Protocol of a randomized controlled multicenter trial investigating process and effectiveness of a participatory...

Evidence links psychosocial work factors to work-related mental health problems, which affect productivity and highlight the need for workplace interventions. In order to establish sustainable change, a participatory strategy that considers the behavioral, organizational, and contextual (BOC) determinants when selecting and implementing interventions is needed. The objective of the current study, Vital@Work, is to prevent and reduce work-related mental health problems by using an evidence based Participatory Approach (PA) as strategy to compose a set of intervention activities tailored to BOC determinants. While the PA has proven effective in other contexts, in this study we examine the impact of contextual factors on the effectiveness of intervention activities delivered through the PA strategy.

The PA is evaluated as a strategy to implement intervention activities to prevent and reduce unfavorable psychosocial work factors in a multicenter cluster randomized controlled trial, including an intervention and control group in four different organizations. These four organizations are characterized by unique BOC determinants and differ in sector, size (small and large organizations), type of organization (private or public) and type of work. Employees in the intervention group receive the PA alongside usual practice, while the control group receives only the usual preventive measures. Effectiveness will be assessed through questionnaires administered at baseline, and 6 (T1) and 12 months (T2) after baseline. According to a power analysis, we strive to include a total sample of 1,040 persons at baseline. As primary outcome, stress will be measured using DASS-21. In addition, various secondary outcomes (sense of community, presenteeism and absenteeism) will be assessed. Longitudinal mixed model analyses, including subgroup analyses, will be conducted, along with a process evaluation to assess implementation.

The current study will evaluate the PA as a strategy to develop and implement a set of mental health intervention activities tailored to the organizational context, in order to prevent and reduce work-related mental health problems. By doing this, we aim to identify common and sector-specific challenges, contributing to knowledge on tailoring workplace interventions.

The trial has been retrospectively registered at ClinicalTrials.gov on 31 May 2024 ( NCT06445101).