E-Emotio Project A Gamified Preventive School-based Paradigm Using Virtual Reality Technologies for Improving Emotional Regulation in Children and Adolescents.

Обзор

Introduction and Significance: Preventive interventions have been shown to reduce the risk of developing anxiety and depression, making them a critical focus area in mental health promotion for children and adolescents. Enhancing emotion regulation (ER) skills in young people is one approach to preventing anxiety and depression, as ER involves cognitive processes of modifying thoughts and behaviors to manage emotional responses in different contexts. Executive functions (EF), such as cognitive flexibility, working memory, and inhibition, play a crucial role in ER development and regulation in children and adolescents. Recently, immersive virtual reality (IVR) has emerged as a novel tool for improving cognitive training interventions' accessibility and effectiveness. IVR allows users to experience immersive, three-dimensional environments, where they can interact with objects and events in a highly engaging and realistic way. Considering these developments, this study aims to explore the potential benefits of Enhance VR, a gamified IVR program designed to improve ER skills and reduce anxiety and depressive symptoms among children and adolescents. Methodology: The study will be a longitudinal, parallel, single-blind, randomized controlled pilot trial involving 80 Spanish - or English-speaking participants aged 10 to 16 years old. Participants will be excluded if they have severe psychiatric or neurodevelopmental disorders, physical, motor, or sensory impairments, or a risk of experiencing high cybersickness symptomatology during the VR experience. Participants will be randomly allocated into two groups: an experimental group receiving E-Emotio VR and a control group receiving a placebo-based VR relaxation experience. Both VR interventions will last five weeks, two times a week, for 30 minutes. The experimental group will engage in six games targeting cognitive flexibility, planning, reappraisal strategies, working memory, divided and sustained attention, and processing speed. The control group will be immersed in ten different nature-based VR environments and perform relaxation exercises. Baseline and post-intervention assessments will be conducted using age-adapted validated measures of depressive and anxiety symptoms, ER, executive function (working memory, cognitive flexibility, inhibition, and planning), and attention. Following the intervention, the assessment battery will be re-administered by a blinded assessor, and statistical analyses will be conducted for all the primary and secondary measures assessed before and after the intervention in both groups. Conclusion: In summary, this study aims to contribute to the development of effective preventive interventions for emotion regulation and mental health symptoms in children and adolescents by promoting ER through gamified VR cognitive training. The study's findings could have significant implications for mental health research, educational and clinical practice. By exploring the potential benefits of VR cognitive training, this research has the potential to inform future studies and clinical interventions aimed at improving young people's mental health and well-being. The gamification of cognitive training interventions could be a powerful tool for increasing engagement and motivation among young people, making them more likely to participate in such interventions.

Вмешательства

• Поведенческое VR cognitive training
  The VR cognitive training group will engage in a subset of six games designed to target specific cognitive functions one game will target cognitive flexibility, requiring participants to switch between different tasks and problem-solving strategies quickly. Another game will focus on planning, asking participants to make a series of decisions to achieve a particular goal. Additionally, the Enhance VR group will also engage in games that target reappraisal strategies, working memory, divided and
• Поведенческое VR nature exposure relaxation
  The control group will be immersed in ten different nature-based VR environments (e.g., forests, lakes, beaches, etc.), where they will tailor its content and perform relaxation exercises (deep breathing techniques).

Первичные конечные точки

• Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) [Срок оценки: At baseline and after 5 weeks.]
• Revised Child Anxiety and Depression Scale (RCADS-47) [Срок оценки: At baseline]
• State-Trait Anxiety Inventory for Children (STAI-C) [Срок оценки: At baseline and after 5 weeks.]
• Children's Depression Inventory (CDI) [Срок оценки: At baseline and after 5 weeks.]
• Positive and Negative Affect Schedule (PANAS) [Срок оценки: At baseline and after 5 weeks.]

Вторичные конечные точки (11)

• General Self-Efficacy Scale (GSE) [Срок оценки: At baseline and after 5 weeks.]
• Ruminative Response Scale (RRS-SF) [Срок оценки: At baseline and after 5 weeks.]
• Child's Report of Parental Behavior Inventory Abbreviated (CRPBI-A) [Срок оценки: At baseline and after 5 weeks.]
• Behavior Rating Inventory of Executive Function 2 (BRIEF-2) [Срок оценки: At baseline and after 5 weeks.]
• Stroop Color and Word Test (SCWT) [Срок оценки: At baseline and after 5 weeks.]
• Trail Making Test A and B (TMT A-B) [Срок оценки: At baseline and after 5 weeks.]
• Digit forward and backward span [Срок оценки: At baseline and after 5 weeks.]
• Wisconsin Card Sorting Test Computer Version 4-Research Edition (WCST:CV4) [Срок оценки: At baseline and after 5 weeks.]
• System Usability Scale (SUS) [Срок оценки: After 5 weeks.]
• Simulator Sickness Questionnaire (SSQ) [Срок оценки: After 5 weeks.]
• Visual Analogue Scales (VAS) [Срок оценки: After each IVR session (Every session, twice a week, for 5 weeks)]

Критерии участия

Критерии включения

• School-aged participants (aged 10 to 16 years old)
• Individuals who provide consent to participate.

Критерии исключения

• A previous diagnosis of severe psychiatric (e.g., maniac, or psychotic symptoms).
• A previous diagnosis of severe psychiatric neurodevelopmental disorders (i.e., severe autism spectrum disorders, intellectual disabilities, etc),
• A previous diagnosis of severe physical, motor, or sensory impairments that could interfere with the examination or the VR program.
• Participants who cannot understand Spanish.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• UIC Barcelona International University of Catalonia — Barcelona

Идентификаторы

NCT: NCT06236919 · 31607

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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