Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL136327 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Minneapolis Heart Institute Foundation | OTHER |
| The Miriam Hospital | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Minnesota |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT-CS | Experimental | 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 | Active Comparator | Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT-CS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Months |
| Depression Symptoms | The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence From Smoking Since Hospital Discharge | No smoking, not even a puff, since hospital discharge | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Busch, PhD | Senior Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37173792 | Background | Adkins-Hempel M, Japuntich SJ, Chrastek M, Dunsiger S, Breault CE, Ayenew W, Everson-Rose SA, Nijjar PS, Bock BC, Wu WC, Miedema MD, Carlson BM, Busch AM. Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial. Addict Sci Clin Pract. 2023 May 12;18(1):29. doi: 10.1186/s13722-023-00388-9. | |
| 41995991 | Derived | Ajayi AA, Adkins-Hempel M, Breault C, Ayenew W, Everson-Rose SA, Japuntich SJ, Dunsiger SI, Busch AM. Racial Disparities in Biopsychosocial Predictors of Short-Term Smoking Cessation Following Acute Coronary Syndrome Hospitalization. J Racial Ethn Health Disparities. 2026 Apr 17. doi: 10.1007/s40615-026-02940-0. Online ahead of print. |
| Label | URL |
|---|---|
| Protocol paper | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D064424 | Tobacco Use |
| D012907 | Smoking |
| D003863 | Depression |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
|
| Smoking Cessation and Health & Wellness | Behavioral | 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. |
|
| 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. | 12 Months |
| Depressed mood | 10 Item Center for Epidemiologic Studies Depression Scale (CESD) | 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. | 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. | 12 Months |
| Systolic and Diastolic Blood Pressure | Resting Systolic and Diastolic Blood Pressure | 12 Months |
| Blood Bio-markers | HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen | 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. | 5 years |
| Health Related Quality of Life | 12-Item Short Form Health Survey (SF-12) | 12 Months |
| Treatment Acceptability | Client Satisfaction Questionnaire | 12 weeks |
| D001519 |
| Behavior |
| D001526 | Behavioral Symptoms |