Evaluating a mobile app for treating chronic insomnia
Official title: Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA RCT
Run by Aarhus University Hospital · NCT06781203 · Data updated 2026-11-12
This study is testing a mobile app that offers therapy for chronic insomnia to see if it can help people sleep better without using medication.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | January 17, 2025 |
| Trial ID | NCT06781203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who report moderate-to-severe insomnia symptoms and have access to a smartphone.
✕Probably not a fit
Patients with mild or no clinically relevant insomnia symptoms, severe comorbidities affecting sleep, or those currently receiving similar therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the feasibility, acceptability, and effectiveness of a fully automated mobile application delivering cognitive behavioral therapy for insomnia (eCBTI) in a general practice setting. It addresses the widespread issue of insomnia, which affects a significant portion of the population and is often treated with potentially harmful medications. The study will also explore the impact of eCBTI on psychological and physical comorbidities, as well as its cost-effectiveness. By integrating eCBTI into general practice, the study seeks to provide a non-pharmacological alternative to traditional treatments.
Why it matters
Potential benefit: If successful, this approach could provide an accessible and effective treatment option for patients suffering from chronic insomnia without the risks associated with medication.
How similar studies have gone: Previous studies have shown that digitally delivered CBTI is effective, but this specific integration into general practice is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years) * Individuals who report moderate-to-severe insomnia symptoms (a score ≥10 on the Insomnia Severity Index, ISI) * Individuals referred by their general practitioner * Individuals with access to a smartphone with internet connection * Individuals who report sufficient technological proficiency (e.g., ability to download apps) Exclusion Criteria: * Children (\<18 years) * Individuals who report mild or no clinically relevant insomnia symptoms (a score \<10 on the ISI) * Individuals who have a shift-work schedule or are on maternity/paternity leave * Individuals who are unable to read Danish * Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cancer, COPD) * Individuals who report other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy) * Individuals who are currently receiving or have recently received CBTI or eCBTI
Where it's running
-
Aarhus University Hospital
Aarhus, Denmark Recruiting
Study contacts
- Principal investigator: Robert Zachariae, Professsor, DMSc, MSc — University of Aarhus and Aarhus University Hospital
- Study coordinator: Morten J Lopdrup, MSc
- Email: mlop@psy.au.dk
- Phone: +45 87 16 90 52
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.