A Randomized Clinical Trial to Assess the Efficacy of a Psychological Treatment to Quit Smoking Assisted with an App: Study Protocol

Numerous studies have shown the efficacy of smoking cessation interventions. However, some challenges, such as relapse rates, remain. The availability of information technologies (ICTs) offers promising opportunities to address such challenges. The aim of this paper is to describe the protocol followed to assess the efficacy of a face-to-face cognitive–behavioral intervention for smoking cessation using a smartphone application as a complement, compared with a control group. A single blind, two-arm, randomized controlled trial is proposed (NCT04765813). The participants will be smokers over 18 years old, who smoke at least eight cigarettes per day. Participants will be randomized to one of two conditions, using a 1:1 allocation ratio: (1) cognitive–behavioral smoking cessation treatment along with an App with active therapeutic components (SinHumo App); or (2) cognitive–behavioral treatment along with the use of a control App (without active components). The experimental App will be used during the eight treatment sessions and for 12 months after the end of treatment. The primary outcome measures will be 7-days point-prevalence abstinence at 12-months follow-up. We expect the experimental App to obtain higher abstinence rates at the end of treatment and at one-year post-treatment follow-ups and lower relapse rates, compared to the control App.