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Smoking and depressed mood are both predictive of mortality following Acute Coronary Syndrome. However, to date, no counseling treatment has been designed to target smoking cessation and manage mood in this population. This trial will test such a treatment based on Behavioral Activation, an approach that has shown promise as an integrated treatment for smoking and mood management in other populations.
The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) can be conceptualized as a "teachable moment," whereby patients may be more receptive to smoking cessation messages. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS hospitalization. Thus, a single, integrated treatment that targets both depressed mood and smoking could be highly effective in reducing post-ACS mortality. Behavioral Activation (BA) may be an ideal treatment for this population as BA can easily integrate both mood and smoking cessation related goals and it focuses on addressing restriction of valued activities, which is common in the post-ACS population.
Thus, the overall aim of the current study is test a BA treatment manual that integrates smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment for cardiac patients who smoke; BAT-CS). We will conduct an RCT (N=72) comparing BAT-CS (1 in-hospital session and 5-9 post-discharge sessions) to Standard Care (SC; 1 in-hospital session and 5 mailed packets of printed self-help materials). Differences in smoking cessation, depressed mood, and positive affect will be compared between conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BA for cardiac patients who smoke | Experimental | Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. |
|
| Standard Care | Active Comparator | Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation (BA) | Behavioral | 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation: 7 Day Point Prevalence Abstinence | No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | 6 months |
| Continuous Abstinence From Smoking Since Discharge | Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | 6 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. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | 6 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. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression: 9 Item Patient Health Questionnaire (PHQ-9) | The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. | Baseline to 6 months |
| Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M Busch, Ph.D | The Miriam Hospital Centers for Behavioral and Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28415979 | Derived | Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7. |
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65 patients were recruited. 1 was found to be ineligible pre-randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | BA for Cardiac Patients Who Smoke | Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge. Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. |
| FG001 | Standard Care | Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Printed Self-help materials for Smoking Cessation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | BA for Cardiac Patients Who Smoke | Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge. Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Cessation: 7 Day Point Prevalence Abstinence | No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | Posted | Number | 95% Confidence Interval | proportion of participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BA for Cardiac Patients Who Smoke | Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge. Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Busch PhD | The Miriam Hospital | 4017938189 | andrew_busch@brown.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D054058 | Acute Coronary Syndrome |
| D012907 | Smoking |
| D003863 | Depression |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Standard Smoking Cessation Counseling | Behavioral | 1 hour of in hospital counseling based on clinical guidelines |
|
| Nicotine patch | Drug | An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. |
|
| Printed Self-help materials for Smoking Cessation | Other |
|
The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. |
| Baseline to 6 months |
| 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 in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance | Baseline to 6 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 in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. | Baseline to 6 months |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG001 | Standard Care | Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Printed Self-help materials for Smoking Cessation |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard Care | Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Printed Self-help materials for Smoking Cessation |
|
|
| Primary | Continuous Abstinence From Smoking Since Discharge | Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | Posted | Number | 95% Confidence Interval | proportion of participants | 6 months |
|
|
|
| Primary | 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. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | Posted | Mean | Standard Error | Days | 6 months |
|
|
|
| Primary | 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. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. | Posted | Mean | Standard Error | Days | 6 months |
|
|
|
| Secondary | Depression: 9 Item Patient Health Questionnaire (PHQ-9) | The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. | Posted | Mean | Standard Error | units on a scale | Baseline to 6 months |
|
|
|
| Secondary | Depression: 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. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. | Posted | Mean | Standard Error | units on a scale | Baseline to 6 months |
|
|
|
| Secondary | 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 in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance | Posted | Mean | Standard Error | units on a scale | Baseline to 6 months |
|
|
|
| Secondary | 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 in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. | Posted | Mean | Standard Error | units on a scale | Baseline to 6 months |
|
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|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Standard Care | Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. Printed Self-help materials for Smoking Cessation | 0 | 31 | 0 | 31 |
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| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001526 | Behavioral Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |