Schizophrenia DisorderVIRTUSNCT07375199
Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol
A study testing VIRTUS in people with Schizophrenia Disorder, run by Centre Hospitalier Henri Laborit at 2 sites in France.
Trial summary
Schizophrenia is a chronic psychiatric disorder, frequently associated with stigma, including within healthcare settings, that significantly impairs quality of life and symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Disorder
- What is being tested?
- VIRTUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Aug 2026to Sep 2028
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- pregnancy or breastfeeding
- legal protection measures
- any condition, in the investigator's opinion that would prevent valid questionnaire completion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Armand Chatard, PhD contact
France2 sites, 2 recruiting
- Recruiting
Unité de Recherche Clinique (URC), Centre Hospitalier Henri Laborit
Poitiers, 86000
Nicolas Langbour, PhD, +33516526118, nicolas.langbour@ch-poitiers.Fr
Pierre-Marie LEBLANC, MD
- Recruiting
Centre Hospitalier Nord-Deux-Sèvres
Thouars
Issa Wassouf, MD-PhD
Issa Wassouf, MD-PhD
About this study
Official title: 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.
Read more
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.
- Conditions
- Schizophrenia Disorder
- Being tested
- VIRTUS, VR Control
- Keywords
- stigma, virtual reality, empathy, implicit associations
- Medical subject headings
- Schizophrenia, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRTUSOther
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.
VR ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Experimental | 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. Receives: Other: VIRTUS |
| CONTROL | Active comparator | 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. Receives: Other: VR Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explicit stigma - 1 month follow up
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.
Measured: Baseline and 1 month after intervention
Secondary outcomes (7)
Implicit stigma - 1 month follow up
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.
Measured: Baseline and 1 month after intervention
Explicit stigma - Immediate effect
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.
Measured: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
Implicit stigma - Immediate effect
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.
Measured: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
Attitudes toward individuals with schizophrenia - 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.
Measured: Baseline and 1 month follow-up
Behaviors toward individuals with schizophrenia - 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.
Measured: Baseline and 1 month follow-up
Attitudes toward individuals with schizophrenia - immediate effect
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
Measured: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
Behaviors toward individuals with schizophrenia - immediate effect
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.
Measured: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start17 Aug 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (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 Schizophrenia DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375199
- Sponsor's protocol ID
- 2025-A01472-47
- Acronym
- VIRTUS
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared upon reasonable request for non-commercial research purposes.
Publications
Leblanc PM, Harika-Germaneau G, Langbour N, Pylouster J, Jaafari N, Chatard A. Reducing mental health stigmatisation among healthcare workers and students using a virtual reality protocol: the VIRTUS protocol, a randomised controlled trial. BMJ Open. 2026 Aug 5;16(8):e111884. doi: 10.1136/bmjopen-2025-111884.
PubMed 42556844
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07375199
- Acronym / sponsor ID
- VIRTUS / 2025-A01472-47
- Conditions
- Schizophrenia Disorder
- Keywords
- stigma, virtual reality, empathy, implicit associations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | Experimental | Other: VIRTUSThe 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. |
| CONTROL | Active comparator | Other: VR ControlThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| VIRTUSParticipants 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. | Other | Schizophrenia |
| VR ControlParticipants 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. | Other | CONTROL |
Primary outcome
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.
7 secondary outcomes
Implicit stigma - 1 month follow up
Time frame: 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)
Implicit stigma - Immediate effect
Time frame: 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
Behaviors toward individuals with schizophrenia - 1 month follow up
Time frame: 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)
Behaviors toward individuals with schizophrenia - immediate effect
Time frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)
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 22 Oct 2026.
- Derived from this study: PubMed 42556844Leblanc PM, Harika-Germaneau G, Langbour N, Pylouster J, Jaafari N, Chatard A. Reducing mental health stigmatisation among healthcare workers and students using a virtual reality protocol: the VIRTUS protocol, a randomised controlled trial. BMJ Open. 2026 Aug 5;16(8):e111884. doi: 10.1136/bmjopen-2025-111884.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared upon reasonable request for non-commercial research purposes.
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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.
Armand Chatard, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIRTUS in people with Schizophrenia Disorder, run by Centre Hospitalier Henri Laborit at 2 sites in France.
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 5 inclusion and 9 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Pierre-Marie LEBLANC, MD (+33549445801, pierre-marie.leblanc@ch-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit stigma - 1 month follow up (time frame: Baseline and 1 month after intervention). 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 NCT07375199, 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 22 Oct 2026.