Determination of Optimal Sleep Treatment Elements - Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determination of Optimal Sleep Treatment Elements (The DOSE Project)

Conditions
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Insomnia Chronic

Intervention / Treatment
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* Behavioral: eCBT-I


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Administration of sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. | Behavioral: eCBT-I<br>* 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.<br>|
| No Intervention: Control<br>Waitlist control (sleep diary only); access to treatment after final measurement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| Sleep diary assessed nocturnal awakenings (NA) at end of intervention | Assessed with the Consensus Sleep Diary (CSD) | Approximately 10 weeks after study entry (randomization) | 
| 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) | 
| 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) | 
| 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) | 
| Cognitions about sleep post-intervention | Assessed with the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16). | 11 weeks after study entry (randomization) | 
| 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) | 
| Usability post-intervention | Assessed with the mHealth App Usability Questionnaire (MAUQ). | 11 weeks after study entry (randomization) |