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Determination of Optimal Sleep Treatment Elements - Pilot

NCT05561790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2023-09-14

No results posted yet for this study

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 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).

Conditions

  • Insomnia Chronic

Interventions

BEHAVIORAL

eCBT-I

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.

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • Enversion A/S

    collaborator UNKNOWN

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Robert Zachariae, DMSc, MSc · Aarhus University, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2022-12-03
Completion
2022-12-03

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 NCT05561790 on ClinicalTrials.gov