@Article{info:doi/10.2196/50555,
author="Shin, Jiyoon
and Kim, Sujin
and Lee, Jooyoung
and Gu, Hyerin
and Ahn, Jihye
and Park, Chowon
and Seo, Mincheol
and Jeon, Jeong Eun
and Lee, Ha Young
and Yeom, Ji Won
and Kim, Sojeong
and Yoon, Yeaseul
and Lee, Heon-Jeong
and Kim, Seog Ju
and Lee, Yu Jin",
title="Efficacy of Mobile App--Based Cognitive Behavioral Therapy for Insomnia: Multicenter, Single-Blind Randomized Clinical Trial",
journal="J Med Internet Res",
year="2024",
month="Jul",
day="26",
volume="26",
pages="e50555",
keywords="digital therapeutics; mobile app--based cognitive behavioral therapy for insomnia; cognitive behavioral therapy; insomnia; mental health; mobile phone",
abstract="Background: Cognitive behavioral therapy for insomnia (CBTi) is the first-line therapy for chronic insomnia. Mobile app--based CBTi (MCBTi) can enhance the accessibility of CBTi treatment; however, few studies have evaluated the effectiveness of MCBTi using a multicenter, randomized controlled trial design. Objective: We aimed to assess the efficacy of Somzz, an MCBTi that provides real-time and tailored feedback to users, through comparison with an active comparator app. Methods: In our multicenter, single-blind randomized controlled trial study, participants were recruited from 3 university hospitals and randomized into a Somzz group and a sleep hygiene education (SHE) group at a 1:1 ratio. The intervention included 6 sessions for 6 weeks, with follow-up visits over a 4-month period. The Somzz group received audiovisual sleep education, guidance on relaxation therapy, and real-time feedback on sleep behavior. The primary outcome was the Insomnia Severity Index score, and secondary outcomes included sleep diary measures and mental health self-reports. We analyzed the outcomes based on the intention-to-treat principle. Results: A total of 98 participants were randomized into the Somzz (n=49, 50{\%}) and SHE (n=49, 50{\%}) groups. Insomnia Severity Index scores for the Somzz group were significantly lower at the postintervention time point (9.0 vs 12.8; t95=3.85; F2,95=22.76; $\eta$p2=0.13; P<.001) and at the 3-month follow-up visit (11.3 vs 14.7; t68=2.61; F2,68=5.85; $\eta$p2=0.03; P=.01) compared to those of the SHE group. The Somzz group maintained their treatment effect at the postintervention time point and follow-ups, with a moderate to large effect size (Cohen d=--0.62 to --1.35; P<.01 in all cases). Furthermore, the Somzz group showed better sleep efficiency (t95=--3.32; F2,91=69.87; $\eta$p2=0.41; P=.001), wake after sleep onset (t95=2.55; F2,91=51.81; $\eta$p2=0.36; P=.01), satisfaction (t95=--2.05; F2,91=26.63; $\eta$p2=0.20; P=.04) related to sleep, and mental health outcomes, including depression (t95=2.11; F2,94=29.64; $\eta$p2=0.21; P=.04) and quality of life (t95=--3.13; F2,94=54.20; $\eta$p2=0.33; P=.002), compared to the SHE group after the intervention. The attrition rate in the Somzz group was 12{\%} (6/49). Conclusions: Somzz outperformed SHE in improving insomnia, mental health, and quality of life. The MCBTi can be a highly accessible, time-efficient, and effective treatment option for chronic insomnia, with high compliance. Trial Registration: Clinical Research Information Service (CRiS) KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214{\&}search{\_}page=L ",
issn="1438-8871",
doi="10.2196/50555",
url="https://www.jmir.org/2024/1/e50555",
url="https://doi.org/10.2196/50555"
}