Actively Recruiting
Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA
Led by Aarhus University Hospital · Updated on 2025-01-17
500
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
T
TrygFonden, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years or older)
- Moderate to severe insomnia symptoms (score 10 or higher on the Insomnia Severity Index)
- Referred by a general practitioner
- Access to a smartphone with internet connection
- Sufficient technological proficiency to download apps
You will not qualify if you...
- Children (under 18 years)
- Mild or no clinically relevant insomnia symptoms (score below 10 on the Insomnia Severity Index)
- Shift-work schedule or currently on maternity/paternity leave
- Unable to read Danish
- Severe physical or psychological conditions affecting sleep (e.g., psychosis, cancer, COPD)
- Other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
- Currently receiving or recently received CBTI or eCBTI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8000
Actively Recruiting
Research Team
M
Morten J Lopdrup, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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