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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00769769

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 III

MedlinePlus related topics: Caregivers Dementia Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Telephone CBT for Depressed African-American Dementia Caregivers

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

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.

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

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

Contacts

Contact: Robert L. Glueckauf, PhD

850-645-1541

robert.glueckauf@med.fsu.edu

Locations

United States, Florida
Florida State University College of Medicine
Tallahassee, Florida, United States, 32306-4300

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Robert L. Glueckauf, PhD

Florida State University

More Information

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

Keywords provided by National Institute of Mental Health (NIMH):

Health Status

Study placed in the following topic categories:

Depression
Depressive Disorder
Dementia
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009