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RecruitingNCT07375199VIRTUSUpdated Oct 22, 2026

Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol

An interventional study of VIRTUS and VR Control in Schizophrenia Disorder, sponsored by Centre Hospitalier Henri Laborit. Recruiting at 2 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Centre Hospitalier Henri Laborit · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 22, 2026Now RecruitingSite recruiting status changed+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Schizophrenia Disorder

Keywords

  • stigma
  • virtual reality
  • empathy
  • implicit associations
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 128 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Centre Hospitalier Henri Laborit is the lead sponsor of 27 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
128 participants (estimated)

Study arms

  • 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.

    Other: VIRTUS

  • 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.

    Other: VR Control

Interventions

  • OtherVIRTUS

    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.

  • OtherVR Control

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 1 month after intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline and 1 month after intervention

  2. 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.

    Time frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)

  3. 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.

    Time frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)

  4. 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.

    Time frame: Baseline and 1 month follow-up

  5. 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.

    Time frame: Baseline and 1 month follow-up

  6. 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

    Time frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)

  7. 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.

    Time frame: Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session)

07

Study locations

2 of 2 sites recruiting
  • Unité de Recherche Clinique (URC), Centre Hospitalier Henri Laborit
    Poitiers, 86000, France
    Recruiting
  • Centre Hospitalier Nord-Deux-Sèvres
    Thouars, France
    Recruiting
    • Issa Wassouf, MD-PhD · Contact
    • Issa Wassouf, MD-PhD · Principal investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) will be shared upon reasonable request for non-commercial research purposes.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Available starting 6 months after publication for 36 months.

Access criteria: Requests reviewed by the study team; data use agreement and IRB/ethics approval required.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 22, 2026
Sites
1 site added. Unité de Recherche Clinique (URC), Centre Hospitalier Henri Laborit is now Recruiting
Show site
  • Centre Hospitalier Nord-Deux-Sèvres · Thouars, France
Oct 22, 2026
Start date
Mar 1, 2026→Aug 17, 2026 (actual)
Oct 22, 2026
Primary completion
Mar 2028→Sep 2028
Oct 22, 2026
Study completion
Mar 2028→Sep 2028
Oct 22, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 42556844 ↗
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Not yet recruiting→Recruiting
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 42556844 ↗
    1 site added. Unité de Recherche Clinique (URC), Centre Hospitalier Henri Laborit is now Recruiting
    Show site
    • Centre Hospitalier Nord-Deux-Sèvres · Thouars, France
    Start date Mar 1, 2026→Aug 17, 2026 (now actual)
    Primary completion Mar 2028→Sep 2028
    Study completion Mar 2028→Sep 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07375199
Lead sponsor
Centre Hospitalier Henri Laborit
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
Aug 17, 2026
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Pierre-Marie LEBLANC, MD
Contact
pierre-marie.leblanc@ch-poitiers.fr
+33549445801
Armand Chatard, PhD
Contact
armand.chatard@univ-poitiers.fr

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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