Status:
RECRUITING
Implementation of DWM in Dutch SMEs
Lead Sponsor:
VU University of Amsterdam
Collaborating Sponsors:
World Health Organization
University of Copenhagen
Conditions:
Anxiety
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Rationale: Small and medium-sized enterprises (SMEs) often lack the resources to combat the negative consequences of work stressors (e.g., high workplace digitalization). This puts their employees at ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT06979089
Start Date
May 19 2025
End Date
September 1 2026
Last Update
December 5 2025
Active Locations (1)
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1
Vrije Universiteit Amsterdam
Amsterdam, North Holland, Netherlands, 1081 HV