Vital@Work: an Intervention for Prevention of Mental Health Complaints at Work (NCT06445101) | Clinical Trial Compass
By InvitationNot Applicable
Vital@Work: an Intervention for Prevention of Mental Health Complaints at Work
Netherlands1,040 participantsStarted 2024-04-17
Plain-language summary
The objective of the current study, Vital@Work, is to keep employees in the Netherlands vital on the long term by preventing work-related mental health problems. Therefore, we test an evidence based Participatory Approach (PA) to compose a mental health program tailored to behavioral, organizational \& contextual (BOC) determinants of individuals and populations at risk. The PA is investigated in four different organizations, which differ in sector, size (small and large organizations), type of organization (private or public) and type of work. The varied organizations, each characterized by unique BOC-determinants, provide an opportunity for researching tailored intervention activities that aim to effectively prevent work-related mental health problems. By identifying common factors across these diverse organizations, we aim to grasp patterns of mechanisms for interventions to mental health at work. By doing this, we come closer to opening black box of how and why interventions work and thus closer to tailoring interventions to needs of both individuals and organizations
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion will be done on cluster level (e.g. team or department), after discussing this with participating organizations. The inclusion criteria for participation in the study comprise being at least 18 years of age, holding an employment contract with the participating organization.
Exclusion Criteria:
* The exclusion criteria include being under 18 years old, not being part of the participating teams/departments, or not having an employment contract with the participating organization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on preventing mental health complaints at work and is enrolling by invitation only — can you find out if I or my employer might be eligible to receive an invitation, or if there's a way to express interest?
2Since this study is listed as Phase NA, which often means it's a behavioral or non-drug intervention rather than a medication trial, can you help me understand what the actual program or intervention involves and whether it's something that fits into my current daily routine at work?
3The trial's primary outcome is measuring stress levels — can you explain what tools or assessments they're likely using to measure stress, and whether those results would be shared with me or my care team?
4Given that this is a prevention-focused workplace study rather than a treatment for an existing condition, how does it compare to other stress management options you might already recommend, like therapy or structured wellness programs?
5Because enrollment is by invitation, is there any chance my workplace or employer is already partnering with this study, and if not, are there similar evidence-based programs you could point me toward in the meantime?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stress
Timeframe: Baseline - 6 months after baseline - 12 months after baseline