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Emotional Regulatione-EmotioNCT06236919

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

A study testing VR cognitive training and VR nature exposure relaxation in people with Emotional Regulation and Virtual Reality, run by Universitat Internacional de Catalunya at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Emotional Regulation, Virtual Reality, Anxiety
What is being tested?
VR cognitive training and VR nature exposure relaxation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSpain
Study dates
1 Feb 2024to 25 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bruno O Porras Garcia, PhD contact

(+34) 935 042 000

bporras@uic.es

Spain1 site, 1 recruiting
  • UIC Barcelona International University of Catalonia

    Barcelona

    Bruno O Porras Garcia

    Recruiting

Other trials in Spain

About this study

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.

Being tested
VR cognitive training, VR nature exposure relaxation
Medical subject headings
Emotional Regulation, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR cognitive trainingBehavioural

    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 nature exposure relaxationBehavioural

    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).

Study groups in NCT06236919
Study groupRoleWhat they receive
VR cognitive trainingExperimentalThe VR cognitive training group will engage in a subset of six games with adaptive difficulty, designed to target specific cognitive functions.
Receives: Behavioral: VR cognitive training
VR nature-exposure relaxation groupActive comparatorThe control group will be immersed in VR nature-based content and perform relaxation exercises.
Receives: Behavioral: VR nature exposure relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and after 5 weeks.

  2. 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.

    Measured: At baseline

  3. 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.

    Measured: At baseline and after 5 weeks.

  4. 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.

    Measured: At baseline and after 5 weeks.

  5. 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.

    Measured: At baseline and after 5 weeks.

Secondary outcomes (11)
  1. General Self-Efficacy Scale (GSE)

    The General Self-Efficacy Scale (GSE) is a self-report measure of self-efficacy that assesses the stable feeling of personal competence to effectively handle a large variety of stressful situations. This scale comprises 10 items and each item is answered with a 10-point Likert-scale from 1 to 10. This scale has a minimum and maximum range of scores from 10-100. Higher scores indicate more self-efficacy perception.

    Measured: At baseline and after 5 weeks.

  2. Ruminative Response Scale (RRS-SF)

    The Ruminative Response Scale (RRS-SF) is a self-report measure that describes individual responses to negative emotions describing self and symptom-focused responses to depressed mood. This scale includes 10 items and is rated on a 4-point Likert scale ranging from 1 (never) to 4 (always). The total score ranges from 10 to 40. Higher scores indicate higher degrees of ruminative symptoms.

    Measured: At baseline and after 5 weeks.

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

    The 29-item abbreviated form of the questionnaire (CRPBI-A) consists of six scales assessing the following 6 child-rearing styles: communicative, hostile/rejection, controlling, permissive, overprotective, and negligent for both mother and father. This scale is rated on a 3-point Likert scale ranging from 1 (almost never) to 3 (many times).

    Measured: At baseline and after 5 weeks.

  4. Behavior Rating Inventory of Executive Function 2 (BRIEF-2)

    The BRIEF-2 questionnaire is a test intended for the evaluation of the most everyday, behavioral and observable aspects of the executive functions of children and adolescents between 5 and 18 years old. The questionnaire can be self-reported (BRIEF-" Self-report) answered by family members (BRIEF-2 Family) and by teachers (BRIEF-2 School), who must indicate the frequency with which certain behaviors are problematic.

    It consists of 63 items that are answered with a frequency scale (never, sometimes times, frequently) in a time of approximately 10 minutes, and it evaluates different scales related to executive functions: inhibition, self-monitoring, flexibility, emotional control, initiative, working memory, planning and organization, task supervision and materials organization.

    Measured: At baseline and after 5 weeks.

  5. Stroop Color and Word Test (SCWT)

    Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test (SCWT). Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.

    Measured: At baseline and after 5 weeks.

  6. Trail Making Test A and B (TMT A-B)

    The Trail Making Test (TMT) is a freely available, timed, neuropsychological test that involves visual scanning and working memory. The TMT has two parts; the TMT-A (visual scanning and processing speed) and TMT-B (executive functioning and cognitive flexibility). In each test the participant is asked to draw a line between 24 consecutive circles that are randomly arranged on a page. The TMT-A uses all numbers, whereas the TMT-B alternates numbers and letters, requiring the patient to switch between numbers and letters in consecutive order. The TMT is scored by how long it takes to complete the test. The time includes correction of errors prompted by the examiner. If the person cannot complete the test in 5 minutes, the test is discontinued. Higher scores mean a better outcome.

    Measured: At baseline and after 5 weeks.

  7. Digit forward and backward span

    Digit Span Forward requires the child to repeat numbers in the same order as read aloud by the examiner (auditory attention), and Digit Span Backward requires the child to repeat the numbers in the reverse order of that presented by the examiner (verbal working memory). Every item on Digit Span consists of two trials, each of which is scored 1 or 0 points. Pacing of the item stimuli is critical on Digit Span, as variations in how quickly or slowly they are provided can greatly impact item difficulty. The numbers are read at the rate of one per second, and there are a number of techniques that examiners use to establish an accurate, consistent pace. The Longest Digit Span Forward (LDSF) and Longest Digit Span Backward (LDSB) process scores permit examination of maximum performance on each task relative to the normative sample. Higher scores mean a better outcome.

    Measured: At baseline and after 5 weeks.

  8. Wisconsin Card Sorting Test Computer Version 4-Research Edition (WCST:CV4)

    The Wisconsin Card Sorting Test (WCST) was created to evaluate the capacity of abstraction, the formation of concepts and the change of cognitive strategies in response to the changes that occur in environmental contingencies. The WCST is used in people from 6,5 years old to 89 and it is made up of 1 set of 64 cards. The cards are composed of a combination of 3 types of attributes or characteristics: shape (triangle, star, cross and circle), color (red, blue, green and yellow) and number (1, 2, 3 or 4 elements). The task is to distribute the cards matching one criterion. When the subject makes 10 consecutive correct answers, it is considered that a category has ended, from then on the classification criterion is changed without prior warning. If you continue classifying the cards with the criteria of the previous category, you will score in perseverative errors.The test ends when the subject completes all 6 series or categories, or when the subject completes 128 trials.

    Measured: At baseline and after 5 weeks.

  9. System Usability Scale (SUS)

    The System Usability Scale (SUS) is a self-report measure that evaluates the usability of a wide variety of products and services, including hardware, software, mobile devices, websites and applications. It consists of a 10 item questionnaire that is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10-50 with higher scores indicating greater levels of usability.

    Measured: After 5 weeks.

  10. Simulator Sickness Questionnaire (SSQ)

    The Simulator Sickness Questionnaire (SSQ) is a self-report measure that is used to assess cybersickness or adverse symptoms associated with VR. It consists of a 16 item questionnaire that is rated on a 4-point Likert scale ranging from 1 ("no symptoms") to 3 ("severe symptoms"). The total score ranges from 10 to 30 with higher scores indicating higher levels of adverse symptoms.

    Measured: After 5 weeks.

  11. Visual Analogue Scales (VAS)

    Visual Analogue Scales (VAS) are psychometric response scales used to measure subjective characteristics or attitudes. The participants have to rate the intensity of their feeling of Immersion and Enjoyment on a scale from 0 (none) - 100 (completely) after the completion of all IVR tasks of each session. Both questions will be asked orally to each participant:

    1. "Rate from 0 to 100 the degree of immersion that you felt inside the virtual environment. With 0 being none and 100 being completely".
    2. "Rate from 0 to 100 how much you liked the virtual environment. With 0 being not at all and 100 being completely".

    Measured: After each IVR session (Every session, twice a week, for 5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion25 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06236919
Sponsor's protocol ID
31607
Acronym
e-Emotio
Status last verified
Sep 2025
First submitted
12 Jan 2024
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VR cognitive training and VR nature exposure relaxation in people with Emotional Regulation and Virtual Reality, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bruno O Porras Garcia, PhD ((+34) 935 042 000, bporras@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) (time frame: At baseline and after 5 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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