Phase 4
Completed N=494
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
Source: ClinicalTrials.gov NCT03688100 ↗Enrolled (actual)
494
Serious AEs
15.1%
Results posted
Mar 2024
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
10citations · ~5 / year
Comparative Effectiveness of Psychotherapy vs Antidepressants for Depression in Heart Failure: A Randomized Clinical Trial.
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.
Linked Publications (2)
-
Comparative Effectiveness of Psychotherapy vs Antidepressants for Depression in Heart Failure: A Randomized Clinical Trial.
-
Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.