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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Apr 20, 2022
Date Accepted: Apr 28, 2022

The final, peer-reviewed published version of this preprint can be found here:

An Integrated mHealth App for Smoking Cessation in Black Smokers With Anxiety: Protocol for a Randomized Controlled Trial

Businelle MS, Garey L, Gallagher MW, Hébert ET, Vujanovic A, Alexander A, Kezbers K, Matoska C, Robison J, Montgomery A, Zvolensky MJ

An Integrated mHealth App for Smoking Cessation in Black Smokers With Anxiety: Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2022;11(5):e38905

DOI: 10.2196/38905

PMID: 35635746

PMCID: 9153912

An Integrated mHealth Application for Smoking Cessation in Black Smokers with Anxiety: Protocol for a Randomized Controlled Trial

  • Michael S. Businelle; 
  • Lorra Garey; 
  • Matthew W. Gallagher; 
  • Emily T. Hébert; 
  • Anka Vujanovic; 
  • Adam Alexander; 
  • Krista Kezbers; 
  • Cameron Matoska; 
  • Jillian Robison; 
  • Audrey Montgomery; 
  • Michael J. Zvolensky

ABSTRACT

Background:

Black smokers have greater difficulty quitting and higher rates of smoking-related disease and disability relative to the general population. The smoking disparities experienced by this group are, in part, a consequence of multiple chronic life stressors (e.g., racial discrimination) that engender increased exposure to interoceptive-stress symptoms (e.g., anxiety), which ultimately can lead to smoking as a means of immediate emotion regulation.

Objective:

The present study will culturally adapt and initially test a novel, mobile intervention (i.e., 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.

Methods:

In Phase I, 25 Black smokers with elevated AS will be administered MASP for 6 weeks. Following completion of Phase I, we will further refine MASP based on qualitative and quantitative data from participants to produce the final MASP iteration. In Phase II, 200 Black smokers with elevated AS will be enrolled and randomly assigned to receive nicotine replacement therapy and either: (1) the smartphone-based National Cancer Institute (NCI) QuitGuide app for standard mobile smoking cessation treatment or (2) the MASP intervention. All participants in Phase I and Phase II will be enrolled remotely, complete an online study screener, smartphone-based baseline assessment, daily smartphone-based ecological momentary assessments for 6 weeks, phone-based end-of-treatment qualitative interview, and smartphone-based follow-up assessments at post-baseline weeks 1, 2 (quit date), 3, 4, 5, 6, 28, and 54 (week 28 and 54 follow-ups will be completed by Phase II participants only). The MASP intervention is intended to offset barriers to treatment and encourage treatment engagement via smartphone.

Results:

This project was funded in September 2020. Phase I data collection began in January 2022. Phase II data collection is scheduled to begin in July 2022.

Conclusions:

If successful, data from the present 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. Clinical Trial: NCT04838236


 Citation

Please cite as:

Businelle MS, Garey L, Gallagher MW, Hébert ET, Vujanovic A, Alexander A, Kezbers K, Matoska C, Robison J, Montgomery A, Zvolensky MJ

An Integrated mHealth App for Smoking Cessation in Black Smokers With Anxiety: Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2022;11(5):e38905

DOI: 10.2196/38905

PMID: 35635746

PMCID: 9153912

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