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The Effectiveness of Mindfulness-based Intervention on Smoking Cessation

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ClinicalTrials.gov Identifier: NCT03480113
Recruitment Status : Unknown
Verified May 2018 by Yeh, Chung Shan Medical University.
Recruitment status was:  Recruiting
First Posted : March 29, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Changhua Christian Hospital
Information provided by (Responsible Party):
Yeh, Chung Shan Medical University

Study Description
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Brief Summary:
The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Mindfulness-based Intervention Behavioral: Physical fitness intervention Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effectiveness of Mindfulness-based Intervention on Smoking Cessation: a Workplace Health-promoting Program
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness-based Intervention
1 session of health education regrading the harms from smoking and 6 sessions of Mindfulness-based intervention, 1 hour each session.
 Behavioral: Mindfulness-based Intervention
mindful breath, body scan, sitting meditation and walking meditation and so on.
Active Comparator: Physical Fitness intervention
1 session of health education regrading the harms from smoking and 6 sessions of physical fitness and stretch exercise, 1 hour each session.
 Behavioral: Physical fitness intervention
giving the lessons of stretch exercise, aerobics to strength muscle and lung fuctions.


Outcome Measures
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Primary Outcome Measures :
  1. Nicotine dependence level [ Time Frame: Up to 8 months ]
    Fagerstrom Dependence Questionnaire was adopted to assess the level of Nicotine dependence


Secondary Outcome Measures :
  1. Self-reported stress [ Time Frame: Up to 8 months ]
    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.

  2. Psychological distress [ Time Frame: Up to 8 months ]
    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.

  3. the Level of mindfulness [ Time Frame: Up to 8 months ]
    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.

  4. the level of CO [ Time Frame: Up to 8 months ]
    The Smokerlyzer was adopted to assess the participants' CO level. <5ppm indicates nonsmoker; 5~7ppm indicates lighter smokers; ≧8ppm indicates heavy smokers.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480113


Contacts
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Contact: Shu-Ling Huang, PhD +886-4-24730022 ext 12301 shuling@csmu.edu.tw

Locations
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Taiwan
AIDC Recruiting
Taichung, Taiwan, 433
Contact: Lingyi Wang, RN         
Principal Investigator: Lingyi Wang, RN         
Sponsors and Collaborators
Chung Shan Medical University
Changhua Christian Hospital
Investigators
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Principal Investigator: Shu-Ling Huang, PhD Department of Psychology, Chung Shan Medical University
More Information
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Responsible Party: Yeh, professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT03480113    
Other Study ID Numbers: CS16175
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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