Internet-based Treatment for Insomnia (SHUTiNorse)
Primary Purpose
Psychophysiologic Insomnia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
CBT for insomnia SHUTi
passive patient education/sleep hygiene
Sponsored by
About this trial
This is an interventional treatment trial for Psychophysiologic Insomnia
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.
Sites / Locations
- Norwegian Institute of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT for insomnia
Sleep Hygiene
Arm Description
Cognitive-behavioral therapy for insomnia
Psychoeducational intervention based on standard sleep hygiene advices
Outcomes
Primary Outcome Measures
Insomnia symptoms
Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU
Secondary Outcome Measures
Daytime functioning (mental health problems and fatigue)
Self-reported questionnaires
Sleep diary data
Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU
Full Information
NCT ID
NCT02261272
First Posted
November 1, 2013
Last Updated
September 20, 2016
Sponsor
Norwegian Institute of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT02261272
Brief Title
Internet-based Treatment for Insomnia
Acronym
SHUTiNorse
Official Title
Internet-based Treatment for Insomnia in Norway.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian Institute of Public Health
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychophysiologic Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT for insomnia
Arm Type
Experimental
Arm Description
Cognitive-behavioral therapy for insomnia
Arm Title
Sleep Hygiene
Arm Type
Active Comparator
Arm Description
Psychoeducational intervention based on standard sleep hygiene advices
Intervention Type
Behavioral
Intervention Name(s)
CBT for insomnia SHUTi
Intervention Description
SHUTi
Intervention Type
Behavioral
Intervention Name(s)
passive patient education/sleep hygiene
Primary Outcome Measure Information:
Title
Insomnia symptoms
Description
Self-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU
Time Frame
Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Secondary Outcome Measure Information:
Title
Daytime functioning (mental health problems and fatigue)
Description
Self-reported questionnaires
Time Frame
Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
Title
Sleep diary data
Description
Sleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU
Time Frame
Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Norwegian Institute of Public Health
City
Bergen
ZIP/Postal Code
5000
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31368382
Citation
Lien M, Bredeli E, Sivertsen B, Kallestad H, Pallesen S, Smith ORF, Faaland P, Ritterband LM, Thorndike FP, Vedaa O. Short and long-term effects of unguided internet-based cognitive behavioral therapy for chronic insomnia in morning and evening persons: a post-hoc analysis. Chronobiol Int. 2019 Oct;36(10):1384-1398. doi: 10.1080/07420528.2019.1647435. Epub 2019 Aug 1.
Results Reference
derived
PubMed Identifier
30621837
Citation
Vedaa O, Hagatun S, Kallestad H, Pallesen S, Smith ORF, Thorndike FP, Ritterband LM, Sivertsen B. Long-Term Effects of an Unguided Online Cognitive Behavioral Therapy for Chronic Insomnia. J Clin Sleep Med. 2019 Jan 15;15(1):101-110. doi: 10.5664/jcsm.7580.
Results Reference
derived
PubMed Identifier
30135764
Citation
Hagatun S, Vedaa O, Harvey AG, Nordgreen T, Smith ORF, Pallesen S, Havik OE, Thorndike FP, Ritterband LM, Sivertsen B. Internet-delivered cognitive-behavioral therapy for insomnia and comorbid symptoms. Internet Interv. 2018 Feb 21;12:11-15. doi: 10.1016/j.invent.2018.02.003. eCollection 2018 Jun.
Results Reference
derived
Learn more about this trial
Internet-based Treatment for Insomnia
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