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

NCT06236919 | Recruiting

• 1 other identifier: 31607
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emotional Regulation; Virtual Reality; Anxiety; Depression; Executive Function

Outcome Measures

Primary Outcomes (5)

• Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)

  The ERQ-CA comprises 10 items assessing the emotion regulation strategies. Items are rated on a 5-point Likert-type response scale, with a minimum and maximum range of scores from 10-50. Higher scores on each scale indicate greater use of emotion regulation strategies.

  At baseline and after 5 weeks.

• Revised Child Anxiety and Depression Scale (RCADS-47)

  The Revised Child Anxiety and Depression Scale (RCADS-47) is a 47-item, youth self-report questionnaire that assess Anxiety and Depression symptoms including six subscales: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Items are rated on a 4-point Likert-scale from 0 ("never") to 3 ("always") with a minimum and maximum range of scores from 0-141. Higher scores indicate higher levels of Anxiety and/or Depression.

  At baseline

• State-Trait Anxiety Inventory for Children (STAI-C)

  The State-Trait Anxiety Inventory for Children (STAI-C) item self-rated scale that assesses the two dimensions of anxiety in children; 1) state anxiety as a temporary emotional condition; 2) and trait anxiety as a relatively stable anxious tendency. This inventory has 40 items, which are answered with an ordinal scale with 4 options (0 to 3, from "almost never" to "always") with a minimum and maximum range of scores from 0-60 in each scale. Higher scores indicate higher levels of Anxiety.

  At baseline and after 5 weeks.

• Children's Depression Inventory (CDI)

  The Children's Depression Inventory (CDI) is a 27 item self-rated scale that assesses Depression symptoms in children. Each item is answered with a 3-point Likert-scale from 0 "absence of the symptom" to 2 "severe symptom" with a minimum and maximum range of scores from 0-54. Higher scores indicate higher levels or risk of Depression.

  At baseline and after 5 weeks.

• Positive and Negative Affect Schedule (PANAS)

  The Positive and Negative Affect Schedule is a brief scale of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely, to measure the extent to which the affect has been experienced in a specified time frame. The scale can be used to measure state affect, dispositional or trait affect, emotional fluctuations throughout a specific period of time, or emotional responses to events.

  At baseline and after 5 weeks.

Secondary Outcomes (11)

• General Self-Efficacy Scale (GSE)

  At baseline and after 5 weeks.

• Ruminative Response Scale (RRS-SF)

  At baseline and after 5 weeks.

• Child's Report of Parental Behavior Inventory Abbreviated (CRPBI-A)

  At baseline and after 5 weeks.

• Behavior Rating Inventory of Executive Function 2 (BRIEF-2)

  At baseline and after 5 weeks.

• Stroop Color and Word Test (SCWT)

  At baseline and after 5 weeks.

Study Arms (2)

VR cognitive training

EXPERIMENTAL

The VR cognitive training group will engage in a subset of six games with adaptive difficulty, designed to target specific cognitive functions.

Behavioral: VR cognitive training

VR nature-exposure relaxation group

ACTIVE COMPARATOR

The control group will be immersed in VR nature-based content and perform relaxation exercises.

Behavioral: VR nature exposure relaxation

Interventions

VR cognitive training BEHAVIORAL

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 sustained attention, impulsivity, and processing speed.

VR cognitive training

VR nature exposure relaxation BEHAVIORAL

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).

VR nature-exposure relaxation group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

UIC Barcelona International University of Catalonia

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Emotional Regulation; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Mental Disorders; Behavioral Symptoms

Central Study Contacts

Bruno O Porras Garcia, PhD

CONTACT

(+34) 935 042 000; bporras@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: April 25, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)