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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Karina Davidson, Columbia University
ClinicalTrials.gov Identifier:
NCT00158054
First received: September 8, 2005
Last updated: February 4, 2016
Last verified: February 2016
  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 Columbia University:

Primary Outcome Measures:
  • Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of participants who rated their depression care as excellent or very good as a percentage.


Secondary Outcome Measures:
  • Level of Depressive Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 symptoms).

  • Number of Participants Experiencing Major Adverse Cardiovascular Events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The table represents the number of participants experiencing 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
Study Completion Date: April 2015
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Condition (INT)
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.
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
  • intervention condition (INT)
Usual Cardiologic Care Condition (UCC)
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.
Behavioral: Referred depression care
Physician notified of depression symptoms, usual care followed.
Other Name: Usual Cardiologic Care (UCC)

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   (Adult, Senior)
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 (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.
  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
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Karina Davidson, Ph.D. Columbia University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karina Davidson, Professor of Behavioral Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00158054     History of Changes
Other Study ID Numbers: AAAB5166  N01HC25197  GCO 02-0247 
Study First Received: September 8, 2005
Results First Received: March 4, 2015
Last Updated: February 4, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
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 December 05, 2016