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临床试验/NCT07375199
NCT07375199尚未招募不适用

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

Centre Hospitalier Henri Laborit1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
128
试验地点
1
主要终点
Explicit stigma - 1 month follow up

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: VIRTUS (Other)

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.

干预措施: VR Control (Other)

结局指标

主要结局

Explicit stigma - 1 month follow up

时间窗: 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.

次要结局

  • 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)
  • Attitudes toward individuals with schizophrenia - immediate effect(Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session))
  • Behaviors toward individuals with schizophrenia - immediate effect(Baseline (pre-intervention) and immediately post-intervention (within 30 minutes after the session))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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