The Mobile Assistance for Regulating Smoking (MARS) Micro-Randomized Trial Design Protocol

Inbal Nahum-Shani, Lindsay Potter, Cho Lam, Jamie Yap, Alexander Moreno, Rebecca Stoffel, Zhenke Wu, Neng Wan, Walter Dempsey, Santosh Kumar, Emre Ertin, Susan Murphy, Jim Rehg, David Wetter (2021+). Contemporary Clinical Trials

Abstract

Smoking is the leading preventable cause of death and disability in the U.S. Empirical evidence suggests that engaging in evidence-based self-regulatory strategies (e.g., behavioral substitution, mindful attention) can improve smokers’ ability to resist craving and build self-regulatory skills. However, poor engagement represents a major barrier to maximizing the impact of self-regulatory strategies. This paper describes the protocol for Mobile Assistance for Regulating Smoking (MARS) – a research study designed to inform the development of a mobile health (mHealth) intervention for promoting real-time, real-world engagement in evidence-based self-regulatory strategies. The study will employ a 10-day Micro-Randomized Trial (MRT) enrolling 112 smokers attempting to quit. Utilizing a mobile smoking cessation app, the MRT will randomize each individual multiple times per day to either: (a) no intervention prompt; (b) a prompt recommending brief (low effort) cognitive and/or behavioral self-regulatory strategies; or (c) a prompt recommending more effortful cognitive or mindfulness-based strategies. Prompts will be delivered via push notifications from the MARS mobile app. The goal is to investigate whether, what type of, and under what conditions prompting the individual to engage in self-regulatory strategies increases engagement. The results will build the empirical foundation necessary to develop a mHealth intervention that effectively utilizes intensive longitudinal self-report and sensor-based assessments of emotions, context and other factors to engage an individual in the type of self-regulatory activity that would be most beneficial given their realtime, real-world circumstances. This type of mHealth intervention holds enormous potential to expand the reach and impact of smoking cessation treatments.

#Key words:

Smoking Cessation; Mobile Health (mHealth); Engagement; Self-Regulatory Strategies; Micro-Randomized Trial (MRT)