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

NCT07364136 | Completed

• 1 other identifier: Multimodal Anxiety Management
• Study Type: interventional
• Target: 587
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorder of Adolescence

Keywords

Adolescent anxiety; Anxiety disorders; Mobile application; mHealth; Digital mental health; AI chatbot; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy; Mindfulness-Based Cognitive Therapy; Mindfulness-Based Stress Reduction; Virtual Reality Exposure Therapy; Group therapy; DSM-5 diagnosis; Middle East; Egyptian Arabic; Teen mental health; Behavioral intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Change in Anxiety Symptoms (SCAS Total Score)

  The primary outcome is the change in anxiety symptom severity, measured by the total score on the Spence Children's Anxiety Scale (SCAS; child self-report version, 44 items, 0-3 Likert scale per item, total range 0-114, higher scores indicate greater anxiety severity). The SCAS assesses symptoms aligned with DSM anxiety disorders (e.g., separation anxiety, social phobia, generalized anxiety, panic, obsessive-compulsive, physical injury fears). A clinically significant reduction is defined as exceeding the 4-6 point Minimal Clinically Important Difference (MCID) threshold established for pediatric anxiety measures. This outcome evaluates the efficacy of the mobile app intervention in reducing anxiety symptoms compared to the control group.

  Baseline to post-intervention (8 weeks)

• Diagnostic Performance of the AI Chatbot (Sensitivity)

  Sensitivity (true positive rate) of the app's AI chatbot diagnostic model (based on DSM-5 and SCID-RV criteria via Gemini API) in correctly identifying anxiety disorders compared to structured clinical assessment or expert confirmation. Reported as percentage. This evaluates the accuracy of the unstructured AI diagnostic approach in adolescents.

  After 8 weeks of Chatbot use

• Diagnostic Performance of the AI Chatbot (Specificity)

  Specificity (true negative rate) of the app's AI chatbot in correctly ruling out anxiety disorders. Reported as percentage.

  After 8 weeks of Chatbot use

Secondary Outcomes (1)

• Diagnostic Performance Metrics (PPV, NPV, Accuracy, MCC, F1 Score)

  After 8 weeks

Study Arms (2)

Mobile App Intervention

EXPERIMENTAL

Participants in this arm received access to a multilingual mobile application designed for adolescents aged 13-19 with anxiety disorders. The app featured: * An AI chatbot using the Gemini API for diagnostic support based on DSM-5 and SCID-RV criteria. * Integrated unstructured therapeutic modules combining Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Stress Reduction (MBSR). * Journaling for thought tracking, history review for context, real-time AI facial-expression and voice-tone analysis for emotional feedback. * Video-based group therapy sessions assigned via the adapted Adolescent Group Therapy Readiness Questionnaire (AGTRQ). * Virtual Reality Exposure Therapy (VRET) modules. Participants used the app as their primary intervention for anxiety management (n=217).

Behavioral: Ísland app

Control Group

NO INTERVENTION

Participants in this arm did not receive access to the mobile application or any study-specific intervention during the trial period. They continued with standard care or no additional anxiety management support (treatment as usual or equivalent passive control; n=370). This group served as the comparison to evaluate the efficacy of the mobile app intervention on anxiety symptoms (measured by SCAS) and diagnostic performance.

Interventions

Ísland app BEHAVIORAL

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.

Mobile App Intervention

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 13 to 19 years (inclusive) at the time of enrollment.
• Presence of anxiety symptoms or diagnosed anxiety disorder
• Access to a compatible smartphone

You may not qualify if:

• Age \<13 years or \>19 years
• Severe psychiatric comorbidities (psychosis or active suicidality)
• Intellectual disability or conditions preventing app use

Sponsors & Collaborators

• STEM Egypt: lead

Study Sites (1)

STEM Egypty

Cairo, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental (app users, n=217) vs. control (n=370), with no crossover, switching, or sequential elements.

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 23, 2026
• Study Start: July 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: January 23, 2026

Record last verified: 2025-12

Locations

EG (1)