Effects of a hybrid digital cognitive-behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial

Talar Rita Moukhtarian, Krishane Patel, Carla Toro, Sean Russel, Guy Daly, Lukasz Walasek, Nicole K.Y. Tang, Caroline Meyer

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    Abstract

    INTRODUCTION: This trial tests the efficacy of implementing a hybrid digital cognitive-behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations. METHODS AND ANALYSIS: This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial. ETHICS AND DISSEMINATION: Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters. TRIAL REGISTRATION NUMBER: ISRCTN13596153.

    Original languageEnglish
    Article numbere058062
    Number of pages12
    JournalBMJ Open
    Volume12
    Issue number7
    DOIs
    Publication statusPublished - 15 Jul 2022

    Bibliographical note

    © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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/.

    Funder

    This research is supported by Midlands Engine (R.ESWM.3932), UK as part of the Mental Health and Productivity Pilot programme (MHPP), which is collaborating across a range of diverse partners to provide an evidence-informed, cost-effective and sustainable resource that supports good mental health at work, reduces stigma and will ultimately increase productivity. The study funders had no role in the study design, collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.

    Keywords

    • Anxiety disorders
    • Depression & mood disorders

    ASJC Scopus subject areas

    • Medicine(all)

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