Gordon Judith S, Armin Julie S, Giacobbi Peter, Hsu Chiu-Hsieh, Marano Kari, Sheffer Christine E
College of Nursing, University of Arizona, Tucson, AZ, United States.
Department of Family and Community Medicine, University of Arizona, Tucson, AZ, United States.
JMIR Res Protoc. 2023 Jun 23;12:e48898. doi: 10.2196/48898.
Tobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines.
This study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation.
This multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment.
Recruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027.
The Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States.
ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48898.
在美国，烟草使用仍然是可预防的主要死亡和疾病原因，每年导致超过48万人死亡。尽管针对烟草使用的治疗方法对许多人有效，但治疗结果存在很大差异，而且这些方法并非对所有试图戒烟的人都有效。需要新的有效治疗方法来满足想要戒烟者的偏好。引导式意象（GI）是一种身心技术，涉及对特定心理意象的引导性可视化，并通过其他感官模式和情感加以强化。初步证据为将GI用作吸烟治疗方法提供了初步支持。荟萃分析表明，通过戒烟热线以电话方式提供的吸烟标准治疗是有效的。一种使用GI的电话干预可能提供另一种有效治疗选择，并提高戒烟热线的覆盖范围和效果。
本研究旨在测试“无烟生活”（Be Smoke Free）的疗效，这是一种通过电话提供的用于戒烟的GI治疗方法。
这项多中心随机临床试验（RCT）将一种新型的通过电话提供的GI戒烟治疗与一种基于证据的标准行为治疗进行比较。该研究将持续5年。在第1阶段，我们为纽约州和西弗吉尼亚州的研究点完善了用于RCT的方案和程序。在第2阶段，我们将对1200名参与者进行RCT：600名（50%）通过戒烟热线招募，600名（50%）通过基于人群的方法招募。参与者将被随机分配到GI组或行为组；两种治疗均由亚利桑那大学的经过培训的研究指导人员提供。评估将在基线时以及入组后3个月和6个月由亚利桑那大学的研究人员进行。主要结局将是入组6个月后自我报告的30天点患病率戒断情况。次要结局包括入组6个月后经生化验证的7天点患病率戒断情况。
西弗吉尼亚州和纽约州的招募工作于2022年10月开始。截至2023年3月31日，共招募了242名参与者。随访评估于2022年11月开始。截至2023年3月31日，在118名符合条件的参与者中，97名（82.2%）完成了3个月评估，93%（26/28）的符合条件参与者完成了6个月评估。生化验证和定性访谈于2023年4月开始。招募工作将持续到2025年，随访评估将持续到2026年。主要结果预计于2027年发表。
“无烟生活”研究是首个将GI纳入基于电话的戒烟治疗的RCT。如果成功，“无烟生活”将对美国各地使用烟草的人的长期健康产生重大益处。
ClinicalTrials.gov NCT05277831；https://clinicaltrials.gov/ct2/show/NCT05277831。
国际注册报告识别码（IRRID）：PRR1-10.2196/48898。
