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ACTIVE NOT RECRUITING
NCT07875816
NA

LLM Psychiatric Intake AI Clinical Performance Study

Sponsor: Gangnam Severance Hospital

View on ClinicalTrials.gov

Summary

This study will evaluate the clinical performance and applicability of a large language model-based psychiatric intake support system for caregivers of patients undergoing an initial or re-intake psychiatric evaluation. Caregivers will complete a single adaptive AI interview remotely before the scheduled outpatient visit. The system will generate a structured clinician-facing report and diagnostic screening candidates for nine prespecified target conditions. Treating clinicians will review the AI-generated information while retaining full authority over the final clinical assessment and diagnosis. The system will be evaluated in terms of diagnostic-assistance performance, interview and information-collection performance, documentation quality, acceptability and user experience, and safety.

Official title: Development and Evaluation of an LLM-Based, Clinician-in-the-Loop Intake System for Mental Health

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-11-07

Completion Date

2027-11-06

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

OTHER

LLM-based clinician-in-the-loop psychiatric AI-assisted intake assistance system

Caregivers complete a single adaptive LLM-based psychiatric intake interview remotely before the patient's scheduled initial or re-intake visit. The web-based interview is accessible by smartphone or tablet and lasts up to 30 minutes. Guided by K-SADS-PL and DSM-5-based clinical domains, the system adaptively explores information typically collected from caregivers during an initial psychiatric assessment. The system generates a structured clinician-facing report containing an interview summary, diagnostic screening candidates for nine prespecified target conditions, safety-related findings, and areas requiring further clarification. The system incorporates mental health-specific safety guardrails tailored to the developmental characteristics and safety needs of children and adolescents. These guardrails restrict diagnostic and treatment advice and detect potential risks, including self-harm, harm to others, suicidal history, substance misuse, psychotic symptoms, and suspected child ab

Locations (1)

Gangnam Severance Hospital

Seoul, Gangnam-gu, South Korea