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Internet-based Treatment for Insomnia (SHUTiNorse)

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ClinicalTrials.gov Identifier: NCT02261272
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Borge Sivertsen, Norwegian Institute of Public Health

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

Condition or disease Intervention/treatment Phase
Psychophysiologic Insomnia Behavioral: CBT for insomnia SHUTi Behavioral: passive patient education/sleep hygiene Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Internet-based Treatment for Insomnia in Norway.
Study Start Date : November 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261272


Locations
Norway
Norwegian Institute of Public Health
Bergen, Norway, 5000
Sponsors and Collaborators
Norwegian Institute of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Borge Sivertsen, Professor, Norwegian Institute of Public Health
ClinicalTrials.gov Identifier: NCT02261272     History of Changes
Other Study ID Numbers: SHUTiNorse
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders