Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial.

Background: Cigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.

Objective: To investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.

Methods: A prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.

Discussion: As tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial. Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652 .