Post-Traumatic Stress Disorder (PTSD) Clinical Trials

Find Post-Traumatic Stress Disorder (PTSD) Clinical Trials Near You

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)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• 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

Locations
Other Locations
Netherlands
Vrije Universiteit Amsterdam
RECRUITING
Amsterdam
Contact Information
Primary
Cătălin Gherdan
c.gherdan@vu.nl
+31 20 59 82587
Backup
Anke B. Witteveen
a.b.witteveen@vu.nl
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2026-09
Participants
Target number of participants: 518
Treatments
Experimental: Doing What Matters in Times of Stress & Care-as-Usual (CAU)
Treatment group will receive the guided-online Doing What Matters in Times of Stress (DWM) program. The program has 5 modules and is delivered in 5 weeks (one module is being made available each week).~Treatment group also receives a weekly support call (15 minutes) from a helper (6 calls in total). Helpers are (graduate) psychology students trained according to the WHO training manual in order to provide support to participants in completing the DWM program.~Participants in treatment group will be allowed to receive any usual care once they are enrolled in the trial.
No_intervention: Care-as-Usual (CAU)
Care-as-Usual ranges from community care to specialised psychological treatments.
Related Therapeutic Areas
Sponsors
Leads: VU University of Amsterdam
Collaborators: University of Copenhagen, World Health Organization, University Hospital Heidelberg

This content was sourced from clinicaltrials.gov