Social Anxiety Disorder (SAD)NCT06876779
Virtual Reality Based Cognitive Behavioral Therapy for Social Anxiety Among Youths in Hong Kong
A study testing VR intervention in people with Social Anxiety Disorder (SAD) and Social Phobia, run by Hong Kong Shue Yan University.
Trial summary
This randomized controlled trial evaluates the effectiveness of a VR-based CBT intervention for social anxiety-driven depression among Hong Kong youth (ages 15-24). Given the limitations of traditional CBT in addressing deep-seated fears, this study explores a more engaging and scalable alternative. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder (SAD), Social Phobia
- What is being tested?
- VR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- youths aged between 15 and 24 years old; and
- scoring above 24 on the Social Phobia Inventory.
Who cannot join
- unable to attempt a baseline assessment (e.g., due to being unpermitted to leave a psychiatric ward);
- photosensitive epilepsy;
- significant visual, auditory, or balance impairment;
- currently receiving another intensive psychological intervention; and
- currently holding active suicidal plans
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Virtual Reality Based Cognitive Behavioral Therapy for Social Anxiety-Driven Depression Among Youths: A Randomized Controlled Trial
This randomized controlled trial evaluates the effectiveness of a VR-based CBT intervention for social anxiety-driven depression among Hong Kong youth (ages 15-24). Given the limitations of traditional CBT in addressing deep-seated fears, this study explores a more engaging and scalable alternative. Ninety participants with depressive symptoms and social difficulties will undergo six 60-minute VR sessions based on Clark and Wells' cognitive model of social phobia, with assessments at baseline, post-treatment, and three-month follow-up using the Social Phobia Inventory and PHQ-9. The study investigates whether VR intervention reduces social anxiety-driven depression and assesses its cost-effectiveness. Expected outcomes include symptom reduction, sustained benefits at follow-up, and evidence for VR as an innovative, scalable mental health intervention, informing clinical practice, research, and policy in Hong Kong and beyond.
Read the detailed description
Background: Youth depression in Hong Kong is a growing concern, with a significant number of secondary school and college students exhibiting depressive symptoms. Social anxiety-driven depression, particularly prevalent in this demographic, poses a complex clinical challenge. Current interventions such as cognitive behavioral therapy (CBT), while promising, have limitations in addressing deep-seated fears that hinder engagement in crucial behavioral experiments, and may not fully cater to youth-specific needs.
Method: This study employs a randomized controlled trial design to evaluate the effectiveness of a virtual reality (VR) based CBT intervention in treating social anxiety-driven depression among Hong Kong youths. 90 participants aged 15-24 years, displaying clinical symptoms of depression with self-reported difficulties in social events, will be enrolled. The intervention protocol, grounded in Clark and Wells' cognitive model of social phobia, includes six 60-minute VR sessions simulating various social scenarios. Measurements will be taken at a baseline, post-treatment, and three-month follow-up using tools such as the Social Phobia Inventory and Patient Health Questionnaire-9.
Research Questions: The study primarily investigates whether VR intervention leads to a significant reduction in social anxiety-driven depression post-treatment and follow-ups, as well as the cost analysis of the VR intervention in managing such depression.
Expected Outcomes and Implications: The study anticipates that VR intervention will effectively reduce depression and social anxiety symptoms among participants, with sustained benefits at the three-month follow-up. It is also expected to offer a cost-effective, scalable, and engaging alternative to traditional therapies, addressing a critical gap in youth depression. The findings could have significant implications for academia, practice, providing evidence for the adoption of innovative technology in mental health interventions, and informing future research and policy decisions regarding mental health care for youths in Hong Kong and beyond.
- Conditions
- Social Anxiety Disorder (SAD), Social Phobia
- Being tested
- VR intervention
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR interventionBehavioural
The intervention comprises six sessions of 60 minutes each. There are six VR scenarios such as a café, MTR, school scene, and classroom. The difficulty levels of these scenarios are determined by several factors: (1) the density and proximity of individuals present, as observed in a café or MTR setting, (2) the presence of familiar individuals, such as acquaintances or classmates who may be encountered and greeted in a school environment, and (3) the level of interaction required, such as engaging in a group discussion within a classroom. Participants have the flexibility to choose a different scenario for each session or repeat a previously selected one.
| Study group | Role | What they receive |
|---|---|---|
| VR arm | Experimental | The intervention comprises six sessions of 60 minutes each. There are six VR scenarios such as a café, MTR, school scene, and classroom. The difficulty levels of these scenarios are determined by several factors: (1) the density and proximity of individuals present, as observed in a café or MTR setting, (2) the presence of familiar individuals, such as acquaintances or classmates who may be encountered and greeted in a school environment, and (3) the level of interaction required, such as engaging in a group discussion within a classroom. Participants have the flexibility to choose a different scenario for each session or repeat a previously selected one. Receives: Behavioral: VR intervention |
| Treat-as-usual | No intervention | Participants in the control group will withhold access to the intervention until after the 3-month follow-up assessment. To prevent confounding effects from relevant concomitant care and interventions, participants will be required to refrain from receiving any other treatments or interventions specifically targeting social phobia during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Phobia Inventory (SPIN)
SPIN is a brief self-report tool consisting of 17 items that assess fear, avoidance, and physiological discomfort in social situations. The scale ranges from 0 to 68, with higher scores indicating worse outcomes.
Measured: baseline, one-month (post-treatment), and three-month follow-up
Secondary outcomes (1)
Patient Health Questionnaire-9
The Patient Health Questionnaire-9 (PHQ-9) is widely used to screen for the presence and severity of depression, monitor the severity of depression over time, and assist with the diagnosis of depression. The scale ranges from 0 to 27, with higher scores indicating worse outcomes, reflecting greater severity of depression.
Measured: baseline, one-month (post-treatment), and three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Shue Yan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Yizhou, Hong Kong Shue Yan University
- Investigators
- Yizhou WANG, Assistant Professor, PhD, Principal investigator, HKSYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876779
- Sponsor's protocol ID
- SATECH
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to ensure participant confidentiality and data security.
Publications
Freeman D, Lister R, Waite F, Galal U, Yu LM, Lambe S, Beckley A, Bold E, Jenner L, Diamond R, Kirkham M, Twivy E, Causier C, Carr L, Saidel S, Day R, Beacco A, Rovira A, Ivins A, Nah R, Slater M, Clark DM, Rosebrock L. Automated virtual reality cognitive therapy versus virtual reality mental relaxation therapy for the treatment of persistent persecutory delusions in patients with psychosis (THRIVE): a parallel-group, single-blind, randomised controlled trial in England with mediation analyses. Lancet Psychiatry. 2023 Nov;10(11):836-847. doi: 10.1016/S2215-0366(23)00257-2. Epub 2023 Sep 21.
PubMed 37742702Wang YZ, Hue MT, Lau KW, Zhou H, Ng SM, Weng X. Therapist-Facilitated Virtual Reality Intervention for Social Anxiety Among Youth: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 11;15:e86937. doi: 10.2196/86937.
PubMed 42579885
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Based Cognitive Behavioral Therapy for Social Anxiety-Driven Depression Among Youths: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06876779
- Acronym / sponsor ID
- SATECH
- Conditions
- Social Anxiety Disorder (SAD), Social Phobia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hong Kong Shue Yan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluates the effectiveness of a VR-based CBT intervention for social anxiety-driven depression among Hong Kong youth (ages 15-24). Given the limitations of traditional CBT in addressing deep-seated fears, this study explores a more engaging and scalable alternative. Ninety participants with depressive symptoms and social difficulties will undergo six 60-minute VR sessions based on Clark and Wells' cognitive model of social phobia, with assessments at baseline, post-treatment, and three-month follow-up using the Social Phobia Inventory and PHQ-9. The study investigates whether VR intervention reduces social anxiety-driven depression and assesses its cost-effectiveness. Expected outcomes include symptom reduction, sustained benefits at follow-up, and evidence for VR as an innovative, scalable mental health intervention, informing clinical practice, research, and policy in Hong Kong and beyond.
Detailed description
Background: Youth depression in Hong Kong is a growing concern, with a significant number of secondary school and college students exhibiting depressive symptoms. Social anxiety-driven depression, particularly prevalent in this demographic, poses a complex clinical challenge. Current interventions such as cognitive behavioral therapy (CBT), while promising, have limitations in addressing deep-seated fears that hinder engagement in crucial behavioral experiments, and may not fully cater to youth-specific needs.
Method: This study employs a randomized controlled trial design to evaluate the effectiveness of a virtual reality (VR) based CBT intervention in treating social anxiety-driven depression among Hong Kong youths. 90 participants aged 15-24 years, displaying clinical symptoms of depression with self-reported difficulties in social events, will be enrolled. The intervention protocol, grounded in Clark and Wells' cognitive model of social phobia, includes six 60-minute VR sessions simulating various social scenarios. Measurements will be taken at a baseline, post-treatment, and three-month follow-up using tools such as the Social Phobia Inventory and Patient Health Questionnaire-9.
Research Questions: The study primarily investigates whether VR intervention leads to a significant reduction in social anxiety-driven depression post-treatment and follow-ups, as well as the cost analysis of the VR intervention in managing such depression.
Expected Outcomes and Implications: The study anticipates that VR intervention will effectively reduce depression and social anxiety symptoms among participants, with sustained benefits at the three-month follow-up. It is also expected to offer a cost-effective, scalable, and engaging alternative to traditional therapies, addressing a critical gap in youth depression. The findings could have significant implications for academia, practice, providing evidence for the adoption of innovative technology in mental health interventions, and informing future research and policy decisions regarding mental health care for youths in Hong Kong and beyond.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR arm | Experimental | Behavioral: VR interventionThe intervention comprises six sessions of 60 minutes each. There are six VR scenarios such as a café, MTR, school scene, and classroom. The difficulty levels of these scenarios are determined by several factors: (1) the density and proximity of individuals present, as observed in a café or MTR setting, (2) the presence of familiar individuals, such as acquaintances or classmates who may be encountered and greeted in a school environment, and (3) the level of interaction required, such as engaging in a group discussion within a classroom. Participants have the flexibility to choose a different scenario for each session or repeat a previously selected one. |
| Treat-as-usual | No intervention | –Participants in the control group will withhold access to the intervention until after the 3-month follow-up assessment. To prevent confounding effects from relevant concomitant care and interventions, participants will be required to refrain from receiving any other treatments or interventions specifically targeting social phobia during the study period. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- youths aged between 15 and 24 years old; and
- scoring above 24 on the Social Phobia Inventory.
Key exclusion criteria (5 listed)
- unable to attempt a baseline assessment (e.g., due to being unpermitted to leave a psychiatric ward);
- photosensitive epilepsy;
- significant visual, auditory, or balance impairment;
- currently receiving another intensive psychological intervention; and
- currently holding active suicidal plans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR interventionThe intervention comprises six sessions of 60 minutes each. There are six VR scenarios such as a café, MTR, school scene, and classroom. The difficulty levels of these scenarios are determined by several factors: (1) the density and proximity of individuals present, as observed in a café or MTR setting, (2) the presence of familiar individuals, such as acquaintances or classmates who may be encountered and greeted in a school environment, and (3) the level of interaction required, such as engaging in a group discussion within a classroom. Participants have the flexibility to choose a different scenario for each session or repeat a previously selected one. | Behavioural | VR arm |
Primary outcome
Social Phobia Inventory (SPIN)
Time frame: baseline, one-month (post-treatment), and three-month follow-up
SPIN is a brief self-report tool consisting of 17 items that assess fear, avoidance, and physiological discomfort in social situations. The scale ranges from 0 to 68, with higher scores indicating worse outcomes.
1 secondary outcome
Patient Health Questionnaire-9
Time frame: baseline, one-month (post-treatment), and three-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 37742702Freeman D, Lister R, Waite F, Galal U, Yu LM, Lambe S, Beckley A, Bold E, Jenner L, Diamond R, Kirkham M, Twivy E, Causier C, Carr L, Saidel S, Day R, Beacco A, Rovira A, Ivins A, Nah R, Slater M, Clark DM, Rosebrock L. Automated virtual reality cognitive therapy versus virtual reality mental relaxation therapy for the treatment of persistent persecutory delusions in patients with psychosis (THRIVE): a parallel-group, single-blind, randomised controlled trial in England with mediation analyses. Lancet Psychiatry. 2023 Nov;10(11):836-847. doi: 10.1016/S2215-0366(23)00257-2. Epub 2023 Sep 21.
- Derived from this study: PubMed 42579885Wang YZ, Hue MT, Lau KW, Zhou H, Ng SM, Weng X. Therapist-Facilitated Virtual Reality Intervention for Social Anxiety Among Youth: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 11;15:e86937. doi: 10.2196/86937.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to ensure participant confidentiality and data security.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yizhou WANG, Assistant Professor, PhD principal investigator
HKSYU
Questions about this trial
What is this clinical trial studying?
A study testing VR intervention in people with Social Anxiety Disorder (SAD) and Social Phobia, run by Hong Kong Shue Yan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhou WANG, Assistant Professor (852+66761756, ywang@hksyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Phobia Inventory (SPIN) (time frame: baseline, one-month (post-treatment), and three-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06876779, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.