Feasibility Study of a Virtual Reality Neuro-Technological Mindfulness Intervention for Adolescents Aged 13 to 18 With Generalised Anxiety Disorder

What this Trial Is About

Researchers are evaluating a neuro-technological approach to help adolescents diagnosed with Generalised Anxiety Disorder GAD. The study aims to test the safety and acceptability of delivering a mindfulness-based anxiety regulation intervention through a virtual reality VR game combined with neuro- and bio-feedback. This intervention uses a novel algorithm designed for early treatment of GAD in outpatient adolescents aged 13 to 18 years. Participants will take part in eight intervention sessions lasting 30 minutes each, held twice a week over four weeks. During these sessions, they will wear a head-mounted VR display and a mobile EEG-biosensor, both non-invasive devices. Each session starts with audio-guided mindfulness practice, followed by a 15-minute VR game that adapts to the participants anxiety levels and their ability to manage it. Participants will continue their usual psychiatric treatment except for changes in psychotropic medications. Throughout the study, participants will complete questionnaires at the beginning and end of the intervention. Researchers will assess outcomes including usability of the intervention at week 4 and anxiety levels reported by both the adolescents and their parents at baseline and after five weeks. The study monitors participant safety and intervention feasibility over the four-week treatment period.

A Neuro-Technological Intervention for Adolescents With GAD