Suonaa Lee, Kyung Mee Park, Do Hyun Lee, Eun Chae Choi, Yujin Lee, Eun Lee
{"title":"坚持数字认知行为疗法对失眠疗效的影响。","authors":"Suonaa Lee, Kyung Mee Park, Do Hyun Lee, Eun Chae Choi, Yujin Lee, Eun Lee","doi":"10.3349/ymj.2024.0398","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Although digital cognitive behavioral therapy for insomnia (dCBT-I) offers a promising solution to the accessibility limitations of traditional face-to-face CBT-I, few studies have examined dCBT-I against a sham app and adherence issues remain. This study assessed the efficacy of dCBT-I compared with a sham app and investigated whether adherence predicts sleep outcomes.</p><p><strong>Materials and methods: </strong>In this combined analysis of two multicenter, double-blind, sham-controlled randomized controlled trials, 120 patients with insomnia were randomized to use the dCBT-I app (n=60) or a sham app (n=60). The primary outcome was the change in sleep efficiency (SE) from baseline after the 6-week intervention. The relationship between adherence to sleep restriction therapy (SRT) and sleep outcomes post-intervention was assessed.</p><p><strong>Results: </strong>After adjusting for age, sex, sleep medication use, and baseline levels of each outcome variable, the dCBT-I group demonstrated better treatment outcomes than the sham app group, with significant improvements of 7.69% in SE [95% confidence interval (CI), 3.09% to 12.30%; <i>p</i>=0.001], -16.77 minutes in sleep onset latency (95% CI, -31.48 to -2.06 minutes; <i>p</i>=0.026), and -0.97 in dysfunctional beliefs about sleep (95% CI, -1.46 to -0.48; <i>p</i><0.001) from baseline. Poorer adherence to SRT was associated with reduced SE (<i>p</i>=0.006) and increased nighttime wakefulness (<i>p</i>=0.002) after controlling for age, sex, years of education, and the baseline value of each outcome variable.</p><p><strong>Conclusion: </strong>This combined analysis demonstrates the efficacy of dCBT-I in improving sleep outcomes compared with a sham app and highlights the role of adherence to SRT in enhancing treatment efficacy. The two studies were registered with ClinicalTrials.gov (NCT05822999, NCT05809544).</p>","PeriodicalId":23765,"journal":{"name":"Yonsei Medical Journal","volume":"66 10","pages":"657-665"},"PeriodicalIF":2.8000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12479198/pdf/","citationCount":"0","resultStr":"{\"title\":\"Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness.\",\"authors\":\"Suonaa Lee, Kyung Mee Park, Do Hyun Lee, Eun Chae Choi, Yujin Lee, Eun Lee\",\"doi\":\"10.3349/ymj.2024.0398\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Although digital cognitive behavioral therapy for insomnia (dCBT-I) offers a promising solution to the accessibility limitations of traditional face-to-face CBT-I, few studies have examined dCBT-I against a sham app and adherence issues remain. This study assessed the efficacy of dCBT-I compared with a sham app and investigated whether adherence predicts sleep outcomes.</p><p><strong>Materials and methods: </strong>In this combined analysis of two multicenter, double-blind, sham-controlled randomized controlled trials, 120 patients with insomnia were randomized to use the dCBT-I app (n=60) or a sham app (n=60). The primary outcome was the change in sleep efficiency (SE) from baseline after the 6-week intervention. The relationship between adherence to sleep restriction therapy (SRT) and sleep outcomes post-intervention was assessed.</p><p><strong>Results: </strong>After adjusting for age, sex, sleep medication use, and baseline levels of each outcome variable, the dCBT-I group demonstrated better treatment outcomes than the sham app group, with significant improvements of 7.69% in SE [95% confidence interval (CI), 3.09% to 12.30%; <i>p</i>=0.001], -16.77 minutes in sleep onset latency (95% CI, -31.48 to -2.06 minutes; <i>p</i>=0.026), and -0.97 in dysfunctional beliefs about sleep (95% CI, -1.46 to -0.48; <i>p</i><0.001) from baseline. Poorer adherence to SRT was associated with reduced SE (<i>p</i>=0.006) and increased nighttime wakefulness (<i>p</i>=0.002) after controlling for age, sex, years of education, and the baseline value of each outcome variable.</p><p><strong>Conclusion: </strong>This combined analysis demonstrates the efficacy of dCBT-I in improving sleep outcomes compared with a sham app and highlights the role of adherence to SRT in enhancing treatment efficacy. 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Impact of Adherence to Digital Cognitive Behavioral Therapy for Insomnia Effectiveness.
Purpose: Although digital cognitive behavioral therapy for insomnia (dCBT-I) offers a promising solution to the accessibility limitations of traditional face-to-face CBT-I, few studies have examined dCBT-I against a sham app and adherence issues remain. This study assessed the efficacy of dCBT-I compared with a sham app and investigated whether adherence predicts sleep outcomes.
Materials and methods: In this combined analysis of two multicenter, double-blind, sham-controlled randomized controlled trials, 120 patients with insomnia were randomized to use the dCBT-I app (n=60) or a sham app (n=60). The primary outcome was the change in sleep efficiency (SE) from baseline after the 6-week intervention. The relationship between adherence to sleep restriction therapy (SRT) and sleep outcomes post-intervention was assessed.
Results: After adjusting for age, sex, sleep medication use, and baseline levels of each outcome variable, the dCBT-I group demonstrated better treatment outcomes than the sham app group, with significant improvements of 7.69% in SE [95% confidence interval (CI), 3.09% to 12.30%; p=0.001], -16.77 minutes in sleep onset latency (95% CI, -31.48 to -2.06 minutes; p=0.026), and -0.97 in dysfunctional beliefs about sleep (95% CI, -1.46 to -0.48; p<0.001) from baseline. Poorer adherence to SRT was associated with reduced SE (p=0.006) and increased nighttime wakefulness (p=0.002) after controlling for age, sex, years of education, and the baseline value of each outcome variable.
Conclusion: This combined analysis demonstrates the efficacy of dCBT-I in improving sleep outcomes compared with a sham app and highlights the role of adherence to SRT in enhancing treatment efficacy. The two studies were registered with ClinicalTrials.gov (NCT05822999, NCT05809544).
期刊介绍:
The goal of the Yonsei Medical Journal (YMJ) is to publish high quality manuscripts dedicated to clinical or basic research. Any authors affiliated with an accredited biomedical institution may submit manuscripts of original articles, review articles, case reports, brief communications, and letters to the Editor.