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

测试可扩展、电话传递、引导图像戒烟干预措施的效果

基本信息

批准号：
10275085
负责人：
JUDITH SARAH GORDON
金额：
$ 59.06万
依托单位：
UNIVERSITY OF ARIZONA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-27 至 2026-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10275085
关键词：
Abstinence Accounting Address Adherence Adult American Arizona Behavior Control Behavior Therapy Behavioral Biochemical Bupropion Cause of Death Cessation of life Clinical Collaborations Consumer Satisfaction Data Dependence Disease Dose Electronic cigarette Enrollment Ethnic Origin Exposure to Feasibility Studies Goals Guam Guided imagery Image Individual Integrative Medicine Internet Intervention Interview Location Measures Methods Mind-Body Intervention Modeling Monitor Motivation New York Outcome Participant Patient Recruitments Patient Self-Report Persons Population Population Heterogeneity Prevalence Procedures Protocols documentation Psyche structure Public Health Puerto Rico Race Randomized Randomized Controlled Trials Reporting Sample Size Smoke Smoker Smoking Smoking Cessation Intervention Standardization Subgroup Surveys Techniques Technology Telephone Time Tobacco Tobacco Use Cessation Tobacco use Training United States Universities Visualization West Virginia aged base behavior change cigarette smoke cigarette smoking design disorder later incidence prevention disorder risk efficacy clinical trial efficacy testing evidence base experience feasibility trial follow up assessment follow-up improved innovation intervention effect multisensory nicotine replacement nicotine use novel novel strategies patient engagement primary outcome programs quitline recruit reduce tobacco use response sex skills smoking abstinence smoking cessation therapeutically effective tobacco cessation intervention tobacco user tool usability

项目摘要

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.

抽象的吸烟是死亡的主要原因，每年死亡超过480,000，而16例百万美国人患有吸烟引起的一种或多种疾病。停止可以大大减少即使对于那些吸烟数十年的人来说，疾病的风险也是如此。使用行为的组合进行干预侧重于维持吸烟者退出动机的方法，为退出和预防复发和使用尼古丁替代疗法（NRT）可有效帮助烟草使用者退出。但是，标准的行为治疗可能对某些吸烟者和新颖的人不吸引或有效需要采取方法来协助这些人。指导图像（GI）是一种思维疗法的一种形式涉及对特定心理图像的受控，多敏感性的可视化。 GI是一种有效的治疗工具改变行为，包括烟草使用。多项研究表明，暴露于GI显着导致与对照组或服用安非他酮的节制率提高。美国很大一部分人口使用综合健康方法。 GI烟草戒烟干预可以吸引吸烟者有兴趣使用行为方法。尽管GI是戒烟的有效工具，但交货通常是亲自限制在大量人群中的传播。系统和元分析评论表明，电话戒烟是一种高度可扩展的方法，可以帮助个人戒烟。戒烟在美国所有50个州，波多黎各和关岛都可以使用。拟议的项目对20杆的响应高度敏感 154通过通过电话提供GI干预，该干预措施高度可扩展，可以大大增加覆盖范围以及有效的胃肠道戒烟干预的可及性。我们最近完成了一个随机的无烟计划的可行性试验。尽管没有动力来确定疗效，但干预措施在帮助参与者退出并表现出较高的消费者满意度方面表现出了希望。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周的保留率> 90％和6个月时> 80％。我们还发现了高水平的依从性。这项随机可行性研究的结果表明有必要对通过电话提供的GI烟草戒烟干预进行全力研究。因此，该R01应用的目的是进行一项随机对照试验以测试与之相比主动行为控制（CC）。该研究将招募来自亚利桑那州三个州的1,200名不同吸烟者约克和西弗吉尼亚州，以提高普遍性。参与者将被随机分配接受由亚利桑那大学学习教练通过电话交付的IC或CC，将在3个月和6个月进行评估研究人员的注册后。主要结果是在生化验证的7天点戒烟率上 6个月。经验丰富的团队进行的创新且严格的设计项目具有潜力通过电话提供创新的综合GI干预来改善公共卫生。