Smoking Cessation; Tobacco DependenceNCT06901713
Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial
A study testing cognitive behaviour thearpy and mindfulness in people with Smoking Cessation; Tobacco Dependence, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation; Tobacco Dependence
- What is being tested?
- cognitive behaviour thearpy and mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou
Yanhui Liao, +86 18814898844, liaoyanhui@zju.edu.cn
About this study
Official title: Protocol for a Smoking Cessation Program With CBT Text and Mindfulness Audio Support: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Smoking Cessation; Tobacco Dependence
- Being tested
- cognitive behaviour thearpy, mindfulness
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behaviour thearpyOther
Participants will access the CBT text materials through a dedicated platform
mindfulnessOther
Participants will access the mindfulness audio via a compatible device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: cognitive behaviour thearpy |
| 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. Receives: Other: cognitive behaviour thearpy; Other: mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (3)
Smoking Frequency
Measured by the number of cigarettes smoked per day at baseline
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.
Craving Intensity
Assessed using a visual analog scale (VAS)
Measured: 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)
Measured: Baseline, Week 12, and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start9 Oct 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking Cessation; Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901713
- Sponsor's protocol ID
- 2024-2068-01
- Status last verified
- Feb 2025
- First submitted
- 24 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27677441Li 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.
PubMed 21696322Chen 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.
PubMed 41857743
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Smoking Cessation Program With CBT Text and Mindfulness Audio Support: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06901713
- Acronym / sponsor ID
- 2024-2068-01
- Conditions
- Smoking Cessation; Tobacco Dependence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT text-based program alone | Active comparator | Other: cognitive behaviour thearpyParticipants 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. |
| CBT text combined with mindfulness audio | Experimental | Other: cognitive behaviour thearpy, Other: mindfulnessIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behaviour thearpyParticipants will access the CBT text materials through a dedicated platform | Other | CBT text combined with mindfulness audio, CBT text-based program alone |
| mindfulnessParticipants will access the mindfulness audio via a compatible device | Other | CBT text combined with mindfulness audio |
Primary outcome
Biological Verification of Abstinence
Time frame: 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.
3 secondary outcomes
Smoking Frequency
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.
Craving Intensity
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.
Emotional Regulation
Time frame: Baseline, Week 12, and Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 27677441Li 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.
- Background: PubMed 21696322Li 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.
- Derived from this study: PubMed 41857743Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behaviour thearpy and mindfulness in people with Smoking Cessation; Tobacco Dependence, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanhui Liao (86 18814898844, liaoyanhui@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Verification of Abstinence (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06901713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.