Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Treatment Acceptability
研究概览
简要总结
Quitting smoking following acute coronary syndrome 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 R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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,
- •smoked 1 or more cigarettes per day before being hospitalized,
- •age of 18-75,
- •English fluency,
- •lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
- •willing to consider quitting smoking at discharge,
- •has telephone, and
- •willing to consent to all study procedures.
排除标准
- •limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
- •presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
- •expected discharge to hospice; and
- •currently attending counseling for depression or smoking cessation.
研究组 & 干预措施
Smoking Cessation and Mood Management
Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
干预措施: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) (Behavioral)
Smoking cessation and Health and Wellness
Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
干预措施: Smoking cessation plus Health and Wellness (Behavioral)
结局指标
主要结局
Treatment Acceptability
时间窗: 12 weeks post-Discharge
Treatment Acceptability as measured by the Client Satisfaction Questionnaire
次要结局
- Smoking Cessation(12 weeks post-Discharge)
- Depression Symptoms(12 weeks post-Discharge)
研究者
Andrew Busch
Assistant Professor
The Miriam Hospital
