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

NCT06473558 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY20240008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Artificial Intelligence (AI)

Keywords

Depression; Anxiety; Emergency Department

Outcome Measures

Primary Outcomes (14)

• Percentage of participants who score 5-9 on the PHQ-9

  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

  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

  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

  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

  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

  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

  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.

  Baseline

• Number of participants that AI screened positive for moderate depression symptoms.

  Baseline

• Number of participants that AI screened positive for moderately severe depression symptoms.

  Baseline

• Number of participants that AI screened positive for severe depression screening

  Baseline

• Number of participants that AI screened positive for mild anxiety symptoms.

  Baseline

• Number of participants that AI screened positive for moderate anxiety symptoms.

  Baseline

• Number of participants that AI screened positive for severe anxiety symptoms.

  Baseline

Study Arms (1)

Participants seen at University Hospitals Cleveland Medical Center Emergency Department

EXPERIMENTAL

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)

Interventions

Biometrics (or AI Biomaker) DEVICE

Patients will be asked to read a story and their facial expressions and audio cues will be recorded.

Participants seen at University Hospitals Cleveland Medical Center Emergency Department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals ED

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Emergencies

Interventions

Biometry

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Kiran Faryar, MD, MPH

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andie M Moore, MS

CONTACT

(216) 286 - 7239; andie.moore@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)