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NCT00158054 · ClinicalTrials.gov registry record · NA
COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 157
- Enrollment target
NCT00158054 is a NA study that has completed, run by Columbia University. The registered enrollment target is 157 participants.
The verdict
NCT00158054, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 157 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Enhanced depression care
- BEHAVIORAL Referred depression care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2005-01 |
| Est. Completion | 2015-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00158054
The ClinicalTrials.gov registry entry for NCT00158054 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhanced depression care is the first listed.
NCT00158054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00158054 about?
NCT00158054 is a clinical study titled "COPES Phase I Randomized Controlled Trial of Treatment For Distress in Heart Disease Patients". 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...
What is the current status of trial NCT00158054?
This trial is currently completed. It is a NA study. The enrollment target is 157 participants. The study started on 2005-01. Estimated completion is 2015-04.
What interventions are being tested in trial NCT00158054?
The interventions under investigation include: Enhanced depression care (BEHAVIORAL), Referred depression care (BEHAVIORAL).
Who is sponsoring clinical trial NCT00158054?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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