Clinical trial NCT01964898: Post Acute Coronary Event Smoking Study
Official title: Integrated Smoking Cessation and Mood Management for Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Acute Coronary Syndrome
Keywords: Smoking
Mood Management
Depression
Behavioral Activation
Acute Coronary Syndrome
Myocardial Infarction
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Cessation: 7 Day Point Prevalence Abstinence
timeFrame: 6 months
measure: Continuous Abstinence From Smoking Since Discharge
timeFrame: 6 months
measure: Time to Smoking Relapse
timeFrame: 6 months
measure: Time to Smoking Lapse
timeFrame: 6 months
Secondary outcomes:
measure: Depression: 9 Item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to 6 months
measure: Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
timeFrame: Baseline to 6 months
measure: Positive Affect
timeFrame: Baseline to 6 months
measure: Negative Affect
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital Centers for Behavioral and Preventive Medicine
name: Andrew M Busch, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.