NCT05982548

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of a VR intervention on (1) stigma, (2) empathy and (3) attitudes towards those experiencing mental disorders. Participants will review a VR intervention, and complete questionnaires at pre-test, post-test and one month follow-up. Researchers will compare the VR intervention with a control VR intervention to evaluate the varying effects on stigma, empathy and attitudes towards those experiencing mental disorders.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

July 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

July 24, 2023

Last Update Submit

October 9, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Desire for Social Distance

    Desire for Social Distance Scale The eight questions are rated on a four-point Likert scale: yes, definitely (0), yes, probably (1), probably not (2) and definitely not (3) with greater scores implying greater desire for social distancing.

    pre-intervention, immediately after the intervention, follow-up at 1 month after intervention

  • Personal Stigma

    Personal Stigma Scale Personal Stigma Scale consisted of two subscales: 'Personal unpredictable/ dangerousness' and 'Personal weak not sick' The questions were calculated as 'strongly agree' (4) to 'strongly disagree' (0), with greater scores implying greater stigmatizing attitudes.

    pre-intervention, immediately after the intervention, follow-up at 1 month after intervention

  • Empathy

    Empathetic concern sub-scale of Interpersonal Reactivity Index The 7-item sub-scale is measured on a five point likert scale ranging from 'does not describe me well' (0) to 'describes me very well' (4).

    pre-intervention, immediately after the intervention, follow-up at 1 month after intervention

  • Attitudes towards those experiencing mental disorders

    modified Attitudes Towards People with Schizophrenia scale The 7-item scale is measured on a nine point likert scale ranging from (1) to (9). Greater scores equate better attitude towards people with schizophrenia.

    pre-intervention, immediately after the intervention, follow-up at 1 month after intervention

Secondary Outcomes (3)

  • Demographic data

    pre-intervention

  • Acceptability of the intervention

    immediately after the intervention

  • Safety of VR intervention

    immediately after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The VR intervention was created using the Unreal Engine software (Unreal Engine, 2022). The VR intervention includes the scenario of a home. Participants will view the home as a first person character and experience psychotic phenomena including auditory hallucinations. The intervention will be delivered in one setting and lasts no more than seven minutes. It will be disseminated using smartphone inserted into VR headset equivalent of google cardboard.

Other: VR intervention

VR control group

ACTIVE COMPARATOR

The VR control group will view the scenario of the same home without the simulated visual and auditory hallucinations.

Other: VR control intervention

Interventions

VR intervention of no more than 7 minutes Participants viewed the home as a first person character and experience psychotic phenomena including auditory hallucinations.

Intervention group

VR intervention of no more than 7 minutes Participants viewed the same home as a first person character without psychotic phenomena

VR control group

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who are aged at least 21 years old
  • Employed by the Institute of Mental Health as a physician, allied health professional or nurse.
  • understands English
  • work directly with patients.

You may not qualify if:

  • unable to use virtual reality interventions due to reasons including motion sickness, disorientation, nausea and vomiting.
  • history of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Mental Health

Singapore, 539747, Singapore

RECRUITING

Related Publications (1)

  • Tay JL, Qu Y, Lim L, Puthran R, Tan CLR, Rajendran R, Wei KC, Xie H, Sim K. Impact of a Virtual Reality Intervention on Stigma, Empathy, and Attitudes Toward Patients With Psychotic Disorders Among Mental Health Care Professionals: Randomized Controlled Trial. JMIR Ment Health. 2025 Jan 21;12:e66925. doi: 10.2196/66925.

MeSH Terms

Conditions

Mental Disorders

Study Design

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

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 8, 2023

Study Start

August 1, 2023

Primary Completion

July 17, 2024

Study Completion

July 17, 2024

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations