Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology

April 21, 2026 updated by: Kiran Faryar, MD, University Hospitals Cleveland Medical Center

Behavioral health problems, such as depression and anxiety, are common yet often are not identified by emergency department doctors and nurses. These mental health conditions can be due to medical issues or can worsen medical problems. One way investigators hope to do a better job of learning about mental health is by training Artificial Intelligence (AI) software to detect anxiety and depression by analyzing facial expression and tone of voice.

Participants are invited to participate in a study which may help improve emergency department care. An audio and video recording of the participant's responses to some simple, non-psychological questions will be analyzed by a computer to determine whether investigators can assess mood and anxiety by analyzing speech and visual patterns. The audio and video will not be listened to nor watched by study personnel, only analyzed by a computer. The investigator's hope is that it will help others in the future by aiding in the assessment of psychological state. This study is being conducted at CMC ED only.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (age 18 and over) who presents to the UHCMC ED voluntarily with no obvious psychological disturbance by self-report or nurse/provider initial assessment
  • English-speaking
  • Patients with non-emergent concerns of Emergency Severity Index (ESI) level 3, 4, or 5

Exclusion Criteria:

  • Prisoners
  • Patients who are deemed to be critically ill (including life or limb threatening illness) or unable to consent
  • Non-English Speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants seen at University Hospitals Cleveland Medical Center Emergency Department
Eligible patients must present with non-emergent concerns of Emergency Severity Index (ESI) level 3, 4, or 5. Patients will complete assessments and questionnaires and end with being recorded reading a story to capture facial expressions and audio cues.
Device: Biometrics (or AI Biomaker)
Patients will be asked to read a story and their facial expressions and audio cues will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who score 5-9 on the PHQ-9
Time Frame: Baseline
Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring, and measuring severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Baseline
Percentage of participants who score 10-14 on the PHQ-9
Time Frame: Baseline
Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring, and measuring severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Baseline
Percentage of participants who score 15-19 on the PHQ-9
Time Frame: Baseline
Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring, and measuring severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Baseline
Percentage of participants who score 20-27 on the PHQ-9
Time Frame: Baseline
Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring, and measuring severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Baseline
Percentage of participants who score 5-9 on the GAD-7
Time Frame: Baseline
Generalized Anxiety Disorder (GAD-7) is a easy to preform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Baseline
Percentage of participants who score 10-14 on the GAD-7
Time Frame: Baseline
Generalized Anxiety Disorder (GAD-7) is a easy to preform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Baseline
Percentage of participants who score above 15 on the GAD-7
Time Frame: Baseline
Generalized Anxiety Disorder (GAD-7) is a easy to preform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Baseline
Number of participants that AI screened positive for mild depression symptoms.
Time Frame: Baseline
Baseline
Number of participants that AI screened positive for moderate depression symptoms.
Time Frame: Baseline
Baseline
Number of participants that AI screened positive for moderately severe depression symptoms.
Time Frame: Baseline
Baseline
Number of participants that AI screened positive for severe depression screening
Time Frame: Baseline
Baseline
Number of participants that AI screened positive for mild anxiety symptoms.
Time Frame: Baseline
Baseline
Number of participants that AI screened positive for moderate anxiety symptoms.
Time Frame: Baseline
Baseline
Number of participants that AI screened positive for severe anxiety symptoms.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Kiran Faryar, MD, MPH, University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20240008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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