Improving mental health in Dutch small and medium-sized enterprises
Improving the Mental Health of Working Adults in Dutch Small and Medium-Sized Enterprises (SMEs): A Cluster RCT of WHO's Doing What Matters in Times of Stress (DWM)
This study is testing if an online mental health program can help employees in small and medium-sized businesses in the Netherlands feel better during stressful times.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 518 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VU University of Amsterdam Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06979089 on ClinicalTrials.gov |
What this trial studies
This cluster randomized controlled trial aims to evaluate the effectiveness of the World Health Organization's online program, Doing What Matters in Times of Stress (DWM), in enhancing mental health among employees in Dutch small and medium-sized enterprises (SMEs). Participants in the intervention group will engage in a 5-week online program supplemented by telephone support, while the control group will receive standard care. The study will assess mental health outcomes and work-related impacts at multiple time points, including baseline, post-intervention, and follow-up. Additionally, it will explore barriers and facilitators to implementing the DWM program on a larger scale within SMEs.
Who should consider this trial
Good fit: Ideal candidates include employees aged 18 and older from Dutch SMEs with elevated psychological distress levels.
Not a fit: Patients who are currently receiving specialized psychological treatment or are at imminent risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and work outcomes of employees in SMEs, leading to a healthier workforce.
How similar studies have performed: Other studies have shown promise in using online interventions for mental health, but this specific approach in SMEs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Amsterdam, North Holland
- Vrije Universiteit Amsterdam — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marit E. Sijbrandij — VU University of Amsterdam
- Study coordinator: Cătălin Gherdan
- Email: c.gherdan@vu.nl
- Phone: +31 20 59 82587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.