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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: Completed NA study, sponsored by Columbia University.

NCT00158054 is a NA study that has completed, run by Columbia University. The registered enrollment target is 157 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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

Interventions

  • BEHAVIORAL Enhanced depression care
  • BEHAVIORAL Referred depression care

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2005-01
Est. Completion 2015-04
Phase NA
Columbia University

958 total trials

What the finished NCT00158054 record still lists

NCT00158054 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Enhanced depression care is the first listed.

NCT00158054 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00158054's enrollment target sits among peer trials

157 656th of 2000 higher than 1,345 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00158054, the US trial registry maintained by the National Library of Medicine. NCT00158054 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.