Clinical trial NCT05561790: Determination of Optimal Sleep Treatment Elements - Pilot
Official title: Determination of Optimal Sleep Treatment Elements (The DOSE Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Enversion A/S
First posted: 2022-09-30
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia severity post-intervention
timeFrame: 11 weeks after study entry (randomization)
Secondary outcomes:
measure: Sleep diary assessed sleep efficiency (SE) at end of intervention
timeFrame: Approximately 10 weeks after study entry (randomization)
measure: Sleep diary assessed sleep onset latency (SOL) at end of intervention
timeFrame: Approximately 10 weeks after study entry (randomization)
measure: Sleep diary assessed wake after sleep onset (WASO) at end of intervention
timeFrame: Approximately 10 weeks after study entry (randomization)
measure: Sleep diary assessed nocturnal awakenings (NA) at end of intervention
timeFrame: Approximately 10 weeks after study entry (randomization)
measure: Sleep diary assessed total sleep time (TST) at end of intervention
timeFrame: Approximately 10 weeks after study entry (randomization)
measure: Sleep diary assessed time in bed (TiB) at end of intervention
timeFrame: Approximately 10 weeks after study entry (randomization)
measure: Daytime fatigue post-intervention
timeFrame: 11 weeks after study entry (randomization)
measure: Cognitions about sleep post-intervention
timeFrame: 11 weeks after study entry (randomization)
measure: Psychological distress post-intervention
timeFrame: 11 weeks after study entry (randomization)
measure: Usability post-intervention
timeFrame: 11 weeks after study entry (randomization)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
state: Midtjylland
Study officials:
affiliation: Aarhus University, Aarhus University Hospital
name: Robert Zachariae, DMSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: