NCT07482852

Brief Summary

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.

Trial Health

65
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Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
23mo left

Started Apr 2026

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 Progress7%
Apr 2026May 2028

First Submitted

Initial submission to the registry

March 15, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

March 15, 2026

Last Update Submit

March 15, 2026

Conditions

Keywords

Virtual RealityExergamingSocial ConnectednessMusic-based Intervention

Outcome Measures

Primary Outcomes (2)

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

    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)

    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 Outcomes (3)

  • 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)

Study Arms (3)

VR Social Music-Movement Exergame

EXPERIMENTAL

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.

Behavioral: VR social musical exergame

VR Solo Music-Movement Exergame

EXPERIMENTAL

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.

Behavioral: VR solo musical exergame

Waitlist Control

ACTIVE COMPARATOR

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.

Other: Waitlist control

Interventions

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.

VR Social Music-Movement Exergame

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.

VR Solo Music-Movement Exergame

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.

Waitlist Control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • GuangZheng Wan, MS

    Hunan University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GuangZheng Wan, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to three parallel groups: a VR social music-movement exergame group, a VR solo exergame group, and a waitlist control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hunan Traditional Chinese Medical College

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 19, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03