The Efficacy of the SinHumo App Combined With a Psychological Treatment to Quit Smoking: A Randomized Clinical Trial

Introduction This study assessed the efficacy of the SinHumo App combined with a cognitive-behavioral smoking cessation treatment on 12-month follow-up abstinence, compared with the same smoking cessation treatment and a control App. Aims and Methods A sample of 288 treatment-seeking people who smoke were randomized: SinHumo App plus smoking cessation treatment (n = 140) and control App plus smoking cessation treatment (n = 148). The primary outcome was 7-day point prevalence abstinence (PPA) at the 12-month follow-up. Secondary outcomes were abstinence rates at the end of the intervention and 3- and 6-month follow-ups, cigarette per day (CPD) reduction over the 12-month follow-up, intervention engagement, and satisfaction. Results Intention-to-treat analyses showed nonsignificant differences in self-reported 7-day PPA at the 12-month follow-up (37.1 and 42.6%, respectively; OR = 0.80). No significant differences were found in abstinence at the end of the treatment (68.6 vs. 62.8%) nor on 7-day PPA at 3- (35.7 vs. 45.9%) and 6-month (35.0 vs. 41.2%) follow-up. Complete case and multiple imputation analyses yielded similar results for abstinence outcomes. A significant reduction in CPD across the 12-month follow-up in the subsample of participants who smoked was observed, but nonsignificant differences between conditions were found. Higher engagement with the SinHumo App was a significant predictor of 12-month abstinence. Satisfaction with the intervention was high and similar in both groups. Conclusions High abstinence rates over the 12-month follow-up and satisfaction were found in both conditions. The inclusion of the SinHumo App did not improve abstinence rates in the intervention. Implications Scarce research has examined the long-term efficacy of smoking cessation treatments, including Apps, to support the quitting process. The present randomized controlled trial contributes to the existing literature about including information and communication technologies i