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NCT Number: NCT06543732

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

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.

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Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Lasting return to work

    Time frame: Baseline - 3 months - 6 months -12 months

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

Secondary outcomes

  1. Stress-related complaints

    Time frame: Baseline - 3 months - 6 months -12 months

    Stress-related complaints (e.g., type of disease, severity of symptoms) by means of the 4DKL (Terluin, 2008), Promis (Terwee et al. 2015).

  2. Psychosocial job characteristics

    Time frame: Baseline - 3 months - 6 months - 12 months

    Psychosocial job characteristics (e.g., mental workload, decision latitude, social support, physical demands, job insecurity) by means of the JCQ (Karasek, Houtman et al. 1995)

  3. Behaviour change

    Time frame: Baseline - 3 months - 6 months - 12 months

    Behaviour change (e.g., attitude, social influence, self-efficacy); by means of the ASE (Damoiseaux et al. 1998), RTW-SE (Volker et al. 2015).

Study contacts

Contact information is provided by the study sponsor or research team.

Han Anema, PhD

CONTACT

[email protected]

+31613731701

Trees Juurlink, PhD

CONTACT

[email protected]

+31613731701

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Health Holland
  • Trimbos

Registry information

Official study title

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

Acronym: Vital@Work

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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