Smoking cessation with CBT and mindfulness: study protocol for a randomized controlled trial

Tobacco smoking remains a significant global health issue, contributing to preventable morbidity and mortality. Smoking cessation is often hindered by cravings and emotional distress. Cognitive behavioral therapy (CBT) has shown promise in addressing these issues, and the integration of mindfulness techniques, such as audio-guided exercises, may further enhance its effectiveness by coping with cravings, boosting self-awareness and emotional regulation. We aim to determine the efficacy of the combined program of CBT text with mindfulness audio support. This study is a parallel-group, assessor-blinded randomized controlled trial (RCT) conducted via an online WeChat-integrated platform in China, with participants randomly assigned to one of two groups: group A (CBT text only) or group B (CBT text + mindfulness audio). The study will enroll approximately 2000 adult smokers aged 18–65 who smoke at least five cigarettes per day and express a desire to quit. The intervention will last for 8 weeks, with follow-up assessments conducted at various intervals up to 26 weeks. Primary outcomes include reductions in smoking frequency and craving intensity, as well as improvements in emotional regulation. Secondary outcomes include changes in sleep quality, nicotine dependence, and weight. Data will be collected through online questionnaires and biological verification (cotinine tests) for participants who report abstinence. Statistical analyses will include logistic regression for group comparisons of primary outcomes and mixed-effects models for secondary outcomes. The study has received ethical approval (No. 2024-2068-01), and participants will provide digital informed consent. All data will be anonymized and stored securely. Results will be disseminated through peer-reviewed publications and may contribute to the development of more effective digital health interventions for smoking cessation. Trial registration number: 2024-2068-01. ClinicalTrials.gov identifier: NCT06901713. Registered on March 30, 2025.