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

Abstract

Background 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. Objective 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. Methods 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. Results 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. Conclusions 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. Trial Registration ClinicalTrials.gov NCT04838236; https://clinicaltrials.gov/ct2/show/NCT04838236 International Registered Report Identifier (IRRID) DERR1-10.2196/38905

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

“…The study eligibility criteria included being aged ≥18 years, having HIV, self-identification as Black or African American, providing a current picture of their cigarette package to verify smoking status [ 48 ], possessing at least a grade 6 reading level (≥4 on the Rapid Estimate of Adult Literacy in Medicine [REALM]) [ 50 ], experiencing elevated AS (ie, Short Scale Anxiety Sensitivity Index [SSASI] score of ≥5) [ 51 ], reporting daily smoking with a minimum of 10 cigarettes per day for at least 2 years, being motivated to quit smoking (>5 on a 10-point scale) [ 52 ], willingness to complete all study surveys or assessments, agreeing to use nicotine replacement medications (nicotine replacement therapy [NRT]; nicotine patch and lozenges), and agreeing to attempt to quit smoking 2 weeks after the date of randomization. Exclusion criteria included not being fluent in English; high blood pressure that is not under control (eg, medicated); experiencing a heart attack (myocardial infarction) within the past 2 weeks; use of any pharmacotherapy targeting smoking cessation beyond what is provided by this study; legal status that would interfere with participation (eg, incarceration with restricted access to mobile devices); cognitive impairment (assessed via the 6-item Cognitive Impairment Test) [ 53 ]; and being non-Black, pregnant, or younger than 18 years.…”

“…To avoid potential data loss as a result of participants losing their phones, each device is programmed to synchronize and upload encrypted data with our secure server multiple times each day (Note: in most studies, <1% of phones have been lost) [ 48 ]. These procedures prevent the collected EMA data from being lost, allow the researchers to remotely monitor participants’ EMA completion rates, and identify when participants need to be contacted for low survey completion.…”

“…The recommended minimum size for any subgroup is 20 interviews [ 107 ]. However, based on our prior work [ 48 ], interviews vary substantially in the content provided, so interviews will be conducted with all enrolled study participants in MASP+ and QuitGuide to meet the saturation of key study questions. Interviewing all MASP+ participants should be sufficient for the saturation of key study questions.…”

“…On the basis of our prior work [ 48 ], we modified our previously developed and tested novel, integrated, smartphone-delivered intervention for AS reduction and smoking (ie, Mobile Anxiety Sensitivity Program [MASP]) [ 49 ] for Black people with HIV/AIDS who smoke, integrating HIV information and care support that is culturally tailored to create the new smartphone-based app: Mobile Anxiety Sensitivity Program for Smoking and HIV (MASP+). MASP+ contains features and content designed to aid Black adults with combustible smoking cessation, HIV care adherence, and AS reduction.…”