NCT07092085

Brief Summary

The goal of this observational study is to test an artificial intelligence (AI) tool that can help screen for mental health risks . The main questions it aims to answer are: Can an AI model that analyzes a person's voice, facial expressions, and language accurately identify students who may be at high risk for mental health conditions, such as depression or OCD? How accurate is the AI model when compared to results from standard mental health questionnaires? Participants will be asked to: Complete a standard mental health questionnaire. Provide consent for their data to be used in the research. Participate in a recorded session to collect video and audio data for the AI model to analyze.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

July 10, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sensitivity

    through study completion, an average of 1 year

  • AUROC

    Area Under the Receiver Operating Characteristic Curve

    through study completion, an average of 1 year

  • Specificity of the AI Model for Mental Health Screening

    The ability of the AI model to correctly identify students without significant psychological distress. It will be calculated as the percentage of participants correctly classified as 'low-risk' by the AI model compared to a 'gold standard' classification

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Positive and Negative Predictive Values

    through study completion, an average of 1 year

  • Correlation Between AI-Identified Risk Scores and Neurobiological Markers

    through study completion, an average of 1 year

Study Arms (2)

Healthy Control

without mental healthy problem

Diagnostic Test: AI model

Mental Diseases

with mental problem, such as depression, OCD

Diagnostic Test: AI model

Interventions

AI modelDIAGNOSTIC_TEST

An AI model provides an objective and rapid assessment of potential mental health risks in students by holistically analyzing their facial expressions, vocal characteristics, and linguistic content from data.

Healthy ControlMental Diseases

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population comprises a large cohort of students recruited from multiple universities. Participants will be included in the main phase for AI model development. Additionally, a sub-group of students will be selected based on their mental health risk levels (e.g., for depression or OCD) to participate in a subsequent neuroscience sub-study.

You may qualify if:

  • Enrolled as a student at a participating university.
  • Age between 14 and 40 years, inclusive.
  • Willing and able to provide written informed consent.
  • Fluent in the language required for the study.

You may not qualify if:

  • Inability to provide video or audio data of sufficient quality for analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 29, 2025

Study Start

March 1, 2023

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations