COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
Heart Diseases, Depression
About this trial
This is an interventional treatment trial for Heart Diseases focused on measuring depression, acute coronary syndrome, clinical trials
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Yale University
- Mount Sinai School of Medicine
- Columbia University
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Intervention Condition (INT)
Usual Cardiologic Care Condition (UCC)
Enhanced depression care: Participants assigned to INT condition will be given an information brochure describing the intervention. This description will include an overview of the two elements of treatment (Problem Solving Therapy (PST), pharmacotherapy), the choice that the participant has for which element of treatment they will receive, and the stepped care aspect of treatment.
Referred depression care: Participants assigned to the usual cardiologic care condition (UCC) condition will be scheduled for their next follow-up visit and thanked for their time.