Determination of Optimal Sleep Treatment Elements - Pilot (DOSE)

University of Aarhus

Status

Completed

Conditions

Insomnia Chronic

Treatments

Behavioral: eCBT-I

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05561790

2016-051-000001-2099-1

Details and patient eligibility

About

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).

Full 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.

Enrollment

169 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults (≥18 years)
Individuals who report moderate-to-severe insomnia symptoms (a score ≥10 on the Insomnia Severity Index, ISI)
Individuals with access to a smartphone or computer 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, if this impacts their sleep quality or amount of sleep
Individuals who are unable to read Danish
Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cardiovascular disease, cancer, COPD)
Individuals who report other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
Individuals who have previously used the "Hvil®"-app, e.g., during the beta test phase