Efficacy of Mobile App–Based Cognitive Behavioral Therapy for Insomnia: Multicenter, Single-Blind Randomized Clinical Trial (Preprint)
Authors: Shin Jiyoon , Kim Sujin , Lee Jooyoung , Gu Hyerin , Ahn Jihye , Park Chowon , Seo Mincheol , Jeon Jeong Eun , Lee Ha Young , Yeom Ji Won , Kim Sojeong , Yoon Yeaseul , Lee Heon-Jeong , Kim Seog Ju , Lee Yu Jin 
Published: July 2023

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<sub>95</sub>=3.85; <i>F</i><sub>2,95</sub>=22.76; η<sub>p</sub><sup>2</sup>=0.13; <i>P</i>&lt;.001) and at the 3-month follow-up visit (11.3 vs 14.7; t<sub>68</sub>=2.61; <i>F</i><sub>2,68</sub>=5.85; η<sub>p</sub><sup>2</sup>=0.03; <i>P</i>=.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 <i>d</i>=–0.62 to –1.35; <i>P</i>&lt;.01 in all cases). Furthermore, the Somzz group showed better sleep efficiency (t<sub>95</sub>=–3.32; <i>F</i><sub>2,91</sub>=69.87; η<sub>p</sub><sup>2</sup>=0.41; <i>P</i>=.001), wake after sleep onset (t<sub>95</sub>=2.55; <i>F</i><sub>2,91</sub>=51.81; η<sub>p</sub><sup>2</sup>=0.36; <i>P</i>=.01), satisfaction (t<sub>95</sub>=–2.05; <i>F</i><sub>2,91</sub>=26.63; η<sub>p</sub><sup>2</sup>=0.20; <i>P</i>=.04) related to sleep, and mental health outcomes, including depression (t<sub>95</sub>=2.11; <i>F</i><sub>2,94</sub>=29.64; η<sub>p</sub><sup>2</sup>=0.21; <i>P</i>=.04) and quality of life (t<sub>95</sub>=–3.13; <i>F</i><sub>2,94</sub>=54.20; η<sub>p</sub><sup>2</sup>=0.33; <i>P</i>=.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.

CLINICALTRIAL

Clinical Research Information Service (CRiS) KCT0007292; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22214&amp;search_page=L