JMIR Publications

ABSTRACT

Background:

Cognitive behavioral therapy for insomnia (CBTi) is the first-line therapy for chronic insomnia. Mobile-application-based CBTi (MCBTi) can enhance the accessibility of CBTi treatment; however, few studies have evaluated the effectiveness of MCBTi using a multi-center, randomized controlled trial (RCT) design.

Objective:

We aimed to assess the efficacy of Somzz, an MCBTi that provides real-time and tailored feedback to users, comparing with an active comparator application.

Methods:

In our multi-center, single-blinded RCT study, a total of 98 participants were recruited from three sites and randomized into a Somzz group and a sleep hygiene education (SHE) group at a 1:1 ratio. The intervention included six sessions for 6 weeks, with follow-up visits over a 4-month period. Somzz provided CBTi treatment through audiovisual sleep education, guidance on relaxation therapy, and real-time customized feedback on participants’ sleep behavior by analyzing the data entered into the app. The primary outcome was the Insomnia Severity Index (ISI), and secondary outcomes included sleep diary measures and mental health self-reports. We analyzed the outcomes based on the intention-to-treat principle.

Results:

ISI scores for the Somzz group were significantly lower at post-intervention (8.30 vs. 12.9, P < .001) and at the 3-month follow-up visit (11.26 vs. 14.70, P = .007) compared to the SHE group. The Somzz group had maintained their treatment effect at post-intervention and follow-ups, with a moderate-to-large effect size (Cohen’s d = −0.68 to −1.45). Furthermore, the Somzz group showed better outcomes in sleep efficiency (P = .015) and mental health, including depression (P = .009), anxiety (P = .011), and quality of life (P = 0.008) at post-intervention. Among those in the Somzz group, 42 (95.45%) participants finished the intervention. Our study had an attrition rate of 4.55% (2 of 44) post-intervention among the Somzz group.

Conclusions:

Somzz outperformed SHE in improving insomnia, mental health, and quality of life. MCBTi can be a highly accessible, time-efficient, and effective treatment option for chronic insomnia, with high compliance. Clinical Trial: cris.nih.go.kr KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214&search_page=L.