Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-01 @ 12:34 AM
Study NCT ID:
NCT05583695
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-based Music Therapy in Blind Elderly Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'at baseline', 'description': 'Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.'}, {'measure': 'Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'In the 8th week from baseline', 'description': 'Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.'}], 'secondaryOutcomes': [{'measure': 'Depression Anxiety Stress Scales-21 (DASS-21)', 'timeFrame': 'at baseline', 'description': 'Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms.'}, {'measure': 'Depression Anxiety Stress Scales-21 (DASS-21)', 'timeFrame': 'In the 8th week from baseline', 'description': 'Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms.'}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': 'at baseline', 'description': 'Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms.'}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': 'In the 8th week from baseline', 'description': 'Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mindfulness', 'Music Therapy', 'Blind', 'Elderly', 'Mood']}, 'referencesModule': {'references': [{'pmid': '37915438', 'type': 'DERIVED', 'citation': 'Chan SHW, Cheung MYC, Chiu ATS, Leung MHT, Kuo MCC, Yip DYC, Hui CCY, Kam SWI, Yeung K, Mui DSP, Wang SM, Yip CCK. Clinical effectiveness of mindfulness-based music therapy on improving emotional regulation in blind older women: A randomized controlled trial. Integr Med Res. 2023 Dec;12(4):100993. doi: 10.1016/j.imr.2023.100993. Epub 2023 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* blind with visual acuity (the best eye) of 20/400 or below\n* aged 65 years or above\n* cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12\n* able to speak Cantonese\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05583695', 'briefTitle': 'Mindfulness-based Music Therapy in Blind Elderly Women', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Mindfulness-based Music Therapy on Emotional Regulation in Blind Elderly Women', 'orgStudyIdInfo': {'id': 'RS-KHAB-2020-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mindfulness-based music therapy', 'interventionNames': ['Behavioral: mindfulness-based music therapy']}, {'type': 'EXPERIMENTAL', 'label': 'mindfulness-based therapy', 'interventionNames': ['Behavioral: mindfulness-based therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'routine care', 'interventionNames': ['Behavioral: routine care']}], 'interventions': [{'name': 'mindfulness-based music therapy', 'type': 'BEHAVIORAL', 'description': 'eight weekly sessions with a combination of both mindfulness and music therapy', 'armGroupLabels': ['mindfulness-based music therapy']}, {'name': 'mindfulness-based therapy', 'type': 'BEHAVIORAL', 'description': 'eight weekly sessions of mindfulness', 'armGroupLabels': ['mindfulness-based therapy']}, {'name': 'routine care', 'type': 'BEHAVIORAL', 'description': 'eight weekly sessions of routine care', 'armGroupLabels': ['routine care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Hong Kong Society for the Blind', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}