Virtual Reality-Based Social Musical Exergame Guided by Self-Determination Theory for Young Adults With Depression and Anxiety: Protocol for a Randomized Controlled Trial.
Depression and anxiety frequently emerge during late adolescence and young adulthood; however, many conventional and app-based interventions struggle to sustain engagement. Virtual reality (VR) exergaming, music-based activities, and social interaction each show promise for supporting young people's mental health, but their combined therapeutic value remains insufficiently tested.
This study aims to evaluate the effectiveness of a 6-week VR-based social musical exergame for reducing depressive and anxiety symptoms in young adults. The secondary objectives are to explore whether changes in basic psychological need satisfaction are associated with symptom change and to assess the effects on loneliness, presence, cardiorespiratory fitness, and in-game music-movement synchronization.
This study is a 3-arm, parallel-group randomized controlled trial. A total of 110 participants aged 18 to 25 years with mild to moderate depression or anxiety will be recruited and randomized in a 1:1:1 ratio to (1) a VR social musical exergame, (2) a matched VR solo musical exergame active control, or (3) a waitlist control receiving standardized mental health guidance. Assessments will be completed at baseline, at the postintervention assessment (week 6), and at the 1-month follow-up assessment (week 10). The primary planned comparison is the experimental group vs the active control group.
This study was approved by the ethics committee of Hunan Traditional Chinese Medical College on September 8, 2025 (YXLL202509006) and prospectively registered at ClinicalTrials.gov on March 15, 2026 (NCT07482852). Internal institutional funding had been secured. As of April 2026, the trial status was "not yet recruiting;" no participants had been enrolled, and no data analysis had been conducted. Recruitment is anticipated to begin in May 2026, with primary completion on March 1, 2028, study completion on May 1, 2028, and publication of the primary findings expected in late 2028.
This protocol describes a self-determination theory-informed, multicomponent VR intervention designed to evaluate whether adding a bundled social layer to a matched solo exergame improves short-term mental health outcomes. The trial is expected to provide initial evidence on efficacy, safety, and potential mechanisms while generating hypotheses for future dismantling and longer-term trials.
ClinicalTrials.gov NCT07482852; https://clinicaltrials.gov/ct2/show/NCT07482852.
PRR1-10.2196/83737.
This study aims to evaluate the effectiveness of a 6-week VR-based social musical exergame for reducing depressive and anxiety symptoms in young adults. The secondary objectives are to explore whether changes in basic psychological need satisfaction are associated with symptom change and to assess the effects on loneliness, presence, cardiorespiratory fitness, and in-game music-movement synchronization.
This study is a 3-arm, parallel-group randomized controlled trial. A total of 110 participants aged 18 to 25 years with mild to moderate depression or anxiety will be recruited and randomized in a 1:1:1 ratio to (1) a VR social musical exergame, (2) a matched VR solo musical exergame active control, or (3) a waitlist control receiving standardized mental health guidance. Assessments will be completed at baseline, at the postintervention assessment (week 6), and at the 1-month follow-up assessment (week 10). The primary planned comparison is the experimental group vs the active control group.
This study was approved by the ethics committee of Hunan Traditional Chinese Medical College on September 8, 2025 (YXLL202509006) and prospectively registered at ClinicalTrials.gov on March 15, 2026 (NCT07482852). Internal institutional funding had been secured. As of April 2026, the trial status was "not yet recruiting;" no participants had been enrolled, and no data analysis had been conducted. Recruitment is anticipated to begin in May 2026, with primary completion on March 1, 2028, study completion on May 1, 2028, and publication of the primary findings expected in late 2028.
This protocol describes a self-determination theory-informed, multicomponent VR intervention designed to evaluate whether adding a bundled social layer to a matched solo exergame improves short-term mental health outcomes. The trial is expected to provide initial evidence on efficacy, safety, and potential mechanisms while generating hypotheses for future dismantling and longer-term trials.
ClinicalTrials.gov NCT07482852; https://clinicaltrials.gov/ct2/show/NCT07482852.
PRR1-10.2196/83737.