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The study will test an internet-based treatment for insomnia.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for insomnia | Experimental | Cognitive-behavioral therapy for insomnia |
|
| Sleep Hygiene | Active Comparator | Psychoeducational intervention based on standard sleep hygiene advices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT for insomnia SHUTi | Behavioral | SHUTi |
| |
| passive patient education/sleep hygiene |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian Institute of Public Health | Bergen | 5000 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31368382 | Derived | 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. | |
| 30621837 |
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| Behavioral |
|
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 |
| 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. |
| 30135764 | Derived | 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. |