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NCT Number: NCT06473558

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biometrics (or AI Biomaker)

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Number of participants that AI screened positive for mild depression symptoms.

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

  11. Number of participants that AI screened positive for severe depression screening

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Andie M Moore, MS

CONTACT

[email protected]

(216) 286 - 7239

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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