- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482852
A Randomized Controlled Trial of a VR Social Music-Movement Exergame for Depression and Anxiety in Young Adults (VR-MOVE)
A Randomized Controlled Trial of a Virtual Reality Music-Movement Exergaming Intervention to Enhance Social Connectedness and Well-being in Adolescents and Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: GuangZheng Wan, MS
- Phone Number: +86 19174157124
- Email: wancso@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Social Music-Movement Exergame
Participants assigned to this arm will engage in a virtual reality (VR) music-movement exergaming program that integrates rhythmic movement and social interaction in a shared virtual environment.
The intervention is designed to promote physical activity, enhance social connectedness, and improve psychological well-being.
|
Participants engage in a virtual reality (VR) social musical exergame twice per week for 6 weeks (45 minutes per session).
The game integrates rhythmic movement with music and allows participants to interact with others in a shared virtual environment.
The intervention is designed to promote physical activity, social interaction, and psychological engagement.
|
|
Experimental: VR Solo Music-Movement Exergame
Participants assigned to this arm will engage in a virtual reality (VR) music-movement exergaming program individually without social interaction.
This condition isolates the effect of the exergaming activity itself without the social component.
|
Participants engage in a VR musical exergame with the same frequency, duration, and exercise intensity as the experimental group, but without social interaction features.
The intervention focuses on individual gameplay without multiplayer interaction.
|
|
Active Comparator: Waitlist Control
Participants assigned to the control group will not receive the intervention during the study period and will be placed on a waitlist to receive the intervention after the trial is completed.
|
Participants assigned to the waitlist control group receive general mental health guidance and continue their usual activities during the 6-week study period.
After the study period, they will be offered access to the VR intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression symptoms measured by the Beck Depression Inventory-II (BDI-II)
Time Frame: 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.
|
Baseline (Week 0) to Post-intervention (Week 6)
|
|
Change in anxiety symptoms measured by the Beck Anxiety Inventory (BAI)
Time Frame: 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.
|
Baseline (Week 0) to Post-intervention (Week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Basic psychological need satisfaction measured by the Basic Psychological Need Satisfaction Scale (BPNS)
Time Frame: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
Basic psychological need satisfaction will be assessed using the Basic Psychological Need Satisfaction Scale (BPNS), which measures the extent to which participants experience autonomy, competence, and relatedness during the intervention.
|
Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
|
Loneliness measured by the UCLA Loneliness Scale
Time Frame: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
Loneliness will be assessed using the UCLA Loneliness Scale, a validated self-report instrument measuring perceived social isolation and subjective feelings of loneliness.
|
Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
|
Cardiorespiratory fitness estimated using the YMCA 3-Minute Step Test
Time Frame: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
Cardiorespiratory fitness will be estimated using the YMCA 3-Minute Step Test, a field-based assessment used to estimate cardiovascular fitness based on heart rate recovery following standardized stepping exercise.
|
Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)
|
Collaborators and Investigators
Investigators
- Principal Investigator: GuangZheng Wan, MS, Hunan University of Chinese Medicine
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR-SDT-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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