Clinical Trial

Implementation of WHO's Doing What Matters in Times of Stress in Dutch Small and Medium-sized Enterprises (SMEs)

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Summary
The goal of this cluster randomized controlled trial is to explore if mental health in Dutch small and medium-sized enterprises (SMEs) can be improved by the World Health Organization's online program Doing What Matters in Times of Stress (DWM). The main questions it aims to answer are: * Does DWM improve the mental health of employees working in Dutch SMEs? * Does DWM improve work-related outcomes in employees working in Dutch SMEs? * How can DWM be implemented at a large scale in Dutch SMEs? Researchers will compare two groups to see if the DWM program is effective. One group will receive the DWM program and Care-as-Usual (group 1), and the other group will receive Care-as-Usual only (group 2). Participants will: * Follow the online DWM program for 5 weeks (only group 1). * Take part in 6 telephone appointments with a facilitator (helper) that provides extra support to complete the program (only group 1). * Complete 3 sets of questionnaires. Each set of questionnaire takes about 15 minutes to be completed (group 1 and group 2).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-15; most recent amendment 2026-07-14.
Trial Details
NCT Number NCT06979089
Lead Sponsor VU University of Amsterdam
Collaborators: World Health Organization, University of Copenhagen, University Hospital Heidelberg
Conditions Anxiety, Depression, Psychological Distress
Enrollment 518 participants
Start Date 2025-05-19
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-16