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.

Abstract

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. 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. 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. ISRCTN13596153.