COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
Completed · Not applicable
Conditions studied: Heart Diseases, Depression
In brief
The specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or depressed mood" is defined by a score on the Beck Depression Inventory (BDI) \>10. The specific treatment approach utilized follows the, "Improving Mood-Promoting Access to Collaborative Treatment" (IMPACT) Clinical Trial, and involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol, patients choose between brief, problem focused psychotherapy and anti-depressant medication. Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up' treatment if patients are not demonstrating sufficient symptom reduction.
Key facts
- Study ID
- NCT00158054
- Run by
- Columbia University
- People needed
- 157
- Starts
- 2005-01-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2017-08-23
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hospitalization with a verified diagnosis of unstable angina (UA) or acute myocardial infarction (AMI). UA is defined as new-onset angina within 2 months, exacerbation of previous angina with pain at rest or with minimal exercise, prolonged chest pain (lasting > 20 minutes), or angina within 2 weeks following discharge for myocardial infarction in patients with documented coronary artery disease (defined as ischemic ECG ST-T segment changes, previously documented MI, positive nuclear treadmill test result, or coronary angiographic evidence of blockage of 50% stenosis in >1 major coronary artery). AMI is defined as at least 2 of the following: ischemic chest pain lasting >20 minutes, acute rise in serum troponin-I >1.0 ng/L, and new pathologic ST segments in >2 contiguous ECG leads.
- Score on the Beck Depression Inventory (BDI) > 10 within 7 days of index ACS event and 3-months later.
You may not qualify if…
- active suicidal or homicidal ideation, as these patients require immediate referral for assessment and treatment (see below for procedures for these patients);
- current alcohol or other substance abuse disorders (as depressive symptoms may be a result of these disorders),
- any current psychotic disorder,
- history of psychotic disorder, bipolar disorder, or serious personality disorders,
- diagnosis of a terminal non-cardiac illness,
- ACS diagnosis secondary to diagnosis of a severe medical disease,
- inability to communicate in English,
- levels of cognitive impairment indicative of dementia,
- unavailability for the period of the study,
- overt hypothyroid, and
- currently taking triptans.
Where it is running
- Yale University — New Haven, Connecticut, United States
- Mount Sinai School of Medicine — New York, New York, United States
- Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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