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. |
Professional Abstract
Objective
To compare the effectiveness of behavioral activation psychotherapy versus antidepressant medication management in reducing depression symptoms in patients with advanced heart failure
Study Design
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 416 patients ages 18 and older with advanced heart failure and untreated depression |
Interventions/ Comparators |
|
Outcomes | Primary: depressive symptom severity Secondary: physical and mental health-related quality of life; heart failure-specific quality of life; caregiver burden; morbidity, as measured by the number of emergency department visits, hospital readmissions, and days spent in the hospital; and mortality |
Timeframe | 6-month follow-up for primary outcome; 12-month follow-up for secondary outcomes |
This pragmatic randomized controlled trial compared two treatment approaches for depression among patients with untreated depression and advanced heart failure.
Researchers randomly assigned patients to one of two treatment approaches:
- Behavioral activation psychotherapy. A therapist guided and supported patients in selecting, personalizing, and engaging in activities they valued and enjoyed.
- Antidepressant management. A care manager—either a registered nurse or a social worker—coordinated patients’ antidepressant treatment in collaboration with a psychiatrist and a treating physician.
In both approaches, patients met with their therapist or care manager in person for an introductory session. Then they had phone or video sessions weekly for the first three months, monthly for the next three months, and then as needed for the rest of the year-long study.
At baseline and again 3, 6, and 12 months later, patients and their caregivers completed surveys to assess depression symptoms, physical and mental health-related quality of life, heart failure-specific quality of life, and caregiver burden. Researchers reviewed patients’ electronic health records to collect morbidity and mortality data.
The study included 416 patients with advanced heart failure and untreated depression. Of patients, 56% were White, 29% were Black, 5% were Asian, and 10% reported their race as other; 14% were Hispanic. The average age was 61, and 58% were male. All were receiving treatment at Cedars-Sinai Medical Center in Los Angeles.
Patients, caregivers of patients with advanced heart failure, physicians, and mental health professionals helped design the study.
Results
At 3, 6, and 12 months, the two treatment approaches did not differ significantly in depressive symptom severity. In both approaches, patients had a nearly 50% reduction in depressive symptoms (both p<0.0001).
Compared with patients who received antidepressant management, patients who received behavioral activation psychotherapy had:
- Greater quality of life related to physical health at 6 months (p=0.044) but not at 3 or 12 months.
- Fewer emergency department visits and fewer days in the hospital at 3, 6, and 12 months (all p<0.01). At 12 months, the average number of emergency department visits was 1.87 for patients receiving behavioral activation psychotherapy and 2.43 for antidepressant management; the average number of days in the hospital was 2.00 for behavioral activation psychotherapy and 2.20 for antidepressant management.
At 3, 6, and 12 months, the two approaches did not differ significantly in mental health-related quality of life, heart failure-specific quality of life, caregiver burden, hospital readmissions, or mortality.
Limitations
Patients received care at one health system. Results may differ in other health systems.
Conclusions and Relevance
In this study, behavioral activation psychotherapy and antidepressant management were effective at reducing the severity of depressive symptoms among patients with heart failure. Patients who received behavioral activation psychotherapy had improved physical health-related quality of life and fewer emergency department visits and hospitalizations than patients receiving antidepressant management.
Future Research Needs
Future research could include multiple health systems.
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.
Engagement Resources
Journal Citations
Results of This Project
Related Journal Citations
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.