Integrated Smoking Cessation and Mood Management for Cardiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Time to Smoking Relapse
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Behavioral Activation (BA) (Behavioral)
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.
干预措施: Standard Smoking Cessation Counseling (Behavioral)
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.
干预措施: Nicotine patch (Drug)
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.
干预措施: Standard Smoking Cessation Counseling (Behavioral)
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.
干预措施: Nicotine patch (Drug)
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.
干预措施: Printed Self-help materials for Smoking Cessation (Other)
结局指标
主要结局
Time to Smoking Relapse
时间窗: 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
时间窗: 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
时间窗: 6 months
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time to Smoking Lapse
时间窗: 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.
次要结局
- Depression: 9 Item Patient Health Questionnaire (PHQ-9)(Baseline to 6 months)
- Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)(Baseline to 6 months)
- Positive Affect(Baseline to 6 months)
- Negative Affect(Baseline to 6 months)
研究者
Andrew Busch
Research Scientist
The Miriam Hospital