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A study conducted in China found that participants who used a smartphone application had improved insomnia severity compared with those who received sleep education.
A smartphone-based, Chinese culture–adapted digital cognitive behavioral therapy for insomnia (DCBT-I) application improved insomnia severity compared with sleep education, according to findings of a study published in JAMA Network Open.
Researchers wanted to study the efficacy of this DCBT-I app compared with sleep education using the same app, for which studies are minimal.
“To our knowledge, this is the first RCT [randomized clinical trial] in which the control group received sleep education provided using the same interface as an intervention,” said the researchers.
Insomnia is a common sleep problem that affects health globally, with a combined global prevalence of insomnia of about 15%; more than 200 million people in China experience insomnia. CBT-I is the current recommended first-line treatment for insomnia in adults, but traditional face-to-face CBT-I is inadequate in China because of the large number of people with insomnia, the length of the process, and the shortage of professional therapists.
This study was a single-blinded RCT conducted from March 2021 to January 2022, with screening and randomization conducted at Peking University First Hospital in China.Following eligibility assessment, eligible participants were enrolled and allocated 1:1 to DCBT-I or sleep education groups, and data were evaluated from January to February 2022. A total of 82 participants were included in the study, with 41 randomized to sleep education and 41 randomized to DCBT-I.
Then, a Chinese smartphone-based app with the same interface was used in both the DCBT-I and sleep education groups over 6 weeks, with follow-ups at 1, 3, and 6 months. The primary outcome was Insomnia Severity Index (ISI) scores with the intention-to-treat principle, with secondary and exploratory outcomes including sleep diary measures; self-reported scales evaluating dysfunctional beliefs about sleep, mental health, and quality of life; and smart bracelet measures.
Mean (SD) ISI scores in the DCBT-I group were significantly lower than those in the sleep education group following the 6-week intervention (12.7 [4.8] points vs 14.9 [5.0] points; P = .048) and at the 3-month follow-up (12.1 [5.4] points vs 14.8 [5.5] points; P = .04). There were significant improvements with large effect sizes from before to after the intervention for the sleep education and DCBT-I groups (sleep education: d = 1.13; DCBT-I: d = 1.71).
Some sleep diary measures and self-reported scales showed more improvements in the DCBT-I group than the sleep education group, like mean (SD) total sleep time (3 months: 403.9 [57.6] minutes vs 363.2 [72.3] minutes; 6 months: 420.3 [58.0] minutes vs 389.7 [59.4] minutes) and sleep efficiency (3 months: 87.4% [8.3%] vs 76.7% [12.1%]; 6 months: 87.5% [8.2%] vs 78.1% [10.9%]).
The DCBT-I group significantly outperformed the control group in improved insomnia severity and subjective sleep quality, demonstrating the intervention’s effectiveness. An exploratory analysis suggested that DCBT-I might be also better than sleep education in terms of reducing depression and anxiety, improving quality of life, and some of objective sleep quality measures, but more study is needed.
Two limitations of the study were that women were overrepresented and that the objective evaluation of sleep was performed using a consumer-grade smart bracelet rather than with a medical measurement. Also, participants with other sleep disorders like periodic limb movement or sleep apnea were not excluded, and there might be a population selection bias because participants were mainly from Beijing.
“These findings suggest that culturally adapted DCBT-I is suitable for the large population of patients with insomnia in China. Future multicenter clinical trials with large sample sizes are needed to validate its effectiveness in the Chinese population,” the researchers concluded.
Reference
Zhang C, Liu Y, Guo X, Liu Y, Shen Y, Ma J. Digital cognitive behavioral therapy for insomnia using a smartphone application in China: a pilot randomized clinical trial. JAMA Netw Open. 2023;6(3):e234866. doi:10.1001/jamanetworkopen.2023.4866