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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Mount Sinai School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00158054
First received: September 8, 2005
Last updated: June 14, 2011
Last verified: June 2011
  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.


Condition Intervention
Heart Diseases
Depression
Behavioral: Enhanced depression care
Behavioral: Referred depression care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Self-reported patient satisfaction with care for depressive symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Satisfaction with depression care


Secondary Outcome Measures:
  • Level of depressive symptoms [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Level of depressive symptoms

  • Major adverse cardiovascular events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Major adverse cardiovascular events

  • All-cause mortality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    All- cause mortality


Enrollment: 157
Study Start Date: January 2005
Estimated Study Completion Date: July 2012
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced depression care Behavioral: Enhanced depression care
Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach
Other Names:
  • Patience-preference
  • stepped care distress treatment
Referred depression care
Usual Care
Behavioral: Referred depression care
Physician notified of depression symptoms, usual care followed
Other Name: Usual Care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 > 10 within 7 days of index ACS event and 3-months later.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158054

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, New York
Columbia University
New York, New York, United States, 10032
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Karina Davidson, Ph.D. Mount Sinai School of Medicine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karina Davidson, Ph.D., Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00158054     History of Changes
Other Study ID Numbers: GCO 02-0247, N01-HC25197
Study First Received: September 8, 2005
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
depression
acute coronary syndrome
clinical trials

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014