Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

Håvard Kallestad, Øystein Vedaa, Jan Scott, Gunnar Morken, Ståle Pallesen, Allison G Harvey, Phil Gehrman, Frances Thorndike, Lee Ritterband, Tore Charles Stiles, Børge Sivertsen, Håvard Kallestad, Øystein Vedaa, Jan Scott, Gunnar Morken, Ståle Pallesen, Allison G Harvey, Phil Gehrman, Frances Thorndike, Lee Ritterband, Tore Charles Stiles, Børge Sivertsen

Abstract

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.

Keywords: adult psychiatry; clinical trials; psychiatry; public health; sleep medicine.

Conflict of interest statement

Competing interests: LR has equity ownership in BeHealth Solutions, a company that develops and makes available products related to the research reported in this manuscript. Specifically, BeHealth Solutions has licensed the SHUTi program and the software platform on which it was built from the University of Virginia. The terms of this arrangement have been reviewed and approved by the University of Virginia in accordance with its conflict of interest policy. FT is Chief Science Officer at BeHealth Solutions and has equity ownership in the company, which has licensed the SHUTi program and software platform from the University of Virginia. FT has no role in data handling or analysis.

© 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.

Figures

Figure 1
Figure 1
Flow chart of timeline for a randomised controlled trial of online interventions for insomnia (see text for predicted attrition rates). CBT-I, cognitive behaviour therapy for insomnia; PE, patient education about sleep.

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