Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial

William Whang, Matthew M. Burg, Robert M. Carney, Kenneth E. Freedland, J. Thomas Bigger, Diane Catellier, Susan Czajkowski, Nancy Frasure-Smith, Donald C. Haas, Allan S. Jaffe, Francois Lespérance, Vivian Medina, Joan Duer-Hefele, Gabrielle A. Osorio, Faith Parsons, Peter A. Shapiro, David S. Sheps, Viola Vaccarino, Karina W. Davidson

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference-based, stepped care protocol for persistent depressive symptoms after acute coronary syndrome (ACS). The overall aim of the vanguard phase was to determine whether the patient-preference, stepped care protocol, which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies (COPES) trial, was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites. Innovative design features of this trial include randomization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care. Additionally, delivery of psychotherapy was accomplished by telephone, or webcam, depending upon patient preference. The vanguard phase provides estimates of eligibility and screening/enrollment ratios, patient acceptance of screening, and retention. In this report, we describe the innovative features and the baseline results of the vanguard phase of CODIACS. The data from this vanguard study will be used to finalize planning for a large, phase III clinical trial designed to evaluate the effect of treatment on depressive symptoms, coronary events, and death.

Original languageEnglish (US)
Pages (from-to)1003-1010
Number of pages8
JournalContemporary Clinical Trials
Volume33
Issue number5
DOIs
StatePublished - Sep 2012

Keywords

  • Acute coronary syndrome
  • Clinical trial
  • Depression

ASJC Scopus subject areas

  • Pharmacology (medical)

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