Depressive symptoms are detected in nearly half of patients with heart failure and constitute a risk factor for functional decline and death. The goal of the proposed research is to generate scientific evidence to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. This real-world randomized pragmatic trial is set to compare the effectiveness of offering patients opportunities to enhance their existing care plans by one of three evidence-based treatment approaches:
- behavioral activation (a patient-centered psychotherapy that emphasizes engagement in enjoyable and valued personalized activities as selected by the patient),
- antidepressant medication management, and
- combined behavioral activation plus antidepressant medication management.
The proposed research will examine the impact of these treatment enhancements on the following outcomes that patients and caregivers have identified as most important or advantageous: depressive symptom reduction; improvement in functioning, quality of life, and overall physical and mental health; and less caregiver burden. We will also examine the following outcomes that patients and caregivers have identified as disadvantageous: morbidity (as evidenced by frequent emergency department visits, hospital readmissions, and longer hospital stays) and mortality.
All patient/caregiver-centered outcomes will be longitudinally collected in order to assess the immediate-, short-, intermediate-, and long-term impact on patients’ lives. The results from this research study will help patients, caregivers, and physicians decide what treatment path to follow to alleviate depressive symptoms during advanced medical illness. Furthermore, this study will include patients and other stakeholder engagement in all stages of the study—study design, outcomes selection, data collection and analysis, recruitment, development, intervention implementation, and dissemination of results—to ensure that a patient-centered research, dissemination, and implementation plan is produced.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.