Businelle Michael S, Garey Lorra, Gallagher Matthew W, Hébert Emily T, Vujanovic Anka, Alexander Adam, Kezbers Krista, Matoska Cameron, Robison Jillian, Montgomery Audrey, Zvolensky Michael J
TSET Health Promotion Research Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.
Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.
JMIR Res Protoc. 2022 May 30;11(5):e38905. doi: 10.2196/38905.
Black smokers have greater difficulty in quitting and higher rates of smoking-related diseases and disabilities than the general population. The smoking disparities experienced by this group are, in part, a consequence of multiple chronic life stressors (eg, racial discrimination) that engender increased exposure to interoceptive stress symptoms (eg, anxiety), which can ultimately lead to smoking as a means of immediate emotion regulation.
This study aimed to culturally adapt and initially test a novel mobile intervention (ie, Mobile Anxiety Sensitivity Program for Smoking [MASP]) that targets anxiety sensitivity (AS; a proxy for difficulty and responsivity to interoceptive stress) among Black smokers. The MASP intervention is culturally informed to address interoceptive stress management difficulties among Black smokers and is thus hypothesized to facilitate smoking cessation.
In phase 1, a total of 25 Black smokers with elevated AS will be administered MASP for 6 weeks. Following the completion of phase 1, we will further refine the MASP based on qualitative and quantitative data from participants to produce the final MASP iteration. In phase 2, a total of 200 Black smokers with elevated AS will be enrolled and randomly assigned to receive nicotine replacement therapy and either the smartphone-based National Cancer Institute QuitGuide app for standard mobile smoking cessation treatment or the MASP intervention. All participants in phases 1 and 2 will be enrolled remotely and will complete a web-based study screener; smartphone-based baseline assessment; daily smartphone-based ecological momentary assessments for 6 weeks; phone-based end-of-treatment qualitative interviews; and smartphone-based follow-up assessments at postbaseline weeks 1, 2 (quit date), 3, 4, 5, 6, 28, and 54 (weeks 28 and 54 follow-ups will be completed by phase 2 participants only). The MASP intervention is intended to offset barriers to treatment and encourage treatment engagement via smartphones.
This project was funded in September 2020. Phase 1 data collection began in January 2022. Phase 2 data collection is scheduled to begin in July 2022.
If successful, data from this study will support culturally informed treatment approaches for Black smokers and, pending findings of efficacy, provide an evidence-based mobile intervention for smoking cessation that is ready for dissemination and implementation.
ClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38905.
与普通人群相比，黑人吸烟者在戒烟方面面临更大困难，与吸烟相关的疾病和残疾发生率更高。该群体所经历的吸烟差异，部分是多种慢性生活压力源（如种族歧视）的结果，这些压力源导致更多地暴露于内感受性应激症状（如焦虑），最终可能导致吸烟成为即时情绪调节的一种方式。
本研究旨在对一种新型移动干预措施（即吸烟的移动焦虑敏感性项目 [MASP]）进行文化适应性调整并初步测试，该项目针对黑人吸烟者的焦虑敏感性（AS；内感受性应激困难和反应性的一个指标）。MASP 干预措施是基于文化设计的，旨在解决黑人吸烟者在内感受性应激管理方面的困难，因此假设其有助于戒烟。
在第 1 阶段，共有 25 名 AS 升高的黑人吸烟者将接受为期 6 周的 MASP 干预。在第 1 阶段完成后，我们将根据参与者的定性和定量数据进一步完善 MASP，以产生最终的 MASP 版本。在第 2 阶段，共有 200 名 AS 升高的黑人吸烟者将被招募并随机分配接受尼古丁替代疗法，以及基于智能手机的美国国立癌症研究所戒烟指南应用程序进行标准的移动戒烟治疗或 MASP 干预。第 1 阶段和第 2 阶段的所有参与者将通过远程方式招募，并将完成基于网络的研究筛选器；基于智能手机的基线评估；为期 6 周的每日基于智能手机的生态瞬时评估；基于电话的治疗结束时的定性访谈；以及在基线后第 1、2（戒烟日期）、3、4、5、6、28 和 54 周进行的基于智能手机的随访评估（第 28 周和第 54 周的随访仅由第 2 阶段的参与者完成）。MASP 干预旨在消除治疗障碍，并通过智能手机鼓励参与治疗。
该项目于 2020 年 9 月获得资助。第 1 阶段的数据收集于 2022 年 1 月开始。第 2 阶段的数据收集计划于 2022 年 7 月开始。
如果成功，本研究的数据将支持针对黑人吸烟者的基于文化的治疗方法，并在疗效结果出来之前，提供一种基于证据的可用于戒烟的移动干预措施，随时准备进行传播和实施。
ClinicalTrials.gov NCT04838236；https://clinicaltrials.gov/ct2/show/NCT04838236。
国际注册报告识别码（IRRID）：DERR1-10.2196/38905。
