The Effectiveness of Mindfulness-based Intervention on Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

A Pilot Study of the Effectiveness of Mindfulness-based Intervention on Smoking Cessation: a Workplace Health-promoting Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480113
• Other study ID #: CS16175
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Chung Shan Medical University
• Contact: Shu-Ling Huang, PhD
• Phone: +886-4-24730022
• Email: shuling[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking.

Description:

The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking. The study will adopt a longitudinal research design with randomized quasi-experimental trial. The smoking workers will recruited and be randomly assigned to Group A (one lesson of health education on smoking cessation and six lessons of MBI) or Group B (one lesson of health education on smoking cessation and six lessons of physical fitness). There will be 50 participants in each group. Data will be collected five times.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• volunteered employees with heavy smoker

• Full-time paid workers

Exclusion Criteria:

• Age < 20y or > 65y

• Part-time workers

• The workers are not willing to take part in the study

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Mindfulness-based Intervention
mindful breath, body scan, sitting meditation and walking meditation and so on.
• Physical fitness intervention
giving the lessons of stretch exercise, aerobics to strength muscle and lung fuctions.

Locations

Country	Name	City	State
Taiwan	AIDC	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nicotine dependence level	Fagerstrom Dependence Questionnaire was adopted to assess the level of Nicotine dependence	Up to 8 months
Secondary	Self-reported stress	10 items of Perceived Stress Scale was adopted to assess the level of perceived stress. This scale uses the Likert five-point scoring method, from 0-4. The higher scores indicate higher pressure levels.	Up to 8 months
Secondary	Psychological distress	Psychological distress was measured by the Chinese Health Questionnaire (CHQ-12), a well-validated instrument. A total of 12 items using the Likert four-point scoring method, with scores ranged from 0-36. The higher scores indicates higher level of psychological distress.	Up to 8 months
Secondary	the Level of mindfulness	Measuring the level of Mindfulness, using the Likert five-point scoring method, a total of 39 questions, including the five concepts, namely: awareness (8 questions), description (8 questions), non-judging (8 questions), observation (8 questions), and non-reaction (7 questions). The higher scores indicate higher levels of mindfulness.	Up to 8 months
Secondary	the level of CO	The Smokerlyzer was adopted to assess the participants' CO level. <5ppm indicates nonsmoker; 5~7ppm indicates lighter smokers; ?8ppm indicates heavy smokers.	Up to 8 months