Return to WorkVital@WorkNCT06543732
Vital@Work: Reintegration Program for Employees with Stress-related Complaints
A study testing Return to work program in people with Return to Work and Mental Health, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Return to Work, Mental Health
- What is being tested?
- Return to work program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 4 sitesNetherlands
- Study dates
- 8 Jan 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Robbert de Leeuw
- Recruiting
GGZ inGeest
Amsterdam
Stephanie Mees ten Oever
- Recruiting
Transavia
Amsterdam
Bonny de Vries
- Recruiting
RSO
The Hague
Fred Verhees
About this study
Official title: 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.
Read the 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.
- Conditions
- Return to Work, Mental Health
- Being tested
- Return to work program
- Keywords
- Return to work, Stress, Absenteeism
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return to work programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lasting return to work
Lasting return to work of at least 28 consecutive days without (partial or full) relapse
Measured: Baseline - 3 months - 6 months -12 months
Secondary outcomes (3)
Stress-related complaints
Stress-related complaints (e.g., type of disease, severity of symptoms) by means of the 4DKL (Terluin, 2008), Promis (Terwee et al. 2015).
Measured: Baseline - 3 months - 6 months -12 months
Psychosocial job characteristics
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)
Measured: Baseline - 3 months - 6 months - 12 months
Behaviour change
Behaviour change (e.g., attitude, social influence, self-efficacy); by means of the ASE (Damoiseaux et al. 1998), RTW-SE (Volker et al. 2015).
Measured: Baseline - 3 months - 6 months - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Return to WorkStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Health Holland, Trimbos
- Responsible party
- Principal investigator, Trees Juurlink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543732
- Sponsor's protocol ID
- 2024.0021
- Acronym
- Vital@Work
- Status last verified
- Jan 2025
- First submitted
- 5 Aug 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Doeveren EEM, de Smalen AW, Schelvis RMC, Beekman ATF, Anema JR, Juurlink TT. Vital@Work reintegration programme for sick-listed workers with stress-related complaints in occupational healthcare in the Netherlands: study protocol of a randomised controlled trial. BMJ Open. 2026 Sep 30;16(9):e116576. doi: 10.1136/bmjopen-2026-116576.
PubMed 42816073
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital@Work: a Personalized Reintegration Program for Employees with Stress-related Complaints
- ClinicalTrials.gov ID
- NCT06543732
- Acronym / sponsor ID
- Vital@Work / 2024.0021
- Conditions
- Return to Work, Mental Health
- Keywords
- Return to work, Stress, Absenteeism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Health Holland, Trimbos
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| eHealth with Participatory Approach if needed | Experimental | Other: Return to work programParticipants receive a personalized eHealth program and if needed, after 6 weeks the Participatory Approach (intervention) next to care as usual from occupational health care. |
| Control condition | No intervention | –Participants receive links to existing websites on return to work next to care as usual from occupational health care. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Return to work programThe 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. | Other | eHealth with Participatory Approach if needed |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 42816073van Doeveren EEM, de Smalen AW, Schelvis RMC, Beekman ATF, Anema JR, Juurlink TT. Vital@Work reintegration programme for sick-listed workers with stress-related complaints in occupational healthcare in the Netherlands: study protocol of a randomised controlled trial. BMJ Open. 2026 Sep 30;16(9):e116576. doi: 10.1136/bmjopen-2026-116576.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Return to work program in people with Return to Work and Mental Health, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trees Juurlink, PhD (+31613731701, t.juurlink@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lasting return to work (time frame: Baseline - 3 months - 6 months -12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.