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| ID | Type | Description | Link |
|---|---|---|---|
| R56HL131711-01A1 | U.S. NIH Grant/Contract | View source |
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Funding for this pilot transitioned into funding for a fully powered study.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Quitting smoking following acute coronary syndrome 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 R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking Cessation and Mood Management | Experimental | Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. |
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| Smoking cessation and Health and Wellness | Active Comparator | Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) | 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 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 |
|---|---|---|
| Treatment Acceptability | Treatment Acceptability as measured by the Client Satisfaction Questionnaire | 12 weeks post-Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | 7 day point-prevalence abstinence. Biochemically verified. | 12 weeks post-Discharge |
| Depression Symptoms | Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02903 | United States |
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| 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 |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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| Smoking cessation plus Health and 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. |
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| 12 weeks post-Discharge |
| D001519 |
| Behavior |
| D001526 | Behavioral Symptoms |