Anxiety Disorder of AdolescenceNCT07364136
AI-Driven Multimodal Therapeutic System With Virtual Reality Integration for Anxiety Disorders in Adolescents
A study testing Ísland app in people with Anxiety Disorder of Adolescence, run by STEM Egypt at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Anxiety Disorder of Adolescence
- What is being tested?
- Ísland app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Age <13 years or >19 years
- Severe psychiatric comorbidities (psychosis or active suicidality)
- Intellectual disability or conditions preventing app use
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the 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
- Being tested
- Ísland app
- 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
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ísland appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: After 8 weeks of Chatbot use
Secondary outcomes (1)
Diagnostic Performance Metrics (PPV, NPV, Accuracy, MCC, F1 Score)
Additional 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.
Measured: After 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Jul 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder of AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental (app users, n=217) vs. control (n=370), with no crossover, switching, or sequential elements.
- Masking
- None (open label)
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- STEM Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364136
- Sponsor's protocol ID
- Multimodal Anxiety Management
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Driven Multimodal Therapeutic System With Virtual Reality Integration for Anxiety Disorders in Adolescents
- ClinicalTrials.gov ID
- NCT07364136
- Acronym / sponsor ID
- Multimodal Anxiety Management
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- STEM EgyptUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental (app users, n=217) vs. control (n=370), with no crossover, switching, or sequential elements.
| Arm | Type | Receives |
|---|---|---|
| Mobile App Intervention | Experimental | Behavioral: Ísland appParticipants 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). |
| 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age <13 years or >19 years
- Severe psychiatric comorbidities (psychosis or active suicidality)
- Intellectual disability or conditions preventing app use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ísland appA 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. | Behavioural | Mobile App Intervention |
Primary outcome
Change in Anxiety Symptoms (SCAS Total Score)
Time frame: 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)
Time frame: After 8 weeks of Chatbot use
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.
Diagnostic Performance of the AI Chatbot (Specificity)
Time frame: After 8 weeks of Chatbot use
Specificity (true negative rate) of the app's AI chatbot in correctly ruling out anxiety disorders. Reported as percentage.
1 secondary outcome
Diagnostic Performance Metrics (PPV, NPV, Accuracy, MCC, F1 Score)
Time frame: After 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ísland app in people with Anxiety Disorder of Adolescence, run by STEM Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Symptoms (SCAS Total Score) (time frame: Baseline to post-intervention (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.