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  • Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

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Mental health
Protocol
Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial
  1. Håvard Kallestad1,2,
  2. Simen Saksvik2,
  3. Øystein Vedaa2,3,
  4. Knut Langsrud1,2,
  5. Gunnar Morken1,2,
  6. Stian Lydersen4,
  7. Melanie R Simpson5,
  8. Signe Karen Dørheim6,
  9. Bjørn Holmøy7,
  10. Sara G Selvik8,
  11. Kristen Hagen2,9,
  12. Tore Charles Stiles10,
  13. Allison Harvey11,
  14. Lee Ritterband12,
  15. Børge Sivertsen2,3,
  16. Jan Scott2,13
  1. 1Department of Mental Health Care, St Olavs Hospital University Hospital in Trondheim, Trondheim, Norway
  2. 2Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway
  3. 3Department of Public Mental Health, Norwegian Institute of Public Health, Bergen, Norway
  4. 4Department of Mental Health Care, Norwegian University of Science and Technology, Trondheim, Norway
  5. 5Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway
  6. 6Department of Mental Health Care, Stavanger University Hospital, Stavanger, Norway
  7. 7Department of Follo, Akershus University Hospital, Lorenskog, Norway
  8. 8Department of Mental Health Care, Namsos Hospital, Namsos, Norway
  9. 9Department of Mental Health, Molde Hospital, Molde, Norway
  10. 10Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway
  11. 11Department of Psychology, University of California Berkeley, Berkeley, California, USA
  12. 12Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA
  13. 13Institute of Neuroscience, Newcastle University, Newcastle, UK
  1. Correspondence to Dr Håvard Kallestad; havard.kallestad{at}ntnu.no

Abstract

Introduction Insomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.

Methods and analysis A parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.

Ethics and dissemination The study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.

Trial registration number ClinicalTrials.gov Registry (NCT04621643); Pre-results.

  • sleep medicine
  • mental health
  • psychiatry
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2021-050661

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    Footnotes

    • Correction notice This article has been corrected since it was published. Sleep apnoea screening has been added in the Exclusion criteria.

    • Contributors Study design was undertaken by the research team: HK, SS, ØV, KL, GM, SL, MRS, SKD, BH, SGS, KH, TCS, AH, LR, BS and JS. HK conceived of the study and produced the first draft of the protocol paper with additional input from SS, ØV and JS. SL and MRS wrote the statistical analytical plan. All authors contributed to the drafting of the submitted version of the study protocol and all authors approved the final version of the manuscript.

    • Funding This study is supported by the Research Council of Norway (grant number 273623).

    • Disclaimer The RCN does not have any role in study design or decision to submit the report for publication.

    • Competing interests LR reports financial or business interests in BeHealth Solutions and Pear Therapeutics, two companies that develop and disseminate digital therapeutics (including licensing the therapy developed) based in part on early versions of the software from the University of Virginia, which is used in the research reported in this article. These companies had no role in preparing this manuscript. LR is also a consultant to Mahana Therapeutics, a separate digital therapeutic company not affiliated with this research. The terms of these arrangements have been reviewed and approved by the University of Virginia in accordance with its policies. All other authors declare no competing interests.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.