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

• 批准号: 10537270
• 负责人: JUDITH SARAH GORDON
• 金额: $ 13.22万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 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/10537270
• 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; National Center for Complementary and Integrative Health; 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; 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; telephone delivery; telephone-based; therapeutically effective; tobacco cessation intervention; tobacco user; tool; usability

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.

摘要 吸烟是导致死亡的主要原因，每年有48万人死亡，16 成千上万的美国人患有一种或多种由吸烟引起的疾病。戒烟可以大大减少 即使是吸烟几十年的人也有患病的风险。使用行为干预的组合 这些方法侧重于保持吸烟者戒烟的动机，提供戒烟的具体技术， 预防复吸和使用尼古丁替代疗法（NRT）可以有效帮助烟草使用者戒烟。 然而，标准的行为治疗可能对一些吸烟者没有吸引力，或者对一些吸烟者没有效果， 需要采取各种办法来帮助这些人。引导意象（GI）是一种身心疗法， 涉及到对特定心理图像的受控的、多感官的可视化。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，暴露于胃肠道会导致 与对照组或服用安非他酮的患者相比，戒断率增加。大部分美国 人口采用综合保健办法。GI戒烟干预可以吸引吸烟者， 对使用行为方法感兴趣。虽然GI是戒烟的有效工具，但 一般都是亲自接生，限制了向大量人口的传播。系统和荟萃分析 回顾表明，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、波多黎各和关岛都有售。该项目是高度响应PAR-20- 154通过电话提供GI干预，这是高度可扩展的，可以大大增加覆盖面 和有效的GI戒烟干预的可及性。我们最近完成了一项随机 无烟计划的可行性试验。虽然没有能力确定疗效，但干预措施 在帮助参与者戒烟方面表现出了希望，并表现出了很高的消费者满意度。我们开发 招募参与者的程序，并超过了我们的招募目标。我们在8周时有>90%的保留率 6个月时>80%。我们还发现了高水平的坚持。这项随机可行性研究的结果 这表明，通过电话提供的GI戒烟干预的充分动力研究是必要的。 因此，本R 01申请的目的是进行一项随机对照试验来测试 Be Smoke Free、基于电话的GI干预（IC）戒烟的有效性， 主动行为控制（CC）。这项研究将招募来自三个州的1,200名不同的吸烟者， 约克和西弗吉尼亚州，以增加普遍性。参与者将被随机分配接受 由亚利桑那大学的学习教练通过电话提供IC或CC，并将在3个月和6个月时进行评估 研究工作人员入组后。主要结果是生化验证的7天点患病率禁欲 六个月大的时候。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GI干预，改善公众健康。