Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Cigarette Smoking; Psychological Interventions
• Intervention / Treatment: Behavioral: Cognitive behavior therapy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 360000
      • Yanhui Liao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Group; 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; Participants will receive CBT intervention for smoking cessation via "wechat"-based mini-program developed by a professional team.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Reduction and Participation	Reductions in number of cigarettes smoked per day and rates of participation in and completion of smoking-cessation programs.	4 weeks

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20220061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No