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

Telephone CBT for Depressed African-American Dementia Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Psychotherapy; Behavioral: Psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephone-based psychotherapy	Behavioral: Psychotherapy; Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.; 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.; Behavioral: Psychotherapy; Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depression clinical diagnosis	Measured before and after 3-month intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Caregiver health status	Measured before and after 3-month intervention

Collaborators and Investigators

• Sponsor: Robert L. Glueckauf
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Robert L. Glueckauf, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 8, 2008
• First Submitted That Met QC Criteria: October 8, 2008
• First Posted (Estimate): October 9, 2008

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Health Status
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: R34MH078999 (U.S. NIH Grant/Contract); DATR A4-GPS