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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00769769 |
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.
Condition | Intervention | Phase |
---|---|---|
Depression |
Behavioral: Psychotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Telephone CBT for Depressed African-American Dementia Caregivers |
Estimated Enrollment: | 106 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Telephone-based psychotherapy: Experimental |
Behavioral: Psychotherapy
Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.
|
Face-to-face psychotherapy: Active Comparator |
Behavioral: Psychotherapy
Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert L. Glueckauf, PhD | 850-645-1541 | robert.glueckauf@med.fsu.edu |
United States, Florida | |
Florida State University College of Medicine | |
Tallahassee, Florida, United States, 32306-4300 |
Principal Investigator: | Robert L. Glueckauf, PhD | Florida State University |
Responsible Party: | Florida State University College of Medicine ( Robert L. Glueckauf, PhD, Principal Investigator ) |
Study ID Numbers: | R34 MH078999, DATR A4-GPS |
Study First Received: | October 8, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00769769 |
Health Authority: | United States: Federal Government |
Health Status |
Depression Depressive Disorder Dementia Behavioral Symptoms |