背景:在美国,烟草使用仍然是导致死亡和疾病的主要可预防原因,占每年>480,000人死亡。尽管使用烟草的治疗对许多人来说是有效的,结果有很大的可变性,这些方法并不是对所有寻求戒烟的人都有效。新,需要有效的治疗方法来满足想要戒烟的人的喜好。引导图像(GI)是一种身心技术,涉及特定心理图像的引导可视化,这与其他感官模式和情绪增强。初步证据为使用GI治疗吸烟提供了初步支持。荟萃分析表明,通过戒烟线通过电话进行的标准吸烟治疗是有效的。使用GI的基于电话的干预可能会提供另一种有效的治疗选择,并增加戒烟线的范围和有效性。
目的:本研究旨在测试无烟的功效,电话提供的戒烟胃肠道治疗。
方法:此多站点随机临床试验(RCT)将比较一种新颖的电话提供的胃肠道戒烟治疗与标准的循证行为治疗。这项研究将持续5年。在第1阶段,我们完善了纽约州和西弗吉尼亚州站点的协议和程序,以用于RCT。在第2阶段,我们将对1200名参与者进行RCT:600名(50%)通过戒烟线招募,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条件或行为条件;两种治疗都将由位于亚利桑那大学的训练有素的研究教练提供。评估将在基线以及亚利桑那大学研究人员入学后3和6个月进行。主要结果将是自我报告的30天点患病率禁欲后6个月。次要结果包括入组后6个月生化验证的7天点患病率禁欲。
结果:西弗吉尼亚州和纽约州的招聘始于2022年10月。截至2023年3月31日,共有242名参与者注册。后续评估于2022年11月开始。截至2023年3月31日,在118名合格参与者中,97(82.2%)完成了为期3个月的评估,93%(26/28)的符合条件的参与者完成了为期6个月的评估.生化验证和定性访谈于2023年4月开始。招聘将持续到2025年,后续评估将持续到2026年。初步结果预计将于2027年公布。
结论:无烟研究是首次将GI纳入电话戒烟治疗的RCT。如果成功,无烟将对美国各地使用烟草的人的长期健康有很大的好处。
背景:ClinicalTrials.govNCT05277831;https://clinicaltrials.gov/ct2/show/NCT05277831。
■PRR1-10.2196/48898。
BACKGROUND: 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.
OBJECTIVE: This
study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831.
UNASSIGNED: PRR1-10.2196/48898.