Artificial Intelligence (AI)NCT06473558
Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology
A study testing Biometrics (or AI Biomaker) in people with Artificial Intelligence (AI), run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence (AI)
- What is being tested?
- Biometrics (or AI Biomaker)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 28 Feb 2028
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prisoners
- Patients who are deemed to be critically ill (including life or limb threatening illness) or unable to consent
- Non-English Speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals ED
Cleveland, Ohio, 44106
Andie M Moore, MS, (216) 286 -7239, andie.moore@uhhospitals.org
About this study
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)
- Being tested
- Biometrics (or AI Biomaker)
- Keywords
- Depression, Anxiety, Emergency Department
- Medical subject headings
- Depression, Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometrics (or AI Biomaker)Device
Patients will be asked to read a story and their facial expressions and audio cues will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Biometrics (or AI Biomaker) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Number of participants that AI screened positive for mild depression symptoms.
Measured: Baseline
Number of participants that AI screened positive for moderate depression symptoms.
Measured: Baseline
Number of participants that AI screened positive for moderately severe depression symptoms.
Measured: Baseline
Number of participants that AI screened positive for severe depression screening
Measured: Baseline
Number of participants that AI screened positive for mild anxiety symptoms.
Measured: Baseline
Number of participants that AI screened positive for moderate anxiety symptoms.
Measured: Baseline
Number of participants that AI screened positive for severe anxiety symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Feb 2027 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Faryar, MD, University Hospitals Cleveland Medical Center
- Investigators
- Kiran Faryar, MD, MPH, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473558
- Sponsor's protocol ID
- STUDY20240008
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No