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

Area of Science:

• Digital Health Interventions
• Behavioral Psychology
• Public Health

Background:

• Tobacco smoking is a major global health concern, leading to significant morbidity and mortality.
• Smoking cessation is challenging due to cravings and emotional distress.
• Mindfulness techniques integrated with Cognitive Behavioral Therapy (CBT) may enhance cessation outcomes.

Purpose of the Study:

• To evaluate the efficacy of a combined CBT text and mindfulness audio program for smoking cessation.
• To assess the impact of the intervention on smoking frequency, craving intensity, and emotional regulation.
• To explore secondary outcomes including sleep quality, nicotine dependence, and weight changes.

Main Methods:

• A parallel-group, assessor-blinded randomized controlled trial (RCT) involving approximately 2000 adult smokers in China.
• Participants were randomized to receive either CBT text only (Group A) or CBT text plus mindfulness audio (Group B) for 8 weeks.
• Primary outcomes measured were smoking frequency, craving intensity, and emotional regulation, with follow-up to 26 weeks. Data collected via online questionnaires and cotinine tests.

Main Results:

• The study is currently enrolling participants and has not yet yielded results.
• Data collection and analysis are ongoing to determine the primary and secondary outcomes.
• The trial is registered (NCT06901713) and ethical approval has been obtained.

Conclusions:

• The findings are expected to contribute to the development of more effective digital health interventions for smoking cessation.
• This research may provide insights into the synergistic effects of CBT and mindfulness for overcoming smoking addiction.
• The study aims to offer evidence-based strategies for public health initiatives targeting smoking cessation.