Smoking CessationNCT03480113
The Effectiveness of Mindfulness-based Intervention on Smoking Cessation
A study testing Mindfulness-based Intervention and Physical fitness intervention in people with Smoking Cessation, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mindfulness-based Intervention and Physical fitness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteered employees with heavy smoker
- Full-time paid workers
Who cannot join
- Age < 20y or > 65y
- Part-time workers
- The workers are not willing to take part in the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
AIDC
Taichung, 433
Lingyi Wang, RN
Lingyi Wang, RN
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Mindfulness-based Intervention, Physical fitness intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based InterventionBehavioural
mindful breath, body scan, sitting meditation and walking meditation and so on.
Physical fitness interventionBehavioural
giving the lessons of stretch exercise, aerobics to strength muscle and lung fuctions.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Intervention | Experimental | 1 session of health education regrading the harms from smoking and 6 sessions of Mindfulness-based intervention, 1 hour each session. Receives: Behavioral: Mindfulness-based Intervention |
| Physical Fitness intervention | Active comparator | 1 session of health education regrading the harms from smoking and 6 sessions of physical fitness and stretch exercise, 1 hour each session. Receives: Behavioral: Physical fitness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine dependence level
Fagerstrom Dependence Questionnaire was adopted to assess the level of Nicotine dependence
Measured: Up to 8 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start16 Mar 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Changhua Christian Hospital
- Responsible party
- Principal investigator, Yeh, Chung Shan Medical University
- Investigators
- Shu-Ling Huang, PhD, Principal investigator, Department of Psychology, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480113
- Sponsor's protocol ID
- CS16175
- Status last verified
- May 2018
- First submitted
- 14 Mar 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of Mindfulness-based Intervention on Smoking Cessation: a Workplace Health-promoting Program
- ClinicalTrials.gov ID
- NCT03480113
- Acronym / sponsor ID
- CS16175
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Changhua Christian Hospital
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Intervention | Experimental | Behavioral: Mindfulness-based Intervention1 session of health education regrading the harms from smoking and 6 sessions of Mindfulness-based intervention, 1 hour each session. |
| Physical Fitness intervention | Active comparator | Behavioral: Physical fitness intervention1 session of health education regrading the harms from smoking and 6 sessions of physical fitness and stretch exercise, 1 hour each session. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- volunteered employees with heavy smoker
- Full-time paid workers
Key exclusion criteria (3 listed)
- Age < 20y or > 65y
- Part-time workers
- The workers are not willing to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Interventionmindful breath, body scan, sitting meditation and walking meditation and so on. | Behavioural | Mindfulness-based Intervention |
| Physical fitness interventiongiving the lessons of stretch exercise, aerobics to strength muscle and lung fuctions. | Behavioural | Physical Fitness intervention |
Primary outcome
Nicotine dependence level
Time frame: Up to 8 months
Fagerstrom Dependence Questionnaire was adopted to assess the level of Nicotine dependence
4 secondary outcomes
Self-reported stress
Time frame: Up to 8 months
Psychological distress
Time frame: Up to 8 months
the Level of mindfulness
Time frame: Up to 8 months
the level of CO
Time frame: Up to 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Ling Huang, PhD principal investigator
Department of Psychology, Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention and Physical fitness intervention in people with Smoking Cessation, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Ling Huang, PhD (+886-4-24730022 ext. 12301, shuling@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine dependence level (time frame: Up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.