Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT05580406
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outreach to Reduce Depression Disparities
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initiation of formal depression treatment', 'timeFrame': 'within 60 days of randomization', 'description': 'Defined as either at least one filled prescription for any antidepressant medication or attending at least one individual psychotherapy visit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'Previous research by Mental Health Research Network (MHRN) investigators and others demonstrates that online messaging and other telehealth technologies can effectively and efficiently address premature discontinuation of depression treatment. These interventions, however, have focused on adherence after treatment initiation and have been tested primarily in non-Hispanic white populations. Less is known about the acceptability and effectiveness of different communication modalities (online messaging, mailed letters, telephone) among racial and ethnic minority populations. Implementation of electronic-Health (eHealth) technologies must take care not to exacerbate health disparities.\n\nThis clinical trial involves a pilot trial to evaluate a population-based outreach program to improve rates of depression treatment initiation among traditionally underserved racial and ethnic groups. This pilot work intends to inform a subsequent full-scale pragmatic trial to examine impact on health disparities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of major depressive disorder or dysthymic disorder at a primary care visit ("new" defined as no depression diagnosis, psychotherapy visit or filled antidepressant prescription in the prior year)\n* Continuously enrolled in the participating health system for 365 days prior to the eligible diagnosis (to assure capture of prior diagnoses or treatments)\n* Patients Health Questionnaire-9 (PHQ-9) depression score of 10 or more within 14 days before to 7 days after the eligible diagnosis\n* No filled prescription for any antidepressant medication OR psychotherapy visit attended within 30 days of the eligible diagnosis\\*\n* No recorded PHQ-9 depression score less than 5 since the eligible diagnosis\n* At least 18 years of age or older\n\nExclusion Criteria:\n\n* Diagnosis of schizophrenia or bipolar disorder in the prior 2 years\n* Not registered to use Electronic Health Record (EHR) patient portal\n* Previously requested to not be contacted for research'}, 'identificationModule': {'nctId': 'NCT05580406', 'briefTitle': 'Outreach to Reduce Depression Disparities', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Outreach to Reduce Depression Disparities', 'orgStudyIdInfo': {'id': '12874'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants assigned to usual care will not receive outreach messages (online or via telephone) by study staff.'}, {'type': 'EXPERIMENTAL', 'label': 'Outreach Messaging', 'description': 'Participants in the outreach messaging arm will receive messages via online secure message system (embedded within the health care record) and/or telephone.', 'interventionNames': ['Behavioral: Outreach messaging']}], 'interventions': [{'name': 'Outreach messaging', 'type': 'BEHAVIORAL', 'description': 'Participants will receive outreach messages via health care system secure messaging and/or phone following a new diagnosis of depression made in primary care if the participant has failed to initiate treatment (pharmacotherapy or psychotherapy) within 30 days of new diagnosis.', 'armGroupLabels': ['Outreach Messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kaiser Permanente, Hawaii Market', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Henry Ford Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}