Depressive Symptoms in Advanced Heart Failure
Key Inclusion Criteria
- New York Heart Association classes II-IV
- Life expectancy of more than 6 months
- PHQ-9 (depression rating scale) score ≥10
- Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia) and Depressive Disorder Unspecified
Key Exclusion Criteria
- Imminent danger to self or others
- Cognitive impairments with a Montreal Cognitive Assessment score of <23
- Bipolar, psychotic and substance-induced disorders
- Patients in active treatment of depression who are already on antidepressants, psychotherapy or both
Full Study Name
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure (IRB no. 54483)
This study focuses on patients who have been diagnosed with advanced heart failure and may be exhibiting signs of depression. The purpose of the study is to compare the effectiveness of two evidence-based treatment approaches to improve depression in patients with advanced heart failure: (1) Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient and (2) Antidepressant Medication Management (MEDS). The study 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, general physical and mental health-related quality of life (HRQoL), heart failure-specific HRQoL and caregiver burden.
Participants will be randomly assigned to one of the two study groups. Behavioral Activation Psychotherapy will consist of an introductory treatment session, followed by 12 weekly videophone or telephone sessions and then monthly for 3 months and as needed thereafter. A typical session will include a review of daily monitoring record forms, discussion of life areas and positive feedback for participation in activities outside of sessions that have brought enjoyment in the past.
Antidepressant Medication Management will include meeting with the patient in an introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will be prescribed a standard-of-care, antidepressant medication, followed by 12 weekly follow-up videophone or telephone visits and then monthly for 3 months, and as needed thereafter.