Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 3:45 PM
Study NCT ID:
NCT02967835
Status:
WITHDRAWN
Last Update Posted:
2019-02-07
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Satisfaction With Brief Synchronous Tele-psychiatry Consult
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'not able to recruit', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Outcome', 'timeFrame': '6 month', 'description': 'Will measure depression outcome by measuring PHQ9 score at baseline and 6 months after initial tele-psychiatry consult.'}, {'measure': 'Anxiety Outcome', 'timeFrame': '6 month', 'description': 'Will measure Anxiety outcome by using GAD7 score at baseline and 6 months after initial tele-psychiatry consult.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction with tele-psychiatry consult', 'timeFrame': 'baseline visit', 'description': 'Assess patient satisfaction with tele-psychiatry consult at baseline visit by use of patient satisfaction questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'Will Tele-psychiatry be effective and acceptable to patients.', 'detailedDescription': 'This pilot aims to provide tele-psychiatry consults to patients at regional Mayo Clinic Florida primary care sites. The primary aim of this study is to assess the impact of brief tele-psychiatry consults on depression and anxiety outcomes for patients enrolled in complex care management; the secondary aim is to assess patient satisfaction with brief tele-psychiatry consults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Enrolled in complex care management\n2. PHQ9 above 10 or GAD7 above 10.\n\nExclusion Criteria\n\n1. Not able to provide informed consent\n2. Severe cognitive impairments or sensory deficits\n3. Not able to understand and speak English'}, 'identificationModule': {'nctId': 'NCT02967835', 'briefTitle': 'Effectiveness and Satisfaction With Brief Synchronous Tele-psychiatry Consult', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot to Assess Effectiveness of and Satisfaction With Brief Synchronous Tele-psychiatry Consult', 'orgStudyIdInfo': {'id': '16-003068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telepsychiatry Consult', 'description': 'One time tele-psychiatry consultation to provide treatment recommendations for patients primary care physician.', 'interventionNames': ['Behavioral: Tele-psychiatry consult']}], 'interventions': [{'name': 'Tele-psychiatry consult', 'type': 'BEHAVIORAL', 'description': 'tele-psychiatry consult for evaluation and treatment recommendations', 'armGroupLabels': ['Telepsychiatry Consult']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Mohit Chauhan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Consultant', 'investigatorFullName': 'Mohit Chauhan, M.B.B.S.', 'investigatorAffiliation': 'Mayo Clinic'}}}}