跳至主要内容
临床试验/NCT07482852
NCT07482852尚未招募不适用

A Randomized Controlled Trial of a Virtual Reality Music-Movement Exergaming Intervention to Enhance Social Connectedness and Well-being in Adolescents and Young Adults

Hunan University of Traditional Chinese Medicine0 个研究点目标入组 130 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
130
主要终点
Change in depression symptoms measured by the Beck Depression Inventory-II (BDI-II)

研究概览

简要总结

This randomized controlled trial aims to evaluate the effectiveness of a virtual reality (VR) music-movement exergaming intervention for improving social connectedness and psychological well-being among young adults. Participants will be randomly assigned to one of three groups: (1) a VR social music-movement exergame group, (2) a VR solo exergame group without social interaction, and (3) a waitlist control group. The intervention integrates rhythmic movement, music-based interaction, and immersive VR environments to promote engagement and social connection. Primary outcomes include changes in depressive symptoms, anxiety, and social connectedness. Secondary outcomes include psychological need satisfaction and physical fitness indicators. Assessments will be conducted at baseline, post-intervention, and follow-up. The study will provide evidence on the potential benefits of immersive VR-based exergaming interventions for mental health and social well-being in young adults.

详细描述

This study is a randomized controlled trial designed to examine the effects of a virtual reality (VR) music-movement exergaming intervention on social connectedness and psychological well-being in young adults. Participants aged 18-25 years will be recruited and randomly assigned to one of three groups: (1) a VR social music-movement exergame group that allows interaction with peers in a shared virtual environment, (2) a VR solo exergame group with identical physical activity and music elements but without social interaction, and (3) a waitlist control group receiving a digital health handbook.

The intervention integrates rhythmic body movement, music-based interaction, and immersive VR environments to enhance engagement and psychological need satisfaction. The theoretical framework of the study is informed by Self-Determination Theory, focusing on the roles of autonomy, competence, and relatedness in promoting mental well-being.

Primary outcomes include depressive symptoms, anxiety levels, and perceived social connectedness. Secondary outcomes include psychological need satisfaction and physical fitness indicators. Outcome measures will be assessed at baseline (T0), post-intervention (T1), and one-month follow-up (T2).

The results of this trial are expected to provide evidence regarding the effectiveness of VR-based exergaming interventions for promoting mental health and social well-being in young adults.

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
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 25 years
  • Meeting criteria for mild to moderate depression (BDI-II score 14-28) or anxiety (BAI score 8-25)
  • Able to understand the study procedures and provide informed consent
  • Willing to participate in the VR intervention and complete all assessments

排除标准

  • Diagnosis of severe mental illness (e.g., psychosis or severe psychiatric disorders)
  • Severe motion sickness or intolerance to virtual reality
  • Currently receiving structured psychotherapy or psychological intervention
  • Any medical condition that would prevent safe participation in moderate physical activity

结局指标

主要结局

Change in depression symptoms measured by the Beck Depression Inventory-II (BDI-II)

时间窗: Baseline (Week 0) to Post-intervention (Week 6)

Depression symptom severity will be assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire widely used to measure depressive symptoms. The outcome measure is the change in BDI-II scores from baseline to post-intervention.

Change in anxiety symptoms measured by the Beck Anxiety Inventory (BAI)

时间窗: Baseline (Week 0) to Post-intervention (Week 6)

Anxiety symptom severity will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire designed to measure anxiety symptoms. The outcome measure is the change in BAI scores from baseline to post-intervention.

次要结局

  • Basic psychological need satisfaction measured by the Basic Psychological Need Satisfaction Scale (BPNS)(Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10))
  • Loneliness measured by the UCLA Loneliness Scale(Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10))
  • Cardiorespiratory fitness estimated using the YMCA 3-Minute Step Test(Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10))

研究者

发起方
Hunan University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guangzheng Wan

Hunan Traditional Chinese Medical College

Hunan University of Traditional Chinese Medicine

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