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Clinical Trials/NCT02261272
NCT02261272
Completed
Not Applicable

Internet-based Treatment for Insomnia in Norway.

Norwegian Institute of Public Health1 site in 1 country200 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychophysiologic Insomnia
Sponsor
Norwegian Institute of Public Health
Enrollment
200
Locations
1
Primary Endpoint
Insomnia symptoms
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The study will test an internet-based treatment for insomnia.

Detailed Description

This study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. Traditional CBT, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an Internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. Phase 1 of this study will involve developing the web program. The investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. Phase 2 will be a large randomized controlled trial testing the Internet intervention compared to passive patient education/sleep hygiene. Two hundred individuals with insomnia will be assessed pre and post the six week treatment program. It is hypothesized that the Internet intervention will promote improvements in sleep, mood, and cognitive functioning. If successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Norwegian Institute of Public Health
Responsible Party
Principal Investigator
Principal Investigator

Borge Sivertsen

Professor

Norwegian Institute of Public Health

Eligibility Criteria

Inclusion Criteria

  • age 18 years or older
  • fulfillment of the DMS-IV criteria for insomnia
  • duration of at least 3 months
  • complaints of impaired daytime functioning

Exclusion Criteria

  • presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview
  • working night shifts and unable to discontinue this work pattern
  • having a serious somatic condition preventing further participation.

Outcomes

Primary Outcomes

Insomnia symptoms

Time Frame: Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU

Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU

Secondary Outcomes

  • Daytime functioning (mental health problems and fatigue)(Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU)
  • Sleep diary data(Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU)

Study Sites (1)

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