Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial

PROJECT SUMMARY Tobacco use remains the leading preventable cause of death and illness in our society and causes 30% of cancer deaths. Despite this, 28.3 million US adults smoke. Most of them (70%) want to quit smoking someday, but are not yet ready to quit or actively seeking treatment--they are ambivalent about quitting. Available evidence-based

stop-smoking treatments (medication and counseling) are not typically offered to people who are ambivalent about quitting smoking (PAQS) due to cost and limited resources, but to meaningfully reduce smoking prevalence, low- cost, scalable interventions are needed that can effectively engage PAQS, encourage them to stop smoking, and

support them through this process, including connecting them to available evidence-based treatment when they are

ready to quit. The current proposal is responsive to this public health goal and to NCI’s call for innovative, scalable mobile health (mHealth) smoking cessation interventions. Building on our programmatic work developing digital therapeutics for smoking cessation, population-level motivational interventions, and user-centered design and

development work with PAQS, we designed a mHealth app (called GEMS) which blends sound scientific theory, evidence-based treatment, and best practice recommendations with novel, theory-based content that is responsive to the needs and preferences of PAQS. The backbone of the intervention is a series of sequential, self-guided

exercises (called ‘personal experiments’) designed especially to help PAQS clarify their health goals; build and strengthen their motivation and confidence for quitting smoking; and teach them the skills necessary to change their smoking behavior. This content is paired with action-oriented guidance how to quit, an ability to earn free nicotine

replacement therapy (NRT), and in-app direct access to free evidence-based tobacco quitline counseling, as well other tools designed to enhance engagement with the app, motivation, and self-efficacy. Findings from a recent randomized pilot of GEMS (n = 57) were positive. Compared to an identical version of the app without the personal

experiments, GEMS was used more often, more users earned the free NRT and requested this treatment, and more accessed free quitline counseling within the app. Moreover, twice as many GEMS users reported smoking abstinence at follow-up. We now propose to test the efficacy of GEMS in a fully-powered randomized controlled trial

(n=800) using nationwide recruitment via social media and from a large health care system to recruit a diverse, representative sample of PAQS. Co-primary outcomes will be objectively measured requests for either NRT or quitline counseling accessed through the app and smoking abstinence at 6-months post-enrollment. App utilization,

smoking reduction, and other tobacco or treatment use will also be examined. GEMS is the first known app

designed exclusively for PAQS. If effective, it could provide a novel, highly scalable tool for increasing treatment use and smoking abstinence among PAQS, thereby addressing a significant and under-researched public health gap.