NCT00158054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

3.1 years

First QC Date

September 8, 2005

Results QC Date

March 4, 2015

Last Update Submit

August 15, 2017

Conditions

Heart DiseasesDepression

Keywords

depressionacute coronary syndromeclinical trials

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.

    Number of participants who rated their depression care as excellent or very good as a percentage.

    6 months

Secondary Outcomes (3)

  • Level of Depressive Symptoms

    6 months

  • Number of Participants Experiencing Major Adverse Cardiovascular Events

    6 months

  • All-cause Mortality

    18 months

Study Arms (2)

Intervention Condition (INT)

EXPERIMENTAL

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

Usual Cardiologic Care Condition (UCC)

OTHER

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

Interventions

Enhanced depression careBEHAVIORAL

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

Also known as: Patience-preference, stepped care distress treatment, intervention condition (INT)
Intervention Condition (INT)
Referred depression careBEHAVIORAL

Physician notified of depression symptoms, usual care followed.

Also known as: Usual Cardiologic Care (UCC)
Usual Cardiologic Care Condition (UCC)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale University

New Haven, Connecticut, 06520, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Publications (2)

  • 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.

    PMID: 24835038DERIVED

  • 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.

    PMID: 20386003DERIVED

MeSH Terms

Conditions

Heart DiseasesDepressionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesBehavioral SymptomsBehaviorMyocardial IschemiaVascular Diseases

Results Point of Contact

Title
Karina W Davidson, PhD
Organization
Columbia University Medical Center
kd2124@cumc.columbia.edu
212-342-4493

Study Officials

  • Karina Davidson, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Behavioral Medicine

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2005

Primary Completion

February 1, 2008

Study Completion

April 1, 2015

Last Updated

August 23, 2017

Results First Posted

March 3, 2016

Record last verified: 2017-08

Locations

US(3)