Evaluation of Mental Health First Aid From the Perspective of Workplace End Users - EMPOWER: Protocol of Trial Phase

The EMPOWER study will implement a cluster randomised controlled trial (cRCT) to examine the effectiveness and cost-effectiveness of MHFA in the workplace on help-seeking behaviours of employees, with embedded qualitative, process and social impact evaluations . In order to best answer questions regarding effectiveness, mechanisms and acceptability/feasibility, a design combining a RCT with a qualitative component will be adopted. The qualitative component will assess the efficiency, utility, usability, feasibility, acceptability as well as the mechanisms underlying the intervention. This registration details the trial element of EMPOWER only.

Data will be collected from employees working in eligible UK organisations expressing an interest to MHFAE in undertaking MHFA training. Organisations expressing an interest (directly to MHFAE), who are willing to take part in the study will be asked to contact Graham Durcan (Centre for Mental Health) for detailed information about the study. If willing to take part, organisations will sign a written agreement and their contact details will be sent to the research team. The research team will email the lead contact, detailing what will happen next, asking for company demographics and requesting organisations send a standard email to ALL employees providing information about the study with a link to the survey for completion of baseline measures. Consent will be sought, using Qualtrics, before completing the online survey. One, two and three weeks later the research team will send the organisation lead another standard email, to be sent to all employees, as a gentle reminder to complete the survey. After this period, participants who have not completed the survey will be treated as lost to follow-up.

Organisations will be assigned randomly to the intervention or control arm after completing baseline measures, using computer-generated random numbers through Random.org:

https://www.random.org/randomness/. An independent researcher not associated with the study will generate the random sequence and communicate this via email to the research team. The unit of randomisation is organisation and randomisation of organisations will be stratified by size of organisation, with three strata being defined22, small (< 50 employees), medium (50-249 employees) and large (> 250 employees).

To optimize completion of follow-up measures, at each follow-up point the research team will send organisations up to four weekly email reminders to ask employees to complete measures.