Effectiveness and Lessons Learned From an Occupational E-Mental Health Intervention for Enhancing Workplace Mental Health: The EMPOWER Cluster Randomized Controlled Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background: Occupational e-mental health (OeMH) interventions emerged as a promising solution to prevent common mental health problems and enhance well-being and work performance. However, they must be subject to robust and reliable assessments for effectiveness. Methods: A multimodal e-mental health intervention (EMPOWER [The European Platform to Promote Wellbeing and Health in the Workplace]) delivered over 7 weeks was developed and evaluated through a cluster randomized controlled trial 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 (recruitment finalized in September 2023 and follow-up completed in May 2024). Inclusion criteria were being 18+ years, having a smartphone, sufficient language knowledge, and agreeing to participate. Clusters (companies or departments) were randomized to intervention or control conditions. The primary outcome was presenteeism, and secondary outcomes were depression and anxiety symptoms, etc, all measured at baseline, postintervention, and in 21 weeks after program completion. The analysis was performed as an intention-to-treat approach using adjusted linear mixed models and as per protocol analysis comparing outcomes by level of engagement. Results: A total of 347 participants were allocated to the intervention group and 361 to the control group. In the overall sample, the intention-to-treat analysis detected no statistically significant short-term (7 wk) or long-term (21 wk postintervention) effects of the EMPOWER intervention on presenteeism (postintervention β=2.186; 95% CI -2.424 to 6.796, follow-up β=1.294; 95% CI -3.608 to 6.396) and on other secondary outcomes such as depressive symptoms (postintervention β=-0.052, 95% CI -1.02 to 0.905, follow-up β=0.202, 95% CI -0.840 to 1.245), anxiety symptoms (postintervention β=-0.328, 95% CI -1.168 to 0.512, follow-up β=0.375, 95% CI -0.537 to 1.287), or general stress level (postintervention β=0.385, 95% CI -0.195 to 0.965, follow-up β=0.123, 95% CI -0.502 to 0.749). Subgroup analyses yielded several notable results, with significant differences between age groups, gender, and psychological symptoms at baseline. The per-protocol analysis showed no significant differences between participants who actively engaged with the intervention (119/347, 34%) and those who did not. Implementation challenges were related to technical problems, the complexity of this study's design, external factors, co-design strategy, and organizational barriers, which led to a smaller sample size, high attrition rates, and low adherence. Conclusions: Our study provides evidence from a large cluster randomized controlled trial evaluating an OeMH intervention implemented in workplace settings, including small to medium enterprises and public agencies in Europe. Although no overall effectiveness was observed, this study contributes important methodological and implementation insights, highlighting the challenges of evaluating OeMH interventions. These findings suggest that future interventions should prioritize feasibility testing, organizational readiness, user engagement, and more targeted and pragmatic evaluation approaches to enhance real-world impact.
DOI: 10.2196/66041
Authors: Carlota de Miquel, Christina M Van der Feltz-Cornelis, Leona Hakkaart-van Roijen, Dorota Merecz-Kot, Marjo Sinokki, Jordi Rodeiro-Boliart, Jennifer Sweetman, Kaja Staszewska, Ellen Vorstenbosch, Daniele Porricelli, Stijn Peeters, José Luis Ayuso-Mateos, Luis Salvador-Carulla, Sue Lukersmith, Oriol Borrega, Carla Sabariego, Christophe Vanroelen, Alberto Raggi, Diletta Porcheddu, Josep Maria Haro, Beatriz Olaya
Institutions: Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, Institut de Recerca Sant Joan de Déu, Universitat de Barcelona, University College London, University of York, Erasmus University Rotterdam, University of Łódź, University of Turku, Swiss Paraplegic Research, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, University of Canberra, Universidad de Cádiz, University of Lucerne, Vrije Universiteit Brussel, Fondazione IRCCS Istituto Neurologico Carlo Besta, Parc Sanitari Sant Joan de Déu, Universitat Autònoma de Barcelona
Language: English
Subfield: Applied Psychology
Field: Psychology
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $1,750
OpenAlex ID: W7125693019