Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients. The specific aim is to:
Aim: Develop a multi-component behavioral treatment to address psychological risk factors among COPD patients. We will conduct a component analysis using single case design experiments with 15 participants to a) examine the contribution of each treatment component to the behavioral target of smoking for affect regulation, and b) establish proof-of-concept on the clinical endpoint of initial cessation (>24 hours abstinence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants will be males and females who are:
- •Diagnosed with COPD (as documented in electronic health record [EHR]),
- •Daily cigarette smokers (5 or more cigarettes per day over past 30 days),
- •Intend to quit smoking within the next 60 days,
- •Report at least moderate level of smoking for affective regulation (SMQ-R coping subscale score 30 or greater),
- •Have access to a smart phone, tablet, or computer, and
- •Are able to communicate fluently in English
排除标准
- •Any concurrent medical or psychiatric condition which would preclude ability to provide informed consent or perform study procedures (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia), as determined by the treating physician or study PI.
结局指标
主要结局
Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
时间窗: 24 hours post-quit date
The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO \< 5 ppm.
次要结局
- Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score(Through active treatment phase (approximately 4 weeks))