Heart Failure Clinical Trial

Stepped Care for Depression in Heart Failure

Summary

This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.

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Full Description

Depression is associated with poor heart failure self-care. Good self-care practices, including following dietary recommendations, taking prescribed medications, monitoring symptoms, and regular light exercise have been shown to improve quality of life and survival in persons with heart failure.

Both CBT and antidepressant medications have been used in previous studies to treat major depression in patients with heart failure. Participants in the intervention arm in this trial will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT may also be referred to their own physician to discuss antidepressant medications.

Heart failure self-care education and support will be provided after the first 8 weeks of the depression intervention. The study will determine whether people with heart failure benefit more from self-care education and support after their depression has been treated with a stepped care intervention, as compared to usual care for depression as provided by primary care providers.

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Eligibility Criteria

Inclusion Criteria:

Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure.
Current major depressive episode.
Baseline Beck Depression Inventory (BDI-II) score 14 or greater

Exclusion Criteria:

Dementia or other significant cognitive or communication deficits
Terminal illness other than HF
Insurmountable logistical barriers to participation
Age less than 25 years
Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder
High risk of suicide
Current participation in non-study psychotherapy for depression or other psychiatric conditions
Initiation or modification of antidepressant medication treatment within past two months
Renal or hepatic conditions that would preclude the use of antidepressants.

Study is for people with:

Heart Failure

Estimated Enrollment:

139

Study ID:

NCT02997865

Recruitment Status:

Completed

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Behavioral Medicine Center Washington University
Saint Louis Missouri, 63108, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

139

Study ID:

NCT02997865

Recruitment Status:

Completed

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

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