Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 9:34 AM
Study NCT ID:
NCT04990492
Status:
UNKNOWN
Last Update Posted:
2022-04-21
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interactive Voice Based Administration of the GAD 7
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-22', 'size': 191331, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-24T14:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study will be a repeated measure, mixed methods design (i.e., it will contain both qualitative and quantitative components). Newly admitted patients will be asked to complete the questionnaires (i.e., GAD 7 and the UEQ) at two different time points (i.e., Baseline and 1-month follow-up). In order to reduce or control for order effects, the procedure will be counterbalanced.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GAD 7 Diagnostic Scores', 'timeFrame': 'Five minutes', 'description': 'Scores from the self administered assessment for general anxiety disorder'}, {'measure': 'User Experience Questionnaire', 'timeFrame': 'Five minutes', 'description': 'Likert based questionnaire on user experience'}], 'secondaryOutcomes': [{'measure': "Patient's Qualitative Responses", 'timeFrame': 'One minute', 'description': 'Comments from patient on usability of the device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'This study investigates a new delivery method for the General Anxiety Disorder - 7 (GAD 7), a clinically accepted tool for diagnosing general anxiety disorder. The new tool records auditory responses to the assessment and the study will examine if the instrument is effective at capturing participant depression levels. If proven effective, future studies may investigate if the new format can be used to improve at home clinical care.', 'detailedDescription': 'This study is an investigation of the construct validity and user experience of a new delivery system for the General Anxiety Disorder - 7 (GAD 7), a clinically accepted tool for diagnosing general anxiety disorder. The purpose of the study is to examine if the new delivery system of the GAD 7 is effective at capturing participant anxiety levels and to assess the differences of usability between the paper and voice administered versions. The voice administered version uses a Mirror device, which is similar to a smart television with a mirror interface. The device records auditory responses to the GAD 7 through Amazon Alexa. The investigators will be comparing the responses on the new device to those given on the clinically established paper format. If proven effective at capturing depression levels of patients, future studies may investigate if the new format can be used to improve at home clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria::\n\n* Newly admitted patients to the Oklahoma State University Behavioral Medicine Clinic\n\nExclusion Criteria:\n\n* Vulnerable populations, such as children (i.e., minors or individuals under the legal age of consent) and individuals who are incarcerated (i.e., prisoners), will be excluded.\n* Individuals who are not their own guardian (i.e., those suffering from severe disabilities) will also be excluded.'}, 'identificationModule': {'nctId': 'NCT04990492', 'briefTitle': 'Interactive Voice Based Administration of the GAD 7', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University Center for Health Sciences'}, 'officialTitle': 'Interactive Voice Based Administration of the GAD 7', 'orgStudyIdInfo': {'id': '2021029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paper Baseline', 'description': 'Half of the participants will complete the GAD 7 in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the GAD 7 on the Mirror device equipped with Amazon Alexa.', 'interventionNames': ['Diagnostic Test: Paper GAD 7', 'Diagnostic Test: Voice Administered GAD 7']}, {'type': 'EXPERIMENTAL', 'label': 'Alexa Baseline', 'description': 'The other half of the participants will complete the GAD 7 on the Mirror device equipped with Amazon in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the GAD 7 in the traditional paper format.', 'interventionNames': ['Diagnostic Test: Paper GAD 7', 'Diagnostic Test: Voice Administered GAD 7']}], 'interventions': [{'name': 'Paper GAD 7', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Clinically Accepted Paper GAD 7'], 'description': 'The paper based GAD 7 that is commonly accepted at clinics', 'armGroupLabels': ['Alexa Baseline', 'Paper Baseline']}, {'name': 'Voice Administered GAD 7', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Alexa GAD 7', 'Mirror GAD 7'], 'description': 'This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.', 'armGroupLabels': ['Alexa Baseline', 'Paper Baseline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75135', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Beaman, D.O.', 'role': 'CONTACT', 'email': 'jason.beaman@okstate.edu', 'phone': '918-561-8269'}, {'name': 'Luke Lawson, M.A.', 'role': 'CONTACT', 'email': 'luke.lawson@okstate.edu', 'phone': '918-2364026'}], 'facility': 'OSU Behavioral Health Clinic', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'centralContacts': [{'name': 'Jason Beaman, D.O.', 'role': 'CONTACT', 'email': 'jason.beaman@okstate.edu', 'phone': '918-561-8269'}, {'name': 'Luke Lawson, M.A.', 'role': 'CONTACT', 'email': 'luke.lawson@okstate.edu', 'phone': '915-241-5853'}], 'overallOfficials': [{'name': 'Jason Beaman, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma State University Center for Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate data and findings will be posted on ClinicalTrials.gov.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University Center for Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oral Roberts University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}