TY - JOUR
T1 - Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial
AU - Whang, William
AU - Burg, Matthew M.
AU - Carney, Robert M.
AU - Freedland, Kenneth E.
AU - Bigger, J. Thomas
AU - Catellier, Diane
AU - Czajkowski, Susan
AU - Frasure-Smith, Nancy
AU - Haas, Donald C.
AU - Jaffe, Allan S.
AU - Lespérance, Francois
AU - Medina, Vivian
AU - Duer-Hefele, Joan
AU - Osorio, Gabrielle A.
AU - Parsons, Faith
AU - Shapiro, Peter A.
AU - Sheps, David S.
AU - Vaccarino, Viola
AU - Davidson, Karina W.
PY - 2012/9
Y1 - 2012/9
N2 - 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.
AB - 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.
KW - Acute coronary syndrome
KW - Clinical trial
KW - Depression
UR - http://www.scopus.com/inward/record.url?scp=84864296261&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84864296261&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2012.05.005
DO - 10.1016/j.cct.2012.05.005
M3 - Article
C2 - 22640924
AN - SCOPUS:84864296261
SN - 1551-7144
VL - 33
SP - 1003
EP - 1010
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 5
ER -