Post Acute Coronary Event Smoking Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integrated Smoking Cessation and Mood Management for Cardiac Patients

Conditions
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Smoking Cessation, Acute Coronary Syndrome

Intervention / Treatment
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* Behavioral: Behavioral Activation (BA)
* Behavioral: Standard Smoking Cessation Counseling
* Drug: Nicotine patch
* Other: Printed Self-help materials for Smoking Cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACS diagnosis documented in medical record smoked 3 or more cigarettes per day before being hospitalized between the ages of 18-75 fluent in English regular access to a telephone lives in the Providence, RI area willing to strongly consider an attempt to quit smoking at discharge Exclusion criteria: limited mental competency (i.e., Mini-Mental Status exam < 20) presence of current psychosis, serious mental illness, or suicidality, expectation that patient will not live through 6 month study period currently regularly attending counseling for depression or smoking cessation and plans to continue after discharge

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BA for cardiac patients who smoke<br>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: Behavioral Activation (BA)<br>* 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.<br>Behavioral: Standard Smoking Cessation Counseling<br>* 1 hour of in hospital counseling based on clinical guidelines<br>Drug: Nicotine patch<br>* An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.<br>|
| Active Comparator: Standard Care<br>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. | Behavioral: Standard Smoking Cessation Counseling<br>* 1 hour of in hospital counseling based on clinical guidelines<br>Drug: Nicotine patch<br>* An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.<br>Other: Printed Self-help materials for Smoking Cessation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Mood Management, Depression, Behavioral Activation, Acute Coronary Syndrome, Myocardial Infarction