Clinical trial NCT06236919: E-Emotio Project A Gamified Preventive School-based Paradigm Using Virtual Reality Technologies for Improving Emotional Regulation in Children and Adolescents.
Official title: E-Emotio Project A Gamified Preventive School-based Paradigm Using Virtual Reality Technologies for Improving Emotional Regulation in Children and Adolescents.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Regulation
Virtual Reality
Anxiety
Depression
Executive Function
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 160
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
timeFrame: At baseline, after 2 weeks and after 5 weeks.
measure: Revised Child Anxiety and Depression Scale (RCADS-47)
timeFrame: At baseline
measure: State-Trait Anxiety Inventory for Children (STAI-C)
timeFrame: At baseline, after 2 weeks and after 5 weeks.
measure: Children's Depression Inventory (CDI)
timeFrame: At baseline, after 2 weeks and after 5 weeks.
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: At baseline, after 2 weeks and after 5 weeks.
Secondary outcomes:
measure: General Self-Efficacy Scale (GSE)
timeFrame: At baseline and after 5 weeks.
measure: Ruminative Response Scale (RRS-SF)
timeFrame: At baseline and after 5 weeks.
measure: Child's Report of Parental Behavior Inventory Abbreviated (CRPBI-A)
timeFrame: At baseline and after 5 weeks.
measure: Behavior Rating Inventory of Executive Function 2 (BRIEF-2)
timeFrame: At baseline and after 5 weeks.
measure: Stroop Color and Word Test (SCWT)
timeFrame: At baseline and after 5 weeks.
measure: Trail Making Test A and B (TMT A-B)
timeFrame: At baseline and after 5 weeks.
measure: Digit forward and backward span
timeFrame: At baseline and after 5 weeks.
measure: Continuous Performance Test VR version (VR-CPT)
timeFrame: At baseline and after 5 weeks.
measure: Wisconsin Card Sorting Test Computer Version 4-Research Edition (WCST:CV4)
timeFrame: At baseline and after 5 weeks.
measure: System Usability Scale (SUS)
timeFrame: After 5 weeks.
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: After 5 weeks.
measure: Visual Analogue Scales (VAS)
timeFrame: After each IVR session (Every session, twice a week, for 5 weeks)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: UIC Barcelona International University of Catalonia
Study officials:
References: