Abstract
BACKGROUND: Detrimental smoking-related health outcomes warrant the investigation of novel smoking cessation interventions; the cessation program nuumi integrates digital behavioral therapy and an electronic cigarette (EC). OBJECTIVE: The relationship between program participation and smoking cessation among adults who smoke and are motivated to quit was investigated, as well as program acceptability, changes in smoking-related outcomes, including cigarettes per day (CPD), urges to smoke and psychophysiological health variables (perceived stress, mindfulness, cessation-related self-efficacy, life satisfaction, subjective psychophysiological health) and their associations with smoking cessation. METHODS: A prospective 6-month single-arm pilot study was conducted; 71 adults who smoked and were motivated to quit received a cognitive behavioral therapy (CBT) app, a closed-system EC, and pods containing decreasing nicotine concentrations. Online surveys were issued at baseline, and at 4, 8, 12, and 24 weeks post-baseline. Intention-to-treat (ITT) and complete-case analyses were conducted to assess self-reported 7-day point prevalence of smoking abstinence (PPA; primary outcome), 30-day PPA, and repeated PPA. T-tests and logistic regressions were used to assess changes in secondary outcomes CPD, urges to smoke, and psychophysiological health variables by smoking status at 12 and 24 weeks, and their relationship with cessation. RESULTS: Per ITT, self-reported abstinence rates were high at 12 weeks (39.4%), and 24 weeks (32.4%), as was 30-day PPA of 32.4% at both 12 and 24 weeks. Repeated PPA per ITT was 22.5% at both 12 and 24 weeks. Non-abstinent participants significantly reduced their CPD at 12 weeks (t(34) = 6.12, p < 0.001), and at 24 weeks (t(30) = 6.38, p < 0.001). Urges to smoke and perceived stress decreased, and mindfulness, cessation-related self-efficacy, life satisfaction and subjective psychophysiological health increased significantly (all ps < 0.05), predominantly in individuals who reported abstinence. Lower urges to smoke, lower perceived stress, and higher self-efficacy and subjective mental health were related to greater odds of cessation at 24 weeks (all ps < 0.05). Most participants rated the program as highly (43%) or moderately (54%) acceptable. DISCUSSION: Program participation seems to support cessation and improvements in smoking-related outcomes, but adjustments to the program may be needed to improve engagement and acceptability. Findings may inform the development of future trials and cessation programs. TRIAL REGISTRATION: German Clinical Trials Register DRKS00032652, registered prospectively 09/15/2023, https://drks.de/search/de/trial/DRKS00032652.