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

NCT ID: NCT00769769

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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Health Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telephone-based psychotherapy

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.

Face-to-face psychotherapy

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type BEHAVIORAL

Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.

Interventions

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Psychotherapy

Participants will receive 12 sessions of cognitive behavioral therapy delivered weekly over a period of 3 months.

Intervention Type BEHAVIORAL

Psychotherapy

Participants will receive 12 sessions of telephone-based cognitive behavioral therapy delivered weekly over 3 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Robert L. Glueckauf

OTHER

Sponsor Role lead

Responsible Party

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Robert L. Glueckauf

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert L. Glueckauf, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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Florida State University College of Medicine

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH078999

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A4-GPS

Identifier Type: -

Identifier Source: secondary_id

R34MH078999

Identifier Type: NIH

Identifier Source: org_study_id

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