Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05274620
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2022-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach', 'timeFrame': '5 months', 'description': '1\\. Number of eligible patients during trial period; 2) number offered IntelliCare; 3) number initiating IntelliCare; 4) number completing IntelliCare'}, {'measure': 'Cost', 'timeFrame': '7 months', 'description': 'Cost of delivering IntelliCare per patient'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Administered weekly over 8 weeks', 'description': 'Patient Health Questionnaire-9 (PHQ-9); higher scores indicate greater symptom severity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings.', 'detailedDescription': "This study will evaluate the implementation of IntelliCare in two settings: Primary care in the McLeod Health system, serving a rural population where mental healthcare workers are scarce, and Northwestern Medicine's Department of Psychiatry, which currently has a 9-month waitlist for psychological services."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who have been identified as depressed or anxious by a care provider in one of the participating healthcare organizations.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05274620', 'briefTitle': 'Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adaptive Health, Inc'}, 'officialTitle': 'Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting', 'orgStudyIdInfo': {'id': 'R44MH114725-05', 'link': 'https://reporter.nih.gov/quickSearch/R44MH114725-05', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'IntelliCare', 'description': '8 weeks of IntelliCare', 'interventionNames': ['Behavioral: IntelliCare']}], 'interventions': [{'name': 'IntelliCare', 'type': 'BEHAVIORAL', 'description': 'A mobile intervention that use principles of computerized therapy to decrease symptoms of depression', 'armGroupLabels': ['IntelliCare']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medicine Dept of Psychiatry', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '29506', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MacLeod HealthCare', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}], 'overallOfficials': [{'name': 'Carolyn MacIver', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adaptive Health, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adaptive Health, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}