Efficacy of cognitive behavioral therapy‐based smartphone app for smoking cessation in China: A randomized controlled trial

Background and aims Smoking is the leading preventable cause of premature death in China, yet less than 10% of smokers seeking to quit receive treatment. This study aimed to test the efficacy of a cognitive behavioral therapy (CBT)‐based smoking cessation intervention (‘Smokefree Life’) via a smartphone app in China. Design A digital, parallel, single‐blind, two‐arm (1:1) randomized controlled trial. Setting This trial was conducted via ‘Smokefree Life’ app in the whole of mainland of China between 13 December 2021 and 15 April 2023. Participants Chinese‐speaking adult smokers (925 males, 102 females, mean age 35.0 ± 6.7) willing to quit within one month were recruited via WeChat, survey sampling and referral from doctors, friends and family and randomized in a 1:1 ratio. Intervention The intervention group ( n = 523) received a 13–14 week CBT‐based smoking cessation intervention via smartphone app and the control group ( n = 504) received only control messages. All participants were followed for 26 weeks post‐quit date. Measurements The primary outcome was biochemically validated continuous abstinence at 26 weeks. Secondary outcomes were self‐reported 7‐day abstinence and continuous abstinence at 26 weeks. Findings By intention‐to‐treat analysis, the biochemically verified 26‐week continuous abstinence rate was statistically significantly higher in the intervention group (6.50%) compared with the control group (2.58%) (odds ratio = 2.63, 95% confidence interval = 1.40–5.22, P = 0.0037). Self‐reported 7‐day and continuous abstinence rates were also consistently higher in the intervention group across follow‐ups (all P < 0.05). Conclusions The ‘Smokefree Life’ app‐based smoking cessation intervention statistically significantly improved 6‐month biochemically confirmed quit rates among adult smokers in China.