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

Tang, Jinsong; Liu, Xiaocong; Chen, Shanshan; Sun, Yunkai; Zhu, Minzhe; Zhou, Zitang; Liu, Yueheng; Yang, Jie et al. · Addiction · 2026

rct · Level II

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Abstract

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. A digital, parallel, single-blind, two-arm (1:1) randomized controlled trial. This trial was conducted via 'Smokefree Life' app in the whole of mainland of China between 13 December 2021 and 15 April 2023. 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. 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. 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. 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). The 'Smokefree Life' app-based smoking cessation intervention statistically significantly improved 6-month biochemically confirmed quit rates among adult smokers in China.

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