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Randomized Controlled Trial
. 2023 May 12;18(1):29.
doi: 10.1186/s13722-023-00388-9.

Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial

Affiliations
Randomized Controlled Trial

Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial

Melissa Adkins-Hempel et al. Addict Sci Clin Pract. .

Abstract

Background: Approximately 400,000 people who smoke cigarettes survive Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) each year in the US. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS. A single, integrated treatment targeting depressed mood and smoking could be effective in reducing post-ACS mortality.

Method/design: The overall aim of the current study is to conduct a fully powered efficacy trial enrolling 324 smokers with ACS and randomizing them to 12 weeks of an integrated smoking cessation and mood management treatment [Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)] or control (smoking cessation and general health education). Both groups will be offered 8 weeks of the nicotine patch if medically cleared. Counseling in both arms will be provided by tobacco treatment specialists. Follow-up assessments will be conducted at end-of-treatment (12-weeks) and 6, 9, and 12 months after hospital discharge. We will track major adverse cardiac events and all-cause mortality for 36 months post-discharge. Primary outcomes are depressed mood and biochemically validated 7-day point prevalence abstinence from smoking over 12 months.

Discussion: Results of this study will inform smoking cessation treatments post-ACS and provide unique data on the impact of depressed mood on success of post-ACS health behavior change attempts.

Trial registration: ClinicalTrials.gov, NCT03413423. Registered 29 January 2018. https://beta.

Clinicaltrials: gov/study/NCT03413423 .

Keywords: Acute coronary syndrome; Behavioral activation; Cardiovascular disease; Depression; Secondary prevention; Smoking.

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Conflict of interest statement

All authors declare that they have no competing interests.

Figures

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Fig. 1
Conceptual model
Fig. 2
Fig. 2
Design overview

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