Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- 7-day point prevalence abstinence (PPA) at 6-month follow-up
研究概览
简要总结
Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?
详细描述
This protocol provides the recommended treatment to achieve smoking cessation (i.e., counseling and nicotine replacement therapy) and randomly assigns individuals to a high-intensity exercise or low-intensity exercise intervention as a strategy to engage the mechanisms relevant to high anxiety sensitive smokers to improve smoking cessation outcomes.
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
- 是
入选标准
- •Adult (age ≥ 18);
- •High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index [SSASI]);
- •Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
- •Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
- •Body mass index <40;
- •Medical clearance to participate.
- •Located near a participating YMCA site (within 50 miles)
排除标准
- •Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months
- •Receiving current intervention for smoking cessation.
- •Outstanding debt to the YMCA
- •Listed as a sex offender on the National Sex Offender Registry
研究组 & 干预措施
High-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
干预措施: Nicotine patch (Drug)
High-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
干预措施: Aerobic Exercise (Behavioral)
High-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
干预措施: Counseling (Behavioral)
Low-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
干预措施: Aerobic Exercise (Behavioral)
Low-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
干预措施: Counseling (Behavioral)
Low-Intensity Aerobic Exercise
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
7-day point prevalence abstinence (PPA) at 6-month follow-up
时间窗: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)
Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; ≤5ppm), saliva cotinine (\<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.
次要结局
- 7-day point prevalence abstinence (PPA) at 12-month follow-up(Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6))
- 7-day point prevalence abstinence (PPA) at 9-month follow-up(Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6))
研究者
Jasper A. Smits
Principal Investigator
University of Texas at Austin