Document Detail


Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial.
MedLine Citation:
PMID:  22640924     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2012-05-25
Journal Detail:
Title:  Contemporary clinical trials     Volume:  33     ISSN:  1559-2030     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-07-30     Completed Date:  2012-12-17     Revised Date:  2014-05-01    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1003-10     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Acute Coronary Syndrome / psychology*
Aged
Clinical Protocols
Depression / complications*,  therapy*
Female
Humans
Male
Middle Aged
Myocardial Infarction / etiology*
Patient Preference
Patient Selection
Psychotherapy / methods*
Secondary Prevention
Serotonin Uptake Inhibitors / administration & dosage,  adverse effects,  therapeutic use*
Socioeconomic Factors
Grant Support
ID/Acronym/Agency:
K24 HL084034/HL/NHLBI NIH HHS; P01 HL088117/HL/NHLBI NIH HHS; RC2 HL101663/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Serotonin Uptake Inhibitors
Comments/Corrections

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