Applying a mobile intervention for chronic insomnia in routine care: Study protocol for a multicenter randomized controlled trial

IF 3.6 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Internet Interventions-The Application of Information Technology in Mental and Behavioural Health Pub Date : 2025-06-20 DOI:10.1016/j.invent.2025.100848

Daa Un Moon , Jeonghun Kim , Jeyoung Hannah Sun , Yujin Lee

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引用次数: 0

Abstract

Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, access to in-person CBT-I remains limited due to a shortage of trained providers and structural barriers. Digital CBT-I (dCBT-I) offers a scalable solution to bridge this treatment gap, yet real-world evidence of its effectiveness remains limited. This study aims to examine the effectiveness of a mobile dCBT-I intervention, “SleepQ,” in a routine clinical setting. This study is a multicenter, two-arm, open-label, randomized controlled trial comparing a mobile dCBT-I intervention to a waitlist control group. A total of 120 adults with chronic insomnia will be recruited from six clinics in South Korea. Participants will be randomly assigned (1:1) to either the intervention group receiving 6 weeks of dCBT-I or the control group, which will gain access to the intervention after the posttreatment assessment. The primary outcome is the Insomnia Severity Index score change from baseline to 6 weeks post-randomization. Secondary outcomes include dysfunctional sleep beliefs, daytime sleepiness, depressive and anxiety symptoms, quality of life, and work productivity. Exploratory outcomes include adherence, usability, app satisfaction, and sleep parameters from the integrated sleep diary. In the intervention group, follow-up assessments will be conducted 3- and 6-months post-randomization to evaluate long-term effects. This trial will evaluate the effectiveness of mobile dCBT-I for chronic insomnia within routine clinical care. Findings will contribute to the evaluation of the clinical implementation of digital therapeutics for insomnia and inform the integration of mobile-based CBT-I into routine care.

Clinical trial registration

https://clinicaltrials.gov/study/NCT06695000, ClinicalTrials.gov (NCT06695000).

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在日常护理中应用移动干预治疗慢性失眠：多中心随机对照试验的研究方案

失眠认知行为疗法（CBT-I）是慢性失眠的一线治疗方法。然而，由于缺乏训练有素的提供者和结构性障碍，获得面对面CBT-I的机会仍然有限。数字CBT-I （dCBT-I）提供了一种可扩展的解决方案来弥补这一治疗差距，但其有效性的实际证据仍然有限。本研究旨在检验移动dCBT-I干预“SleepQ”在常规临床环境中的有效性。本研究是一项多中心、双臂、开放标签、随机对照试验，比较了移动dCBT-I干预组和候补对照组。共有120名患有慢性失眠症的成年人将从韩国的6家诊所招募。参与者将被随机（1:1）分配到接受6周dCBT-I的干预组或对照组，对照组将在治疗后评估后进入干预。主要结局是失眠严重程度指数评分从基线到随机化后6周的变化。次要结果包括不正常的睡眠信念、白天嗜睡、抑郁和焦虑症状、生活质量和工作效率。探索性结果包括依从性、可用性、应用满意度和综合睡眠日记中的睡眠参数。干预组将在随机化后3个月和6个月进行随访评估，以评估长期效果。本试验将评估移动dCBT-I在常规临床护理中治疗慢性失眠的有效性。研究结果将有助于评估失眠数字治疗的临床实施，并为将基于移动的CBT-I整合到常规护理中提供信息。临床试验注册：https://clinicaltrials.gov/study/NCT06695000, ClinicalTrials.gov （NCT06695000）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Internet Interventions-The Application of Information Technology in Mental and Behavioural Health Medicine-Health Informatics

CiteScore

6.50

自引率

9.30%

发文量

审稿时长

6 weeks

期刊介绍： Official Journal of the European Society for Research on Internet Interventions (ESRII) and the International Society for Research on Internet Interventions (ISRII). The aim of Internet Interventions is to publish scientific, peer-reviewed, high-impact research on Internet interventions and related areas. Internet Interventions welcomes papers on the following subjects: • Intervention studies targeting the promotion of mental health and featuring the Internet and/or technologies using the Internet as an underlying technology, e.g. computers, smartphone devices, tablets, sensors • Implementation and dissemination of Internet interventions • Integration of Internet interventions into existing systems of care • Descriptions of development and deployment infrastructures • Internet intervention methodology and theory papers • Internet-based epidemiology • Descriptions of new Internet-based technologies and experiments with clinical applications • Economics of internet interventions (cost-effectiveness) • Health care policy and Internet interventions • The role of culture in Internet intervention • Internet psychometrics • Ethical issues pertaining to Internet interventions and measurements • Human-computer interaction and usability research with clinical implications • Systematic reviews and meta-analysis on Internet interventions