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Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA

RecruitingNAAges 18 Years - anyAllAarhus University Hospital
NCT06781203 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Digitally delivered CBTI (eCBTI)
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Where

1 site
Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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