Internet-based Treatment for Insomnia (SHUTiNorse)

September 20, 2016 updated by: Borge Sivertsen, Norwegian Institute of Public Health

Internet-based Treatment for Insomnia in Norway.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5000
        • Norwegian Institute of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT for insomnia
Cognitive-behavioral therapy for insomnia
Behavioral: CBT for insomnia SHUTi
SHUTi
Active Comparator: Sleep Hygiene
Psychoeducational intervention based on standard sleep hygiene advices
Behavioral: passive patient education/sleep hygiene

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHUTiNorse

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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