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Набор скоро начнётся NCT07482852

A Randomized Controlled Trial of a VR Social Music-Movement Exergame for Depression and Anxiety in Young Adults

Без фазы С лечением Depression Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: VR social musical exergame, VR solo musical exergame, Waitlist control.
Кому может быть актуально
Состояния в реестре: Depression, Anxiety. Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое VR social musical exergame
    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.
  • Поведенческое VR solo musical 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.
  • Другое Waitlist control
    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.

Первичные конечные точки

  • Change in depression symptoms measured by the Beck Depression Inventory-II (BDI-II) [Срок оценки: Baseline (Week 0) to Post-intervention (Week 6)]
  • Change in anxiety symptoms measured by the Beck Anxiety Inventory (BAI) [Срок оценки: Baseline (Week 0) to Post-intervention (Week 6)]
Вторичные конечные точки (3)
  • Basic psychological need satisfaction measured by the Basic Psychological Need Satisfaction Scale (BPNS) [Срок оценки: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)]
  • Loneliness measured by the UCLA Loneliness Scale [Срок оценки: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)]
  • Cardiorespiratory fitness estimated using the YMCA 3-Minute Step Test [Срок оценки: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 10)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Wan G, Zhang Y, Li M. Virtual Reality-Based Social Musical Exergame Guided by Self-Determination Theory for Young Adults With Depression and Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 May 1;15:e83737. doi: 10.2196/83737. PMID 42066290

Идентификаторы

NCT: NCT07482852 · VR-SDT-RCT-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗