Internet-based Treatment for Insomnia

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

Detailed Description
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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

Official Title
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Internet-based Treatment for Insomnia in Norway.

Conditions
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Psychophysiologic Insomnia

Intervention / Treatment
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* Behavioral: CBT for insomnia SHUTi
* Behavioral: passive patient education/sleep hygiene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for insomnia<br>Cognitive-behavioral therapy for insomnia | Behavioral: CBT for insomnia SHUTi<br>* SHUTi<br>|
| Active Comparator: Sleep Hygiene<br>Psychoeducational intervention based on standard sleep hygiene advices | Behavioral: passive patient education/sleep hygiene<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |