Viewing Study NCT00998400



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Last Modification Date: 2024-10-26 @ 10:11 AM
Study NCT ID: NCT00998400
Status: COMPLETED
Last Update Posted: 2020-02-11
First Post: 2009-10-19

Brief Title: Treatment of Depression in Acute Coronary Syndrome ACS Patients
Sponsor: University of Bologna
Organization: University of Bologna

Study Overview

Official Title: Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome
Status: COMPLETED
Status Verified Date: 2020-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TREATED-ACS
Brief Summary: Emotional states of depression in association with ischemic heart diseases such as myocardial infarction or unstable angina are risk factors for subsequent cardiac events and mortality However the only psychological intervention trial attempting to reduce cardiac risk in depressed ACS patients showed that changes in depression did not translate into improved survival Such intervention did not address issues such as lifestyle modification and improvement in psychological well-being which were found to affect individual vulnerability to medical disease Our research group has developed a well-being enhancing psychotherapeutic strategy well-being therapy WBT which has been validated in a number of clinical trials The aim of this project is to evaluate the efficacy of cognitive behavioral treatment CBT together with lifestyle modification and WBT in reducing cardiac risk in depressed andor demoralized ACS patients compared to a standard clinical procedure of patients management the clinical management CM The same protocol will be carried out in two centres Bologna and Torino 100 patients after a first episode of myocardial infarction or unstable angina meeting DSM-IV criteria for depressive disorders and DCPR criteria for demoralization will be randomized to one of two treatment groups 1 CBT supplemented by lifestyle modification and WBT 2 CM In both groups treatment will consist of twelve 45-minute sessions once a week A two-year follow-up will be performed It is expected that psychological treatment may significantly decrease cardiac morbidity and mortality at follow-up compared to clinical management The findings may entail considerable preventive implications and possible large reductions in health costs
Detailed Description: The same protocol will be carried out in the two participating centres Maggiore Hospital in Bologna and San Giovanni Battista Hospital in Torino

Participants will be patients recovering from a first episode of acute myocardial infarction or unstable angina Myocardial infarction will be documented by cardiac symptoms presence of acute chest epigastric neck jaw or arm pain or discomfort or pressure without apparent non- cardiac source and signs acute congestive heart failure or cardiogenic shock in the absence of non-CHD causes associated with ECG findings characteristic evolutionary ST-T changes or new Q waves andor cardiac biomarkers blood measures of myocardial necrosis specifically CK CK-MB CK-MBm or troponin cTn Instable angina will be documented by cardiac symptoms chest pain lasting less than 20 minutes with likely ECG findings ST-segment depression and abnormal T-wave in absence of myocardial necrosis biomarkers

Medically eligible patients involved in the study have to meet when screened 30 days after their index event the inclusion criteria

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None