Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
研究概览
简要总结
The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-65 years of age
- •Smoke 10+ cigarettes/day
- •< 3 months abstinence in the past year
- •Have a smartphone; and motivated to quit smoking
- •Score >18 of 20 on Action subscale of the Readiness to Change Questionnaire
排除标准
- •Any usage of psychotropic medication: not on a stable dosage 6+ months
- •Prior participation in a mindfulness course or regular meditation practice (>20 min/week)
- •Serious psychiatric, cognitive, or medical disorder
- •MRI contraindications
- •Structural brain damage as well as other brain abnormalities revealed by the MRI
- •Claustrophobia
- •Not being fluent in English
- •Recreational drug use
- •Pregnant women
- •History of a neurological disorder
- •Current participation in a smoking study
- •Adults unable to consent
- •Prisoners
研究组 & 干预措施
Active Comparator App/Training
This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.
干预措施: App/Training (Behavioral)
Active Comparator App/Training
This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.
干预措施: Smartphone (Device)
Experimental App/Training
This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.
干预措施: App/Training (Behavioral)
Experimental App/Training
This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.
干预措施: Smartphone (Device)
结局指标
主要结局
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal
时间窗: 1 month
BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping
次要结局
未报告次要终点
研究者
Judson Brewer
Principal Investigator
Brown University