Validation of the Accuracy of an AI-Based System for Diagnosing Anxiety Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anxiety Disorders. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Accuracy of an Artificial Intelligence-Based System for Diagnosing Anxiety Disorders: A Paired Comparison With Psychiatrist Clinical Diagnoses
Overview
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.
Detailed description
This study evaluates the performance of the AI-assisted diagnostic system for identifying anxiety disorders and its applicability in clinical settings. Utilizing a paired design with psychiatrists' clinical diagnoses as the gold standard, the study compares the system's diagnostic results with those of physicians to determine sensitivity and specificity, thus validating its clinical effectiveness in real-world outpatient scenarios. Additionally, standardized scales are used to assess users' perceptions of the system's usability, trustworthiness, and satisfaction, offering evidence to support the clinical integration of AI technology in mental health screening.
Primary outcome measures
- Diagnostic Accuracy (Sensitivity, Specificity, and Area Under the Curve) of the AI-Based Screening System for Anxiety Disorders [Time frame: through study completion, an average of 1 week]
Eligibility criteria
- 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.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Shanghai Mental Health Center — Shanghai
Identifiers
NCT: NCT07311655 · MZhao-022