Post Acute Cardiac Event Smoking (PACES) Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management

Conditions
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Acute Coronary Syndrome, Tobacco Use

Intervention / Treatment
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* Behavioral: BAT-CS
* Behavioral: Smoking Cessation and Health & Wellness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospital inpatients with an ACS diagnosis documented in medical record within the past 30 days smoked equal or greater than 1 cigarette per day before being hospitalized age of 18-75 years English fluency willing to consider quitting smoking at discharge has a telephone or is willing to use a study issued cell phone willing to consent to all study procedures. Exclusion Criteria: limited mental competency presence of severe mental illness that would interfere with participation or suicidality expected discharge to hospice or greater than 50% chance of 6 month mortality per risk calculator currently attending counseling for depression or smoking cessation.

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: BAT-CS<br>Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. | Behavioral: BAT-CS<br>* 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.<br>* Other names: Smoking Cessation and Mood Management;|
| Active Comparator: Smoking Cessation and Health & Wellness<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, depression, Behavioral Activation, Mood management, Secondary Prevention