Accuracy of an Artificial Intelligence-Based System for Diagnosing Depressive Disorders: A Paired Comparison With Psychiatrist Clinical Diagnoses
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy (Sensitivity, Specificity, and Area Under the Curve) of the AI-Based Screening System for Depressive Disorders
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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）
排除标准
- •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 （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:
结局指标
主要结局
Diagnostic Accuracy (Sensitivity, Specificity, and Area Under the Curve) of the AI-Based Screening System for Depressive Disorders
时间窗: 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 depression. Specificity : Calculated as \[True Negatives / (True Negatives + False Positives)\], evaluating the AI system's ability to correctly exclude non-depressed 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 .
次要结局
未报告次要终点