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临床试验/NCT06876779
NCT06876779尚未招募不适用

Virtual Reality Based Cognitive Behavioral Therapy for Social Anxiety-Driven Depression Among Youths: A Randomized Controlled Trial

Hong Kong Shue Yan University0 个研究点目标入组 90 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Social Phobia Inventory (SPIN)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: VR intervention (Behavioral)

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.

结局指标

主要结局

Social Phobia Inventory (SPIN)

时间窗: 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.

次要结局

  • Patient Health Questionnaire-9(baseline, one-month (post-treatment), and three-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Yizhou

Assistant Professor

Hong Kong Shue Yan University

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