Post Acute Coronary Event Smoking Study

Not Applicable

Completed

Conditions: Smoking Cessation
Acute Coronary Syndrome

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

Registration Number: NCT01964898

Lead Sponsor: The Miriam Hospital

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BA for cardiac patients who smoke	Behavioral Activation (BA)	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.
BA for cardiac patients who smoke	Standard Smoking Cessation Counseling	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	Standard Smoking Cessation Counseling	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 Care	Printed Self-help materials for Smoking Cessation	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.
BA for cardiac patients who smoke	Nicotine patch	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	Nicotine patch	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.

Primary Outcome Measures

Name	Time	Method
Time to Smoking Relapse	6 months	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.
Smoking Cessation: 7 Day Point Prevalence Abstinence	6 months	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.
Continuous Abstinence From Smoking Since Discharge	6 months	Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time to Smoking Lapse	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Depression: 9 Item Patient Health Questionnaire (PHQ-9)	Baseline to 6 months	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.
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)	Baseline to 6 months	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.
Positive Affect	Baseline to 6 months	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
Negative Affect	Baseline to 6 months	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.