Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00638

2 Trial Registration Date

2018-12-04

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

The production of the virtual reality is funded by the Jockey Club Charities Trust

5 Primary Sponsor

Deparment of Psychology, The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Sin Yan YUEN

ii Address

Rm 326C, Sino Building,
Department of Psychology,
The Chinese University of Hong Kong,
Shatin, N.T., Hong Kong

iii Phone

+85260679963

iv Email

1155077604@link.cuhk.edu.hk

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Sin Yan YUEN

ii Address

Flat 3005, Hoi Lam Hse, Hoi Fu Crt, Mongkok, KLN

iii Phone

+85260679963

iv Email

1155077604@link.cuhk.edu.hk

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The Effects of Immersive Virtual Reality on Psychiatric Stigma Change: Randomized Controlled Trial

10 Public Title

The Effects of Immersive Virtual Reality on Psychiatric Stigma Change: Randomized Controlled Trial

i Public Title in Chinese 研究名稱

沉浸式虛擬實境對態度及行為的影響: 隨機對照試驗

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-11-28

iii Full Name of IRB/IEC

Other

Please specify

Survey and Behavioural Research Ethics Committee (SBREC), The Chinese University of Hong Kong

iv IRB/IEC approval reference number

SBRE-18-078

14 Medical Condition Being Studied

Mental health stigma

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Immersive Virtual Reality (IVR) Condition
In the IVR condition, participants will experience as the story's protagonist who has lived experience of depression and anxiety while seated and being immersed into the virtual world.

iii Dosage form of the intervention

Immersive virtual reality

iv Dosage of the intervention

NA

v Duration of the intervention

15 minutes

vi Frequency of the intervention

1

16 Comparative Treatments

i Description/ name of comparative treatments

There are two control conditions:
1) Audio narrative condition
In the audio narrative condition, participants will listen and read the identical story from the IVR condition. While reading the story, participants will wear the IVR headset without being immersed into the virtual world.

2) VR universe control condition
In the VR universe control condition, participants will listen to a narration for various planets of the universe and view the universe with IVR headset.

ii Dosage form of the comparative treatments

Audio narrative; VR universe control

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

15 minutes

v Frequency of the comparative treatments

1

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Fluent in Cantonese

Fluent in Chinese Writing

Each participant can only participate once

ii Exclusion Criteria

NA

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Participants will be randomly assigned into 3 conditions

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-12-20

21 Target Sample Size

150

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

Public mental health stigma

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

immediate & a week later

24 Secondary Outcome

i The Name of the outcome

Sense of embodiment

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

Immediate

Secondary Outcome

i The Name of the outcome

Transportation of the story content

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

Immediate

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-12-06

27 Primary Registry and Trial Identifying Number

ChiCTR1900021026

28 Date of Registration in Primary Registry

2018-12-20

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Trial History Detail on 2020-04-13