| NCT ID | NCT06979089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VU University of Amsterdam |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 518 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 518 participants in total. It began in 2025-05-19 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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)
Contact & Investigator
Marit E. Sijbrandij
PRINCIPAL INVESTIGATOR
VU University of Amsterdam
Frequently Asked Questions
Who can join the NCT06979089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06979089 currently recruiting?
Yes, NCT06979089 is actively recruiting participants. Contact the research team at c.gherdan@vu.nl for enrollment information.
Where is the NCT06979089 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06979089 clinical trial?
NCT06979089 is sponsored by VU University of Amsterdam. The principal investigator is Marit E. Sijbrandij at VU University of Amsterdam. The trial plans to enroll 518 participants.
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