Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 4

Conditions: Heart Failure; Depression

Treatments: Drug: Medication Management; Behavioral: Behavioral Activation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03688100

Pro00054483

Details and patient eligibility

About

We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.

Full description

Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.

Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.

Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HF New York Heart Association classes: II-IV.
2. Life expectancy of more than 6 months.
3. PHQ-9 score ≥10.
4. Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.

Exclusion criteria

1. Imminent danger to self or others.
2. Cognitive impairments with a MOCA score of < 23.
3. Bipolar, Psychotic, and Substance-induced Disorders.
4. Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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494 participants in 4 patient groups

Patients: Medication Management (MEDS)

Active Comparator group

Description:

The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter.

Treatment:

Drug: Medication Management

Patients: Behavioral Activation Therapy (BA)

Active Comparator group

Description:

BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement.

Treatment:

Behavioral: Behavioral Activation Therapy

Caregivers: Medication Management (MEDS)

No Intervention group

Description:

Caregivers of patients receiving the the above described Medication Management (MEDS) intervention were monitored for caregiver burden at 3, 6, and 12 months.

Caregivers: Behavioral Activation Psychotherapy (BA)

No Intervention group

Description:

Caregivers of patients receiving the the above described Behavioral Activation Psychotherapy (BA) intervention were monitored for caregiver burden at 3, 6, and 12 months.