Depression and Self-care in Heart Failure

Official Title: “Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression”

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.

Intervention(s) in this Clinical Trial

• Behavioral: Cognitive Behavior Therapy
  • 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.
• Other: Heart Failure Self-care Education
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Cognitive Behavior Therapy
• Other: Usual Care
  • Participants who are randomly assigned to usual care will receive whatever treatment (if any) for depression their own physician may prescribe. In most cases, treatment (if any is provided) is likely to consist of a serotonin reuptake inhibitor (SSRI) antidepressant such as sertraline or citalopram.

Primary Measures

• BDI-II score at 6 months
  • Time Frame: Baseline, 3 months, 6 months, 9 months , 12 months
    Safety Issue?: No

Secondary Measures

• Self-care of Heart Failure Index
  • Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
    Safety Issue?: No
• Beck Anxiety Inventory
  • Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
    Safety Issue?: No
• Medical outcomes study SF-12
  • Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
    Safety Issue?: No
• PROMIS Physical Functioning Scale
  • Time Frame: Baseline, 6 months
    Safety Issue?: No
• Kansas City Cardiomyopathy Questionnaires
  • Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
    Safety Issue?: No
• 6 Minute Walk Test
  • Time Frame: Baseline, 6 months
    Safety Issue?: No
• Depression Interview and Structured Hamilton (DISH)
  • Time Frame: Baseline, 6 months
    Safety Issue?: No

Inclusion Criteria:

• New York Heart Association Class I, II, or III Heart Failure (Clinically diagnosed at least 3 months ago)
• Meets the DSM-IV criteria for a current major depressive episode, or for current minor depression with a past history of at least one major depressive episode.
• PHQ-9 score of 10 or greater plus 2 or 3 on question 1 or 2 over the last 2 weeks including today

Exclusion Criteria:

• Less than 30 years old
• Current ETOH / drug abuse
• Bipolar disorder, schizophrenia, or other psychotic disorder
• Communication barrier
• Dementia
• Currently in competing research protocol
• High risk for suicide
• Insurmountable logistical barriers to laboratory assessment visits
• Major mobility-limiting physical disability
• Poor 1 year prognosis not r/t heart failure
• Hospitalized for heart failure or acute coronary syndrome in last month
• Initiated antidepressant therapy in the past 4 weeks
• Current non-study psychotherapy for depression or other psychiatric problem

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Washington University School of Medicine Other

Overall Clinical Trial Officials and Contacts

Kenneth E. Freedland, Ph.D. Principal Investigator Washington University School of Medicine Behavioral Medicine Center  

Overall Contact: Rebekah A McNiff, RN 314-286-1309 mcniffr@bmc.wustl.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01028625

Study ID Number: 201013037

ClinicalTrials.gov Identifier: NCT01028625

Health Authority: United States: Institutional Review Board