The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart failure self-care education is superior to "usual care" for depression.
Comorbid depression is common in heart failure, but little is known about how to treat it. This randomized, controlled, efficacy trial will compare cognitive behavior therapy (CBT) to usual care (UC) for depression in heart failure. CBT will be integrated with an intervention to improve heart failure self-care, because depression and inadequate self-care are thought to be interrelated problems. It will also be integrated with clinical attention to primary caregiver stress. Basic heart failure education will be provided to all participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
CBT utilizes a variety of strategies and techniques to modify cognitions and behaviors that contribute to depression such as behavioral activation; identifying and challenging distressing thoughts, beliefs, and attitudes; and systematic problem-solving. In this trial, CBT will be integrated with an intervention aimed at improving heart failure self-care, and with attention to primary caregiver stress. The CBT sessions will usually last about 50 minutes and will be scheduled weekly for up to 6 months, with additional maintenance contacts after that. The frequency of sessions will be tapered prior to 6 months if the participant meets the study criteria for depression remission and has acquired relapse-prevention skills.
Participants in both arms will receive heart failure educational material from the Heart Failure Society of America. In addition, a RN will review educational material with participants during baseline visit and with 3 weekly follow up phone calls.
Washington University School of Medicine Behavioral Medicine Center
St Louis, Missouri, United States
BDI-II score at 6 months
Time frame: Baseline, 3 months, 6 months, 9 months , 12 months
Self-care of Heart Failure Index
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Beck Anxiety Inventory
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Medical outcomes study SF-12
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
PROMIS Physical Functioning Scale
Time frame: Baseline, 6 months
Kansas City Cardiomyopathy Questionnaires
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
6 Minute Walk Test
Time frame: Baseline, 6 months
Depression Interview and Structured Hamilton (DISH)
Time frame: Baseline, 6 months
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