Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

NCT05788068 | Completed

• 1 other identifier: 20220061
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Psychological Interventions; Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Self-reported 7-day Point Abstinence

  4 weeks

• Self-reported Continuous Abstinence

  4 weeks

Other Outcomes (1)

• Smoking Reduction and Participation

  4 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Cognitive behavior therapy BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Yanhui Liao

Hanzhou, Zhejiang, 360000, China

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 28, 2023
• Study Start: March 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

CN (1)