Effect of smartphone-based cognitive behavioral therapy app on insomnia: a randomized, double-blind study

Abstract Study Objectives This study assessed the effects and safety of the smartphone-based cognitive behavioral therapy for insomnia (CBT-I) app compared with the sham app. Methods In this multicenter, double-blind, and parallel-group study, 175 patients with insomnia were randomized to a smartphone-based CBT-I app (Active, n = 87) or a sham app (Sham, n = 88) group. The primary endpoint was the change in Athens Insomnia Score (AIS) from baseline after 8 weeks of treatment. Results The change in AIS (mean ± standard deviation) from baseline, assessed using a modified-intent-to-treat analysis, was −6.7 ± 4.4 in the Active group and −3.3 ± 4.0 in the Sham group. The difference in the mean change between the groups was −3.4 (p < .001), indicating a greater change in the Active group. The change in CGI-I from the baseline was 1.3 ± 0.8 in the Active group and 0.7 ± 0.8 in the Sham group (p < .001). The proportion of patients with an AIS less than 6 was 37.9% in the Active group and 10.2% in the Sham group (p < .001). As for the safety assessment, no adverse reactions or device failures were detected in the Active group. Conclusions This study demonstrated the effectiveness of a smartphone-based CBT-I system for treating insomnia. Clinical Trial Registration ID: jRCT2032210071; trial name: Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yukumi in patients with insomnia disorders (verification study); URL: https://jrct.niph.go.jp/en-latest-detail/jRCT2032210071