The Effectiveness of Mindfulness-based Intervention on Smoking Cessation

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

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

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Mindfulness-based Intervention; Behavioral: Physical fitness intervention

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 433
    • Recruiting
    • AIDC
    • Contact: Lingyi Wang, RN
    • Principal Investigator: Lingyi Wang, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nicotine dependence level	Fagerstrom Dependence Questionnaire was adopted to assess the level of Nicotine dependence	Up to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: Changhua Christian Hospital
• Investigators: Principal Investigator: Shu-Ling Huang, PhD, Department of Psychology, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CS16175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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