Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT02499094
Status:
COMPLETED
Last Update Posted:
2015-07-15
First Post:
2015-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1004}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2015-07-14', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depression symptom severity', 'timeFrame': '6 months', 'description': 'Change in the 9-item Patient Health Questionnaire (PHQ-9) score from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in patient activation', 'timeFrame': '6 months', 'description': 'Change in the 13-item Patient Activation Measure score from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate the effectiveness of using an integrated mobile sensing platform to deliver large-scale data-driven interventions to patients with depression.', 'detailedDescription': "This study is a smartphone-based, randomized, single-blind, controlled parallel-\n\ndesign study with two intervention arms and one control arm. The two intervention arms\n\nwill receive in-app messages and phone-based support, which will be triggered by\n\nparticipant's self-reported surveys and passive behavioral data gathered through a\n\nsmartphone app. The study will include a nationwide sample of adult (18 years or older)\n\nsmartphone users, who are currently experiencing depressive symptoms. The primary\n\noutcome will be decrease in depression symptom severity, as measured by the 9-item\n\nPatient Health Questionnaire, over 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently suffering from depression (as measured by a PHQ-9 score of 10 or more at the time of screening)\n* Own an iPhone or Android smartphone with a mobile voice calling plan with a US carrier\n* Fluency in English\n\nExclusion Criteria:\n\n* Participants with visual or hearing impairment\n* Recent history of pregnancy (currently pregnant or those who have given birth within the past four months at the time of screening)\n* Recent loss of a loved one (within the past two months at the time of screening)\n* Unable or unwilling to accept End User License Agreement, or to provide information regarding their demographic characteristics and mental health history'}, 'identificationModule': {'nctId': 'NCT02499094', 'briefTitle': 'Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ginger.io'}, 'officialTitle': 'Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder: Protocol for a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'GIO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention A- Heuristic based', 'description': 'Behavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as simple heuristic-based behavioral measures', 'interventionNames': ['Other: Behavioral-data driven support']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention B- Machine Learning Based', 'description': 'Behavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as machine learning model-based behavioral measures', 'interventionNames': ['Other: Behavioral-data driven support']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Behavioral-data driven support', 'type': 'OTHER', 'description': 'Phone-based support (e.g. triaging of the situation, emotional support, and guidance on next steps for the patient) and in-app support (health education content based on cognitive behavioral therapies, mindfulness, and behavioral activation)', 'armGroupLabels': ['Intervention A- Heuristic based', 'Intervention B- Machine Learning Based']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ginger.io', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Data Scientist', 'investigatorFullName': 'Gourab De', 'investigatorAffiliation': 'Ginger.io'}}}}