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Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert L. Glueckauf, Florida State University
ClinicalTrials.gov Identifier:
NCT00769769
First received: October 8, 2008
Last updated: August 22, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Depression clinical diagnosis [ Time Frame: Measured before and after 3-month intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caregiver health status [ Time Frame: Measured before and after 3-month intervention ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: October 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769769

Locations
United States, Florida
Florida State University College of Medicine
Tallahassee, Florida, United States, 32306-4300
Sponsors and Collaborators
Robert L. Glueckauf
Investigators
Principal Investigator: Robert L. Glueckauf, PhD Florida State University
  More Information

No publications provided

Responsible Party: Robert L. Glueckauf, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier: NCT00769769     History of Changes
Other Study ID Numbers: R34 MH078999, R34MH078999, DATR A4-GPS
Study First Received: October 8, 2008
Last Updated: August 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Florida State University:
Health Status

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 20, 2014