Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06781203

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

Led by Aarhus University Hospital · Updated on 2025-01-17

500

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

A

Aarhus University Hospital

Lead Sponsor

T

TrygFonden, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (18 years or older)
  • Moderate to severe insomnia symptoms (score 10 or higher on the Insomnia Severity Index)
  • Referred by a general practitioner
  • Access to a smartphone with internet connection
  • Sufficient technological proficiency to download apps
Not Eligible

You will not qualify if you...

  • Children (under 18 years)
  • Mild or no clinically relevant insomnia symptoms (score below 10 on the Insomnia Severity Index)
  • Shift-work schedule or currently on maternity/paternity leave
  • Unable to read Danish
  • Severe physical or psychological conditions affecting sleep (e.g., psychosis, cancer, COPD)
  • Other diagnosed sleep or circadian rhythm disorders (e.g., sleep apnea, narcolepsy)
  • Currently receiving or recently received CBTI or eCBTI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Denmark, 8000

Actively Recruiting

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Research Team

M

Morten J Lopdrup, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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