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

• Authors: William Whang, Columbia University; Matthew M. Burg, Columbia University; Robert M. Carney, Washington Univiversity; Kenneth E. Freedland, Washington Univiversity; J. Thomas Bigger, Columbia University; Diane Catellier, University of North Carolina; Susan Czajkowski, National Heart Lung and Blood Institute; Nancy Frasure-Smith, McGill University; Donald C. Haas, University of Pennsylvania; Allan S. Jaffe, Mayo Clinic; Francois Lesperance, University of Montreal; Vivian Medina, Columbia University; Joan Duer-Hefele, Columbia University; Gabrielle A. Osorio, Columbia University; Faith Parsons, Columbia University; Peter A. Shapiro, Columbia University; David S. Sheps, Emory University; Viola Vaccarino, Emory University; Karina W. Davidson, Columbia University
• Journal Title: Contemporary Clinical Trials
• Volume: Volume 33, Number 5
• Publisher: Elsevier: 12 months | 2012-09-01, Pages 1003-1010
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.cct.2012.05.005
• Subjects: Health Sciences, Rehabilitation and Therapy; Health Sciences, General
• Keywords: Science & Technology; Life Sciences & Biomedicine; Medicine, Research & Experimental; Pharmacology & Pharmacy; Research & Experimental Medicine; Clinical trial; Depression; Acute coronary syndrome; MYOCARDIAL-INFARCTION; HEART-DISEASE; CARE MANAGEMENT; METAANALYSIS; ASSOCIATION; SYMPTOMS; EVENTS; ANTIDEPRESSANT; PSYCHOTHERAPY; PREVENTION

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. © 2012 Elsevier Inc..