NCT06236919: e-Emotio

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

Recruiting now NA Last updated 6 October 2025

What this trial tests

NA trial testing VR cognitive training in Emotional Regulation in 160 participants. Currently enrolling.

Timeline

1 February 2024

Primary endpoint
30 December 2025

25 April 2026

Quick facts

Lead sponsor	Universitat Internacional de Catalunya
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	160
Start date	1 February 2024
Primary completion	30 December 2025
Estimated completion	25 April 2026
Sites	1 location across Spain

Drugs / interventions tested

• VR cognitive training
• VR nature exposure relaxation

Conditions studied

• Emotional Regulation — all drugs for Emotional Regulation →
• Virtual Reality — all drugs for Virtual Reality →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →

Sponsor

Universitat Internacional de Catalunya — full company profile →

Who can join

Adults 10 to 16, any sex, with Emotional Regulation or Virtual Reality. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploring Sex Differences in the Relationship Between Emotion Regulation and Eating Disorders Symptoms During Early Adolescence.
   Gámiz-Sanfeliu M, Fernández-Capo M, Rojas-Rincón J, Ampatzoglou A, et al · · 2026 · PMID 41682916 · DOI 10.3390/jcm15031237