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Applying a mobile intervention for chronic insomnia in routine care: Study protocol for a multicenter randomized
Daa Un Moon1,2, Jeonghun Kim3, Jeyoung Hannah Sun3
1Department of Psychiatry and Neurosciences, Charité Campus Mitte, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, Berlin, Germany.
Internet Interventions
|July 10, 2025
Summary
This study evaluates a mobile cognitive behavioral therapy for insomnia (CBT-I) app, "SleepQ," in a clinical trial. Findings will assess the effectiveness of digital CBT-I for chronic insomnia treatment.
Area of Science:
- Digital health interventions
- Sleep medicine
- Behavioral therapy
Background:
- Cognitive behavioral therapy for insomnia (CBT-I) is a first-line treatment, but access is limited.
- Digital CBT-I (dCBT-I) offers a scalable solution to address treatment gaps.
- Real-world evidence for mobile dCBT-I effectiveness is needed.
Purpose of the Study:
- To examine the effectiveness of the mobile dCBT-I intervention,
- SleepQ,
- in a routine clinical setting.
- To evaluate the clinical implementation of digital therapeutics for insomnia.
- To inform the integration of mobile-based CBT-I into routine care.
Main Methods:
- A multicenter, two-arm, open-label, randomized controlled trial.
- 120 adults with chronic insomnia assigned to mobile dCBT-I or a waitlist control.
- Primary outcome: Insomnia Severity Index change at 6 weeks.
Main Results:
- The study is ongoing; results are not yet available.
- Primary and secondary outcomes will be assessed at 6 weeks.
- Long-term effects will be evaluated at 3- and 6-month follow-ups.
Conclusions:
- This trial will evaluate the effectiveness of mobile dCBT-I for chronic insomnia in routine clinical care.
- Findings will contribute to the broader understanding of digital therapeutics for insomnia.
- Results will guide the integration of mobile-based CBT-I into standard practice.
Keywords:
CBT-IChronic insomniaDigital cognitive behavioral therapyDigital interventionDigital therapeuticsInsomniaMobile healthmHealthMore Related Videos
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