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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07364136
Enrollment
587
Registered
2026-01-23
Start date
2025-07-15
Completion date
2025-09-15
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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).

Interventions

BEHAVIORALÍsland 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.

Sponsors

STEM Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Anxiety Symptoms (SCAS Total Score)Baseline to post-intervention (8 weeks)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.
Diagnostic Performance of the AI Chatbot (Sensitivity)After 8 weeks of Chatbot useSensitivity (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.
Diagnostic Performance of the AI Chatbot (Specificity)After 8 weeks of Chatbot useSpecificity (true negative rate) of the app's AI chatbot in correctly ruling out anxiety disorders. Reported as percentage.

Secondary

MeasureTime frameDescription
Diagnostic Performance Metrics (PPV, NPV, Accuracy, MCC, F1 Score)After 8 weeksAdditional diagnostic validity indicators including Positive Predictive Value (PPV), Negative Predictive Value (NPV), overall accuracy, Matthews Correlation Coefficient (MCC), and F1 score of the AI diagnostic model. These provide a comprehensive evaluation of the chatbot's reliability for anxiety disorder classification in adolescents. Reported as percentages or coefficients.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026