Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-03-02 @ 7:34 PM
Study NCT ID:
NCT06473558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-18
First Post:
2024-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001699', 'term': 'Biometry'}], 'ancestors': [{'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who score 5-9 on the PHQ-9', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Percentage of participants who score 10-14 on the PHQ-9', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Percentage of participants who score 15-19 on the PHQ-9', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Percentage of participants who score 20-27 on the PHQ-9', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Percentage of participants who score 5-9 on the GAD-7', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Percentage of participants who score 10-14 on the GAD-7', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Percentage of participants who score above 15 on the GAD-7', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Number of participants that AI screened positive for mild depression symptoms.', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants that AI screened positive for moderate depression symptoms.', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants that AI screened positive for moderately severe depression symptoms.', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants that AI screened positive for severe depression screening', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants that AI screened positive for mild anxiety symptoms.', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants that AI screened positive for moderate anxiety symptoms.', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants that AI screened positive for severe anxiety symptoms.', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Depression', 'Anxiety', 'Emergency Department'], 'conditions': ['Artificial Intelligence (AI)']}, 'descriptionModule': {'briefSummary': "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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* English-speaking\n* Patients with non-emergent concerns of Emergency Severity Index (ESI) level 3, 4, or 5\n\nExclusion Criteria:\n\n* Prisoners\n* Patients who are deemed to be critically ill (including life or limb threatening illness) or unable to consent\n* Non-English Speaking'}, 'identificationModule': {'nctId': 'NCT06473558', 'briefTitle': 'Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology', 'orgStudyIdInfo': {'id': 'STUDY20240008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants seen at University Hospitals Cleveland Medical Center Emergency Department', 'description': '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.', 'interventionNames': ['Device: Biometrics (or AI Biomaker)']}], 'interventions': [{'name': 'Biometrics (or AI Biomaker)', 'type': 'DEVICE', 'description': 'Patients will be asked to read a story and their facial expressions and audio cues will be recorded.', 'armGroupLabels': ['Participants seen at University Hospitals Cleveland Medical Center Emergency Department']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Andie M Moore, MS', 'role': 'CONTACT', 'email': 'andie.moore@uhhospitals.org', 'phone': '(216) 286 -7239'}], 'facility': 'University Hospitals ED', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Andie M Moore, MS', 'role': 'CONTACT', 'email': 'andie.moore@uhhospitals.org', 'phone': '(216) 286 - 7239'}], 'overallOfficials': [{'name': 'Kiran Faryar, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}