StressNCT06445101
Vital@Work: an Intervention for Prevention of Mental Health Complaints at Work
A study testing Participatory Approach in people with Stress, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Participatory Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 4 sitesNetherlands
- Study dates
- 17 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites
Amsterdam UMC
Amsterdam
GGZ Ingeest
Amsterdam
Transavia
Amsterdam
RSO
The Hague
About this study
Official title: Vital@Work: an Evidence-based Intervention Program for Prevention of Mental Health Complaints at Work, Tailored to Specific Organisational Needs and Contextual Factors
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
Read the detailed description
This study evaluates the PA as a strategy to implement measures to prevent or reduce work-related mental health problems by a cluster randomized controlled trial, including an intervention and control group. Employees in departments allocated to the intervention group receive the PA intervention in addition to the existing range of preventive mental health measures within the organization. Departments assigned to the control group receive standard practice and therefore only the existing range of preventive interventions will be highlighted and further drawn to the attention of employees (without the PA intervention). Due to the PA intervention and associated activities, it is not possible to blind the researchers and department managers. However, employees in the departments randomized to the intervention or control group are not aware of the research design. Only department managers are informed about the research design and the outcome of randomization, and they are asked not to communicate the research design to the employees.
The PA consists of six steps: 1) preparation: create prerequisites and initiate the PA, 2) risk assessment: analysis of bottlenecks and risks 3) solutions: Analysis of potential solutions 4) action planning: jointly formulating a plan of action to realize solutions 5) implementation: implementing measures by means of the action plan and 6) evaluation: evaluation of the approach.
For each intervention group, a participatory working group will be established, comprising 5-7 employees, a department manager/supervisor, a health and safety coordinator, an HR representative, and a communication specialist. Each intervention group is coordinated by a process facilitator who is responsible for preparing the meetings with the working group and leading the discussions during these sessions. To prepare individuals for this role, the process facilitator receives training, provided by researchers experienced in the PA.
The participative working group will go through steps 2 to 4 of the PA during a day session, resulting in an action plan for the intervention activities to be implemented. Subsequently, this action plan will be implemented throughout the entire team comprising the intervention group. This implementation process will be led by the process facilitator, supported by change agents. Ideally, (some of) the working group members will act as change agents. Change agents have the task of implementing interventions as widely as possible within the department and ensuring a smooth implementation process so that employees actually make use of the innovations. In order to act as catalysts for the implementation process within the department, the change agents and the process facilitator are trained by researchers experienced in the PA. The duration of the entire implementation period is approximately 12 months, but depends on the selected intervention activities, with short-term implementations lasting < 3 months, and long-term implementations lasting > 3 months.
- Conditions
- Stress
- Being tested
- Participatory Approach
- Keywords
- work-related emotional exhaustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory ApproachOther
The participatory approach is a stepwise, collaborative approach to the analysis and solvation of bottlenecks that cause stress in employees.
| Study group | Role | What they receive |
|---|---|---|
| Participatory Approach (intervention) | Experimental | Employees in departments allocated to the intervention group receive the PA strategy in addition to the existing range of preventive mental health measures within the organization. Receives: Other: Participatory Approach |
| Care as usual | No intervention | Departments assigned to the control group receive usual strategies and therefore only have access to the existing range of preventive interventions within the organization (without the PA intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Stress will be assessed using the stress subscale of the short version of the Depression Anxiety and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), designed to measure the emotional states of depression, anxiety and stress. The stress subscale of DASS-21 comprises seven statements. Participants indicate the extent to which these statements applied to them during the past week, using a Likert scale ranging from 0 ('never') to 3 ('almost always').
Measured: Baseline - 6 months after baseline - 12 months after baseline
Secondary outcomes (5)
Work related psychosocial risk factors
At the individual level, we will assess work-related psychosocial risk factors, including job demands, autonomy, supervisor support and co-worker support. For measuring job demands, we will utilize four subscales from the validated Dutch version of The Copenhagen Psychosocial Questionnaire (COPSOQ-III; Burr et al., 2019; Kristensen et al., 2005) subscales quantitative demands, cognitive demands, emotional demands and work pace. The COPSOQ is a globally recognized and extensively employed tool for assessing a range of psychosocial factors in workplaces (Burr et al., 2019)
Measured: Baseline - 6 months after baseline - 12 months after baseline
Sense of community
Sense of Community will be measured using three items form the validated Dutch version of COPSOQ-III (Burr et al., 2019; Kristensen et al., 2005)
Measured: Baseline - 6 months after baseline - 12 months after baseline
Psychosocial safety climate
At employee level, the Psychosocial Safety Climate (PSC) is assessed using the Dutch translation of the PSC-4, a shortened version of the PSC-12 (Dollard, 2019).
Measured: Baseline - 6 months after baseline - 12 months after baseline
Presenteeism and absenteeism
Presenteeism will be assessed by two items of the World Health Organization Health and Work Performance Questionnaire (HPQ) (Kessler et al., 2003) and an item obtained from Vänni et al. (2018). The absenteeism history of the employee in the twelve months prior to the survey will be assessed using a set of three questions. Additionally, two questions will be included regarding the most recent absenteeism incident experienced by employees. This most recent incident may potentially have occurred more than twelve months ago, allowing for responses from employees who have not been absent in the past twelve months but were absent before that period. They are asked about the type of complaints that led to their most recent absence and whether these complaints were work-related.
Measured: Baseline - 6 months after baseline - 12 months after baseline
Implementation outcomes
To assess implementation outcomes, a series of questions (12 items) will be used concerning existing and recently introduced resources (interventions, measures, policies, and additional support) designed to foster mental health and prevent related issues. These items focus on the availability and utilization of existing and newly provided resources.
Measured: Baseline - 6 months after baseline - 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start17 Apr 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster randomized controlled trial comparing intervention group with care as usual group. Randomization is carried out at the cluster (team or department) level to prevent contamination between employees assigned to the intervention group and those in the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Health Holland, Stichting Trimbos-Instituut
- Responsible party
- Principal investigator, Luuk Bouwens, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445101
- Sponsor's protocol ID
- LSHM22035-H025
- Status last verified
- Sep 2025
- First submitted
- 31 May 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouwens L, Anema JR, Juurlink TT, Beekman ATF, Schelvis RMC. Protocol of a randomized controlled multicenter trial investigating process and effectiveness of a participatory organizational approach for preventing work-related mental health problems among employees: vital@work. BMC Public Health. 2025 Aug 30;25(1):2970. doi: 10.1186/s12889-025-24367-8.
PubMed 40885945
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital@Work: an Evidence-based Intervention Program for Prevention of Mental Health Complaints at Work, Tailored to Specific Organisational Needs and Contextual Factors
- ClinicalTrials.gov ID
- NCT06445101
- Acronym / sponsor ID
- LSHM22035-H025
- Conditions
- Stress
- Keywords
- work-related emotional exhaustion
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Health Holland, Stichting Trimbos-Instituut
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study evaluates the PA as a strategy to implement measures to prevent or reduce work-related mental health problems by a cluster randomized controlled trial, including an intervention and control group. Employees in departments allocated to the intervention group receive the PA intervention in addition to the existing range of preventive mental health measures within the organization. Departments assigned to the control group receive standard practice and therefore only the existing range of preventive interventions will be highlighted and further drawn to the attention of employees (without the PA intervention). Due to the PA intervention and associated activities, it is not possible to blind the researchers and department managers. However, employees in the departments randomized to the intervention or control group are not aware of the research design. Only department managers are informed about the research design and the outcome of randomization, and they are asked not to communicate the research design to the employees.
The PA consists of six steps: 1) preparation: create prerequisites and initiate the PA, 2) risk assessment: analysis of bottlenecks and risks 3) solutions: Analysis of potential solutions 4) action planning: jointly formulating a plan of action to realize solutions 5) implementation: implementing measures by means of the action plan and 6) evaluation: evaluation of the approach.
For each intervention group, a participatory working group will be established, comprising 5-7 employees, a department manager/supervisor, a health and safety coordinator, an HR representative, and a communication specialist. Each intervention group is coordinated by a process facilitator who is responsible for preparing the meetings with the working group and leading the discussions during these sessions. To prepare individuals for this role, the process facilitator receives training, provided by researchers experienced in the PA.
The participative working group will go through steps 2 to 4 of the PA during a day session, resulting in an action plan for the intervention activities to be implemented. Subsequently, this action plan will be implemented throughout the entire team comprising the intervention group. This implementation process will be led by the process facilitator, supported by change agents. Ideally, (some of) the working group members will act as change agents. Change agents have the task of implementing interventions as widely as possible within the department and ensuring a smooth implementation process so that employees actually make use of the innovations. In order to act as catalysts for the implementation process within the department, the change agents and the process facilitator are trained by researchers experienced in the PA. The duration of the entire implementation period is approximately 12 months, but depends on the selected intervention activities, with short-term implementations lasting < 3 months, and long-term implementations lasting > 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial comparing intervention group with care as usual group. Randomization is carried out at the cluster (team or department) level to prevent contamination between employees assigned to the intervention group and those in the control group.
| Arm | Type | Receives |
|---|---|---|
| Participatory Approach (intervention) | Experimental | Other: Participatory ApproachEmployees in departments allocated to the intervention group receive the PA strategy in addition to the existing range of preventive mental health measures within the organization. |
| Care as usual | No intervention | –Departments assigned to the control group receive usual strategies and therefore only have access to the existing range of preventive interventions within the organization (without the PA intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participatory ApproachThe participatory approach is a stepwise, collaborative approach to the analysis and solvation of bottlenecks that cause stress in employees. | Other | Participatory Approach (intervention) |
Primary outcome
Stress
Time frame: Baseline - 6 months after baseline - 12 months after baseline
Stress will be assessed using the stress subscale of the short version of the Depression Anxiety and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), designed to measure the emotional states of depression, anxiety and stress. The stress subscale of DASS-21 comprises seven statements. Participants indicate the extent to which these statements applied to them during the past week, using a Likert scale ranging from 0 ('never') to 3 ('almost always').
5 secondary outcomes
Work related psychosocial risk factors
Time frame: Baseline - 6 months after baseline - 12 months after baseline
Sense of community
Time frame: Baseline - 6 months after baseline - 12 months after baseline
Psychosocial safety climate
Time frame: Baseline - 6 months after baseline - 12 months after baseline
Presenteeism and absenteeism
Time frame: Baseline - 6 months after baseline - 12 months after baseline
Implementation outcomes
Time frame: Baseline - 6 months after baseline - 12 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 40885945Bouwens L, Anema JR, Juurlink TT, Beekman ATF, Schelvis RMC. Protocol of a randomized controlled multicenter trial investigating process and effectiveness of a participatory organizational approach for preventing work-related mental health problems among employees: vital@work. BMC Public Health. 2025 Aug 30;25(1):2970. doi: 10.1186/s12889-025-24367-8.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory Approach in people with Stress, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Baseline - 6 months after baseline - 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.