NCT05561790

Determination of Optimal Sleep Treatment Elements - Pilot

Determination of Optimal Sleep Treatment Elements (The DOSE Project)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed. In this pilot study, a smartphone and web application developed to treat insomnia using these treatment components will be tested. Two future studies will investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia by means of the Multiphase Optimization Strategy (MOST), and verify this intervention's effect in a randomized controlled trial (RCT).

Detailed description

As a pilot study for a Multiphase Optimization Strategy (MOST) study, the current study will assess the effects of a newly developed smartphone and web application for digitized cognitive behavioural therapy for insomnia (eCBT-I). All treatment components, i.e., sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy, will be tested in order to receive feedback on the functioning of the application as well as to get an initial impression of possible treatment effects.

Conditions

• Insomnia Chronic

Interventions

Type	Name	Description
BEHAVIORAL	eCBT-I	Automated digital administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy modules via mobile or web application, lasting approximately six weeks.

Timeline

• Start date: 2022-09-06
• Primary completion: 2022-12-03
• Completion: 2022-12-03
• First posted: 2022-09-30
• Last updated: 2023-09-14

Locations

1 site across 1 country: Denmark