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
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
Approved 24/09/2019, 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), Applying Cluster: NTEC, IRB/ REC Reference No. : 2019.254, Submission Reference No.: NTEC-2019-0250
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
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
- ISRCTN12882676_PROTOCOL_V1.1_13Aug19.pdf Uploaded 18/02/2020
- ISRCTN12882676_PROTOCOL_V2.0_07May20.pdf Uploaded 03/07/2020