Efficacy and Neuroimaging Mechanisms of Mindfulness-based Smoking Cessation in China

• Sponsor: Sir Run Run Shaw Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05788068
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 44.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking; Psychological Interventions; Smoking Cessation	Behavioral: Mindfulness-based smoking cessation; Behavioral: Cognitive behavior therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Neuroimaging Mechanisms of Mindfulness-based Smoking Cessation in China: A Randomized Controlled Trial
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Participants in the intervention group will receive both mindfulness-based smoking cessation and cognitive behavioral therapy (CBT) for smoking cessation. The main content of mindfulness-based smoking cessation is to feel the current cravings and emotional reactions (depression, anxiety, sadness, anger, etc.), and accept such reactions and changes without criticism. This part of content will run through the whole course. The eight-week smoking cessation course is divided into 8-week online courses, about 2 hours each time. The CBT 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 8 weeks and follow up to the 26th week after the start of smoking cessation.	Behavioral: Mindfulness-based smoking cessation; Participants who allocate to the intervention group will receive regular mindfulness-based smoking cessation by professional team.; Behavioral: Cognitive behavior therapy; Participants who allocate to the control group will receive CBT for smoking cessation by professional team.
Active Comparator: Control Group Compared with the intervention group, the participants in the control group just won't accept the mindfulness-based smoking cessation intervention, and the rest are the same, including the follow-up assements (at week 1, 4, 8, 12, 16, 20 and 26 points).	Behavioral: Cognitive behavior therapy; Participants who allocate to the control group will receive CBT for smoking cessation by professional team.

Outcome Measures

Primary Outcome Measures

1. Biochemically Validated Continuously Abstinence [26 weeks]

   Biochemical validation of 26-week continuous smoking abstinence by urine cotinine test.

2. Brain Structural Characteristics [8 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.

3. Brain Functional activity [8 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 Outcome Measures

1. Self-reported 7-day Point Abstinence [26 weeks]

   Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date.

2. Self-reported Continuous Abstinence [26 weeks]

   Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.

Other Outcome Measures

1. Smoking Reduction and Participation [26 weeks]

   Reductions in number of cigarettes smoked per day and rates of participation in and completion of smoking-cessation programs.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yanhui Liao	Hanzhou	Zhejiang	China	360000

Sponsors and Collaborators

• Sir Run Run Shaw Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yanhui Liao, Deputy Chief Physician, Sir Run Run Shaw Hospital
• ClinicalTrials.gov Identifier: NCT05788068
• Other Study ID Numbers: 20220061
• First Posted: Mar 28, 2023
• Last Update Posted: Mar 28, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 28, 2023