Smoking Cessation Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
China | 2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | The Lok Sin Tong Benevolent Society Kowloon |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported quit rate for the past 7 days | Quit rate of participants who stop smoking in the past 7 days | 6-month follow-up | No |
Secondary | Biochemically validated quit rate | Validated quit rate of participants who passed the bio-chemical validation for testing whether the participants have stopped smoking | 6-month follow-up | No |
Secondary | 50% smoking reduction | Reduce at least 50% cigarette consumption compared with baseline | 6-month follow-up | No |
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