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

NCT ID: NCT07311655

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-03-15

Brief Summary

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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

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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.

Conditions

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Anxiety Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.

* 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.

* 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.

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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Facility Contacts

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Min Zhao, MD

Role: primary

Yiqun Tu, MA

Role: backup

Other Identifiers

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MZhao-022

Identifier Type: -

Identifier Source: org_study_id