Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

Conditions
-----------------
Cigarette Smoking, Psychological Interventions, Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use cigarettes for no less than 1 year, and use cigarettes ≥ 10 per day Nicotine dependence (FTCD ≥ 3) Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and . No other addictions except nicotine Education level of junior high school or above Age between 18 to 45 years old Right-handed No contraindication of MRI scanning Willing to provide informed consent to participate in the study. Exclusion Criteria: Patients who are receiving medication Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations. Brain organic disease, brain injury history, coma history Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination Pregnant and lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants in the intervention group will receive CBT-based digital smoking cessation intervention. The intervention is a set of smoking cessation methods based on the theoretical study of cognitive behavioral therapy for smoking cessation, and its effectiveness has been confirmed through our large sample of randomized controlled studies. This study plans to intervene smokers for 4 weeks after the start of smoking cessation. | Behavioral: Cognitive behavior therapy<br>* Participants will receive CBT intervention for smoking cessation via wechat-based mini-program developed by a professional team.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically Validated Continuously Abstinence | Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test. | 4 weeks | 
| Brain Structural Characteristics | 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. | 4 weeks | 
| Brain Functional activity | 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 7-day Point Abstinence | Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date. | 4 weeks | 
| Self-reported Continuous Abstinence | Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date. | 4 weeks |