CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 157 enrolled
Drug / intervention
Enhanced depression care +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Hospitalization with verified unstable angina (UA) or acute myocardial infarction (AMI)
  • ✓Beck Depression Inventory (BDI) score > 10 within 7 days of index ACS event and again at 3 months
Key exclusion· 10
  • ✕Active suicidal or homicidal ideation
  • ✕Current alcohol or other substance abuse disorders
  • ✕Current psychotic disorder
  • ✕History of psychotic disorder, bipolar disorder, or serious personality disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00158054
NCT00158054N/ACompleted
CompareCT.gov

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

Columbia University·interventional·Posted Sep 12, 2005·Updated Aug 23, 2017

In Brief

A clinical study evaluating Enhanced depression care and Referred depression care for Heart Diseases and Depression. Completed, enrolled 157 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Diseases, Depression
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartJan 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.8 years ago

Interventions

Enhanced depression carebehavioral

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

Referred depression carebehavioral

Physician notified of depression symptoms, usual care followed.