VIRTUS: virtual reality exposure training for adolescents with social anxiety - a randomized controlled trial.

While virtual reality exposure (VRE) has shown effectiveness in treating social anxiety in adults, research on its efficacy for adolescents remains limited. Given that adolescence is a critical period for early intervention, this study aims to address this gap by evaluating the efficacy and acceptability of VRE compared to in vivo exposure (IVE) in a non-referred sample of socially anxious adolescents. Additionally, we seek to identify mechanisms of change-such as expectancy violation, habituation, and self-efficacy-as well as predictors of treatment response, including clinical, personality, and VR-related factors. Using a randomized controlled trial (RCT), 120 adolescents (ages 12-16) with subclinical to moderate social anxiety will be assigned to one of three conditions: VRE, IVE, or a waitlist control (WL). Participants in the active conditions will undergo a seven-session exposure-based intervention (either in VR or in vivo). Primary (SPAI-18, LSAS-avoidance) and secondary (SPWSS) measures of social anxiety, along with general well-being indicators (e.g., resilience, depression, psychosocial functioning), will be assessed at baseline, post-treatment, and 3- and 6-month follow-ups. A series of linear mixed model (LMM) analyses will be used to examine and compare the effects of the interventions. We hypothesize that both VRE and IVE will significantly reduce social anxiety symptoms compared to WL at post-assessment, with comparable long-term efficacy between the two exposure methods. Additionally, thematic analyses will be conducted to explore participants' experiences and acceptance of VRE and IVE through qualitative interviews. The findings of this study aim to advance digital mental health research by evaluating the potential of VRE as an early intervention and identifying mechanisms and predictors to inform personalized treatments for socially anxious youth.Trial registrationClinicaltrials.gov: NCT06379633, registered on April, 23, 2024.