JMIR Publications

ABSTRACT

Background:

Occupational eMental Health (OeMH) interventions have emerged as a promising solution to prevent common mental health problems and enhance the well-being and work performance of employees. However, it is essential that they are subject to robust and reliable assessments of their effectiveness.

Objective:

In this study, we evaluate the feasibility and effectiveness of an OeMH intervention developed in the European Platform to Promote Wellbeing and Health in the workplace (EMPOWER) project and discuss various challenges and lessons learned from the study.

Methods:

A multi-modal e-mental health intervention (EMPOWER) for employees with a duration of 7 weeks was developed and evaluated through a large-scale multi-country cluster RCT conducted mainly in small to medium enterprises and public agencies from Spain (n = 127), Finland (n = 141), Poland (n = 51), and the United Kingdom (n = 389) between February 2022 and May 2024. The primary outcome was presenteeism, secondary outcomes were depression severity, anxiety symptoms, stress, wellbeing, somatization, physical activity, mental health related quality of life, insomnia, absenteeism, and unpaid labour, all measured at baseline, post-intervention and in 21 weeks after program completion. The analysis was performed as ITT and as per protocol analysis comparing outcomes for all participants depending on their level of engagement with the app. The trial was registered at the ClinicalTrial.gov (NCT04907604).

Results:

The ITT analysis detected no statistically significant short-term (7 weeks) or long-term (21 weeks post-intervention) effects of the EMPOWER intervention on depression, anxiety, stress, well-being, insomnia, physical activity, physical health, absenteeism, or presenteeism. The per-protocol analysis also showed no significant differences between those participants who actively engaged with the intervention and those who did not. Indeed, only 34% of participants in the intervention group were considered active users. Implementation challenges were related to technical problems with the app that hindered engagement, the complexity of the study design, external contextual factors, co-design strategy, and organizational barriers, which have potentially lead to a smaller sample size, high attrition rates and low adherence.

Conclusions:

While several implementation challenges may have hindered the trial in detecting the effectiveness of the intervention, they also offer valuable insights for future digital health trials in the workplace. These insights include the need to perform a feasibility study to address any issues with the app before engaging in an RCT evaluation, and the importance of assessing organizational readiness before implementation and finding a balance between more strict study protocols such as traditional RCT designs or a more pragmatic study implementation. Clinical Trial: The trial was registered at the ClinicalTrial.gov (NCT04907604).