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Completed

NCT Number: NCT02261272

Internet-based Treatment for Insomnia

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian Institute of Public Health

Bergen, 5000, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT for insomnia SHUTi

Behavioral

SHUTi

passive patient education/sleep hygiene

Behavioral

Primary outcomes

  1. 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

  1. Daytime functioning (mental health problems and fatigue)

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

    Self-reported questionnaires

  2. Sleep diary data

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

    Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Registry information

Official study title

Internet-based Treatment for Insomnia in Norway.

Acronym: SHUTiNorse

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 10, 2014
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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