Depression and Self-care in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure; Depression
• Interventions: Behavioral: Cognitive Behavior Therapy; Other: Heart Failure Self-care Education

• Registration Number: NCT01028625
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-09
• Study Start: 2010-01
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavior Therapy	Cognitive Behavior Therapy	-
Cognitive Behavior Therapy	Heart Failure Self-care Education	-
Usual Care	Heart Failure Self-care Education	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 Outcome Measures

Name	Time	Method
BDI-II score at 6 months	Baseline, 3 months, 6 months, 9 months , 12 months

Secondary Outcome Measures

Name	Time	Method
Self-care of Heart Failure Index	Baseline, 3 months, 6 months, 9 months, 12 months
Beck Anxiety Inventory	Baseline, 3 months, 6 months, 9 months, 12 months
Medical outcomes study SF-12	Baseline, 3 months, 6 months, 9 months, 12 months
PROMIS Physical Functioning Scale	Baseline, 6 months
Kansas City Cardiomyopathy Questionnaires	Baseline, 3 months, 6 months, 9 months, 12 months
6 Minute Walk Test	Baseline, 6 months
Depression Interview and Structured Hamilton (DISH)	Baseline, 6 months

Trial Locations

Locations (1)

Washington University School of Medicine Behavioral Medicine Center; 🇺🇸 St. Louis, Missouri, United States