NCT06876779

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

February 14, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 15, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

February 14, 2025

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, one-month (post-treatment), and three-month follow-up

Secondary Outcomes (1)

  • Patient Health Questionnaire-9

    baseline, one-month (post-treatment), and three-month follow-up

Study Arms (2)

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.

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.

Interventions

VR interventionBEHAVIORAL

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.

VR arm

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • youths aged between 15 and 24 years old; and
  • scoring above 24 on the Social Phobia Inventory.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37742702BACKGROUND

Related Links

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Yizhou WANG, Assistant Professor, PhD

    HKSYU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhou WANG, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 14, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared to ensure participant confidentiality and data security.

Available IPD Datasets

Study Protocol Access