Post Acute Cardiac Event Smoking (PACES) Study
- Conditions
- Acute Coronary SyndromeTobacco Use
- Interventions
- Behavioral: BAT-CSBehavioral: Smoking Cessation and Health & Wellness
- Registration Number
- NCT03413423
- Lead Sponsor
- Hennepin Healthcare Research Institute
- 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).
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 233
- hospital inpatients with an ACS diagnosis documented in medical record within the past 30 days
- smoked equal or greater than 1 cigarette per day before being hospitalized
- age of 18-75 years
- English fluency
- willing to consider quitting smoking at discharge
- has a telephone or is willing to use a study issued cell phone
- willing to consent to all study procedures.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAT-CS BAT-CS Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. Smoking Cessation and Health & Wellness Smoking Cessation and Health & Wellness Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
- Primary Outcome Measures
Name Time Method Depression Symptoms 12 Months The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
7-day point prevalence abstinence from smoking 12 Months Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed with saliva cotinine or by carbon monoxide in a breath sample
- Secondary Outcome Measures
Name Time Method Depressed mood The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Positive Affect 12 Months As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect.
Continuous Abstinence From Smoking Since Hospital Discharge 12 Months No smoking, not even a puff, since hospital discharge
Time to Smoking Lapse 12 Months Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.
Major adverse cardiac events (MACE) and all cause mortality 5 years Time in days to MACE or all cause mortality. MACE = non-fatal myocardial infarction (using standard American Heart Association definitions), hospitalization for unstable angina, or urgent coronary revascularization.
Time to Smoking Relapse 12 Months Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing.
Negative Affect 12 Months As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.
Systolic and Diastolic Blood Pressure 12 Months Resting Systolic and Diastolic Blood Pressure
Blood Bio-markers 12 Months HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen
Treatment Acceptability 12 weeks Client Satisfaction Questionnaire
Health Related Quality of Life 12 Months 12-Item Short Form Health Survey (SF-12)
Trial Locations
- Locations (1)
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States