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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT text-based program alone | Active Comparator | Participants in this group will receive CBT text messages focused on smoking cessation strategies, including identifying triggers, developing coping mechanisms, and setting goals. These messages will be sent at regular intervals over the course of the 8-week program. |
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| CBT text combined with mindfulness audio | Experimental | In addition to the CBT text messages similar to Group A, participants in this group will also have access to a series of mindfulness audio recordings. These recordings will guide participants through mindfulness exercises such as body scans, breath awareness, and meditation, designed to enhance self-awareness and emotion regulation in the context of smoking cessation. The audio will be provided weekly, corresponding to the weekly themes of the program. Participants in this group will receive emotional support and peer-related information from chatbots. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive behaviour thearpy | Other | Participants will access the CBT text materials through a dedicated platform |
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| Measure | Description | Time Frame |
|---|---|---|
| Biological Verification of Abstinence | 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Frequency | Measured by the number of cigarettes smoked per day at baseline | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26. |
| Craving Intensity | Assessed using a visual analog scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhui Liao | Contact | 86 18814898844 | liaoyanhui@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27677441 | Background | Li S, Meng L, Chiolero A, Ma C, Xi B. Trends in smoking prevalence and attributable mortality in China, 1991-2011. Prev Med. 2016 Dec;93:82-87. doi: 10.1016/j.ypmed.2016.09.027. Epub 2016 Sep 24. | |
| 21696322 | Background | Li Q, Hsia J, Yang G. Prevalence of smoking in China in 2010. N Engl J Med. 2011 Jun 23;364(25):2469-70. doi: 10.1056/NEJMc1102459. No abstract available. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| mindfulness | Other | Participants will access the mindfulness audio via a compatible device |
|
| Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26. |
| Emotional Regulation | Evaluated using the Depression, Anxiety, and Stress Scale (DASS-21) | Baseline, Week 12, and Week 26 |
| 41857743 | Derived | Chen R, Ye R, Liao Y. Smoking cessation with CBT and mindfulness: study protocol for a randomized controlled trial. Trials. 2026 Mar 19;27(1):325. doi: 10.1186/s13063-026-09611-9. |
| D001523 |
| Mental Disorders |