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

NCT ID: NCT00158054

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2015-04-30

Brief 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.

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.

Conditions

Heart Diseases; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Enhanced depression care

Intervention Type: BEHAVIORAL

Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach.

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.

Group Type: OTHER

Referred depression care

Intervention Type: BEHAVIORAL

Physician notified of depression symptoms, usual care followed.

Interventions

Enhanced depression care

Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach.

Intervention Type: BEHAVIORAL

Referred depression care

Physician notified of depression symptoms, usual care followed.

Intervention Type: BEHAVIORAL

Other Intervention Names

Patience-preference; stepped care distress treatment; intervention condition (INT); Usual Cardiologic Care (UCC)

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Karina Davidson

Professor of Behavioral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karina Davidson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Yale University

New Haven, Connecticut, United States

Mount Sinai School of Medicine

New York, New York, United States

Columbia University

New York, New York, United States

Countries

United States

References

Ye S, Shaffer JA, Rieckmann N, Schwartz JE, Kronish IM, Ladapo JA, Whang W, Burg MM, Davidson KW. Long-term outcomes of enhanced depression treatment in patients with acute coronary syndromes. Am J Med. 2014 Oct;127(10):1012-6. doi: 10.1016/j.amjmed.2014.05.004. Epub 2014 May 14.

Reference Type: DERIVED

PMID: 24835038 (View on PubMed)

Davidson KW, Rieckmann N, Clemow L, Schwartz JE, Shimbo D, Medina V, Albanese G, Kronish I, Hegel M, Burg MM. Enhanced depression care for patients with acute coronary syndrome and persistent depressive symptoms: coronary psychosocial evaluation studies randomized controlled trial. Arch Intern Med. 2010 Apr 12;170(7):600-8. doi: 10.1001/archinternmed.2010.29.

Reference Type: DERIVED

PMID: 20386003 (View on PubMed)

Other Identifiers

GCO 02-0247

Identifier Type: OTHER

Identifier Source: secondary_id

N01HC25197-0-0-0

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAB5166

Identifier Type: -

Identifier Source: org_study_id