RecruitingNot Applicable

Implementation of DWM in Dutch SMEs

Netherlands518 participantsStarted 2025-05-19

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (SMEs): * Having 10 to 250 employees * Being located in the Netherlands * (In case of insufficient recruitment among SMEs, a mitigation strategy is to recruit individual departments from larger organizations) Inclusion Criteria (Individual participants): * 18 years or older * Having elevated levels of psychological distress (Kessler Psychological Distress Scale; K10 scores \> 15.9) * Sufficient literacy and mastery (written and spoken) of one of the languages the DWM intervention is being delivered in (i.e., Dutch or English) * Having access to an electronic device with internet access to follow the intervention * Written informed consent before entering the study Exclusion Criteria (Individual participants): * Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up * Currently receiving specialized psychological treatment (e.g., EMDR or CBT) at the time of screening * In case of current psychotropic medication use: being on an unstable dose for at least 2 months or a change in dosage over the past 2 months. * Having participated in the preceding ASCEND trial as supervisor (see NCT ID: NCT06989398)

What they're measuring

Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Timeframe: Change from Baseline (week 1) to 1-week post intervention (week 7)

Trial details

NCT IDNCT06979089

SponsorVU University of Amsterdam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Cătălin Gherdan

+31 20 59 82587 c.gherdan@vu.nl