Determination of Optimal Sleep Treatment Elements - Pilot

Insomnia Chronic Clinical Trial

— DOSE  

Official title:

Determination of Optimal Sleep Treatment Elements (The DOSE Project)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561790
• Other study ID #: 2016-051-000001-2099-1
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: December 3, 2022

Study information

• Verified date: September 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 3, 2022
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Chronic

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus	Midtjylland

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Enversion A/S, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity post-intervention	Assessed with the Insomnia Severity Index (ISI), with scores ranging from 0 to 28, where higher scores indicate higher insomnia severity, and a score equal to or above 10 indicates clinical significance.	11 weeks after study entry (randomization)
Secondary	Sleep diary assessed sleep efficiency (SE) at end of intervention	Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for total sleep time, total time in bed, and sleep efficiency to be calculated. SE is calculated as the proportion of time spent asleep out of time spent in bed in percent (TST/TiB*100).	Approximately 10 weeks after study entry (randomization)
Secondary	Sleep diary assessed sleep onset latency (SOL) at end of intervention	Assessed with the Consensus Sleep Diary (CSD)	Approximately 10 weeks after study entry (randomization)
Secondary	Sleep diary assessed wake after sleep onset (WASO) at end of intervention	Assessed with the Consensus Sleep Diary (CSD)	Approximately 10 weeks after study entry (randomization)
Secondary	Sleep diary assessed nocturnal awakenings (NA) at end of intervention	Assessed with the Consensus Sleep Diary (CSD)	Approximately 10 weeks after study entry (randomization)
Secondary	Sleep diary assessed total sleep time (TST) at end of intervention	Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for total sleep time to be calculated.	Approximately 10 weeks after study entry (randomization)
Secondary	Sleep diary assessed time in bed (TiB) at end of intervention	Based on the Consensus Sleep Diary (CSD) which measures bedtime, rise-time, sleep- and waking time, sleep onset latency, wakefulness after initial sleep onset, allowing for time in bed to be calculated.	Approximately 10 weeks after study entry (randomization)
Secondary	Daytime fatigue post-intervention	Assessed with the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-Fatigue), which covers physical fatigue, functional fatigue, and social consequences of fatigue.	11 weeks after study entry (randomization)
Secondary	Cognitions about sleep post-intervention	Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16).	11 weeks after study entry (randomization)
Secondary	Psychological distress post-intervention	Assessed with the Depression, Anxiety, and Stress Scales-21 (DASS-21), which evaluates the constructs depression, anxiety, and stress on sub-scales.	11 weeks after study entry (randomization)
Secondary	Usability post-intervention	Assessed with the mHealth App Usability Questionnaire (MAUQ).	11 weeks after study entry (randomization)