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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Overcoming insomnia: Protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep
BMJ Open, Volume 8, No. 8, Article e025152, Year 2018
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Description
Introduction Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions. Methods and analysis A parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibility criteria will be randomised to receive direct access to fully automated online CBT-I or to an online PE programme. The primary outcome is change in insomnia severity immediately postintervention; secondary outcomes are change in daytime functioning and other sleep measures postintervention and at 6-month and 24-month follow-up. Objective data from national registries will be obtained at two time points (1 year and 2 years post-treatment), allowing a mirror image study of preintervention and postintervention rates of sick leave, and of medication and healthcare utilisation by condition. Ethics and dissemination The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in South East Norway (2015/134). Findings from the RCT will be disseminated in peer-reviewed publications and conference presentations. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to patient advocacy and other relevant organisations. Trial registration number NCT02558647; Pre-results. © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Authors & Co-Authors
Kallestad, Håvard
Norway, Trondheim
Universitetssykehuset I Trondheim
Norway, Trondheim
Norges Teknisk-naturvitenskapelige Universitet
Vedaa, Øystein
Norway, Trondheim
Universitetssykehuset I Trondheim
Norway, Trondheim
Norges Teknisk-naturvitenskapelige Universitet
Norway, Oslo
Folkehelseinstituttet
Scott, Jan L.
Norway, Trondheim
Norges Teknisk-naturvitenskapelige Universitet
United Kingdom, Newcastle
Newcastle University
Morken, Gunnar
Norway, Trondheim
Norges Teknisk-naturvitenskapelige Universitet
Norway, Trondheim
Universitetssykehuset I Trondheim
Pallesen, Ståle
Norway, Bergen
Universitetet I Bergen
Harvey, Allison G.
United States, Berkeley
University of California, Berkeley
Ritterband, Lee M.
United States, Charlottesville
University of Virginia
Sivertsen, Børge
Norway, Trondheim
Norges Teknisk-naturvitenskapelige Universitet
Norway, Oslo
Folkehelseinstituttet
Statistics
Citations: 16
Authors: 8
Affiliations: 8
Identifiers
Doi:
10.1136/bmjopen-2018-025152
ISSN:
20446055
Research Areas
Health System And Policy
Study Design
Randomised Control Trial
Cohort Study
Exploratory Study
Study Approach
Quantitative