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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
Norwegian Institute of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychophysiologic Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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

First Posted
November 1, 2013
Last Updated
September 20, 2016
Sponsor
Norwegian Institute of Public Health
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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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