Post Acute Cardiac Event Smoking (PACES) Study
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/11/2018 |
| Start Date: | January 29, 2018 |
| End Date: | January 29, 2026 |
| Contact: | Andrew Busch, PhD |
| Email: | andrew.busch@hcmed.org |
| Phone: | 612-873-6681 |
Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
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).
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.
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.
Inclusion Criteria:
- hospital inpatients with an ACS diagnosis documented in medical record
- smoked equal or greater than 1 cigarette per day before being hospitalized
- age of 18-75 years
- English fluency
- lives within a 1.5 hour drive of study hospital and has no plans to move away from the
area for 1 year
- willing to consider quitting smoking at discharge
- has a telephone
- willing to consent to all study procedures.
Exclusion Criteria:
- limited mental competency
- presence of severe mental illness that would interfere with participation or
suicidality
- expected discharge to hospice or greater than 50% chance of 6 month mortality per risk
calculator
- currently attending counseling for depression or smoking cessation.
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