Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-17 @ 4:37 PM
Study NCT ID:
NCT04609267
Status:
UNKNOWN
Last Update Posted:
2021-07-08
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interactive Voice-Based Administration of the PHQ-9
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study will be counterbalanced with no masking components'}, '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., PHQ-9 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': '2020-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PHQ-9 Total Scores', 'timeFrame': 'Immediate', 'description': 'Measure for Major Depressive Disorder from questionnaire responses'}, {'measure': 'User Experience Survey', 'timeFrame': 'Immediate', 'description': '26 item questionnaire tracking user experience'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study investigates a new delivery method for the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The new tool records auditory responses to the assesment 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 a new delivery system of the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The purpose of the study is to examine if the new delivery system of the PHQ-9 is effective at capturing participant depression levels. The new version uses a Mirror device, which is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9 through Amazon Alexa. We will be comparing the responses from the Mirror 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': 'NCT04609267', 'briefTitle': 'Interactive Voice-Based Administration of the PHQ-9', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University Center for Health Sciences'}, 'officialTitle': 'Interactive Voice-Based Administration of the PHQ-9', 'orgStudyIdInfo': {'id': '2020039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paper Baseline', 'description': 'Half of the participants will complete the PHQ-9 in the traditional paper format at their first appointment. At their second appointment 1-month later, they will complete the PHQ-9 on the Mirror device equipped with Amazon Alexa.', 'interventionNames': ['Diagnostic Test: PHQ-9 - Mirror format']}, {'type': 'EXPERIMENTAL', 'label': 'Mirror Baseline', 'description': 'Half of the participants will complete the PHQ-9 on the Mirror device equipped with Amazon Alexa at their first appointment. At their second appointment 1-month later, they will will complete the PHQ-9 in the traditional paper format.', 'interventionNames': ['Diagnostic Test: PHQ-9 - Mirror format']}], 'interventions': [{'name': 'PHQ-9 - Mirror format', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PHQ-9 - Amazon Alexa equipped device'], 'description': 'The intervention we will be using is a new delivery system of the PHQ-9 using an Amazon Alexa equipped Mirror device. This Mirror device is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9. We will be comparing the responses from the Mirror device to those given on the clinically established paper format.', 'armGroupLabels': ['Mirror 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'}], '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'}}}}