Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-12 @ 4:18 AM
Study NCT ID:
NCT05645835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2022-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2022-11-28', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the WHO-5 Well-Being Index', 'timeFrame': 'Change in well-being from baseline to directly after completing the intervention (6 weeks)', 'description': 'WHO-5 ranges from 0-25, with higher values indicating higher well-being'}], 'secondaryOutcomes': [{'measure': 'Change in the 20-item UCLA loneliness scale', 'timeFrame': 'Change in loneliness from baseline to directly after completing the intervention (6 weeks)', 'description': 'This scale ranges from 20-80, with higher values indicating higher loneliness'}, {'measure': 'Change in the General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Change in anxiety from baseline to directly after completing the intervention (6 weeks)', 'description': 'This scale ranges from 0-21, with higher values indicating higher anxiety'}, {'measure': 'Change in Psychological Stress Measure (PSM-9)', 'timeFrame': 'Change in stress from baseline to directly after completing the intervention (6 weeks)', 'description': 'This scale ranges from 9-72, with higher values indicating higher stress'}, {'measure': 'Change in Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Change in depression from baseline to directly after completing the intervention (6 weeks)', 'description': 'This scale ranges from 0-27, with higher values indicating higher depression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Loneliness', 'Older Adults', 'fMRI', 'Emotions', 'EEG', 'Digital Intervention', 'Meditation']}, 'descriptionModule': {'briefSummary': 'Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years of age or older\n* English language fluency\n* Naive to meditation practices (not actively meditating more than one hour per month and/or meditation practice for less than a year in their entire life-time)\n* No MRI contra-indications\n* Cognitively healthy (no diagnosis of dementia, stroke, developmental disorders, or major systemic diseases that may impact cognitive function)\n\nExclusion Criteria:\n\n* Below 60 years of age\n* Not fluent in English\n* Active meditator (meditating more than one hour per month and/or meditation practice for more than a year in their entire life-time).\n* Presence of a severe psychiatric (e.g. schizophrenia, bipolar disorder, PTSD), neurological (epilepsy, traumatic brain injury, dementia, multiple sclerosis), or developmental disorder (e.g. autism)\n* Systemic disease (e.g. major recent surgeries, cancer)\n* Claustrophobia\n* Contraindications for MR safety (e.g. metal in body, cochlea implants)'}, 'identificationModule': {'nctId': 'NCT05645835', 'acronym': 'Dynamo', 'briefTitle': 'Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults', 'orgStudyIdInfo': {'id': '22-37461'}, 'secondaryIdInfos': [{'id': 'R00AG065457', 'link': 'https://reporter.nih.gov/quickSearch/R00AG065457', 'type': 'NIH'}, {'id': 'K99AG065457', 'link': 'https://reporter.nih.gov/quickSearch/K99AG065457', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks.', 'interventionNames': ['Behavioral: intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'waitlist control', 'description': 'Participants will be randomized to a waitlist group for six weeks. The waitlist control group will then be able to use the meditation app for six weeks as the primary intervention group', 'interventionNames': ['Behavioral: waitlist control']}, {'type': 'OTHER', 'label': 'Baseline physiology', 'description': 'A subset of participants will not participate in the intervention. Only baseline fMRI and EEG data will be collected in these participants.', 'interventionNames': ['Other: No Interventions']}], 'interventions': [{'name': 'intervention', 'type': 'BEHAVIORAL', 'description': 'the digital meditation app will be installed on participants iPad or android. Lonely older adults will use the app five days a week for six weeks total. Neuroimaging will be performed before and after the intervention.', 'armGroupLabels': ['intervention']}, {'name': 'waitlist control', 'type': 'BEHAVIORAL', 'description': 'Participants in the waitlist group will have to wait six weeks after being screened before being able to use the meditation app after the assessment of primary and secondary endpoints', 'armGroupLabels': ['waitlist control']}, {'name': 'No Interventions', 'type': 'OTHER', 'description': 'No intervention. Only baseline fMRI and EEG assessment.', 'armGroupLabels': ['Baseline physiology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Lorenzo Pasquini, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}