Internet-based Treatment for Insomnia

Psychophysiologic Insomnia Clinical Trial

— SHUTiNorse  

Official title:

Internet-based Treatment for Insomnia in Norway.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261272
• Other study ID #: SHUTiNorse
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: September 20, 2016
• Start date: November 2013
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Institute of Public Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychophysiologic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• CBT for insomnia SHUTi
SHUTi
• passive patient education/sleep hygiene

Locations

Country	Name	City	State
Norway	Norwegian Institute of Public Health	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia symptoms	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	No
Secondary	Daytime functioning (mental health problems and fatigue)	Self-reported questionnaires	Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FU	No
Secondary	Sleep diary data	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	No