Ireland
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Starting soon Observational

Validation of the Accuracy of an AI-Based System for Diagnosing Anxiety Disorders

NCT07311655 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-02-01
Last updated
2025-12-31

Condition(s) studied

Anxiety Disorders

Study summary

The trial aimed to evaluate the efficacy of an artificial intelligence-based system for diagnosing anxiety disorders. Specifically, it sought to determine whether the system's assessment validity is non-inferior to that of psychiatric specialists.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
1. Subjects with anxiety disorders * Inclusion Criteria: * In accordance with ICD-11 for Anxiety Disorders; * Between the ages of 18-60; * Ability to use computers or smartphone; * Native Chinese speaker; * Signing informed consent. * Exclusion Criteria: * With severe psychiatric symptoms requiring hospitalization, or unable to complete the required assessment and treatment; * With a high risk of suicide or self-injury; * With severe physical diseases, central nervous system diseases, or substance abuse; * With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems. 2. Health Control * Inclusion Criteria: * Not meet ICD-11 criteria for Mental Disorders; * Between the ages of 18-60; * Ability to use computers or smartphone; * Native Chinese speaker; * Signing informed consent. * Exclusion Criteria: * With mental illness, or unable to complete the required assessment and treatment; * With severe physical diseases, central nervous system diseases, or substance abuse; * With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems. 3. Psychiatrist * Inclusion Criteria: * Over 18 years old; * A minimum of three years' experience in anxiety and other mental health fields; * Intermediate or higher professional title; * Currently employed in the selected test region; * Signing informed consent.

Primary outcome measure(s)

  • Diagnostic Accuracy (Sensitivity, Specificity, and Area Under the Curve) of the AI-Based Screening System for Anxiety Disorders — through study completion, an average of 1 week
    In this study, the evaluation results of the subjects were taken as the gold standard based on the diagnostic conclusions of psychiatrists. The screening results of the aided-diagnostic system were compared with the diagnostic conclusions of the psychiatrists to verify the screening effectiveness of this system. Sensitivity : Calculated as \[True Positives / (True Positives + False Negatives)\], evaluating the AI system's ability to correctly identify patients with anxiety. Specificity : Calculated as \[True Negatives / (True Negatives + False Positives)\], evaluating the AI system's ability to correctly exclude non-anxious individuals.Area Under the Receiver Operating Characteristic Curve (AUC), which comprehensively evaluates the diagnostic discriminative power of the system by plotting sensitivity versus 1-specificity across different decision thresholds and calculating the AUC value .

Trial sites (1)

FacilityCityRegionStatus
Shanghai Mental Health Center Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07311655 on ClinicalTrials.gov ↗ ← All trials in China