Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention

摘要 吸烟是导致死亡的主要原因，每年有超过48万人死于吸烟，其中16人 数以百万计的美国人患有一种或多种由吸烟引起的疾病。戒烟可以显著减少 即使对那些吸烟几十年的人来说，也有患病的风险。使用行为组合的干预 注重保持吸烟者戒烟动机的方法，提供具体的戒烟技巧和 预防复发和使用尼古丁替代疗法(NRT)在帮助烟草使用者戒烟方面是有效的。 然而，标准的行为治疗对一些吸烟者和新奇的人来说可能并不吸引或有效 需要采取各种方法来帮助这些个人。引导意象(GI)是一种身心疗法， 涉及对特定心理图像的受控、多感官可视化。GI是一种有效的治疗工具 改变包括烟草使用在内的行为。多项研究表明，暴露在胃肠道中会导致显著的 与对照组或服用安非他酮的人相比，禁酒率增加。美国有很大比例的人。 人口使用综合保健方法。GI戒烟干预可以吸引吸烟者而不是 对使用行为方法感兴趣。虽然GI是一种有效的戒烟工具，但 通常是当面交付，将传播限制在大量人口中。系统化和元分析 评论表明，电话戒烟是帮助个人戒烟的一种高度可扩展的方式。放弃行数 在美国所有50个州，波多黎各和关岛都可以使用。拟议的项目高度响应PAR-20- 154通过电话提供高度可扩展的GI干预，可以极大地扩大覆盖范围 以及有效的胃肠道戒烟干预措施的可及性。我们最近完成了一项随机调查 BE无烟计划的可行性试验。尽管不能确定疗效，但干预措施 在帮助参与者戒烟方面表现出了承诺，并表现出了很高的消费者满意度。我们开发了 招募参与者的程序，并超过了我们的招聘目标。我们在8周时有90%的保留率 6个月龄时为80%。我们也发现了很高的忠诚度。这项随机可行性研究的结果 表明有必要对通过电话进行的胃肠道戒烟干预进行全能研究。 因此，R01应用程序的目标是进行随机对照试验，以测试 无烟、基于电话的胃肠道干预(IC)戒烟效果与 主动行为控制(CC)。这项研究将从亚利桑那州、纽约州和纽约州三个州招募1200名不同的吸烟者 约克郡和西弗吉尼亚州，以增加普适性。参与者将被随机分配以获得 IC或CC由亚利桑那大学的学习教练通过电话提供，并将在3个月和6个月时进行评估 招生后由学习人员负责。主要结果是生物化学证实的7天点戒毒盛行 6个月的时候。这个由经验丰富的团队进行的创新和严谨设计的项目具有潜力 通过电话提供创新的综合胃肠疾病干预，以改善公众健康。

ABSTRACT Cigarette smoking is the leading cause of death accounting for more than 480,000 deaths each year, and 16 million Americans suffer from one or more diseases caused by smoking. Cessation can significantly reduce the risk of disease even for those who have smoked for decades. Interventions using a combination of behavioral approaches that focus on maintaining smokers' motivation to quit, providing specific techniques for quitting and relapse prevention, and using Nicotine Replacement Therapy (NRT) are effective at helping tobacco users quit. However, standard behavioral treatment may not appeal to, or be effective for, some smokers and novel approaches are needed to assist these individuals. Guided Imagery (GI) is a form of mind-body therapy that involves controlled, multi-sensory visualization of specific mental images. GI is an effective therapeutic tool to change behaviors including tobacco use. Multiple studies have shown that exposure to GI results in significantly increased abstinence rates compared to controls or those taking bupropion. A large proportion of the U.S. population uses integrative health approaches. A GI tobacco cessation intervention could appeal to smokers not interested in using a behavioral approach. Although GI is an effective tool for smoking cessation, the mode of delivery has generally been in person, limiting dissemination to large populations. Systematic and meta-analytic reviews have shown that telephone quitlines are a highly scalable way to help individuals quit smoking. Quitlines are available in all 50 U.S. states, Puerto Rico and Guam. The proposed project is highly responsive to PAR-20- 154 by delivering a GI intervention via telephone which is highly scalable and could greatly increase the reach and accessibility of an effective GI smoking cessation intervention. We recently completed a randomized feasibility trial of the Be Smoke Free program. Although not powered to determine efficacy, the intervention showed promise in helping participants to quit and showed high consumer satisfaction. We developed procedures for recruiting participants and surpassed our recruitment goals. We had >90% retention at 8-weeks and >80% at 6-months. We also found high levels of adherence. The results of this randomized feasibility study indicate that a fully powered study of a GI tobacco cessation intervention delivered via telephone is warranted. Therefore, the objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, 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.