- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06876779
Virtual Reality Based Cognitive Behavioral Therapy for Social Anxiety Among Youths in Hong Kong
Virtual Reality Based Cognitive Behavioral Therapy for Social Anxiety-Driven Depression Among Youths: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yizhou WANG, Assistant Professor
- Phone Number: 852+66761756
- Email: ywang@hksyu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- youths aged between 15 and 24 years old; and
- scoring above 24 on the Social Phobia Inventory.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR arm
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.
|
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.
|
|
No Intervention: Treat-as-usual
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, one-month (post-treatment), and three-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9
Time Frame: baseline, one-month (post-treatment), and three-month follow-up
|
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.
|
baseline, one-month (post-treatment), and three-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yizhou WANG, Assistant Professor, PhD, HKSYU
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SATECH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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