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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06543732
Acronym
Vital@Work
Enrollment
208
Registered
2024-08-09
Start date
2025-01-08
Completion date
2026-12-01
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health, Return to Work

Keywords

Return to work, Stress, Absenteeism

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.

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

OTHERReturn 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.

Sponsors

Health Holland
CollaboratorOTHER
Trimbos
CollaboratorUNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lasting return to workBaseline - 3 months - 6 months -12 monthsLasting return to work of at least 28 consecutive days without (partial or full) relapse

Secondary

MeasureTime frameDescription
Stress-related complaintsBaseline - 3 months - 6 months -12 monthsStress-related complaints (e.g., type of disease, severity of symptoms) by means of the 4DKL (Terluin, 2008), Promis (Terwee et al. 2015).
Psychosocial job characteristicsBaseline - 3 months - 6 months - 12 monthsPsychosocial job characteristics (e.g., mental workload, decision latitude, social support, physical demands, job insecurity) by means of the JCQ (Karasek, Houtman et al. 1995)
Behaviour changeBaseline - 3 months - 6 months - 12 monthsBehaviour change (e.g., attitude, social influence, self-efficacy); by means of the ASE (Damoiseaux et al. 1998), RTW-SE (Volker et al. 2015).

Countries

Netherlands

Contacts

Primary ContactTrees Juurlink, PhD
t.juurlink@amsterdamumc.nl+31613731701
Backup ContactHan Anema, PhD
h.anema@amsterdamumc.nl+31613731701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026