跳至主要内容
临床试验/NCT03029923
NCT03029923撤回不适用

Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)

The Miriam Hospital2 个研究点 分布在 1 个国家开始时间: 2017年2月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Busch

Assistant Professor

The Miriam Hospital

研究点 (2)

Loading locations...

相似试验