Menu
Recruiting NCT06543732

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

No phase Interventional Return to Work Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Return to work program.
Who it may be relevant to
Registry conditions: Return to Work, Mental Health. Basic parameters: 18 years — 68 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

This study evaluates the effectiveness of a program, incorporating diverse components, to improve sustainable return to work, stress-related outcomes and cost effectiveness among sick-listed workers with stress-related complaints compared to usual care. The study design is a randomized controlled trial, including an intervention and control group. Sick-listed workers between 2 - 12 weeks sick, in the intervention group receive a tailored eHealth program based on their questions on a distress screener, if needed followed by the Participatory Approach (PA). Sick-listed workers in the control group receive standard practice and general information about return to work. If sick-listed workers did not return to work after 6 weeks in the eHealth program, the PA starts. The PA is a structured and stepwise procedure that involves the sick-listed worker, their direct supervisor, and a neutral party (either physically present or working in the background) to guide the conversation. This collaborative process aims to identify workplace-related bottlenecks, and subsequently develop a consensus-based return to work plan based on a strong commitment of both the sick listed worker and employer. This study offers two different forms of PA: individual work modifications (guided by a neutral process facilitator) and job coaching (guided by the employer, with the process facilitator providing support in the background). If sick-listed workers are experiencing stress-related complaints originating from work, they will be offered individual work modifications. Conversely, if the issues are unrelated to work, the worker will receive job coaching. As information on this tailored PA approach is lacking, the effectiveness of this approach is investigated. By combining these different intervention components, the investigators strive to fill the research gap concerning the identification of an effective re-integration program for sick-listed workers suffering from stress-related complaints. Participants will be followed for 1 year.

Interventions

  • Other Return to work program
    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.

Primary outcome measures

  • Lasting return to work [Time frame: Baseline - 3 months - 6 months -12 months]
Secondary outcome measures (3)
  • Stress-related complaints [Time frame: Baseline - 3 months - 6 months -12 months]
  • Psychosocial job characteristics [Time frame: Baseline - 3 months - 6 months - 12 months]
  • Behaviour change [Time frame: Baseline - 3 months - 6 months - 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Netherlands · 4 centers
  • Amsterdam UMC — Amsterdam
  • GGZ inGeest — Amsterdam
  • Transavia — Amsterdam
  • RSO — The Hague

Identifiers

NCT: NCT06543732 · 2024.0021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗