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

Shanghai Mental Health Center

Status: Not yet enrolling

Conditions: Depressive Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT07311668

MZhao-023

Details and patient eligibility

About

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

Full description

This study evaluates the performance of the AI-assisted diagnostic system for identifying depressive 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Subjects with anxiety disorders （1）Inclusion Criteria:

   • In accordance with ICD-11 for Depressive Disorders;
   • Between the ages of 18-60;
   • Ability to use computers or smartphone;
   • Native Chinese speaker;
   • Signing informed consent. （2）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 （1）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. （2）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 （1）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.