COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients

Objectives: 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.

Research Design: The Study utilizes a Phase-I RCT design to achieve this Aim.

Methodology: Patients with confirmed ACS are screened for symptoms of distress and/or
depressed mood within 7 days of the index ACS event, using the Beck Depression Inventory
(BDI). Those meeting inclusion criterion on the BDI (score>10) and consenting to study are
followed for 3-months, at which time they are re-assessed. Those continuing to show BDI
score >10 and consenting, are randomized to the intervention condition (INT) or to usual
cardiologic care (UCC). INT is defined by up to 6-months of a patient preference, stepped
care treatment whereby patients chose between brief, problem-focused psychotherapy (PST) and
antidepressant medication (MED). Patients are re-evaluated at 2- and 4-months after
randomization. Those not showing sufficient improvement in symptoms receive augmented
therapy. Those who initially choose PST can receive more frequent sessions and/or the
addition of MED; those who initially choose MED can receive a change of agent, an increase
in dosage, an additional medication, and/or PST.

Hypotheses to be tested are:

1. Patient satisfaction within intervention treatment (INT) will be higher than in the
usual cardiologic care (UCC) condition, as evidenced by self-report and levels of
participation

2. The INT group will experience a greater reduction in symptoms of distress and/or
depression over the treatment period than the UCC group (secondary hypothesis).

3. Improvement in symptoms of distress and/or depression will be associated with reduction
in levels of inflammatory markers and improvement in adherence with physician
prescribed aspirin therapy (secondary hypothesis).

This is a multi-site study involving Mt. Sinai, and Yale and Columbia University Schools of
Medicine. A total of 500 people will be screened into the initial 'observational period',
which occurs at the time of new ACS diagnosis. From among these, it is anticipated that 200
people will evidence persistent BDI > 10 at 3-month follow-up and agree to be enrolled in
the Phase 1 RCT.

The clinical relevance of the Study concerns demonstration of the acceptability and
satisfaction with the treatment approach by post-ACS patients, as preliminary to a Phase-III
RCT that would test the effect of such an intervention on event-free survival after ACS.

Inclusion Criteria:

1. 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.

2. Score on the Beck Depression Inventory (BDI) > 10 within 7 days of index ACS event
and 3-months later.

Exclusion Criteria:

1. active suicidal or homicidal ideation, as these patients require immediate referral
for assessment and treatment (see below for procedures for these patients);

2. current alcohol or other substance abuse disorders (as depressive symptoms may be a
result of these disorders),

3. any current psychotic disorder,

4. history of psychotic disorder, bipolar disorder, or serious personality disorders,

5. diagnosis of a terminal non-cardiac illness,

6. ACS diagnosis secondary to diagnosis of a severe medical disease,

7. inability to communicate in English,

8. levels of cognitive impairment indicative of dementia,

9. unavailability for the period of the study,

10. overt hypothyroid, and

11. currently taking triptans.