Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT03447860
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-11', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': '4-6 weeks', 'description': 'The Perceived Stress Scale (PSS) is a 10-item self-report scale developed to measure the degree to which each participant perceives and appraises recent life events as stressful'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': "The Primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) compared to an established cognitive behavior therapy based dementia caregiver intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving caregiver burden and quality of life of care recipient.", 'detailedDescription': 'The study is a randomized controlled trial comparing a mindfulness-enhanced evidence-based caregiver skill-building intervention (PAACC) to REACH-VA to reduce caregiver burden and increase quality of life of the care recipient. For this, caregivers of persons with ADRD or TBI-AD who have moderate to severe burden will be randomly assigned to either receive PAACC or receive REACH-VA. Both the interventions will include 4 biweekly sessions delivered by trained interventionists, followed by an outcome testing session after the intervention. Outcomes of caregiver stress, health and well being will be assessed at baseline and at the end of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Caregivers will include family members living with the individual diagnosed with Alzheimer's Disease( AD) or Alzheimer's disease related dementia(ADRD) or Traumatic Brain Injury -AD(TBI-AD) with moderate to severe caregiver burden .\n* Care recipients with diagnosis of Diagnosis of AD or ADRD or TBI-related AD .\n\nExclusion Criteria:\n\n* Care givers: Determined to be an imminent risk to self or others,the Care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr.\n* Care recipient: Determined to be an imminent risk to self or others, Caregiver is not interested in the study, unable to obtain informed consent from the Care recipient"}, 'identificationModule': {'nctId': 'NCT03447860', 'acronym': 'PAACC', 'briefTitle': 'Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)', 'organization': {'class': 'FED', 'fullName': 'Salem Veterans Affairs Medical Center'}, 'officialTitle': 'Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC): A Randomized Controlled Trial on the Effectiveness of a Mindfulness Based Caregiver Multicomponent Intervention', 'orgStudyIdInfo': {'id': 'MS0010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'REACH-VA', 'description': 'A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress.', 'interventionNames': ['Behavioral: REACH-VA']}, {'type': 'EXPERIMENTAL', 'label': 'PAACC', 'description': 'A mindfulness-based multi-component caregiver intervention to reduce caregiver stress.', 'interventionNames': ['Behavioral: PAACC']}], 'interventions': [{'name': 'PAACC', 'type': 'BEHAVIORAL', 'description': 'Mindfulness based caregiver intervention that includes education , problem solving, skill building, stress management and mindfulness to help enhance compassion and acceptance of self and others', 'armGroupLabels': ['PAACC']}, {'name': 'REACH-VA', 'type': 'BEHAVIORAL', 'description': 'A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress', 'armGroupLabels': ['REACH-VA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Health Care system', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '24153', 'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Salem VAMC', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}], 'overallOfficials': [{'name': 'Mamta Sapra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salem VAMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salem Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'VA Boston Healthcare System', 'class': 'FED'}, {'name': 'Virginia Polytechnic Institute and State University', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Geriatric psychiatrist, MD', 'investigatorFullName': 'Mamta Sapra', 'investigatorAffiliation': 'Salem Veterans Affairs Medical Center'}}}}