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.

抽象的吸烟是导致死亡的主要原因，每年导致超过 48 万人死亡，16 数百万美国人患有一种或多种由吸烟引起的疾病。戒烟可以显着减少即使对于那些已经吸烟数十年的人来说，也有患病的风险。结合行为干预侧重于维持吸烟者戒烟动机的方法，提供戒烟的具体技术和预防复吸和使用尼古丁替代疗法 (NRT) 可有效帮助烟草使用者戒烟。然而，标准的行为治疗可能对某些吸烟者没有吸引力或无效，并且新颖需要采取一些方法来帮助这些人。意象引导（GI）是一种身心疗法，涉及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行为，包括吸烟。多项研究表明，接触胃肠道会导致显着的与对照组或服用安非他酮的患者相比，戒断率有所增加。美国的很大一部分人口采用综合健康方法。胃肠道戒烟干预可能会吸引吸烟者对使用行为方法感兴趣。虽然GI是戒烟的有效工具，但戒烟的方式交付通常是亲自进行，限制了向大量人群的传播。系统性和荟萃分析审查表明，电话戒烟热线是帮助个人戒烟的一种高度可扩展的方式。戒烟热线在美国所有 50 个州、波多黎各和关岛均有销售。拟议项目对 PAR-20 高度响应 154 通过电话提供 GI 干预，这种干预具有高度可扩展性，可以大大增加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无烟计划的可行性试验。尽管无法确定疗效，但干预措施在帮助参与者戒烟方面表现出承诺，并表现出很高的消费者满意度。我们开发了招募参与者的程序并超越了我们的招募目标。 8 周后我们的保留率超过 90% 6 个月时>80%。我们还发现了很高的依从性。本次随机可行性研究的结果表明有必要对通过电话提供的 GI 戒烟干预措施进行全面的研究。因此，本 R01 应用的目的是进行随机对照试验来测试与基于电话的 Be Smoke Free 胃肠道干预 (IC) 相比，戒烟效果主动行为控制（CC）。该研究将招募来自亚利桑那州、新州三个州的 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收 IC 或 CC 由亚利桑那大学学习教练通过电话提供，并将在 3 个月和 6 个月时进行评估由研究人员进行注册后。主要结局是经生化验证的 7 天点流行率戒断率 6个月大时。这个由经验丰富的团队进行的创新且严格设计的项目具有潜力通过电话提供创新的综合胃肠道干预措施来改善公共卫生。