NCT07375199

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

January 12, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 12, 2026

Last Update Submit

January 21, 2026

Conditions

Keywords

stigmavirtual realityempathyimplicit associations

Outcome Measures

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.

    Baseline and 1 month after intervention

Secondary Outcomes (7)

  • Implicit stigma - 1 month follow up

    Baseline and 1 month after intervention

  • Explicit stigma - Immediate effect

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

  • Implicit stigma - Immediate effect

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

  • Attitudes toward individuals with schizophrenia - 1 month follow up

    Baseline and 1 month follow-up

  • Behaviors toward individuals with schizophrenia - 1 month follow up

    Baseline and 1 month follow-up

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: VR Control

Interventions

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.

Schizophrenia

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.

CONTROL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Recherche Clinique (URC), Centre Hospitalier Henri Laborit

Poitiers, 86000, France

Location

MeSH Terms

Conditions

SchizophreniaSocial Stigma

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehavior

Central Study Contacts

Armand Chatard, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 29, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared upon reasonable request for non-commercial research purposes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations