Shin J, Kim S, Lee J, Gu H, Ahn J, Park C, Seo M, Jeon JE, Lee HY, Yeom JW, Kim S, Yoon Y, Lee HJ, Kim SJ, and Lee YJ
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; t 95 =3.85; F 2,95 =22.76; η p 2 =0.13; P<.001) and at the 3-month follow-up visit (11.3 vs 14.7; t 68 =2.61; F 2,68 =5.85; η p 2 =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 (t 95 =-3.32; F 2,91 =69.87; η p 2 =0.41; P=.001), wake after sleep onset (t 95 =2.55; F 2,91 =51.81; η p 2 =0.36; P=.01), satisfaction (t 95 =-2.05; F 2,91 =26.63; η p 2 =0.20; P=.04) related to sleep, and mental health outcomes, including depression (t 95 =2.11; F 2,94 =29.64; η p 2 =0.21; P=.04) and quality of life (t 95 =-3.13; F 2,94 =54.20; η p 2 =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., (©Jiyoon Shin, Sujin Kim, Jooyoung Lee, Hyerin Gu, Jihye Ahn, Chowon Park, Mincheol Seo, Jeong Eun Jeon, Ha Young Lee, Ji Won Yeom, Sojeong Kim, Yeaseul Yoon, Heon-Jeong Lee, Seog Ju Kim, Yu Jin Lee. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 26.07.2024.)