Condition category
Mental and Behavioural Disorders
Date applied
29/08/2019
Date assigned
13/09/2019
Last edited
06/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
By putting on a headset, participants can enter a three-dimensional Virtual Reality (VR) computer-generated simulation of the world. VR is often used to play computer games. The researchers wish to learn about the effects of their new VR programme on social avoidance. Participants will be guided by an avatar within the VR to go through a series of graded tasks in different environments that reflect everyday situations (e.g., cafe, bus, street, doctor’s waiting room).

Who can participate?
Individuals who are 18 or above who find themselves anxious about social situations. As the intervention will be conducted in Cantonese, the participants will need to be able to understand Cantonese.

What does the study involve?
If participants are happy to take part in the study, they will sign a consent form. If they consent to take part, they will be randomly allocated to one of two groups: the VR treatment group or the control group. If they are in the treatment group they will attend around 6 sessions of VR. Each session will take about 30 minutes. Two sessions may be run consecutively. They will be asked to complete questionnaires about social avoidance at the beginning, immediately after, and one month after the programme. At the beginning and at the end of each VR session, participants will be asked to fill out some assessments to help keep track of their progress. For the control group, they will be asked to complete a set of questionnaires about social avoidance three times: once at the beginning, once after 3-5 weeks (i.e. post-assessment), and finally 4 weeks after the post-assessment. They will be offered the opportunity to receive the virtual reality treatment after the study has ended. This means everyone can receive the VR treatment if they take part.

What are the possible benefits and risks of participating?
It is possible participants may feel less anxious after the programme. The researchers hope to learn more about these aspects of VR on social avoidance from this study. There are very minimal risks in participating in this study. Some people, with some VR programmes/games, can occasionally experience motion sickness, similar to travel sickness. The researchers recommend people to stop using the VR if they start to feel sick. The way they have designed the VR programme reduces the likelihood that anyone will experience motion sickness. It is also the case that participants may feel anxious when experiencing social situations in VR. This is part of the programme, allowing them to learn that they will be okay. The headset is cleaned after a person uses it.

Where is the study run from?
The CUHK Medical Clinic (Hong Kong)

When is the study starting and how long is it expected to run for?
February 2019 to December 2020

Who is funding the study?
AXA China Region Insurance Company Limited

Who is the main contact?
1. Prof. Winnie Wing Sze Mak
wwsmak@cuhk.edu.hk
2. Dr Amy Chan
atychan@cuhk.edu.hk

Trial website

https://www.axa.com.hk/en/oxford-vr

Contact information

Type

Public

Primary contact

Dr Tsz Ying Amy Chan

ORCID ID

http://orcid.org/0000-0002-5816-1451

Contact details

Rm 326C
3rd Floor
Sino Building
Department of Psychology
Chinese University of Hong Kong
Shatin
NT
Hong Kong
999077
Hong Kong
+852 (0)91569727
atychan@cuhk.edu.hk

Type

Scientific

Additional contact

Prof Winnie Wing Sze Mak

ORCID ID

http://orcid.org/0000-0002-9714-7847

Contact details

Rm 354
3rd Floor
Sino Building
Department of Psychology
Chinese University of Hong Kong
Shatin
NT
Hong Kong
999077
Hong Kong
+852 (0)39436577
wwsmak@cuhk.edu.hk

Type

Scientific

Additional contact

Prof Daniel Freeman

ORCID ID

http://orcid.org/0000-0002-2541-2197

Contact details

Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
+44 (0)1865 613109
daniel.freeman@psych.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NTEC-2019-0250

Study information

Scientific title

Using Virtual Reality (VR) to reduce social avoidance: a pilot and a randomized controlled trial of a virtual reality cognitive behavioral therapy based program for social avoidance

Acronym

VR Social Avoidance

Study hypothesis

Compared with usual care (i.e. waitlist control), the VR intervention group will experience a significant reduction in social avoidance symptoms after treatment and this benefit will persist until the 4-week follow-up.

Ethics approval

Approval pending, The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC) (8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong; Tel: +852 (0)3505 3935; Email: crec@cuhk.edu.hk)

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

https://www.axa.com.hk/en/oxford-vr. More detailed participant information sheet can be requested by contacting the applicant.

Condition

Social avoidance

Intervention

Randomization method is block-randomization.

The current VR intervention will be designed to help people feel safer and more confident in social situations. Participants will be guided by a virtual coach through a series of graded tasks in different environments that reflect everyday situations (e.g., café, bus, street, doctor’s waiting room) for people who might avoid social situations. By testing beliefs that inhibit confidence in a safe and controlled environment, participants will complete tasks with increasing difficulty and learn that they can cope in situations that they previously avoid. This program is intended for use by adults who are 18 or above.

Control group will be a wait-list control. After submitting the 1-month follow-up survey, the control group will be eligible to receive the same VR intervention as the intervention group.

There will be a total of 4 visits to the study venue. Participants will be asked to complete a baseline questionnaire before they get randomized to either intervention or control group. For the intervention group, they will visit the study venue 3 more times to receive the VR treatment. The last visit will also end with the completion of the post-survey. Participants will be notified to complete the online one-month follow-up survey on their own. The entire intervention should take about 1 month, followed by 1-month follow-up survey.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Social avoidance measured at baseline, post-intervention and 1-month follow-up using:
1. Mobility Inventory for Agoraphobia
2. Liebowitz Social Anxiety Scale (LSAS)
3. Social Interaction Anxiety Scale (SIAS)
4. Oxford Behavioural Avoidance Task (OBAT)

Secondary outcome measures

Measured at baseline, post-intervention and 1-month follow-up:
1. Depression-related symptoms assessed using Patient Health Questionnaire (PHQ-9)
2. Anxiety-related symptoms assessed using Generalized Anxiety Disorder Assessment (GAD-7)
3. Work and social adjustment assessed using Work and Social Adjustment Scale (WSAS)

Overall trial start date

01/02/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18 or above
2. Can read traditional Chinese and understand Cantonese
3. Self report on experiencing social avoidance symptoms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Pilot: 50; RCT: 208

Participant exclusion criteria

1. People who are currently receiving psychological intervention for social avoidance
2. People who have participated in the pilot study of this project
3. History of photosensitive epilepsy
4. Impairment of stereoscopic vision
5. Balance problems

Recruitment start date

17/06/2019

Recruitment end date

01/11/2020

Locations

Countries of recruitment

Hong Kong

Trial participating centre

The CUHK Medical Clinic
5/F, Podium Plaza 5 Hanoi Road Tsim Sha Tsui Kowloon
Hong Kong
999077
Hong Kong

Sponsor information

Organisation

AXA China Region Insurance Company Limited

Sponsor details

20/F Vertical Sq
28 Heung Yip Road
Wong Chuk Hang
Hong Kong
999077
Hong Kong
+852 (0)37022309
yimien.koh@axa.com.hk

Sponsor type

Industry

Website

https://www.axa.com.hk/en

Funders

Funder type

Industry

Funder name

AXA China Region Insurance Company Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Identify topic relevant peer-reviewed journal for publication

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Winnie Wing Sze Mak (wwsmak@cuhk.edu.hk ). The data will be in CSV format and will become available after the data collection and analysis. All personally identifiable information will be removed from the dataset prior to any kind of sharing. data sharing will require permission from all collaborating parties.

Intention to publish date

31/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes