- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06888999
In Vitro Exposure by VR to Enhance Return to Work After Sick Leave Due to Mental Health Related Complaints
January 8, 2026 updated by: Roosmarijn Schelvis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
The goal of this pilot randomised controlled trial is to investigate whether in vitro exposure by VR enhances return to work (RTW) in flight cabin crew on sick leave with mental health related complaints.
The main research questions are: 1.
Does VR enhances time to RTW? 2. Does VR increase self-efficacy and positive cognitions regarding RTW, and decrease job anxiety?
Researchers will compare a control group receiving care as usual as provided by the occupational physician and a psychologist to an intervention group receiving care as usual plus (al least) one session with VR-glasses in which participants are virtually exposed to their workplace.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study evaluates the effectiveness of in vitro exposure to the workplace by means of VR to decrease time to RTW of sick-listed flight cabin crew with mental health related complaints compared to usual care.
The study design is a pilot randomized controlled trial, including an intervention and control group.
Sick-listed workers in the control group receive care as usual from the occupational physician and a psychologist.
Sick-listed workers in the intervention group receive care as usual from the occupational physician and a psychologist and participate in a VR-session.
During the VR-session, guided by the psychologist, participants are virtually exposed to their workplace.
Data on the primary outcome of RTW is collected based on the register data from the occupational health service (6 and 12 months after baseline).
Data on secondary outcomes (self-efficacy, cognitions regarding RTW and job anxiety) is collected with baseline and follow-up questionnaires (4 months after baseline).
Study Type
Interventional
Enrollment (Estimated)
118
Phase
- 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
- Name: Maartje C. Bakhuys Roozeboom, PhD
- Phone Number: 0031619352778
- Email: m.c.bakhuysroozeboom@amsterdamumc.nl
Study Locations
-
-
-
Schiphol, Netherlands, 1117 CJ
- Recruiting
- KLM Health Services
-
Contact:
- Ruby Corveleijn
- Phone Number: 0031 020 6491415
- Email: rcorveleijn.health@klm.com
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- sick listed cabin crew with mental health related complaints that are referred by the occupational physician to a specific psychotherapist practice
Exclusion Criteria:
- epilepsy
- vestibular disorder
- no signed 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Care as usual plus VR
Participants in the intervention group receive care as usual from the occupational physician and a psychologist and participate (al least once) in a VR-session.
During the VR-session, guided by the psychologist, participants are virtually exposed to their workplace.
|
During the VR-session, guided by the psychologist, participants are virtually exposed to their workplace using VR glasses.
Based on the experience of the participants during the vitual visit to their workplace, the psychologist can adjust the therapy.
In addition care as usual is provided (see description active comparator).
|
|
Active Comparator: Care as usual
Participants in the care as usual group receive care as usual from the occupational physician and a psychologist.
|
Guidance by the occupational physician and a psychologist from a psychologist practice specialized in counseling cabin crew and guiding them with returning to work.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to RTW
Time Frame: 6 months and 12 months after baseline
|
Time between start of sickness absence until participant is considered 'fit to fly' by the occupational physician, measured by register data from the occupational health service.
|
6 months and 12 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress-related complaints
Time Frame: Baseline and 4-months follow-up
|
Stress-related complaints (e.g., type of disease, severity of symptoms) by means of Perceived Stress Scale (PSS-10).
The PSS-10 consists of 10 items rated on a 5-point Likert scale, ranging from 0 (never) to 4 (very often).
A high score means more stress-related complaints
|
Baseline and 4-months follow-up
|
|
Self-efficacy regarding return to work
Time Frame: Baseline and 4-months follow-up
|
Self-efficacy regarding return to work measured by Return-to-Work Self-Efficacy scale (RTW-SE).
The RTW-SE contains of 11 items.
The items are rated on a five point scale The response categories vary from 1 (totally disagree) to 6 (totally agree).
A high score means more return to work self-efficacy
|
Baseline and 4-months follow-up
|
|
Attitude regarding return to work
Time Frame: Baseline and 4-months follow-up
|
Scale on attitude regarding return to work.
Attitude regarding return to work is measured with a 8-item scale measuring the attitude towards working again.
The items are rated on a 4-point scale ranging from 1 (disagree very strongly) to 4 (agree very strongly).
A higher score means a more positive attitude towards return to work.
|
Baseline and 4-months follow-up
|
|
Job anxiety
Time Frame: Baseline and 4-months follow-up
|
Anxiety related to the job measured by the Job Anxiety Scale.
The items are rated on a 5-point Likert scale, ranging from of 0 (no agreement) to 4 (full agreement).
A higher score means more job anxiety.
|
Baseline and 4-months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roosmarijn M.C. Schelvis, PhD, Amsterdam UMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Schmalbach I, Schmalbach B, Kalkbrenner A, Bassler M, Hinz A, Petrowski K. Psychometric properties of the job anxiety scale. Front Psychol. 2023 Apr 25;14:1020596. doi: 10.3389/fpsyg.2023.1020596. eCollection 2023.
- Muschalla B, Linden M, Olbrich D. The relationship between job-anxiety and trait-anxiety--a differential diagnostic investigation with the Job-Anxiety-Scale and the State-Trait-Anxiety-Inventory. J Anxiety Disord. 2010 Apr;24(3):366-71. doi: 10.1016/j.janxdis.2010.02.001. Epub 2010 Feb 11.
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)
November 17, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
March 20, 2025
First Submitted That Met QC Criteria
March 20, 2025
First Posted (Actual)
March 21, 2025
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025.0183
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We will not publish the complete dataset to protect the privacy of the participants.
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
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