A preventive school-based paradigm using virtual reality technologies for improving emotional regulation, depressive and anxiety symptoms in children and adolescents (e-Emotio project): a randomized controlled pilot trial.

IntroductionPreventive transdiagnostic interventions for depression and anxiety symptoms in children and adolescents are important in reducing the development of disorders later in life, and emotion regulation (ER) is one potentially relevant factor to consider. Impairments in executive functions play a critical role in emotion development and regulation in these ages. Immersive Virtual Reality (IVR) technology has exhibited potential to augment traditional cognitive training interventions. In this project, we propose to use Enhance IVR, a gamified cognitive training that can be tailored to specific ER strategies that individuals may face, such as difficulty with attention control, inhibition, or cognitive flexibility. Methods and analysisThis is a longitudinal, parallel, single-blind, randomized, controlled pilot trial with an estimated sample of 160 participants. The first group (experimental group) will receive the gamified IVR program (Enhance IVR), while the second group (active control group) will receive a comparable IVR relaxation experience. Both Enhance IVR and the control IVR interventions will last five weeks, two times a week, 30 minutes (10 sessions per participant). Participants will undergo a baseline assessment that includes several measures related to mental health, ER, executive functioning, and cognitive performance, and another post intervention assessment with the same measures. Finally, variables related to system usability and cybersickness with the IVR tool will be evaluated for both groups. Ethics and disseminationThis study was approved by the Ethical Committee of the International University of Catalonia (PSI-2023-04). The findings will be disseminated through peer-reviewed journals, reports, conferences, and other scientific events. Strengths and limitations of this studyO_LIThis is a controlled, randomized, and single-blind design, which provides rigorous evidence for a virtual reality (VR) intervention effect. C_LIO_LIThe intervention has a strong ecological validity as it is done in the participants natural context (i.e. school) and the assessment involves students, family, and school. C_LIO_LIThe gamified VR design is innovative and engaging, and there is an equivalent active-based VR control condition. C_LIO_LIOne limitation is there is no follow-up assessment and no double-blind experimental design due to the nature of the study. C_LIO_LIA second limitation is the potential drop-out rates due the preventive nature of the interventions. C_LI