Results Summary

What was the research about?

Heart failure occurs when the heart doesn’t pump blood well enough to meet the body’s needs. In advanced heart failure, people may feel tired, eat less, and feel short of breath even when resting. About half of people with heart failure also have depression. With depression, people feel sad, hopeless, or empty.

In this study, the research team compared two approaches to treat depression in patients with advanced heart failure:

  • Behavior therapy. A therapist helped patients find activities they liked to do and make plans to do them.
  • Medicine to lift mood. A social worker or nurse worked with doctors to prescribe medicine to treat patients’ depression.

What were the results?

After 3, 6, and 12 months, patients receiving behavior therapy or medicine had similar levels of depression. In both approaches, patients’ symptoms improved by 50 percent by the end of the study.

Compared with patients who received medicine to lift mood, patients who received behavior therapy had:

  • Better quality of life related to physical health at 6 months but not at 3 or 12 months
  • Fewer emergency room visits at 3, 6, and 12 months
  • Fewer days in the hospital at 3, 6, and 12 months

At 3, 6, and 12 months, the two approaches didn’t differ in:

  • Quality of life related to mental health
  • Quality of life related to having heart failure
  • Caregiver stress
  • The number of patients who returned to the hospital after discharge
  • The number of deaths

Who was in the study?

The study included 416 patients with advanced heart failure and untreated depression. Among patients, 56 percent were White, 29 percent were Black, 5 percent were Asian, and 10 percent reported their race as other; 14 percent were Hispanic. The average age was 61, and 58 percent were men. All received care at Cedars-Sinai Medical Center in Los Angeles.

What did the research team do?

The research team assigned patients by chance to receive behavior therapy or medicine. At the start of the study, all patients met with a therapist or care manager in person. After that, they met by phone or video once a week for the first three months, once a month for next three months, and then as needed for the rest of the year.

At the start of the study and again 3, 6, and 12 months later, patients completed surveys about their symptoms and quality of life. Caregivers completed surveys about their stress. The research team looked at patients’ health records for emergency room visits, hospital stays, and deaths.

Patients, caregivers of patients with advanced heart failure, doctors, and mental health professionals helped design the study.

What were the limits of the study?

The study took place in one health system. Results may differ in other health systems.

Future research could expand the study to include more health systems.

How can people use the results?

Patients with advanced heart failure and their doctors can use these results when considering treatment for depression.

PCORI identified relief of symptoms that patients with advanced illness often experience as an important research topic. Patients, clinicians, and others wanted to learn how different treatment strategies affect pain, fatigue, insomnia, nausea, depression, and other common symptoms. To address this issue, PCORI launched an initiative in 2017 on Symptom Management for Patients with Advanced Illness. The initiative funded this research project and others.

Final Research Report

This project's final research report is expected to be available by November 2024.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers requested a substantial amount of additional information in the report that would be necessary to fully evaluate the scientific validity of the study. Among the sections added or revised by the researchers were: a causal model; a more complete list of study outcomes, how they were measured and how they were collected; study methods related to participant eligibility, recruitment and enrollment; and summary statistics for the main outcome measures.
  • The reviewers noted that the researchers described the study as pragmatic but did not explain the pragmatic nature of the trial in the report. The researchers responded by adding a section to their study results explaining how their study met the expected characteristics of a pragmatic study. In particular, the researchers described the interventions they were comparing in the study to what would be delivered when the same treatments are offered in usual care.
  • The reviewers noted that the researchers claimed their study results were generalizable to the population of individuals with heart failure and depression, and asked the researchers to justify their statement by comparing their hospital site to other settings and geographical locations in the United States. The researchers compared their participant sample to the U.S. Census 2020 population, noting the considerable diversity produced from their study sample. The limits on study generalizability came primarily from healthsystem factors and comparison to less resource-rich healthcare settings.
  • The reviewers wanted more explanation for the hypothesis that behavioral activation would have superior outcomes to antidepressant medication in the study’s sample of patients with depression and heart failure, especially since the report stated that the two treatments and comparable effects for depression treatment. The researchers explained that patients with heart failure were prone to inactivity, which is also a symptom of depression. Behavioral activation specifically targets inactivity and therefore should be a more direct treatment compared to medication.

Conflict of Interest Disclosures

Project Information

Waguih William IsHak, MD, FAPA
Cedars-Sinai Health System
$2,633,608
Personalized Treatments for Depressive Symptoms in Patients with Advanced Heart Failure

Key Dates

April 2018
June 2023
2018
2024

Study Registration Information

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Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 14, 2024