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

January 28, 2025 updated by: Trees Juurlink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Vital@Work: a Personalized 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC
        • Contact:
          • Robbert de Leeuw
      • Amsterdam, Netherlands
        • Recruiting
        • GGz inGeest
        • Contact:
          • Stephanie Mees ten Oever
      • Amsterdam, Netherlands
        • Recruiting
        • Transavia
        • Contact:
          • Bonny de Vries
      • Den Haag, Netherlands
        • Recruiting
        • RSO
        • Contact:
          • Fred Verhees

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eHealth with Participatory Approach if needed
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
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.
No Intervention: Control condition
Participants receive links to existing websites on return to work next to care as usual from occupational health care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline - 3 months - 6 months -12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline - 3 months - 6 months -12 months
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)
Baseline - 3 months - 6 months - 12 months
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).
Baseline - 3 months - 6 months - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Holland
Trimbos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024.0021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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