Post Acute Coronary Event Smoking Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-04-30

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.

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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.

Conditions

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Smoking Cessation Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral Activation (BA)

Intervention Type 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.

Standard Smoking Cessation Counseling

Intervention Type BEHAVIORAL

1 hour of in hospital counseling based on clinical guidelines

Nicotine patch

Intervention Type DRUG

An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

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.

Group Type ACTIVE_COMPARATOR

Standard Smoking Cessation Counseling

Intervention Type BEHAVIORAL

1 hour of in hospital counseling based on clinical guidelines

Nicotine patch

Intervention Type 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

Intervention Type OTHER

Interventions

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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.

Intervention Type BEHAVIORAL

Standard Smoking Cessation Counseling

1 hour of in hospital counseling based on clinical guidelines

Intervention Type BEHAVIORAL

Nicotine patch

An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Intervention Type DRUG

Printed Self-help materials for Smoking Cessation

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No