N/A
N=1,500
Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes
Acute Coronary Syndrome · Depressive Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01993017 ↗Enrolled (actual)
1,500
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Quality-Adjusted Life Years (QALYs) — -0.06; -0.06; -0.06 quality-adjusted life years (QALYs) — p=0.98
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy (CBT) (Other); Antidepressant Medication (Drug); Standard Care (Other); Depressive symptom screener (Other); No intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality-Adjusted Life Years (QALYs) |
-0.06; -0.06; -0.06 | 0.98 |
| SECONDARY Depression-free Days |
343.1; 351.3; 339.0 | — |
| SECONDARY Cost of Health Care Utilization |
6745; 6204; 7440 | — |
Summary
The purpose of this study is to examine, in a randomized controlled trial, the benefits and costs of the American Heart Association's (AHA) advisory for depression screen and treatment of post-acute coronary syndrome patients.
Eligibility Criteria
Inclusion Criteria
- With a documented acute coronary syndrome (ACS) within the past 2-12 months
- Over the age of 21 years
- Has access to a phone
Exclusion Criteria
Medical Exclusions:
- Terminal illness (life expectancy <1 year as determined by physician/medical record) defined as, but not limited to:
- NYHA class IV, ACC class D CHF requiring inotropes or mechanical assist devices or critical aortic stenosis without plan for correction
- End-stage COPD/emphysema
- Advanced cirrhosis with encephalopathy, varices, severe ascites
- Severe rheumatologic diseases requiring frequent hospitalizations, and multiple cytotoxic agents and/or disease modifying drugs
- Metastatic pancreatic, esophageal, colorectal or stomach cancer
- Metastatic sarcoma, ovarian, melanoma or renal cell cancer
- Metastatic breast cancer with multiple recurrences despite treatment
- Advanced CNS malignancies
- Recurrent hematologic malignancies with multiple recurrences despite treatment
- Persistent AIDS, untreated or treated
Psychiatric Exclusions:
- History of major depression
- Currently receiving depression treatment
- Dementia
- History of bipolar disorder
- History of psychosis
- History of suicide attempt or self-inflicted injuries
- Current alcohol or substance abuse
Other Exclusions:
- Non-English and non-Spanish speaking
Data sourced from ClinicalTrials.gov (NCT01993017). 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.