Phase 4
N=494
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
Depression · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03688100 ↗Enrolled (actual)
494
Serious AEs
15.1%
Results posted
Mar 2024
Primary outcome: Primary: Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up — 14.31; 14.54; 8.09; 7.53 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Behavioral Activation Therapy (Behavioral); Medication Management (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up |
14.31; 14.54; 8.09; 7.53 | — |
| SECONDARY Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results |
35.56; 35.89; 37.46; 37.69; 37.12; 38.82 | — |
| SECONDARY Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. |
60.57; 62.03; 61.43; 64.35; 65.48; 63.24 | — |
| SECONDARY Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. |
68.06; 65.14; 61.52; 57.70; 57.38; 55.27 | — |
| SECONDARY Mean Number of Emergency Department Visits |
0.90; 0.55; 1.51; 1.31; 2.43; 1.87 | 0.005 sig |
| SECONDARY Mean Number of Readmissions (Hospitalization) |
0.86; 0.67; 1.48; 1.30; 2.20; 2.00 | >0.05 |
| SECONDARY If Hospitalized, Mean Number of Total Days in the Hospital |
5.50; 3.84; 8.79; 7.18; 15.19; 11.11 | 0.002 sig |
| SECONDARY Mortality Was Also Measured |
16; 7; 24; 15; 36; 27 | >0.05 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- HF New York Heart Association classes: II-IV.
- Life expectancy of more than 6 months.
- PHQ-9 score ≥10.
- Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.
Exclusion Criteria
- Imminent danger to self or others.
- Cognitive impairments with a MOCA score of < 23.
- Bipolar, Psychotic, and Substance-induced Disorders.
- Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.
Data sourced from ClinicalTrials.gov (NCT03688100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.