Vital@Work: an Intervention for Prevention of Mental Health Complaints at Work

NCT06445101 | Enrolling By Invitation

• 1 other identifier: LSHM22035-H025
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Stress

Keywords

work-related emotional exhaustion

Outcome Measures

Primary Outcomes (1)

• 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').

  Baseline - 6 months after baseline - 12 months after baseline

Secondary Outcomes (5)

• Work related psychosocial risk factors

  Baseline - 6 months after baseline - 12 months after baseline

• Sense of community

  Baseline - 6 months after baseline - 12 months after baseline

• Psychosocial safety climate

  Baseline - 6 months after baseline - 12 months after baseline

• Presenteeism and absenteeism

  Baseline - 6 months after baseline - 12 months after baseline

• Implementation outcomes

  Baseline - 6 months after baseline - 12 months after baseline

Study Arms (2)

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.

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).

Interventions

Participatory Approach OTHER

The participatory approach is a stepwise, collaborative approach to the analysis and solvation of bottlenecks that cause stress in employees.

Participatory Approach (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Health Holland: collaborator
• Stichting Trimbos-Instituut: collaborator

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

Location

GGZ Ingeest

Amsterdam, Netherlands

Location

Transavia

Amsterdam, Netherlands

Location

RSO

The Hague, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40885945 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the PA intervention and associated activities, it is not possible to blind the researchers and department managers to the condition they are assigned to. 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: April 17, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

NL (4)