Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Telephone CBT for Depressed African-American Dementia Caregivers |
- Depression clinical diagnosis [ Time Frame: Measured before and after 3-month intervention ] [ Designated as safety issue: No ]
- Caregiver health status [ Time Frame: Measured before and after 3-month intervention ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: Telephone-based psychotherapy |
Behavioral: Psychotherapy
Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.
|
| Active Comparator: Face-to-face psychotherapy |
Behavioral: Psychotherapy
Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Provides care for a relative 60 years of age or older with progressive dementia
- Primary informal care provider for the care recipient with dementia
- Spends a minimum of 6 hours per week in providing direct care to the person with progressive dementia
- Scores a minimum of 10 on the Patient Health Questionnaire-9 (PHQ-9)
Exclusion Criteria:
- Endorses fewer than three problems on the depression and disruptive behaviors factors of the modified version of Revised Memory and Behavior Problem Checklist
- Meets criteria for psychotic disorder on the Mini-International Neuropsychiatric Interview (MINI 5.0.0)
- Meets criteria for moderate or high suicide risk on the MINI 5.0.0
- Provides care for a dementia care recipient who has received a terminal diagnosis of 6 months, as defined by hospice care
Contacts and Locations| Contact: Robert L. Glueckauf, PhD | 850-645-1541 | robert.glueckauf@med.fsu.edu |
| United States, Florida | |
| Florida State University College of Medicine | Recruiting |
| Tallahassee, Florida, United States, 32306-4300 | |
| Contact: Robert L. Glueckauf, PhD 850-645-1541 robert.glueckauf@med.fsu.edu | |
| Contact: William S. Davis, PhD. 850-645-2745 william.davis@med.fsu.edu | |
| Principal Investigator: Robert L. Glueckauf, PhD | |
| Principal Investigator: | Robert L. Glueckauf, PhD | Florida State University |
More Information
No publications provided
| Responsible Party: | Robert L. Glueckauf, PhD, Principal Investigator, Florida State University College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00769769 History of Changes |
| Other Study ID Numbers: | R34 MH078999, DATR A4-GPS |
| Study First Received: | October 8, 2008 |
| Last Updated: | March 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Health Status |
Additional relevant MeSH terms:
|
Dementia Depression Depressive Disorder Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on June 18, 2013