Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial.
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.
Columbia University Medical Center, New York, NY, USA.
William
W
Whang
Matthew M
MM
Burg
Robert M
RM
Carney
Kenneth E
KE
Freedland
J Thomas
JT
Bigger
Diane
D
Catellier
Susan
S
Czajkowski
Nancy
N
Frasure-Smith
Donald C
DC
Haas
Allan S
AS
Jaffe
Francois
F
Lespérance
Vivian
V
Medina
Joan
J
Duer-Hefele
Gabrielle A
GA
Osorio
Faith
F
Parsons
Peter A
PA
Shapiro
David S
DS
Sheps
Viola
V
Vaccarino
Karina W
KW
Davidson
D054058:Acute Coronary Syndrome / Q000523:psychology*; D000368:Aged; D002985:Clinical Protocols; D003863:Depression / Q000150:complications* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology*; D057240:Patient Preference; D018579:Patient Selection; D011613:Psychotherapy / Q000379:methods*; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012959:Socioeconomic Factors
D017367:Selective Serotonin Reuptake Inhibitors