Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Health Status
Eligibility 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
Sites / Locations
- Florida State University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telephone-based psychotherapy
Face-to-face psychotherapy
Arm Description
Outcomes
Primary Outcome Measures
Depression clinical diagnosis
Secondary Outcome Measures
Caregiver health status
Full Information
NCT ID
NCT00769769
First Posted
October 8, 2008
Last Updated
August 22, 2013
Sponsor
Robert L. Glueckauf
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00769769
Brief Title
Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers
Official Title
Telephone CBT for Depressed African-American Dementia Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert L. Glueckauf
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Health Status
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone-based psychotherapy
Arm Type
Experimental
Arm Title
Face-to-face psychotherapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.
Primary Outcome Measure Information:
Title
Depression clinical diagnosis
Time Frame
Measured before and after 3-month intervention
Secondary Outcome Measure Information:
Title
Caregiver health status
Time Frame
Measured before and after 3-month intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Glueckauf, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University College of Medicine
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306-4300
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Delivery Methods of Cognitive Behavioral Therapy for Depressed African-American Dementia Caregivers
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