Efficacy of Mobile App-Based Cognitive Behavioral Therapy for Insomnia: Multicenter, Single-Blind Randomized Clinical Trial.

Autor: Shin J; Department of Psychiatry and Center for Sleep and Chronobiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.; Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Gyeonggi-do, Republic of Korea., Kim S; Department of Psychiatry, Seoul National University College of Medicine, Seoul, Republic of Korea., Lee J; Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea., Gu H; Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea., Ahn J; Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea., Park C; Department of Psychiatry, Severance Hospital, Seoul, Republic of Korea., Seo M; Department of Psychiatry, Veteran Health Service Medical Center, Seoul, Republic of Korea., Jeon JE; Department of Psychiatry and Center for Sleep and Chronobiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea., Lee HY; Department of Psychiatry and Center for Sleep and Chronobiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea., Yeom JW; Chronobiology Institute, Korea University, Seoul, Republic of Korea.; Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea., Kim S; Department of Psychology, University of Oregon, Eugene, OR, United States., Yoon Y; Chronobiology Institute, Korea University, Seoul, Republic of Korea., Lee HJ; Chronobiology Institute, Korea University, Seoul, Republic of Korea.; Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea., Kim SJ; Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea., Lee YJ; Department of Psychiatry and Center for Sleep and Chronobiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jazyk: angličtina
Zdroj: Journal of medical Internet research [J Med Internet Res] 2024 Jul 26; Vol. 26, pp. e50555. Date of Electronic Publication: 2024 Jul 26.
DOI: 10.2196/50555
Abstrakt: 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.)
Databáze: MEDLINE
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