Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT06302504
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nature-based Mindfulness Intervention Program for Family Carers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depression', 'timeFrame': 'Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention', 'description': 'measured by Depression Anxiety and Stress Scale (DASS-21)'}, {'measure': 'anxiety', 'timeFrame': 'Change from 1-month before intervention, pre-intervention, to 1 month follow-up, to 3-month after intervention', 'description': 'measured by Depression Anxiety and Stress Scale (DASS-21)'}, {'measure': 'stress', 'timeFrame': 'Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention', 'description': 'measured by Depression Anxiety and Stress Scale (DASS-21)'}, {'measure': 'family functioning', 'timeFrame': 'Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention', 'description': 'measured by The Family Adaptation, Partnership, Growth, Affection, Resolve Scale'}, {'measure': 'family conflict', 'timeFrame': 'Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention', 'description': 'measured by The Conflict Tactics Scale'}, {'measure': 'well-being', 'timeFrame': 'Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention', 'description': 'measured by The World Health Organization Well-being Index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caregiver', 'mindfulness-based program', 'nature'], 'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parents with children experiencing divorce or separation\n* parents of children with special needs\n* family caregivers who are the primary caregivers of an older adult with dementia\n\nExclusion Criteria:\n\n* parents or caregivers who cannot understand Cantonese version of Chinese\n* parents or caregivers who have psychosis or developmental disabilities who are not able to comprehend the program'}, 'identificationModule': {'nctId': 'NCT06302504', 'briefTitle': 'Nature-based Mindfulness Intervention Program for Family Carers', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Nature-based Mindfulness Intervention Program for Family Caregivers with High Levels of Caring Related Stress', 'orgStudyIdInfo': {'id': 'Nature'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nature-based mindfulness program', 'description': 'The program will include mindfulness exercises, including body scan, mindful stretching, mindful sitting, and befriending exercise. At least one of the four sessions will be conducted in retreat center in nature area.', 'interventionNames': ['Behavioral: Nature-based mindfulness program']}], 'interventions': [{'name': 'Nature-based mindfulness program', 'type': 'BEHAVIORAL', 'description': 'only one arm is included in this study', 'armGroupLabels': ['Nature-based mindfulness program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The funder decided not to share the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}