Improving mental health in Dutch small and medium-sized enterprises

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 public and non-profit organizations, and units of larger organizations, all employing between 10 and 250 employees.

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.