Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-15 @ 1:51 PM
Study NCT ID:
NCT02219620
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2014-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009068', 'term': 'Movement'}, {'id': 'D012926', 'term': 'Social Control, Formal'}], 'ancestors': [{'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'emotional functioning', 'timeFrame': 'pre-post 10 week treatment and 6 week FU'}], 'secondaryOutcomes': [{'measure': 'cognitive functioning', 'timeFrame': 'pre-post 10 week intervention and 6 week FU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['creative arts', 'older adults', 'intervention study'], 'conditions': ['Emotion', 'Impaired Cognition']}, 'descriptionModule': {'briefSummary': 'To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and cognitive functioning in residents living in a community-based adult long-term care facility.\n\nHypothesis 1: Residents who participate in the MiM group will improve in emotional functioning, as compared to residents in the control group.\n\nHypothesis 2: Residents who participate in the MiM group will improve in cognitive functioning, as compared to residents in the control group.', 'detailedDescription': 'To implement a community-based integrated music, art and imagery, and movement intervention to improve mood and promote cognitive functioning in older adult residents living in a long-term care facility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident in assisted living at long-term care facility with MMSE score above 20\n\nExclusion Criteria:\n\n* co-morbid psychiatric diagnosis and/or staff clinical evaluation that determines inappropriateness for study inclusion'}, 'identificationModule': {'nctId': 'NCT02219620', 'acronym': 'MiM', 'briefTitle': 'Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care', 'organization': {'class': 'OTHER', 'fullName': 'George Mason University'}, 'officialTitle': 'Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care', 'orgStudyIdInfo': {'id': '14-953118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music, Imagery, Movement intervention', 'description': 'Music, Imagery, Movement intervention: psychosocial intervention incorporating Music, Imagery and Movement', 'interventionNames': ['Behavioral: Music, Imagery, Movement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Social Control', 'description': 'social control/interaction group', 'interventionNames': ['Behavioral: Social Control']}], 'interventions': [{'name': 'Music, Imagery, Movement', 'type': 'BEHAVIORAL', 'description': 'Implementation of music, art and imagery activation, and movement in group modality', 'armGroupLabels': ['Music, Imagery, Movement intervention']}, {'name': 'Social Control', 'type': 'BEHAVIORAL', 'description': 'social conversational group facilitated by care counselor', 'armGroupLabels': ['Social Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Assisted Living at Birmingham Green', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}], 'overallOfficials': [{'name': 'Holly Matto, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Mason University'}, {'name': 'Cathy Tompkins, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Mason University'}, {'name': 'Emily Ihara, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Mason University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Mason University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Holly Matto', 'investigatorAffiliation': 'George Mason University'}}}}