

Figure 1.
Figure 1.
Flow diagram of trial: participant inclusion, timing of assessments, and completion rates.
Figure 2.
Figure 2.
Difference in estimated mean scores on the Insomnia Severity Index between the two interventions and their 95% CI relative to the non-inferiority margin. Figure adapted from the CONSORT statement for non-inferiority trials [17].

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