Addressing Psychological Risk Factors Underlying Smoking Persistence: The Fresh Start-II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Two-Week Smoking Abstinence
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 proposed research will develop and 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: Examine effects of psychological risk factor reduction on smoking outcome. We will conduct a pilot trial in which 62 participants are randomized to the multi-component behavioral treatment (9 weekly sessions) or self-guided treatment (mailing of printed self-help materials).The primary outcome is number of days abstinent for 2 weeks post-quit (range = 0-14 days).
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
- 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.
研究组 & 干预措施
Multi-component Behavioral Treatment
This treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist.
干预措施: Unified Protocol adapted for smoking cessation (Behavioral)
Multi-component Behavioral Treatment
This treatment consists of nine weekly phone-based individual treatment sessions, 45-60 minutes each, delivered by a trained study therapist.
干预措施: American Lung Association self-management strategies for smoking cessation (Behavioral)
Self-guided Treatment
This treatment consists of self-help materials from the American Lung Association that address evidence-based smoking cessation and self-management strategies.
干预措施: American Lung Association self-management strategies for smoking cessation (Behavioral)
结局指标
主要结局
Two-Week Smoking Abstinence
时间窗: 14 days post-quit date
Number of days abstinent for 2 weeks post-quit, as verified by CO \< 5 ppm
次要结局
- Smoking Status(3 months post-quit)