An interventional study of BAT-CS and Smoking Cessation and Health & Wellness in Acute Coronary Syndrome and Tobacco Use, sponsored by Hennepin Healthcare Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Hennepin Healthcare Research Institute · Not applicable, Interventional, and Treatment
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).
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's enrollment of 233 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Hennepin Healthcare Research Institute is the lead sponsor of 67 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
Behavioral: BAT-CS
Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
Behavioral: Smoking Cessation and Health & Wellness
All participants will receive one hour standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.
Also known as: Smoking Cessation and Mood Management
All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking Cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.
7-day point prevalence abstinence from smoking
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
Time frame: 12 Months
Depression Symptoms
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
Time frame: 12 Months
Continuous Abstinence From Smoking Since Hospital Discharge
No smoking, not even a puff, since hospital discharge
Time frame: 12 Months
Time to Smoking Relapse
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.
Time frame: 12 Months
Time to Smoking Lapse
Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.
Time frame: 12 Months
Depressed mood
10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Time frame: The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
Positive Affect
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.
Time frame: 12 Months
Negative Affect
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.
Time frame: 12 Months
Systolic and Diastolic Blood Pressure
Resting Systolic and Diastolic Blood Pressure
Time frame: 12 Months
Blood Bio-markers
HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen
Time frame: 12 Months
Major adverse cardiac events (MACE) and all cause mortality
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 frame: 5 years
Health Related Quality of Life
12-Item Short Form Health Survey (SF-12)
Time frame: 12 Months
Treatment Acceptability
Client Satisfaction Questionnaire
Time frame: 12 weeks
Plan to share: No — Completely de-identified data (i.e.,data that has been cleaned of all 18 types of HIPAA identifiers) will be available to other qualified researchers. Within 18 months of study completion, we will make datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely). The NIH will be notified of transmissions of the data to interested investigators.
Ran from Jan 2018 to primary completion in May 2024, 75 months.
Of 210 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's 75 months is above that.
Counting every sponsor, half of 225 studies reached it within 34 months; a quarter within 18 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hennepin Healthcare Research Institute