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Smoking CessationNCT02497339

Mindfulness Training for Smoking Cessation in Women in Workplaces

A study testing Mindfulness training in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Smoking Cessation
What is being tested?
Mindfulness training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
1 siteChina
Study dates
Jan 2015to Apr 2016
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • 2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society

    Hong Kong

Other trials in China

About this study

Official title: 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
Read more

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
  1. 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.

Being tested
Mindfulness training
Keywords
Smoking cessation interventions, mindfulness training
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 trainingBehavioural

    Using mindfulness training (Thinking and Yoga class) to help women smokers in workplaces to quit smoking

Study groups in NCT02497339
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention 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.
Receives: Behavioral: Mindfulness training
Control groupExperimentalControl group (Self-help smoking cessation booklet): Only the self-help booklet related to quitting will be provided to the participants.
Receives: Behavioral: Mindfulness training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported quit rate for the past 7 days

    Quit rate of participants who stop smoking in the past 7 days

    Measured: 6-month follow-up

Secondary outcomes (2)
  1. Biochemically validated quit rate

    Validated quit rate of participants who passed the bio-chemical validation for testing whether the participants have stopped smoking

    Measured: 6-month follow-up

  2. 50% smoking reduction

    Reduce at least 50% cigarette consumption compared with baseline

    Measured: 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02497339
Sponsor's protocol ID
LSTWomen
Status last verified
May 2016
First submitted
9 Jul 2015
Last updated
12 May 2016
Results posted
No

Publications

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PubMed 39868569
  • Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

    PubMed 35420700

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness training in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2016. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported quit rate for the past 7 days (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02497339, which also lists 2 linked publications.

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 12 May 2016.

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