Smoking Cessation; Tobacco Dependence
Conditions
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.
Interventions
OTHERcognitive behaviour thearpy
Participants will access the CBT text materials through a dedicated platform
OTHERmindfulness
Participants will access the mindfulness audio via a compatible device
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactYanhui Liao
Outcome results
None listed