Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 9:12 PM
Study NCT ID:
NCT00769769
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2008-10-08', 'studyFirstSubmitQcDate': '2008-10-08', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression clinical diagnosis', 'timeFrame': 'Measured before and after 3-month intervention'}], 'secondaryOutcomes': [{'measure': 'Caregiver health status', 'timeFrame': 'Measured before and after 3-month intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Health Status'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This study will compare the effectiveness of face-to-face cognitive behavioral therapy versus telephone-based cognitive behavioral therapy for treating African Americans who care for family members with dementia.', 'detailedDescription': 'Approximately 4.5 million Americans suffer from progressive dementia, with higher rates among African Americans than among European Americans. The majority of caregivers for dementia patients are family members, who often deal with difficult behavior, agitation, and aggressiveness in the people for whom they care. Because of the challenges they face, family caregivers for dementia patients are at increased risk of mental health problems, particularly depression. Promising research has shown that cognitive behavioral therapy (CBT) can combat distress in African-American caregivers. One way to deliver CBT is through telephone-based interventions, which have been shown to lead to better psychological outcomes than routine education and support. This study will create treatment manuals for CBT tailored to the needs and preferences of African Americans who care for family members with dementia and will develop procedures and strategies for treatment delivery to and retention of members of this population. The study will then compare the effectiveness of face-to-face versus telephone-based CBT in improving mental health outcomes for African Americans who care for family members with dementia.\n\nParticipation in this study will last 3 months. Participants will be randomly assigned to receive either face-to-face or telephone-based CBT. Both groups will receive 12 weekly sessions of therapy targeting caregiver depression and social functioning over time. Before and after treatment, participants will be assessed on measures of depression and social functioning through standardized questionnaires given over the telephone. Additional data will be collected on social and demographic factors, stressors, caregiver appraisal of resources, and use and costs of both mental and physical health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provides significant care for a spouse, parent, or relative who meets National Institute of Neurological and Communicative Disorders and Strokes-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable dementia\n* Provides care for a relative 60 years of age or older with progressive dementia\n* Primary informal care provider for the care recipient with dementia\n* Spends a minimum of 6 hours per week in providing direct care to the person with progressive dementia\n* Scores a minimum of 10 on the Patient Health Questionnaire-9 (PHQ-9)\n\nExclusion Criteria:\n\n* Endorses fewer than three problems on the depression and disruptive behaviors factors of the modified version of Revised Memory and Behavior Problem Checklist\n* Meets criteria for psychotic disorder on the Mini-International Neuropsychiatric Interview (MINI 5.0.0)\n* Meets criteria for moderate or high suicide risk on the MINI 5.0.0\n* Provides care for a dementia care recipient who has received a terminal diagnosis of 6 months, as defined by hospice care"}, 'identificationModule': {'nctId': 'NCT00769769', 'briefTitle': 'Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Telephone CBT for Depressed African-American Dementia Caregivers', 'orgStudyIdInfo': {'id': 'R34MH078999', 'link': 'https://reporter.nih.gov/quickSearch/R34MH078999', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R34MH078999', 'link': 'https://reporter.nih.gov/quickSearch/R34MH078999', 'type': 'NIH'}, {'id': 'DATR A4-GPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telephone-based psychotherapy', 'interventionNames': ['Behavioral: Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Face-to-face psychotherapy', 'interventionNames': ['Behavioral: Psychotherapy']}], 'interventions': [{'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.', 'armGroupLabels': ['Face-to-face psychotherapy']}, {'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.', 'armGroupLabels': ['Telephone-based psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32306-4300', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida State University College of Medicine', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'overallOfficials': [{'name': 'Robert L. Glueckauf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert L. Glueckauf', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert L. Glueckauf', 'investigatorAffiliation': 'Florida State University'}}}}