NCT07364136

AI-Driven Multimodal Therapeutic System With Virtual Reality Integration for Anxiety Disorders in Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 587 (actual)
• Sponsor: STEM Egypt · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

Many young people in the Middle East face anxiety problems, and social stigma often stops them from getting help. Doctors' usual talks sometimes miss the right diagnosis, and most treatments only target one part of anxiety (thoughts, feelings, or body reactions). This study tested a free mobile app designed to help teens aged 13-19 manage anxiety better on their own or with support. The app uses artificial intelligence (AI) to chat with users, ask questions based on standard medical guidelines, and suggest a personalized plan. It combines four proven therapy styles: * Cognitive Behavioral Therapy (CBT) - helps change unhelpful thoughts and behaviors * Acceptance and Commitment Therapy (ACT) - teaches accepting feelings while focusing on what matters * Mindfulness-Based Cognitive Therapy (MBCT) - combines mindfulness with ways to handle negative thoughts * Mindfulness-Based Stress Reduction (MBSR) - uses mindfulness exercises to reduce stress Users can also write in a private journal, review their past entries to track patterns, join video group sessions with other teens (after a short readiness check to ensure a good fit), and try virtual reality exercises to face fears safely. The app works in many languages, including Egyptian Arabic dialects, keeps chats private and encrypted, and only shares info with a psychiatrist for diagnosis help if needed. It also uses AI to read facial expressions and voice tone for real-time feedback on emotions. We enrolled 587 teens (some used the app, others did not as a comparison group) and measured how well the app diagnosed anxiety and reduced symptoms.

Detailed description

Anxiety disorders show rising prevalence in the Middle East (estimated at 6.33% in recent data), compounded by cultural stigma that limits help-seeking. Conventional diagnostic interviews are prone to misclassification, and unimodal therapies often fail to address the full cognitive, emotional, and physiological dimensions of anxiety. This randomized controlled trial evaluated a mobile application delivering an integrated, AI-assisted intervention for adolescents aged 13-19 years with anxiety symptoms or disorders. The app employs an unstructured diagnostic model powered by the Gemini API, synthesizing DSM-5 and SCID-RV criteria via natural language processing to inform personalized treatment pathways. The core intervention integrates four evidence-based psychotherapeutic modalities within a single platform: * Cognitive Behavioral Therapy (CBT) techniques for cognitive restructuring and behavioral experiments * Acceptance and Commitment Therapy (ACT) modules emphasizing values clarification, defusion, and committed action * Mindfulness-Based Cognitive Therapy (MBCT) for relapse prevention and metacognitive awareness * Mindfulness-Based Stress Reduction (MBSR) practices for stress physiology regulation Additional components include: * Secure, encrypted journaling for thought/emotion tracking * Historical data review to contextualize symptom patterns * Video-based synchronous group therapy sessions, with group assignment guided by the adapted Adolescent Group Therapy Readiness Questionnaire (AGTRQ; derived from GTQ/GRQ) to optimize therapeutic fit and cohesion * Real-time AI-driven analysis of facial expressions and vocal prosody for emotional state feedback * Virtual Reality Exposure Therapy (VRET) modules for graduated exposure to anxiety triggers * Full multilingual support, including colloquial Egyptian Arabic * Privacy safeguards restrict psychiatrist access to diagnostic outputs only. The trial used a parallel-group design with an experimental arm (app access; n=217) versus control (n=370; likely treatment-as-usual or waitlist based on standard practices).

Conditions

• Anxiety Disorder of Adolescence

Interventions

Type	Name	Description
BEHAVIORAL	Ísland app	A mobile application delivering an integrated behavioral intervention for anxiety disorders in adolescents aged 13-19. It uses an AI chatbot for diagnostic support (DSM-5/SCID-RV criteria) and personalized delivery of four evidence-based therapies: Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Stress Reduction (MBSR). Additional features include secure journaling, session history review, AI real-time emotional feedback via facial expression and voice-tone analysis, video-based group therapy with readiness screening (AGTRQ), Virtual Reality Exposure Therapy (VRET) modules, multilingual support (including Egyptian Arabic dialects), and encrypted data privacy with limited psychiatrist access for diagnostic purposes only.

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Egypt