NCT05393596

Brief Summary

The purpose of the research is to contribute to the reduction of stigma among university students among people with serious psychiatric illnesses and to improve future educational processes focused on the social inclusion of people with these mental health problems. For this purpose, the methodology proposed is a mixed (qualitative and quantitative), with an experimental design. Students of the Universidad del Desarrollo will be contacted and invited to participate voluntarily, after signing an informed consent of the research. This procedure will consist of the use of a virtual reality software in the university premises, together with the application of a survey with scales validated in Chile before and after the intervention, in addition to a semi-structured interview about the experience in the use of the software, together with the identification of strengths and opportunities for improvement of the intervention. The total estimated duration of the procedure is approximately 35 minutes. It is expected to determine the level of stigma towards mental illness before and after the development of the virtual reality intervention, in addition to describing the perception of the students' experience after participating in the intervention (including an analysis of strengths and opportunities for improvement). The general objective of the present research is to evaluate the effect of a virtual reality intervention on levels of stigma towards people with mental illness in university students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

May 18, 2022

Last Update Submit

December 4, 2022

Conditions

Keywords

StigmaVirtual RealityRandomized Control Trial

Outcome Measures

Primary Outcomes (2)

  • Changes in stigma levels pre- and post-intervention.

    Stigma levels will be evaluated in the experimental and control groups, pre- intervention and immediately after the intervention of the Virtual Reality Software, through the measurement of the following scale validated in Spanish: a) Attribution Questionnaire AQ-27

    Pre intervention and immediately post intervention

  • Changes in stigma levels pre- and post-intervention.

    Stigma levels will be evaluated in the experimental and control groups, pre- intervention and immediately after the intervention of the Virtual Reality Software, through the measurement of the following scale validated in Spanish: b) Questionnaire on Student Attitudes toward Schizophrenia.

    Pre intervention and immediately post intervention.

Secondary Outcomes (1)

  • Qualitative perception of the experience, strengths and opportunities to improve the software, after participating in the Virtual Reality Experimental group intervention (Inclúyete VR).

    Immediately post intervention

Study Arms (2)

Experimental Group (Incluyete VR Software)

EXPERIMENTAL

Through virtual reality headsets, the software Inclúyete VR will be used, in which situations related to stigma in Severe Mental Disorder are recreated. Specifically, its purpose is to put the participant in a virtual world that shows how the stigma towards people with severe mental health problems is and also to experience situations of rehabilitation and social inclusion, thus giving a more real and closer image of what can be the current treatment in mental health. The approximate duration is 15 minutes.

Behavioral: Virtual Reality Software Intervention

Control Group (Welcome Oculus Software)

ACTIVE COMPARATOR

Participants will use the default virtual reality headset welcome game, unrelated to mental health. It presents an interactive virtual environment, with various playful interfaces and instructions for use. The duration is approximately 15 minutes.

Behavioral: Virtual Reality Software Intervention

Interventions

Virtual Reality Software Intervention

Control Group (Welcome Oculus Software)Experimental Group (Incluyete VR Software)

Eligibility Criteria

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

You may qualify if:

  • Age over 18 years
  • Being an undergraduate or postgraduate student at Universidad del Desarrollo

You may not qualify if:

  • \- Participants who have not signed the full or abbreviated informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad del Desarrollo

Santiago, Chile

Location

Related Publications (5)

  • Rodriguez-Rivas ME, Cangas AJ, Fuentes-Olavarria D. Controlled Study of the Impact of a Virtual Program to Reduce Stigma Among University Students Toward People With Mental Disorders. Front Psychiatry. 2021 Feb 9;12:632252. doi: 10.3389/fpsyt.2021.632252. eCollection 2021.

    PMID: 33633613BACKGROUND
  • Yuen ASY, Mak WWS. The Effects of Immersive Virtual Reality in Reducing Public Stigma of Mental Illness in the University Population of Hong Kong: Randomized Controlled Trial. J Med Internet Res. 2021 Jul 14;23(7):e23683. doi: 10.2196/23683.

    PMID: 34259636BACKGROUND
  • Cangas AJ, Galván B. Estudio preliminar de la utilidad de un programa de realidad virtual contra el estigma en salud mental. Rev INFAD Psicol Int J Dev Educ Psychol. 2020;1(1):45-52. doi:10.17060/ijodaep.2020.n1.v1.1760

    BACKGROUND
  • Rodriguez-Rivas ME, Cangas AJ, Cariola LA, Varela JJ, Valdebenito S. Innovative Technology-Based Interventions to Reduce Stigma Toward People With Mental Illness: Systematic Review and Meta-analysis. JMIR Serious Games. 2022 May 30;10(2):e35099. doi: 10.2196/35099.

    PMID: 35635744BACKGROUND
  • Rodriguez-Rivas ME, Cangas AJ, Martin A, Romo J, Perez JC, Valdebenito S, Cariola L, Onetto J, Hernandez B, Ceric F, Cea P, Corrigan P. Reducing Stigma Toward People with Serious Mental Illness Through a Virtual Reality Intervention: A Randomized Controlled Trial. Games Health J. 2024 Feb;13(1):57-64. doi: 10.1089/g4h.2023.0118. Epub 2023 Sep 11.

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Matías E. Rodríguez-Rivas

    Universidad del Desarrollo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 26, 2022

Study Start

June 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations