Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
Status: | Recruiting |
---|---|
Conditions: | Depression, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/1/2019 |
Start Date: | November 9, 2018 |
End Date: | September 1, 2022 |
Contact: | Vicki A Manoukian, Coordinator, MA |
Email: | vicki.manoukian@cshs.org |
Phone: | 310-423-5067 |
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.
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.
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-12), 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.
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-12), 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.
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.
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Waguih W Ishak, MD, FAPA
Phone: 310-423-5067
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Click here to add this to my saved trials