Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Aarhus University Hospital
- Trial code
- NCT06781203
- Record updated
- 17 January 2025
- Original description
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.Read full original descriptionShow less
Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA RCT
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.
Inclusion: 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: Individuals who are currently receiving or have recently received CBTI or eCBTI; 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); 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.