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

What this Trial Is About

Insomnia is a common condition affecting about 10% of the general population and even more among patients in general practice. This trial evaluates a fully automated mobile application delivering cognitive behavioral therapy for insomnia (eCBTI) as a non-drug treatment option. The study aims to assess the feasibility, acceptability, and effectiveness of eCBTI in general practice, while also examining its effects on psychological and physical health, possible factors influencing its success, and its cost-effectiveness. The study compares two groups: one receiving care as usual with generic sleep hygiene advice, and the other using the mobile-based eCBTI program called Hvil®, which includes components such as sleep hygiene, sleep optimization, stimulus control therapy, relaxation training, and cognitive therapy. The intervention lasts about six to nine weeks. Patients in the control group receive access to the treatment after the study period. The trial is cluster-randomized with general practitioners recruiting patients with moderate to severe insomnia. Participants will be assessed at the start, halfway through, at the end of the intervention (about 11 weeks), and at six months follow-up. Researchers will measure insomnia severity using the Insomnia Severity Index, sleep diary outcomes, sleep quality, fatigue, psychological distress, quality of life, and usability of the app. Cost-effectiveness will be evaluated using healthcare and employment data. The study includes ongoing monitoring and uses advanced statistical methods to analyze treatment effects and factors influencing outcomes.

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