Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03413423
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2018-01-19
Brief Title:
Post Acute Cardiac Event Smoking PACES Study
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Hennepin Healthcare Research Institute
Study Overview
Official Title:
Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Summary of the Project
Quitting smoking following acute coronary syndrome ACS can reduce mortality up to 50 However depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality Thus a single integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality Behavioral Activation BA is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers Behavioral Activation Treatment for Cardiac Smokers BAT-CS
Objective For this R01 the investigators will evaluate the efficacy of using a single integrated treatment that targets both depressed mood and smoking BAT-CS
Quitting smoking following acute coronary syndrome ACS can reduce mortality up to 50 However depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality Thus a single integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality Behavioral Activation BA is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers Behavioral Activation Treatment for Cardiac Smokers BAT-CS
Objective For this R01 the investigators will evaluate the efficacy of using a single integrated treatment that targets both depressed mood and smoking BAT-CS
Detailed Description:
This project will implement a fully powered efficacy trial enrolling 324 smokers with ACS and randomize them to 12 weeks of either Behavioral Activation Treatment for Cardiac Smokers BAT-CS or control condition including contact match BAT-CS interventions will focus on smoking cessation and mood management while the control condition will focus on smoking cessation and general health education Both groups will be offered the nicotine patch if medically safe Follow-up assessments will be conducted at end-of-treatment 12 weeks post-discharge for index event and 6 9 and 12 months after hospital discharge The occurrence of major adverse cardiac events and all-cause mortality will be tracked for up to 60 months post discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL136327 | NIH | None | httpsreporternihgovquickSearch1R01HL136327 |