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Internet-based Treatment for Insomnia

Internet-based Treatment for Insomnia in Norway.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02261272
Acronym
SHUTiNorse
Enrollment
200
Registered
2014-10-10
Start date
2013-11-30
Completion date
2016-08-31
Last updated
2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychophysiologic Insomnia

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

Interventions

BEHAVIORALCBT for insomnia SHUTi

SHUTi

BEHAVIORALpassive patient education/sleep hygiene

Sponsors

Norwegian Institute of Public Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Insomnia symptomsAssessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FUSelf-reported questionnaires (Berge Insomnia Scale and Insomnia Severity Index)): change from baseline to post-treatment and FU

Secondary

MeasureTime frameDescription
Daytime functioning (mental health problems and fatigue)Assessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FUSelf-reported questionnaires
Sleep diary dataAssessment points: pre- and post-treatment (6 weeks after baseline), and 6 and 18 month FUSleep duration, sleep onset latency and nocturnal wake time: change from baseline to post-treatment and FU

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026