Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,209
- 试验地点
- 2
- 主要终点
- Number of participants who achieve biochemically verified 7 day smoking abstinence
研究概览
简要总结
The objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, guided imagery (GI) intervention (IC) for smoking cessation compared to active behavioral control (CC). The study will recruit 1,200 diverse smokers from three states, Arizona, New York, and West Virginia to increase generalizability. Participants will be randomly assigned to receive either the IC or CC delivered by telephone by University of Arizona study coaches and will be assessed at 3- and 6-months post-enrollment by study staff. The primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone.
详细描述
The Specific Aims of the proposed study are to:
Aim 1: Test the efficacy of a telephone-delivered, integrative GI tobacco cessation intervention (IC) vs. an active behavioral control (CC) on biochemically verified 7-day point prevalence and self-reported 30-day smoking abstinence at 6 months post-enrollment. Four weeks of nicotine replacement therapy (NRT) will be included in both conditions. The investigators will assess self-reported 7-day and 30-day tobacco use at baseline, and 3- and 6-months post-enrollment. Our primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months using the Smokerlyzer iCO expired CO monitor.
H1: Participants in the IC will have 10% higher quit rates than those in the CC. A 10% increase is clinically meaningful on a population level. A sample size of 1200 will provide 90% power to detect a 10% increase over a control condition quit rate of 30% with 20% missing data.
Aim 2: Conduct dose-response analyses on the effect of IC adherence (measured by self-reported minutes of intervention use per week, number of times GI skills practiced per weeks, number of sessions attended, and coach-rated participant engagement in sessions) on abstinence at 6 months. The investigators will also examine effects of the IC and CC on tobacco use for those participants who do not report abstinence at 6-months.
H2A: IC participants who are more adherent will have higher rates of biochemically verified abstinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Report daily smoking in the last 30 days
- •Age 18 or over
- •Speak English
- •Have a smart phone with internet access
- •Willing to receive coaching over the phone
排除标准
- •No internet access
- •Does not speak English
- •More than one person per household
- •Psychosis
结局指标
主要结局
Number of participants who achieve biochemically verified 7 day smoking abstinence
时间窗: 6 months
Smoking abstinence will be biochemically verified with expired carbon monoxide
次要结局
- Number of participants who report 7 day smoking abstinence(Baseline, 3 months, and 6 months)
- Number of minutes of intervention use per week(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Number of intervention sessions attended(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
- Number of participants who report 30 day smoking abstinence(Baseline, 3 months, and 6 months)
- Number of minutes guided imagery and other integrative skills practiced per day(3 months, 6 months)
研究者
Judith S. Gordon, PhD
Professor and Associate Dean for Research
University of Arizona