Over 5 million Americans have heart failure (HF), a disabling medical illness with a poor prognosis and profound effects on quality of life. Depression is common in patients with HF, and it worsens functional impairment and quality of life, and decreases survival. Treatment of depression might improve these outcomes, yet there have been very few treatment studies. Safe and effective antidepressant options are limited for these patients. We propose to conduct a randomized, controlled, single-blind trial of a cognitive behavioral intervention for depressed outpatients with HF.
The specific aims are: 1) To test the hypothesis that cognitive behavior therapy (CBT) is superior to supportive clinical management (SCM) with respect to depression, heart failure self-care, and HF-related quality of life outcomes;2) to compare CBT to SCM on secondary outcomes including anxiety, general health-related quality of life, physical activity and walk test performance, HF-related biomarkers, and cardiac hospitalizations and deaths;and 3) To identify predictors, moderators, and mediators of treatment outcomes, including sociodemographic characteristics, non-study antidepressants, severity of depression, severity and chronicity of heart failure, medical comorbidity, use of HF specialty care, and participation in cardiac rehabilitation. The participants will be 240 adults age >30 years in NYHA Class I, II, or III heart failure who meet the DSM-IV criteria for current major depression or for current minor depression with a past history of major depression. The baseline evaluation will assess depression, HF self-care, and quality of life, as well as medical history, left ventricular function via echocardiography, biomarkers including BNP and CRP, 6-minute walk test performance, physical activity via actigraphy, and anxiety. All participants will receive HF education materials and HF education contacts by a cardiac nurse. Participants will be randomly assigned to individual CBT or SCM with an experienced therapist. CBT will focus on cognitive and behavioral strategies for improving self-care, functioning, and mood. SCM will provide supportive attention to depression and coping with illness. The intervention will last up to 6 months, and brief maintenance therapy contacts will continue until one year after randomization. Sessions will be conducted by telephone if the patient is unable to participate in clinic sessions. Consenting primary caregivers will also be invited to participate in monthly sessions with the therapist. Participants will be asked to return for a 6-month evaluation at which time all of the baseline tests except for echocardiography will be repeated. They will also be asked to complete the self-report questionnaire battery at 3, 9, and 12 months. Hospitalizations will be tracked during the 12-month follow-up, and mortality will be tracked throughout the trial. If the intervention is efficacious in reducing depression and improving HF self- care, it will offer an important addition to the care of patients with HF and comorbid depression.
Over 5 million Americans suffer from heart failure and 550,000 new cases are diagnosed annually. As a progressive disease with a relatively rapid downward course, heart failure has profoundly negative effects on functioning, quality of life, health care utilization, and survival, all of which are worsened when it is accompanied by depression. This clinical trial will test the efficacy of cognitive-behavioral treatment of depression with an emphasis on improving self-care, in order to improve functioning and quality of life. The effects of treatment on other outcomes such as physical activity and rehospitalizations will also be investigated.
|Freedland, Kenneth E; Carney, Robert M; Rich, Michael W (2011) Effect of depression on prognosis in heart failure. Heart Fail Clin 7:11-21|
|Freedland, Kenneth E; Mohr, David C; Davidson, Karina W et al. (2011) Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med 73:323-35|