Integrated Smoking Cessation and Mood Management for ACS Patients

Study Overview
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Brief Summary
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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.

Official Title
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Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)

Conditions
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Acute Coronary Syndrome, Tobacco Use

Intervention / Treatment
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* Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)
* Behavioral: Smoking cessation plus Health and 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, smoked 1 or more cigarettes per day before being hospitalized, age of 18-75, English fluency, lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year, willing to consider quitting smoking at discharge, has telephone, and willing to consent to all study procedures. Exclusion Criteria: limited mental competency (i.e., Mini Mental Status Exam score ≤ 23); presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality; expected discharge to hospice; and 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking Cessation and Mood Management<br>Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. | Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)<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 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>|
| Active Comparator: Smoking cessation and Health and 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 plus Health and 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 |
| --- | --- | --- |
| Treatment Acceptability | Treatment Acceptability as measured by the Client Satisfaction Questionnaire | 12 weeks post-Discharge | 

Secondary Outcome Measures

| Outcome Measure | 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) | 12 weeks post-Discharge | 

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