Cigarette Smoking, Psychological Interventions, Smoking Cessation
Conditions
Brief summary
This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.
Interventions
BEHAVIORALCognitive behavior therapy
Participants will receive CBT intervention for smoking cessation via wechat-based mini-program developed by a professional team.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Use cigarettes for no less than 1 year, and use cigarettes ≥ 10 per day 2. Nicotine dependence (FTCD ≥ 3) 3. Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and . 4. No other addictions except nicotine 5. Education level of junior high school or above 6. Age between 18 to 45 years old 7. Right-handed 8. No contraindication of MRI scanning 9. Willing to provide informed consent to participate in the study.
Exclusion criteria
1. Patients who are receiving medication 2. Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations. 3. Brain organic disease, brain injury history, coma history 4. Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination 5. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Validated Continuously Abstinence | 4 weeks | Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test. |
| Brain Structural Characteristics | 4 weeks | Differences of brain structure between successful and unsuccessful smokers after intervention, which will be measured by white matter volume, gray matter volume, cortical thickness, and surface area. |
| Brain Functional activity | 4 weeks | Differences of whole brain function activity between successful and unsuccessful smokers after intervention, which will be measured by ReHo, ALFF, fALFF, and functional connectivity (FC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 7-day Point Abstinence | 4 weeks | Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date. |
| Self-reported Continuous Abstinence | 4 weeks | Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Smoking Reduction and Participation | 4 weeks | Reductions in number of cigarettes smoked per day and rates of participation in and completion of smoking-cessation programs. |
Countries
China
Outcome results
None listed