NCT06781203 Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA
| NCT ID | NCT06781203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Insomnia Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2024-12-17 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Insomnia is a widespread public health challenge considering its impact on daily life, comorbidity with other disorders, and socio-economic costs. Previous research has shown the efficacy of cognitive behavioral therapy for insomnia (CBTI), and recent research indicates that digitally delivered CBTI (eCBTI) is highly efficacious, and statistically significantly equivalent to in-person delivered CBTI (ipCBTI) for treating insomnia. However, research is limited as to how eCBTI can be integrated into general practice as a non-pharmacological alternative to hypnotics. This study aims to evaluate the feasibility, acceptability, and effectiveness of a fully automated mobile application for treating insomnia in general practice. The secondary aims are to examine effects on psychological and physical comorbidities, possible moderators and mediators of the effect of eCBTI, and cost-effectiveness.
Eligibility 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
Contact & Investigator
Robert Zachariae, Professsor, DMSc, MSc
PRINCIPAL INVESTIGATOR
University of Aarhus and Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06781203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06781203 currently recruiting?
Yes, NCT06781203 is actively recruiting participants. Contact the research team at mlop@psy.au.dk for enrollment information.
Where is the NCT06781203 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06781203 clinical trial?
NCT06781203 is sponsored by Aarhus University Hospital. The principal investigator is Robert Zachariae, Professsor, DMSc, MSc at University of Aarhus and Aarhus University Hospital. The trial plans to enroll 500 participants.
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