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Search / Trial NCT06979089

Implementation of DWM in Dutch SMEs

Launched by VU UNIVERSITY OF AMSTERDAM · May 15, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Depression Anxiety Psychological Distress Mental Health Work Place Mental Health Employee Well Being Digital Intervention Online Intervention Doing What Matters In Times Of Stress Small And Medium Sized Enterprises

ClinConnect Summary

This clinical trial is exploring whether an online program called Doing What Matters in Times of Stress (DWM) can help improve mental health for employees working in small and medium-sized businesses (SMEs) in the Netherlands. The researchers want to find out if this program can reduce feelings of anxiety, depression, and psychological distress among employees and if it can lead to better work outcomes. To do this, they will compare two groups: one group will use the DWM program along with regular support (Care-as-Usual), while the other group will only receive the regular support.

To participate in the trial, you need to be at least 18 years old, work for a business with 10 to 250 employees in the Netherlands, and have higher levels of psychological distress. Participants in the DWM group will follow the online program for five weeks and have six phone calls with a helper for extra support. Everyone in both groups will fill out three sets of questionnaires to track their progress. It's important to note that individuals currently at risk of suicide or receiving specialized psychological treatment cannot join the study. If you or someone you know fits the criteria, this trial could be a valuable opportunity to improve mental well-being in the workplace.

Gender

ALL

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: \[to be updated once available\])

About Vu University Of Amsterdam

VU University Medical Center, part of the Vrije Universiteit Amsterdam, is a leading academic institution dedicated to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, the center integrates cutting-edge scientific inquiry with clinical practice to develop new treatments and improve patient outcomes. Committed to ethical standards and patient safety, VU University Medical Center fosters a dynamic research environment that attracts top talent and facilitates groundbreaking studies across various medical fields. Through its clinical trials, the institution aims to translate research findings into effective healthcare solutions, ultimately enhancing the quality of care for diverse populations.

Locations

Amsterdam, Noord Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Marit E. Sijbrandij

Principal Investigator

VU University of Amsterdam

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported