An interventional study of Biometrics (or AI Biomaker) in Artificial Intelligence (AI), sponsored by University Hospitals Cleveland Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Screening
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 30 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Number of participants that AI screened positive for mild depression symptoms.
Time frame: Baseline
Number of participants that AI screened positive for moderate depression symptoms.
Time frame: Baseline
Number of participants that AI screened positive for moderately severe depression symptoms.
Time frame: Baseline
Number of participants that AI screened positive for severe depression screening
Time frame: Baseline
Number of participants that AI screened positive for mild anxiety symptoms.
Time frame: Baseline
Number of participants that AI screened positive for moderate anxiety symptoms.
Time frame: Baseline
Number of participants that AI screened positive for severe anxiety symptoms.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2028, 12 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center →