Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 8, 2008 | ||||
| Last Updated Date | March 9, 2009 | ||||
| Start Date ICMJE | October 2008 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Depression clinical diagnosis [ Time Frame: Measured before and after 3-month intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00769769 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Caregiver health status [ Time Frame: Measured before and after 3-month intervention ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers | ||||
| Official Title ICMJE | Telephone CBT for Depressed African-American Dementia Caregivers | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. Participation 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 106 | ||||
| Estimated Completion Date | March 2011 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00769769 | ||||
| Other Study ID Numbers ICMJE | R34 MH078999, DATR A4-GPS | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Robert L. Glueckauf, PhD, Principal Investigator, Florida State University College of Medicine | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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