Effects of a hybrid digital Cognitive Behavioural Therapy for Insomnia and Emotion Regulation in the workplace (SLEEP)

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 on the SPIRIT (Standard Protocol Items for Randomized Trials) 2013 recommendations.Methods and analysis: Mixed methods evaluation with a two-arm randomised waitlist control design of a six weeks dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine fidelity of delivery and experiences of the intervention. Primary outcomes are the Insomnia Severity Index (ISI), the Patient Health Questionnaire (PHQ-9) and the Generalised Anxiety Disorder (GAD-7). 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 post-randomisation (T2). We will recruit 156 workers with sleep and emotion regulation 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 2.8_Aug21. Publication of results will inform the scientific, clinical, and business communities through peer-reviewed articles, webinars, conferences, and newsletters.Trial registration: ISRCTN, ID: ISRCTN13596153. Registered on 08/06/2021.