Determination of Optimal Sleep Treatment Elements - MOST
DOSE
1 other identifier
interventional
489
1 country
1
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 restriction, 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. By means of the Multiphase Optimization Strategy (MOST), this study aims to investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia. A future study will verify this intervention's effect in a randomized controlled trial (RCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2022
CompletedFirst Submitted
Initial submission to the registry
September 28, 2022
CompletedFirst Posted
Study publicly available on registry
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2024
CompletedNovember 18, 2025
May 1, 2025
1.7 years
September 28, 2022
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Insomnia severity at 6 month follow-up
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.
6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Secondary Outcomes (15)
Sleep diary outcomes post-intervention
11 weeks after study entry (randomization)
Sleep diary outcomes at 6-month follow-up
6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Sleep quality post-intervention
11 weeks after study entry (randomization)
Sleep quality at 6-month follow-up
6 months (180 days) after post-questionnaire, approximately 8,5 months after study entry (randomization).
Daytime fatigue post-intervention
11 weeks after study entry (randomization)
- +10 more secondary outcomes
Study Arms (16)
Sleep Hygiene
EXPERIMENTALAdministration of sleep hygiene education (single intervention)
Cognitive Therapy
EXPERIMENTALAdministration of cognitive therapy only (single intervention)
Relaxation Training
EXPERIMENTALAdministration of relaxation training only (single intervention)
Relaxation Training, Cognitive Therapy, Sleep Hygiene
EXPERIMENTALAdministration of relaxation training, cognitive therapy, and sleep hygiene education (3 interventions)
Stimulus Control
EXPERIMENTALAdministration of stimulus control therapy only (single intervention)
Stimulus Control, Cognitive Therapy, Sleep Hygiene
EXPERIMENTALAdministration of stimulus control therapy, cognitive therapy, and sleep hygiene education (3 interventions)
Stimulus Control, Relaxation Training, Sleep Hygiene
EXPERIMENTALAdministration of stimulus control therapy, relaxation training, and sleep hygiene education (3 interventions)
Stimulus Control, Relaxation Training, Cognitive Therapy
EXPERIMENTALAdministration of stimulus control therapy, relaxation training, and cognitive therapy (3 interventions)
Sleep Optimization
EXPERIMENTALAdministration of sleep optimization only (single intervention)
Sleep Optimization, Cognitive Therapy, Sleep Hygiene
EXPERIMENTALAdministration of sleep optimization, cognitive therapy, and sleep hygiene education (3 interventions)
Sleep Optimization, Relaxation Training, Sleep Hygiene
EXPERIMENTALAdministration of sleep optimization, relaxation training, and sleep hygiene education (3 interventions)
Sleep Optimization, Relaxation Training, Cognitive Therapy
EXPERIMENTALAdministration of sleep optimization, relaxation training, and cognitive therapy (3 interventions)
Sleep Optimization, Stimulus Control, Sleep Hygiene
EXPERIMENTALAdministration of sleep optimization, stimulus control therapy, and sleep hygiene education (3 interventions)
Sleep Optimization, Stimulus Control, Cognitive Therapy
EXPERIMENTALAdministration of sleep optimization, stimulus control therapy, and cognitive therapy (3 interventions)
Sleep Optimization, Stimulus Control, Relaxation Training
EXPERIMENTALAdministration of sleep optimization, stimulus control therapy, and relaxation training (3 interventions)
Sleep Optimization, Stimulus Control, Relaxation Training, Cognitive Therapy, Sleep Hygiene
EXPERIMENTALAdministration of sleep optimization, stimulus control therapy, relaxation training, cognitive therapy, and sleep hygiene education (5 interventions)
Interventions
Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.
Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.
Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.
Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.
Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- TrygFonden, Denmarkcollaborator
- Enversion A/Scollaborator
Study Sites (1)
Aarhus University
Aarhus, Central Jutland, 8000, Denmark
Related Publications (48)
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BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Zachariae, DMSc, MSc
Aarhus University, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2022
First Posted
September 30, 2022
Study Start
September 8, 2022
Primary Completion
May 18, 2024
Study Completion
May 18, 2024
Last Updated
November 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- No later than six months after publication, no end date.
- Access Criteria
- Data will be shared exclusively with other researchers and for research purposes only. Researchers requesting the data will have to provide a methodologically sound research proposal clarifying how the data will be used and for what purpose.
All individual participant data collected during the study will be made available in an irreversibly anonymized form. However, only data of those participants can be shared who have explicitly given consent to this as part of their informed consent to study participation. This means that it may not be possible to share all data underlying a certain publication. Data will be shared exclusively for research purposes.