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Mental DisordersNCT07875816

LLM Psychiatric Intake AI Clinical Performance Study

A study testing LLM-based clinician-in-the-loop psychiatric AI-assisted intake assistance system in people with Mental Disorders, run by Gangnam Severance Hospital at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Disorders
What is being tested?
LLM-based clinician-in-the-loop psychiatric AI-assisted intake assistance system
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSouth Korea
Study dates
7 Nov 2025to 6 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • [Caregivers]
  • Caregiver of a patient presenting for a first visit or re-intake visit at the Department of Psychiatry, Gangnam Severance Hospital
  • Provides signed informed consent for study participation
  • Able to use an electronic device such as a smartphone or tablet
  • [Mental health experts]
  • Holds psychiatrist board certification, clinical psychologist certification, or mental health clinical psychologist qualification
Show all 14Show fewer
  • Has clinical experience in psychiatric care or assessment
  • Has received sufficient explanation of the study purpose and procedures and provides written informed consent
  • Able to understand and complete the study rating instruments
  • [Treating clinicians]
  • Psychiatrist or psychiatry resident
  • Has clinical experience in psychiatric care or assessment
  • Provides consent to study participation
  • Able to understand and complete the study assessment tools

Who cannot join

  • [Caregivers]
  • Does not consent to participation
  • Withdraws consent
  • [Mental health experts]
  • Difficulty understanding study procedures or completing rating tools
  • Circumstances during the study period that may substantially affect participation (e.g., prolonged absence, health problems)
Show all 11Show fewer
  • Direct conflict of interest related to the study
  • [Treating clinicians]
  • Difficulty understanding study procedures or completing assessment tools
  • Circumstances during the study period that may substantially affect participation (e.g., prolonged absence, health problems)
  • Direct conflict of interest related to the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Gangnam Severance Hospital

    Seoul, Gangnam-gu, 06273

Other trials in South Korea

About this study

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

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.

Read the detailed description
  1. Study Overview
  • This study will evaluate an LLM-based psychiatric intake support system across five domains: diagnostic-assistance performance, interview and information-collection performance, documentation and information-integration performance, acceptability and user experience, and safety. The system functions as a clinical support tool and does not replace the treating clinician's assessment or determine the final diagnosis.
  1. Study Design
  • Type: Prospective, single-arm, multi-stakeholder, mixed-methods study.
  • Workflow: Hybrid remote-in-person model consisting of a remote AI intake interview followed by a scheduled in-person psychiatric evaluation.
  • Setting: Department of Psychiatry, Gangnam Severance Hospital.
  • Duration: Up to 24 months after IRB approval.
  1. Participants and Sample Size: Total anticipated enrollment: 120 participants.
  • Caregivers: n=110.
  • Mental health experts: n=7.
  • Treating clinicians: n=3.
  • Based on the Buderer method, 73 evaluable target-condition cases are required, assuming an expected overall sensitivity of 0.75, a 95% confidence level, and a margin of error of ±0.10.
  • Assuming that 80% of caregiver cases will have a target-condition reference primary diagnosis and that 85% will provide evaluable data, the minimum caregiver enrollment is 108; this was rounded to 110.
  1. Recruitment and Consent
  • Outpatient clinic nurses will send caregivers a link containing appointment information together with information about the study as part of the standard pre-visit communication process. The research team will not participate in sending the link and will not access caregivers' contact information or other personal identifiers before consent.
  • Caregivers who choose to participate will provide electronic informed consent before completing any study procedures. Participation or withdrawal will not affect the patient's scheduled psychiatric care.
  1. Procedures
  2. Caregivers: Caregivers will complete pre-interview measures before using the AI system. Each caregiver will complete one adaptive AI intake interview remotely at home before the patient's scheduled initial or re-intake psychiatric visit. The interview will last up to 30 minutes and will conversationally explore information typically collected from caregivers during an initial psychiatric assessment. Caregivers will complete post-interview measures immediately after the AI interview. Participants will subsequently attend the scheduled outpatient visit and undergo an in-person psychiatric evaluation according to standard clinical practice. Caregivers who provide separate additional consent may participate in a one-time qualitative interview on the scheduled visit date.
  3. Treating-Clinician Procedures
  • Following the interview, 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 report before conducting the scheduled psychiatric evaluation. Clinicians may approve or defer individual AI-generated findings within the system. Final clinical interpretation, diagnosis, and decision-making authority will remain with the treating clinician.
  • After completion of study-wide data collection, treating clinicians will participate in a one-time qualitative interview regarding clinical usefulness, workflow integration, potential bias, and safety.
  1. Mental Health Expert Procedures • Mental health experts will independently evaluate de-identified AI interview logs and clinician-facing reports. Standardized and study-specific measures will be used to assess interview competence, communication performance, documentation quality, and safety. Experts may participate in a one-time qualitative interview after completing their assigned evaluations.
Being tested
LLM-based clinician-in-the-loop psychiatric AI-assisted intake assistance system
Keywords
LLM, Large Language Models, Artificial Intelligence, AI intake, Psychiatric Intake, psychiatric interview, digital intake, Clinician-in-the-Loop, clinical performance, screening, mental health, Caregiver
Medical subject headings
Mental Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called AI psychiatric intake chatbot; LLM-based preliminary intake system; clinician-in-the-loop AI intake

    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

Study groups in NCT07875816
Study groupRoleWhat they receive
LLM-Based Psychiatric Intake InterviewExperimentalCaregivers complete an approximately 30-minute adaptive LLM-based AI psychiatric intake interview before/around the outpatient visit. The AI system generates a structured intake report for the treating clinician. Experts rate de-identified AI interview logs/reports. Treating clinicians review the AI report in routine care and provide qualitative feedback.
Receives: Other: LLM-based clinician-in-the-loop psychiatric AI-assisted intake assistance system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pooled sensitivity of AI-generated diagnostic candidates for the nine target disorders

    The pooled sensitivity of the AI-generated diagnostic candidates will be evaluated against the reference primary diagnosis determined by a psychiatrist based on clinical information accumulated during the 8 weeks following the initial clinical visit. Among participants whose reference primary diagnosis corresponds to one of the nine target disorders, a true-positive case is defined as one in which the AI-generated candidate list includes the reference diagnosis. A false-negative case is defined as one in which the AI does not include the reference diagnosis or returns a deferred decision. Pooled sensitivity is calculated as the number of true-positive cases divided by the total number of participants whose reference primary diagnosis is one of the nine target disorders. The outcome ranges from 0 to 1, with higher values indicating better diagnostic candidate-generation performance.

    Measured: Up to 8 weeks after the day 1

Secondary outcomes (12)
  1. Disorder-specific sensitivity of AI-generated diagnostic candidates for each of the nine target disorders

    Sensitivity will be calculated separately for each of the nine target disorders. For each disorder, a true-positive case is defined as a participant whose reference primary diagnosis is the corresponding target disorder and whose AI-generated candidate list includes that disorder. A false-negative case is defined as a participant whose reference diagnosis is the corresponding target disorder but for whom the AI does not include the disorder or returns a deferred decision. Sensitivity is calculated as true positives divided by the sum of true positives and false negatives and will be reported with a 95% confidence interval. The outcome ranges from 0 to 1, with higher values indicating better performance.

    Measured: Up to 8 weeks after the day 1

  2. Specificity of AI-generated diagnostic candidates for identifying cases outside the nine target disorders

    Specificity will be evaluated among participants whose reference primary diagnosis is outside the nine target disorders. A true-negative case is defined as one in which the AI does not suggest any of the nine target disorders and returns a deferred decision. A false-positive case is defined as one in which the AI suggests at least one target disorder. Specificity is calculated as the number of true-negative cases divided by the total number of participants whose reference diagnosis is outside the target-disorder range. The outcome ranges from 0 to 1, with higher values indicating more appropriate deferral performance.

    Measured: Up to 8 weeks after the day 1

  3. Clinical information-gathering and interviewing performance assessed by the modified Mini-CEX

    (*Note: Seven separately enrolled mental health experts retrospectively rate AI intake transcripts within 1 month after caregiver data collection (approximately 2-3 months.) Seven mental health experts who are psychiatrists or qualified clinical psychologists independently assess the AI system using a modified version of the Mini-Clinical Evaluation Exercise. The modified instrument includes five domains: medical interviewing skills, humanistic qualities and professionalism, clinical judgment, organization and efficiency, and overall clinical competence. Each domain is rated on a 9-point scale, with scores of 1-3 indicating unsatisfactory performance, 4-6 indicating satisfactory performance, and 7-9 indicating superior performance. The five domain scores are summed to produce a total score ranging from 5 to 45. Higher scores indicate better clinical information-gathering and interviewing performance.

    Measured: Within 1 month after completion of caregiver data collection

  4. Information-elicitation and communication performance assessed by the SEGUE Framework

    (*Note: Seven separately enrolled mental health experts retrospectively rate AI intake transcripts within 1 month after caregiver data collection (approximately 2-3 months.) Seven mental health experts who are psychiatrists or qualified clinical psychologists independently assess the AI conversation transcripts using the 25-item SEGUE Framework. The framework evaluates observable communication behaviors across five domains: setting the stage, eliciting information, giving information, understanding the user's perspective, and ending the encounter. Each behavior is coded as present or absent. The item scores are summed to produce a total score, with higher scores indicating that the AI demonstrated a greater number of appropriate information-elicitation and communication behaviors.

    Measured: Within 1 month after completion of caregiver data collection

  5. Clinical summarization and documentation quality assessed by the PDSQI-9

    (*Note: Seven separately enrolled mental health experts retrospectively rate AI intake transcripts within 1 month after caregiver data collection (approximately 2-3 months.) Seven mental health experts who are psychiatrists or qualified clinical psychologists independently evaluate the AI-generated clinical summaries using the 9-item Provider Documentation Summarization Quality Instrument. The instrument assesses clinically relevant dimensions of documentation quality, including accuracy, completeness, organization, usefulness, hallucinations, omissions, and stigmatizing language. Responses are coded according to a prespecified scoring procedure and combined to produce a total documentation quality score. Higher total scores indicate better clinical summarization and documentation quality.

    Measured: Within 1 month after completion of caregiver data collection

  6. Clinical safety of the AI intake system assessed by the total safety risk score

    (*Note: Seven separately enrolled mental health experts retrospectively rate AI intake transcripts within 1 month after caregiver data collection (approximately 2-3 months.) Seven mental health experts who are psychiatrists or qualified clinical psychologists independently review each AI conversation for safety concerns in six domains: inappropriate intervention, hallucination within the conversation, failure to detect a crisis signal, inappropriate emotional or relational response, ethical or boundary violation, and failure to consider developmental characteristics. Each domain is classified as safe, minor, potentially risky, or critical failure and coded as 0, 1, 2, or 3, respectively. The six domain scores are summed to produce a total safety risk score ranging from 0 to 18. Higher scores indicate greater clinical safety concerns.

    Measured: Within 1 month after completion of caregiver data collection

  7. Clinical safety: Activation and response outcomes of the automated safety guardrail

    Safety guardrail events are automatically recorded by the AI intake system and extracted by the research team after completion of overall study data collection. For each AI intake, the system records whether the safety guardrail was activated, the time of activation, the type of risk signal detected, the response provided by the system, and whether the AI intake was automatically discontinued. The number and proportion of AI intakes involving guardrail activation will be reported, together with the distribution of detected risk-signal categories, system responses, and safety-related intake discontinuations. Because guardrail activation depends on the occurrence of risk signals, a higher activation rate does not necessarily indicate poorer system safety.

    Measured: Day 1

  8. Emotional safety of the AI intake assessed by change in caregiver-reported emotional symptom intensity

    The participating caregiver completes the five Emotion Thermometers immediately before and immediately after using the AI intake system. Four thermometers assess distress, anxiety, depression, and anger, and the fifth assesses the perceived need for help. Each domain is rated from 0 to 10. The distress, anxiety, depression, and anger scores are summed to produce a prespecified exploratory composite emotional symptom intensity score ranging from 0 to 40, with higher scores indicating greater overall emotional symptom intensity. Changes in the four individual emotional-domain scores are also reported separately. The need-for-help score is analyzed separately and is not included in the composite score because it assesses perceived help-seeking need rather than emotional symptom intensity.

    Measured: Day 1

  9. Caregiver-perceived communication quality assessed by the Communication Assessment Tool

    The participating caregiver evaluates the AI system's communication quality immediately after completing the AI intake. Communication quality is assessed using 14 communication-focused items adapted from the Communication Assessment Tool. The items assess whether the AI system enabled the caregiver to speak without interruption, paid attention to the caregiver's responses, used understandable language, checked understanding, encouraged questions, demonstrated care and concern, treated the caregiver with respect, and used an appropriate amount of time. Each item is rated on a 5-point scale from 1, poor, to 5, excellent. The 14 item scores are summed to produce a prespecified total score ranging from 14 to 70. Higher scores indicate better caregiver-perceived communication quality.

    Measured: Day 1

  10. Comfort with self-disclosure during the AI intake

    The participating caregiver completes a 4-item self-report measure immediately after using the AI intake system. The measure assesses perceived comfort, ease, and openness in disclosing personal or sensitive information during the AI intake. Each item is rated on a 7-point Likert scale from 1, strongly disagree, to 7, strongly agree. The mean of the four item scores is calculated, producing a score ranging from 1 to 7. Higher scores indicate greater comfort with self-disclosure during the AI intake.

    Measured: Day 1

  11. Acceptability and appropriateness of the AI intake assessed by the AIM

    The participating caregiver evaluates the acceptability and perceived appropriateness of the AI intake system using the Acceptability of Intervention Measure. The Acceptability of Intervention Measure consists of 4 items assessing whether the AI intake is perceived as acceptable, appealing, likable, and welcome. Each item is rated on a 5-point Likert scale from 1, completely disagree, to 5, completely agree. The mean of the four item scores is calculated separately for each measure, producing an acceptability score and an appropriateness score, each ranging from 1 to 5. Higher scores indicate greater acceptability or greater perceived appropriateness, respectively. The scores of the two measures are not combined into a single total score.

    Measured: Day 1

  12. Acceptability and appropriateness of the AI intake assessed by the IAM

    The participating caregiver evaluates the acceptability and perceived appropriateness of the AI intake system using the Intervention Appropriateness Measure. The Intervention Appropriateness Measure consists of 4 items assessing whether the AI intake is perceived as fitting, suitable, applicable, and a good match for its intended purpose and clinical context. Each item is rated on a 5-point Likert scale from 1, completely disagree, to 5, completely agree. The mean of the four item scores is calculated separately for each measure, producing an acceptability score and an appropriateness score, each ranging from 1 to 5. Higher scores indicate greater acceptability or greater perceived appropriateness, respectively. The scores of the two measures are not combined into a single total score.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start7 Nov 2025
  3. Primary completion27 Feb 2027 (estimated)
  4. Study completion6 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective single-arm clinical performance evaluation. All enrolled caregivers receive the LLM-based AI psychiatric intake interview. Experts and treating clinicians evaluate AI outputs and clinical usefulness. No randomization and no control arm.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07875816
Sponsor's protocol ID
3-2025-0301
Status last verified
Sep 2026
First submitted
10 Feb 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Whether de-identified individual participant data will be made available after study completion to researchers outside the IRB-approved study team has not been determined. Any future external sharing will require institutional and IRB review and must be consistent with the scope of participant consent.

Publications

  • Jung Y, Vo THA, Moon HS, Choi JY, Oh H, Lee U, Kim E, Lee TY, Lee U. Toward Flexible Psychiatric History-Taking and Visualization: Exploring Clinician Perspectives with Large Language Models. Proceedings of the 2026 CHI Conference on Human Factors in Computing Systems. 2026; Article 503:1-23. doi:10.1145/3772318.3790970.

Questions about this trial

What is this clinical trial studying?

A study testing LLM-based clinician-in-the-loop psychiatric AI-assisted intake assistance system in people with Mental Disorders, run by Gangnam Severance Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pooled sensitivity of AI-generated diagnostic candidates for the nine target disorders (time frame: Up to 8 weeks after the day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07875816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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