1 Patel K, et al. BMJ Open 2022;12:e060545. doi:10.1136/bmjopen-2021-060545 Open access Digital cognitive behavioural therapy intervention in the workplace: study protocol for a feasibility randomised waitlist-controlled trial to improve employee mental well-being, engagement and productivity Krishane Patel , 1 Talar Rita Moukhtarian , 2 Sean Russell, 3 Guy Daly, 3 Lukasz Walasek, 4 Nicole K Y Tang , 4 Carla Toro , 2 Caroline Meyer 2 To cite: Patel K, Moukhtarian TR, Russell S, et al. Digital cognitive behavioural therapy intervention in the workplace: study protocol for a feasibility randomised waitlist-controlled trial to improve employee mental well-being, engagement and productivity. BMJ Open 2022;12:e060545. doi:10.1136/ bmjopen-2021-060545 ► Prepublication history and additional supplemental material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2021-060545). Received 07 January 2022 Accepted 21 November 2022 For numbered affliations see end of article. Correspondence to Dr Carla Toro; carla.toro@warwick.ac.uk Protocol © 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. ABSTRACT Introduction One in six workers experience some form of mental health problems at work costing the UK economy an estimated £70 billion/year. Digital interventions provide low cost and easily scalable delivery methods to implement psychological interventions in the workplace. This trial tests the feasibility of implementing a self-guided 8-week digital cognitive behavioural therapy intervention for subthreshold to clinical depression and/ or anxiety versus waitlist control (ie, life as usual) in the workplace. Methods and analysis Feasibility of implementation will be tested using a mixed-methods evaluation of the two-arm randomised waitlist-control trial. Evaluation will include examination of organisational buy-in, and the engagement of employees through the trial indicated by the completion of outcome measures. In addition, we also explore how participants use the platform, the appropriateness of the analysis both with reference to the outcome measures and linear modelling. Finally, we examine the acceptability of the intervention based on participants experiences using qualitative interviews. Assessments take place at baseline (T0), at 8 weeks post-treatment (T1), at short-term follow-up 4 weeks post-treatment (T2) and long-term follow-ups (6 and 12 months after-end of treatment). We will recruit from 1 July 2021 to 31 December 2021 for employees and self- employed workers with depression and anxiety symptoms (subclinical and clinical levels) who are not seeking or 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 (August 2021). Publication of results in peer-reviewed journals will inform the scientifc, clinical and business communities. We will disseminate results through webinars, conferences, newsletter as well as a lay summary of results on the study website (mhpp.me). Trial registration number ISRCTN31161020. INTRODUCTION In the UK, poor mental health costs the economy an estimated £70 billion/year, equivalent to 4.5% of the UK’s Gross Domestic Product (GDP). 1 Common mental disorders (CMD) comprising of depressive and anxiety-related disorders are a major contributor to these costs. Within the work- place, one in six workers experience some form of mental health problems 2 which may or may not be as a result of their work- place environment. Furthermore, workers who experience CMDs are significantly less likely to remain in employment than their healthy counterparts. 3 4 The prevalence of mental illness in the workplace is problematic because of (a) absenteeism where the loss in workforce as a result of sickness, with an esti- mated 11.6% of sickness absence caused by CMD, 5 totalling almost 16 million days across the UK labour market; (b) mental health can diminish productivity in the workplace, a concept called presenteeism 6 which can have STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ REST is a novel self-guided, light touch, accessible and low-cost intervention of digital cognitive be- havioural therapy for employees in the workplace. ⇒ A detailed mixed-methods evaluation will provide multiple insights to feasibility and acceptability of the intervention. ⇒ To enhance rigour, the design of this feasibility study incorporates single-blinding and randomisation. ⇒ The study will be underpowered to examine effcacy of the intervention, but may still inform a future full- scale randomised controlled trial. on January 24, 2023 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2021-060545 on 9 December 2022. Downloaded from