N/A
Completed N=139
Stepped Care for Depression in Heart Failure
Heart Failure · Depressive Disorder, Major
Source: ClinicalTrials.gov NCT02997865 ↗
Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Beck Depression Inventory (BDI-2) Total Score — 15.6; 19.6 score on a scale
Summary
This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Depression Inventory (BDI-2) Total Score |
15.6; 19.6 | — |
| PRIMARY Self Care of Heart Failure Index (SCHFI) Maintenance Subscale |
70.4; 73.0 | — |
| SECONDARY Beck Anxiety Inventory |
12.5; 15.1 | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire (KCCQ) |
63.7; 61.2 | — |
| SECONDARY Hamilton Rating Scale for Depression (HAM-D-17) |
12.5; 15.0 | — |
| SECONDARY Actigraphy |
— | — |
Eligibility Criteria
Inclusion Criteria
- Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure.
- Current major depressive episode.
- Baseline Beck Depression Inventory (BDI-II) score 14 or greater
Exclusion Criteria
- Dementia or other significant cognitive or communication deficits
- Terminal illness other than HF
- Insurmountable logistical barriers to participation
- Age less than 25 years
- Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder
- High risk of suicide
- Current participation in non-study psychotherapy for depression or other psychiatric conditions
- Initiation or modification of antidepressant medication treatment within past two months
- Renal or hepatic conditions that would preclude the use of antidepressants.
Data sourced from ClinicalTrials.gov (NCT02997865). 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.