Depression and Self-care in Heart Failure (DASH)

The Washington University

Status: Completed

Conditions: Depression; Heart Failure

Treatments: Other: Heart Failure Self-care Education; Behavioral: Cognitive Behavior Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01028625

1R01HL091918 (U.S. NIH Grant/Contract)

201013037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Cognitive Behavior Therapy

Active Comparator group

Treatment:

Behavioral: Cognitive Behavior Therapy

Other: Heart Failure Self-care Education

Usual Care

Other group

Description:

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.

Treatment:

Other: Heart Failure Self-care Education