- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375199
Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol (VIRTUS)
Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol, a Randomized Controlled Trial
Schizophrenia is a chronic psychiatric disorder, frequently associated with stigma, including within healthcare settings, that significantly impairs quality of life and symptoms. Virtual Reality (VR), as an immersive tool, may allow healthy individuals to experience the first-person perspective of a patient undergoing psychotic symptoms. VR exposure may facilitate perspective-taking, fosters empathy, and studies suggest VR could be a valuable tool to reduce stigma. However, the findings remain incomplete, with considerable variation between protocols and no data on implicit stigma. This study is designed to evaluate the effectiveness of a VR protocol simulating psychotic symptoms on explicit and implicit stigma.
Methods and Analysis A randomized controlled trial involving 128 participants will be conducted. Participants will include healthcare workers and students (medicine, nursing, or psychology) recruited from CH Henri Laborit in Poitiers (France), Poitiers University Hospital, CH Nord-Deux-Sèvres in Thouars (France), and the University of Poitiers. Recruitment will take place over a two-year period. Participants will be randomly assigned to either the intervention group or the control group.
The protocol involves two short VR scenarios. In the intervention condition only, both scenarios will simulate auditory and visual hallucinations and persecutory delusions, to immerse participants in the experience of someone living with schizophrenia. Stigma will be assessed before the VR intervention, immediately afterward, and at one-month follow-up. Assessment will be conducted using self-report scales (Attribution Questionnaire-27 items by Corrigan et al., 2003 (AQ-27), Community Attitudes toward the Mentally Ill, Taylor & Dear 1981 (CAMI) and Reported and Intended Behavior Scale by Evans-Lacko et al., 2011 (RIBS) for explicit stigma, and a behavioural test (Implicit Association Task, Greenwald, McGhee et Schwartz en 1998 (IAT)) for the implicit stigma.
The primary outcome is the reduction in stigma toward individuals with schizophrenia, assessed with the AQ-27 scale, from baseline to the one-month follow-up, comparing the intervention and control groups. The expected result is a greater reduction in stigma in the intervention group compared to the control group. Secondary outcomes include a one-month reduction in implicit associations, immediate post-intervention effects on stigma, changes in self-reported prejudice and discrimination over time.
Ethics and Dissemination All participants receive both oral and written information and provided signed informed consent. The study is under review from the French Research Ethics Committee (reference number: 2025-A01472-47). Results will be disseminated through presentations, conferences, and publications in peer-reviewed scientific journals.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre-Marie LEBLANC, MD
- Phone Number: +33549445801
- Email: pierre-marie.leblanc@ch-poitiers.fr
Study Contact Backup
- Name: Armand Chatard, PhD
- Email: armand.chatard@univ-poitiers.fr
Study Locations
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Poitiers, France, 86000
- Unité de Recherche Clinique (URC), Centre Hospitalier Henri Laborit
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Contact:
- Nicolas Langbour, PhD
- Phone Number: +33516526118
- Email: nicolas.langbour@ch-poitiers.Fr
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Principal Investigator:
- Pierre-Marie LEBLANC, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged between 18 and 65
- currently employed as a healthcare professional or enrolled as a advanced-grade student in medicine, nursing, or psychology
- no history of psychiatric or addictive disorders (except for tobacco dependence)
- covered by French social security
- able to provide informed written consent after receiving appropriate information.
Exclusion Criteria:
- current or past psychiatric or addictive disorder (except tobacco dependence)
- use of antipsychotic medication; first-degree family history of schizophrenia; cognitive impairment
- susceptibility to cybersickness
- recent (<1 year) or acute neurological disorders
- history of epilepsy
- known otorhinolaryngologic conditions causing vertigo, nausea or vomiting
- pregnancy or breastfeeding
- legal protection measures
- any condition, in the investigator's opinion that would prevent valid questionnaire completion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Schizophrenia
The protocol involves two short VR scenarios.
In the intervention condition only ("schizophrenia"), both scenarios will simulate auditory and visual hallucinations and persecutory delusions, to immerse participants in the experience of someone living with schizophrenia.
|
Participants will watch two brief VR videos.
The first simulates an office environnement , the second simulates a university classroom environment.
In the experimental group, psychotic-like phenomena commonly reported by individuals with schizophrenia during acute episodes (e.g., auditory hallucinations, visual hallucinations, paranoid ideation) will be incorporated into both videos.
The purpose is to simulate the lived experience of schizophrenia.
The two VR environnements were adapted form Marques (virtual Stroop test, Marques et al., 2022) and Abrams (University classroom, Abrams et al., 2024), and programmed using Unity2021.3.11 with C#.
Some assets in scenes were developped with Blender 4.4.
We used MetaQuest2 as headset VR.
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Active Comparator: CONTROL
The protocol involves two short VR scenarios.
In the control condition participant will see the same VR video, without auditory and visual hallucinations or persecutory delusions.
|
Participants will watch two brief VR videos.
The first simulates an office environnement , the second simulates a university classroom environment.
Contrary to the experimental group, psychotic-like phenomena (auditory hallucinations, visual hallucinations, paranoid ideation) will not be incorporated into videos.
The two VR environnements are programmed using Unity2021.3.11 with C#.
Some assets in scenes were developped with Blender 4.4.
We used MetaQuest2 as headset VR.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explicit stigma - 1 month follow up
Time Frame: Baseline and 1 month after intervention
|
Change from baseline to 1 month follow-up, in the Attribution Questionnaire-27 (AQ-27) total score, comparing the intervention and control groups.
Higher scores indicate greater explicit stigma toward individuals with schizophrenia.
|
Baseline and 1 month after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implicit stigma - 1 month follow up
Time Frame: Baseline and 1 month after intervention
|
Change from baseline in Implicit Association Test (IAT) score for the schizophrenia-violence association. Higher scores indicate a stronger implicit association in the direction defined by the scoring algorithm. A greater reduction in implicit associations, as measured by the IAT, is expected at one month in the intervention group compared with the control group. |
Baseline and 1 month after intervention
|
|
Explicit stigma - Immediate effect
Time Frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
Change from baseline to immediate post-intervention, in the Attribution Questionnaire-27 (AQ-27) total score. Higher scores indicate greater explicit stigma toward individuals with schizophrenia. An immediate decrease in stigma scores on the AQ-27 in the intervention group compared to the control group is expected. |
Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
|
Implicit stigma - Immediate effect
Time Frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
Change from baseline to immediate post-intervention, in implicit association between schizophrenia and violence, measured by the Implicit Association Test (IAT) score (higher absolute score indicates stronger implicit association).
A greater immediate reduction in implicit associations linking schizophrenia with violence is expected in the intervention group compared to controls.
|
Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
|
Attitudes toward individuals with schizophrenia - 1 month follow up
Time Frame: Baseline and 1 month follow-up
|
Change from baseline to immediate post-intervention, in the Community Attitudes toward the Mentally Ill (CAMI) total score.
Higher scores indicate more bad attitudes toward individuals with schizophrenia.
An immediate decrease in stigma scores on the CAMI in the intervention group compared to the control group is expected.
|
Baseline and 1 month follow-up
|
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Behaviors toward individuals with schizophrenia - 1 month follow up
Time Frame: Baseline and 1 month follow-up
|
Change from baseline to immediate post-intervention, in the Reported and Intended Behavior Scale (RIBS) total score.
Higher scores indicate more bad behaviors toward individuals with schizophrenia.
An immediate decrease in stigma scores on the RIBS in the intervention group compared to the control group is expected.
|
Baseline and 1 month follow-up
|
|
Attitudes toward individuals with schizophrenia - immediate effect
Time Frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
Change from baseline to immediate post-intervention, in the Community Attitudes toward the Mentally Ill (CAMI) total score.
Higher scores indicate more bad attitudes toward individuals with schizophrenia.
An immediate decrease in stigma scores on the CAMI in the intervention group compared to the control group is expected
|
Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
|
Behaviors toward individuals with schizophrenia - immediate effect
Time Frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
Change from baseline to immediate post-intervention, in the Reported and Intended Behavior Scale (RIBS) total score.
Higher scores indicate more bad behaviors toward individuals with schizophrenia.
An immediate decrease in stigma scores on the RIBS in the intervention group compared to the control group is expected.
|
Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A01472-47
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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