Vital@Work: Reintegration Program for Employees with Stress-related Complaints

NCT06543732 | Recruiting

• 1 other identifier: 2024.0021
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this study, Vital@Work reintegration program, is to support sick-listed workers with stress-related complaints in their return to work based on a personalized program. Therefore, the aim of this study is test whether participants supported by a tailored eHealth program, and if needed, additionally supported by a structured and stepwise Participatory Approach (PA) involving the sick-listed worker, their direct supervisor and a neutral party, show a faster and sustainable return to work as compared to participants in the control condition. This program 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.

Conditions

Return to Work; Mental Health

Keywords

Return to work; Stress; Absenteeism

Outcome Measures

Primary Outcomes (1)

• Lasting return to work

  Lasting return to work of at least 28 consecutive days without (partial or full) relapse

  Baseline - 3 months - 6 months -12 months

Secondary Outcomes (3)

• Stress-related complaints

  Baseline - 3 months - 6 months -12 months

• Psychosocial job characteristics

  Baseline - 3 months - 6 months - 12 months

• Behaviour change

  Baseline - 3 months - 6 months - 12 months

Study Arms (2)

eHealth with Participatory Approach if needed

EXPERIMENTAL

Participants receive a personalized eHealth program and if needed, after 6 weeks the Participatory Approach (intervention) next to care as usual from occupational health care.

Other: Return to work program

Control condition

NO INTERVENTION

Participants receive links to existing websites on return to work next to care as usual from occupational health care.

Interventions

Return to work program OTHER

The eHealth modules focus on psychoeducation, perceptions of return to work based on a personal plan including problem-solving exercises, relapse prevention, and continuous monitoring. If needed, followed by the participatory approach, a stepwise, collaborative approach to analyse and solve bottlenecks to develop a consensus-based plan for return to work.

eHealth with Participatory Approach if needed

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sick-listed employees from participating organisations (Amsterdam UMC, GGZ inGeest, Rijksschoonmaakorganisatie \[RSO\], and Transavia)
• Aged 18-68
• Between 2 and 12 weeks on sick leave
• Suffering from stress-related complaints

You may not qualify if:

• Non-sick-listed employees
• Suffering from severe psychiatric disorders (e.g., suicidality, mania, psychosis, schizophrenia) or other chronic conditions (e.g., terminal illness) that could significantly affect the employee's mental health and, hence, prevent the return-to work process
• Being pregnant or less than three months after delivery
• Sick-listed for more than 12 weeks
• Inability to complete either the eHealth modules or questionnaires
• Presence of a legal conflict with the employer
• Not signing informed consent

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Health Holland: collaborator
• Trimbos: collaborator

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

GGZ inGeest

Amsterdam, Netherlands

RECRUITING

Transavia

Amsterdam, Netherlands

RECRUITING

RSO

The Hague, Netherlands

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Trees Juurlink, PhD

CONTACT

+31613731701; t.juurlink@amsterdamumc.nl

Han Anema, PhD

CONTACT

+31613731701; h.anema@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the PA intervention, it is not possible to blind the researchers and process facilitators. However, workers randomized to the intervention or control group are not aware of the research design. Process facilitators providing the PA 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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: Randomized controlled trial comparing intervention group with care as usual group. Randomization is carried out at the individual level stratified by organisation type and whether problems are perceived as work-related or not.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

NL (4)