Project Summary

PCORI has identified relief of symptoms that patients with advanced illness often experience, as an important research topic. Patients, clinicians, and others want 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.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Heart failure is a long-term health problem in which the heart can’t pump enough blood to the rest of the body. Patients with heart failure have symptoms such as shortness of breath, fatigue, and rapid heartbeat. Nearly half of these patients also have symptoms of depression. Depression is a health problem that causes people to feel sad, hopeless, or empty on most days, for periods lasting more than two weeks. Having depression with heart failure decreases a patient’s quality of life and can increase the risk of death.

In this study, the research team is comparing two treatments for depression among patients with advanced heart failure. The first treatment is behavioral activation, or BA. BA can decrease symptoms of depression by helping patients take part in activities they value and enjoy. The second treatment is medicine management. Patients receive an antidepressant medicine, and a care manager follows up with the patient on their use of the medicine.

Who can this research help?

Doctors, patients, and caregivers can use these results when considering how to manage depression in advanced heart failure.

What is the research team doing?

The research team is enrolling 416 patients with advanced heart failure and depression who get treatment at a large academic medical center. The team is assigning patients by chance to receive either BA or medicine management.

In the BA group, patients have therapy sessions where a therapist asks them about their life and values and helps them think of activities they like. If patients can’t do the activities they used to enjoy, the BA therapist works with them to modify the activities or try new ones. The therapist encourages patients to take part in these activities and record them in a daily log book. The first therapy session is a one-on-one, in-person, introductory session with a BA therapist. Patients then have 12 weekly phone sessions with the therapist, and then three more monthly phone sessions to help them stay involved in activities. All sessions last 50 minutes.

Patients in the medicine management group have an initial in-person, one-on-one treatment session with a care manager. During this session, patients get information about depression and antidepressant medicine options, and a doctor prescribes antidepressant medicine. They then receive 12 weekly phone visits from their care manager, followed by 3 monthly phone visits. After that, patients check in with their care manager as needed.

Six months after treatment starts, the research team is asking patients about symptoms of depression. The team is also surveying patients about their quality of life at the start of the study and again 3, 6, and 12 months later. At these same timepoints, the team is asking each patient’s primary caregiver about physical, emotional, or social burdens they have had in the past four weeks.

The research team is looking at patients’ medical records to learn about emergency room, or ER, or hospital visits or deaths among patients, and comparing these outcomes between the two groups.

Patients who have had heart failure and depression and their caregivers, mental health professionals, and cardiologists are helping to plan and conduct this study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 416 patients ages 18 and older diagnosed with advanced heart failure and a depressive disorder 
Interventions/
Comparators
  • BA therapy
  • Antidepressant medicine management
Outcomes

Primary: depressive symptom severity 

Secondary: physical and mental health-related quality of life, heart-failure-specific quality of life, caregiver burden, ER visits, hospital readmissions, total number of days spent in the hospital, mortality 

Timeframe 6-month follow-up for primary outcome

Project Information

Waguih Ishak, MD
Cedars-Sinai Health System
$2,633,622
Personalized Treatments for Depressive Symptoms in Patients with Advanced Heart Failure

Key Dates

April 2018
June 2023
2018

Study Registration Information

Tags

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 15, 2022