N/A
N=157
COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
Heart Diseases · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00158054 ↗Enrolled (actual)
157
Serious AEs
28.0%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. — 54.2; 18.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced depression care (Behavioral); Referred depression care (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. |
54.2; 18.8 | — |
| SECONDARY Level of Depressive Symptoms |
13.2; 17.7 | — |
| SECONDARY Number of Participants Experiencing Major Adverse Cardiovascular Events |
3; 10 | — |
| SECONDARY All-cause Mortality |
9; 7 | — |
Summary
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.
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.
Data sourced from ClinicalTrials.gov (NCT00158054). 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.