Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Smoking Cessation; Tobacco Dependence

• Registration Number: NCT06901713
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

This protocol describes a randomized controlled trial evaluating the effectiveness of a smoking cessation program with two intervention methods. One method provides only CBT text messages (Group A), while the other combines CBT text with mindfulness audio (Group B). The study aims to compare the two approaches in reducing smoking frequency, managing cravings, and improving emotional regulation.

This study investigates the effects of two different smoking cessation interventions: (1) CBT text-based program alone (Group A), and (2) CBT text combined with mindfulness audio (Group B). The primary outcomes include reductions in smoking frequency and cravings, as well as improvements in emotional regulation and quality of life.

Detailed Description

Design: A randomized controlled trial (RCT) will be used to compare the outcomes of the two intervention groups.

Setting: The study will be conducted online. Participants will access the CBT text materials through a dedicated platform and the mindfulness audio via a compatible device. Recruitment will be done through social media, community outreach, and online advertisements.

Study Timeline

• Study Start: 2024-10-09
• Status Verified: 2025-02
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Who smoke at least 5 cigarettes per day.
• Express a desire to quit or reduce smoking.
• Who has the ability to access and use the provided digital materials.

Exclusion Criteria

• Those currently enrolled in other smoking cessation programs.
• Individuals with severe psychiatric disorders that may interfere with participation.
• Those without access to the necessary digital devices.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biological Verification of Abstinence	6 Months	Confirmation of smoking abstinence at the end of the study period using cotinine test strips. This will be the main measure to assess the effectiveness of the smoking cessation interventions.

Secondary Outcome Measures

Name	Time	Method
Smoking Frequency	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.	Measured by the number of cigarettes smoked per day at baseline
Craving Intensity	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.	Assessed using a visual analog scale (VAS)
Emotional Regulation	Baseline, Week 12, and Week 26	Evaluated using the Depression, Anxiety, and Stress Scale (DASS-21)

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, China