Expired Study
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New Haven, Connecticut 06520


Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

AAAB5166


NCT ID:

NCT00158054


Secondary ID:

GCO 02-0247


Study Acronym:


Brief Title:

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


Official Title:

Consortium for Translation of Psychosocial Depression Theories to Interventions and Dissemination - Project 2: Phase I Randomized Controlled Trial of Patient Preference, Stepped-Care Treatment For Distress in Heart Disease Patients


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

157


Enrollment Type:

Actual


Overall Contact Information

Official Name:Karina Davidson, Ph.D.
Principal Investigator
Columbia University

Study Dates

Start Date:January 2005
Completion Date:April 2015
Completion Type:Actual
Primary Completion Date:February 2008
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 15, 2017
First Received Date:September 8, 2005
First Results Date:March 4, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.
Time Frame:6 months
Safety Issues:False
Description:Number of participants who rated their depression care as excellent or very good as a percentage.
Outcome Type:Secondary Outcome
Measure:Level of Depressive Symptoms
Time Frame:6 months
Safety Issues:False
Description:Depressive symptoms were measured using the Beck Depression Inventory (BDI), which is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst sympt
Outcome Type:Secondary Outcome
Measure:Number of Participants Experiencing Major Adverse Cardiovascular Events
Time Frame:6 months
Safety Issues:False
Description:The table represents the number of participants experiencing major adverse cardiovascular events
Outcome Type:Secondary Outcome
Measure:All-cause Mortality
Time Frame:18 months
Safety Issues:False
Description:All- cause mortality

Study Interventions

Intervention Type:Behavioral
Name:Enhanced depression care
Description:Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach.
Arm Name:Intervention Condition (INT)
Other Name:Patience-preference
Intervention Type:Behavioral
Name:Referred depression care
Description:Physician notified of depression symptoms, usual care followed.
Arm Name:Usual Cardiologic Care Condition (UCC)
Other Name:Usual Cardiologic Care (UCC)

Study Arms

Study Arm Type:Experimental
Arm Name:Intervention Condition (INT)
Description: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.
Study Arm Type:Other
Arm Name:Usual Cardiologic Care Condition (UCC)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Columbia University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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