Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Depression Symptoms
研究概览
简要总结
Summary of the Project :
Quitting smoking following acute coronary syndrome (ACS) 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 R01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (BAT-CS).
详细描述
This project will implement a fully powered efficacy trial enrolling 324 smokers with ACS and randomize them to 12 weeks of either Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) or control condition (including contact match). BAT-CS interventions will focus on smoking cessation and mood management, while the control condition will focus on smoking cessation and general health education. Both groups will be offered the nicotine patch if medically safe. Follow-up assessments will be conducted at end-of-treatment (12 weeks post-discharge for index event), and 6, 9, and 12 months after hospital discharge. The occurrence of major adverse cardiac events and all-cause mortality will be tracked for up to 60 months post discharge.
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
- •hospital inpatients with an ACS diagnosis documented in medical record within the past 30 days
- •smoked equal or greater than 1 cigarette per day before being hospitalized
- •age of 18-75 years
- •English fluency
- •willing to consider quitting smoking at discharge
- •has a telephone or is willing to use a study issued cell phone
- •willing to consent to all study procedures.
排除标准
- •limited mental competency
- •presence of severe mental illness that would interfere with participation or suicidality
- •expected discharge to hospice or greater than 50% chance of 6 month mortality per risk calculator
- •currently attending counseling for depression or smoking cessation.
结局指标
主要结局
Depression Symptoms
时间窗: 12 Months
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
7-day point prevalence abstinence from smoking
时间窗: 12 Months
Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed with saliva cotinine or by carbon monoxide in a breath sample
次要结局
- Depressed mood(The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.)
- Positive Affect(12 Months)
- Continuous Abstinence From Smoking Since Hospital Discharge(12 Months)
- Health Related Quality of Life(12 Months)
- Time to Smoking Lapse(12 Months)
- Major adverse cardiac events (MACE) and all cause mortality(5 years)
- Time to Smoking Relapse(12 Months)
- Negative Affect(12 Months)
- Systolic and Diastolic Blood Pressure(12 Months)
- Blood Bio-markers(12 Months)
- Treatment Acceptability(12 weeks)
研究者
Andrew Busch
Senior Investigator
Hennepin Healthcare Research Institute