Mindfulness Training for Smoking Cessation in Women in Workplaces

May 10, 2016 updated by: The University of Hong Kong

Mindfulness Training for Smoking Cessation in Women in the Workplace - a Pilot Randomized Controlled Trial

This study has the following objectives:

  1. To raise the awareness of female smokers about the harmfulness of tobacco towards their life issues
  2. To encourage female smokers to stop using tobacco
  3. To assess the effectiveness of mindfulness approach for smoking cessation in women

We will use cluster randomisation. About 40 companies (5 smokers / company) involved in the study will be matched on the company characteristics (e.g. company size, the industry the company belongs to). Using random generator in Excel, random number will be first generated to each pair i.e. there will be 1-40 random numbers. For each pair, the two companies will be randomly assigned to 0 or 1. Companies who are assigned to 1 will be allocated to intervention . Interviewers (assessors) in the follow-ups will not be involved in the randomization process and be totally blinded to the group assignment (allocation concealment).

Invitation letter will be sent to beauty and retail industries or other women-related industries by Lok Sin Tong. Health talks on smoking and its hazard will deliver to each company. For those who join the workshops after the health talks will fill in pre- and post- workshop questionnaires (Appendix 4-5). Women who attend the health talk will be recruited on site. Women will be screened by the criteria of eligibility form (Appendix 1) and all eligible women smokers will be asked to sign on informed consents (Appendix 2, 3) before they participate in the programs. After they consent to participate, they will fill in a baseline questionnaire (Appendix 6), and will be assigned to intervention or control group according to the allocation of their company. Some of the eligible women may miss the health talks and directly join the intervention program, because of this situation the intervention group will be further divided into Group A and B: women in Group A will attend health talks and intervention program, women in Group B will only attend intervention program.

Intervention group (Mindfulness Smoking cessation program): Women in intervention group will be provided 2 sessions mindfulness training within 2 weeks. Each session will last for 2 hours with 8-20 participants. For mindfulness training, it aims to understand women smokers' own life planning, stressors and their correlation with smoking; to help women smokers sit with negative affect and alleviate stress through mindfulness; to educate women smokers gain the self-control and replace the smoking habit; to teach women smokers how to prevent craving and relapse. The tentative agenda is shown below:

Session 1 (Introductory) Contents

  1. Pre-questionnaire
  2. Introducing mindfulness and managing craving with mindfulness

  3. Understanding the components of craving and its management

    • The relationship between habitual response and learned association
    • The physiological and psychological withdrawal symptoms
  4. Mindfulness yoga practices

Responsible person* Smoking Cessation Program in Workplace (SCPW) staff & Yoga teacher

Session 2 (Advanced)

Contents

  1. Knowledge about impacts of smoking on women's health
  2. Recapture the management of craving through mindfulness
  3. Mindfulness exercises
  4. Mindfulness yoga practices

Responsible person* SCPW staff & Yoga teacher

* SCPW staff would be responsible for the whole session except for the part "stress reduction and self-control through mindfulness yoga". It would be held by the yoga teacher.

Control group (Self-help smoking cessation booklet): Only the self-help booklet related to quitting will be provided to the participants.

Evaluation: 1-month telephone interviews will be conducted for control group at 1- (Appendix 97) and 6-month follow-ups will be conducted for both groups (after the last interventions) by trained interviewers (blinded to the group assignment). Participants who have reported abstinence in past 7 days from smoking at 6-month follow-ups will undergo a non-biochemical validation to check their quitting status. They will be invited to have biochemical validation tests (saliva cotinine test and exhaled CO test) at 6-month follow-up.

In-depth face-to-face interview will be conducted by trained interviewers in 10 randomly selected participants in each group (in total 20 participants) to better understand their quitting process, quitting difficulty, and their own feeling and experience in the project.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • 2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Women who smoked at least 1 cigarette a day by the time of the study starts
  • Aged 18 or above
  • Able to communicate in Cantonese or Mandarin, and read and write Chinese

Exclusion criteria:

  • Women smokers with unstable physical or psychological conditions as advised by a doctor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Intervention group (Mindfulness Smoking cessation program): Women in intervention group will be provided 2 sessions mindfulness training within 2 weeks. Each session will last for 2 hours with 8-20 participants. For mindfulness training, it aims to understand women smokers' own life planning, stressors and their correlation with smoking; to help women smokers sit with negative affect and alleviate stress through mindfulness; to educate women smokers gain the self-control and replace the smoking habit; to teach women smokers how to prevent craving and relapse.
Behavioral: Mindfulness training
Using mindfulness training (Thinking and Yoga class) to help women smokers in workplaces to quit smoking
Experimental: Control group
Control group (Self-help smoking cessation booklet): Only the self-help booklet related to quitting will be provided to the participants.
Behavioral: Mindfulness training
Using mindfulness training (Thinking and Yoga class) to help women smokers in workplaces to quit smoking

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported quit rate for the past 7 days
Time Frame: 6-month follow-up
Quit rate of participants who stop smoking in the past 7 days
6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemically validated quit rate
Time Frame: 6-month follow-up
Validated quit rate of participants who passed the bio-chemical validation for testing whether the participants have stopped smoking
6-month follow-up
50% smoking reduction
Time Frame: 6-month follow-up
Reduce at least 50% cigarette consumption compared with baseline
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lok Sin Tong Benevolent Society, Kowloon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Man-ping Wang, PhD, School of Nursing, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSTWomen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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