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Determination of Optimal Sleep Treatment Elements (The DOSE Project) - DISA

NCT06781203 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-01-17

No results posted yet for this study

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.

Conditions

  • Insomnia Chronic

Interventions

BEHAVIORAL

Digitally delivered CBTI (eCBTI)

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.

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • Enversion

    collaborator UNKNOWN

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Robert Zachariae, Professsor, DMSc, MSc · University of Aarhus and Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06781203 on ClinicalTrials.gov