Heart Failure Clinical Trial

Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

Summary

We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.

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Full Description

Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.

Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.

Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

HF New York Heart Association classes: II-IV.
Life expectancy of more than 6 months.
PHQ-9 score ≥10.
Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.

Exclusion Criteria:

Imminent danger to self or others.
Cognitive impairments with a MOCA score of < 23.
Bipolar, Psychotic, and Substance-induced Disorders.
Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

494

Study ID:

NCT03688100

Recruitment Status:

Completed

Sponsor:

Cedars-Sinai Medical Center

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There is 1 Location for this study

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Cedars Sinai Medical Center
Los Angeles California, 90048, United States

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Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

494

Study ID:

NCT03688100

Recruitment Status:

Completed

Sponsor:


Cedars-Sinai Medical Center

How clear is this clinincal trial information?

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