Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial
Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial
Blog Article
Abstract 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 Stroller Accessories 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 MULTI BASICS-3 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.