Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT06840457
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-21
First Post:
2025-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COMPASS: a Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4400}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression as measured by the Patient Health Questionnaire 9(PHQ-9)', 'timeFrame': 'From enrollment to the 6-week assessment.', 'description': 'The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores range from 0-27 and 27 indicates severe depression.'}, {'measure': 'Anxiety as measured using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale', 'timeFrame': 'From enrollment to the 6-week assessment.', 'description': 'GAD-7 consists total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health']}, 'descriptionModule': {'briefSummary': 'This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seeking mental health services from Michigan Medicine, University Health Services, or collaborative clinics and services.\n* Must have daily access to a smartphone version that is compatible with study activity trackers.\n* Understands English to enable consent and use of the MyDataHelps app and app-based interventions\n\nExclusion Criteria:\n\n* Self-reported or medical record indication of a current eating disorder\n* Unable to provide informed consent (e.g., cognitive or guardianship restrictions)\n* Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)'}, 'identificationModule': {'nctId': 'NCT06840457', 'acronym': 'COMPASS', 'briefTitle': 'COMPASS: a Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'COMPASS: Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment', 'orgStudyIdInfo': {'id': 'HUM00248932'}, 'secondaryIdInfos': [{'id': '1U01MH136025', 'link': 'https://reporter.nih.gov/quickSearch/1U01MH136025', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness with tailored messages', 'description': 'Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.', 'interventionNames': ['Behavioral: Mindfulness + Tailored Messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness without tailored messages', 'description': 'Participants will receive an app-based intervention and standard feedback from activity tracker.', 'interventionNames': ['Behavioral: Mindfulness without Tailored Messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy (CBT) with tailored messages', 'description': 'Participants will receive an app-based intervention, tailored messages from the MyDataHelps study app, and activity tracker.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT) + Tailored Messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy (CBT) without tailored messages', 'description': 'Participants will receive an app-based intervention and standard feedback from activity tracker.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT) without Tailored Messages']}], 'interventions': [{'name': 'Mindfulness + Tailored Messages', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness'], 'description': 'Tailored Messages (TM) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Messages will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual messages.\n\nThe study will use an app designed to train the user in mindfulness practices.', 'armGroupLabels': ['Mindfulness with tailored messages']}, {'name': 'Mindfulness without Tailored Messages', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness'], 'description': 'The study will use an app designed to train the user in mindfulness practices.', 'armGroupLabels': ['Mindfulness without tailored messages']}, {'name': 'Cognitive Behavioral Therapy (CBT) + Tailored Messages', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'Tailored Messages (TM) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Messages will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual messages.\n\nThe study will use an app designed to deliver cognitive behavioral therapy.', 'armGroupLabels': ['Cognitive Behavioral Therapy (CBT) with tailored messages']}, {'name': 'Cognitive Behavioral Therapy (CBT) without Tailored Messages', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'The study will use an app designed to deliver cognitive behavioral therapy.', 'armGroupLabels': ['Cognitive Behavioral Therapy (CBT) without tailored messages']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Shared within National Institute of Mental Health Data Archive via grant data collaborator core.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amy S.B. Bohnert', 'investigatorAffiliation': 'University of Michigan'}}}}