Internet-based Treatment for Insomnia

NCT ID: NCT02261272

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-08-31

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

Conditions

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Psychophysiologic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CBT for insomnia

Cognitive-behavioral therapy for insomnia

Group Type EXPERIMENTAL

CBT for insomnia SHUTi

Intervention Type BEHAVIORAL

SHUTi

Sleep Hygiene

Psychoeducational intervention based on standard sleep hygiene advices

Group Type ACTIVE_COMPARATOR

passive patient education/sleep hygiene

Intervention Type BEHAVIORAL

Interventions

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CBT for insomnia SHUTi

SHUTi

Intervention Type BEHAVIORAL

passive patient education/sleep hygiene

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Borge Sivertsen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Norwegian Institute of Public Health

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 31368382 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30621837 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30135764 (View on PubMed)

Other Identifiers

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SHUTiNorse

Identifier Type: -

Identifier Source: org_study_id

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