Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA
DISA
2 other identifiers
interventional
500
1 country
1
Brief Summary
Insomnia is a widespread public health challenge considering its impact on daily life, comorbidity with other disorders, and socio-economic costs. Previous research has shown the efficacy of cognitive behavioral therapy for insomnia (CBTI), and recent research indicates that digitally delivered CBTI (eCBTI) is highly efficacious, and statistically significantly equivalent to in-person delivered CBTI (ipCBTI) for treating insomnia. However, research is limited as to how eCBTI can be integrated into general practice as a non-pharmacological alternative to hypnotics. This study aims to evaluate the feasibility, acceptability, and effectiveness of a fully automated mobile application for treating insomnia in general practice. The secondary aims are to examine effects on psychological and physical comorbidities, possible moderators and mediators of the effect of eCBTI, and cost-effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
September 13, 2024
CompletedStudy Start
First participant enrolled
December 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
January 17, 2025
January 1, 2025
2 years
September 13, 2024
January 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia severity
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.
Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Secondary Outcomes (10)
Sleep diary outcomes
Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Sleep quality
Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Daytime fatigue
Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Cognitions about sleep
Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
Physical and mental functioning
Baseline (week 0), post-treatment (approximately week 11), follow-up (approximately week 37)
- +5 more secondary outcomes
Study Arms (2)
Care as usual waitlist control
NO INTERVENTIONWaitlist control; care as usual coupled with generic sleep hygiene advice. Access to treatment provided after final measurement.
Digitally delivered CBTI (eCBTI)
EXPERIMENTALBased on the existing consensus concerning non-pharmacological treatment of insomnia, Hvil® includes the following treatment components: sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. Intervention duration is approximately six to nine weeks.
Interventions
Based on the existing consensus concerning non-pharmacological treatment of insomnia, Hvil® includes the following treatment components: sleep hygiene, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. Intervention duration is approximately six to nine weeks.
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 referred by their general practitioner
- Individuals with access to a smartphone 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
- Individuals who are unable to read Danish
- Individuals who report severe physical or psychological comorbidity with known effects on sleep (e.g., psychosis, cancer, COPD)
- Individuals who report other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
- Individuals who are currently receiving or have recently received CBTI or eCBTI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- TrygFonden, Denmarkcollaborator
- Enversioncollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Zachariae, Professsor, DMSc, MSc
University of Aarhus and Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- In addition to investigator masking, we aim to mask the participants as much as possible. Participants in the intervention group will know that they recieve treatment, whereas participants in the care as usual waitlist control group will receive standard sleep hygiene advice, and be informed that they will receive an offer for treatment upon completed data collection. However, neither group will know that there are other groups involved. Care providers (GPs) are not masked, but any potential bias arising from this is expected to be minimal, as they do not deliver the intervention treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DMSc, MSc
Study Record Dates
First Submitted
September 13, 2024
First Posted
January 17, 2025
Study Start
December 17, 2024
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
January 17, 2025
Record last verified: 2025-01
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.