Smoking CessationNCT03930329
Mindfulness-based Treatment to Prevent Smoking Relapse
A study testing MBRP group in people with Smoking Cessation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Smoking causes a variety of health problems and causes burden to healthcare systems. Even when support is provided, local data suggest that around 50% of biochemically confirmed quitters resume smoking within 6 months of participating in a smoking cessation program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- MBRP group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jul 2019to 31 Jul 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years
- self-reported smokers
- can speak and read Cantonese and Chinese
- willing to participate in at least 7 of the 8 sessions of the MBRP program
Who cannot join
- pregnancy (they will have different motivations for quitting smoking)
- significant physical illness or severe cognitive impairment that prevents communication, such as blindness or severe hearing loss, because mindfulness exercise instructions are given verbally and reading materials are given out after each class
- history of psychotic disorders or symptoms, because MBRP is not confirmed safe or effective in this group of patients
- suicidal tendency as detected by PHQ-9 (see below)
- we will not exclude participants with mood disorders for the reasons stated in the introduction, but participants with drug changes for their mood disorders in the last 3 months will be excluded (ethics approval and informed consent will be obtained for assessing patients' medical records, CMS of the hospital authority or e-health, to confirm drug information)
- active illicit drug use and
- past mindfulness course or practices in the previous 12 months
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Tung Wah Group of Hospitals, Integrated Centre on Smoking Cessation, Tuen Mun Centre
Hong Kong
About this study
Official title: Mindfulness-based Treatment to Prevent Smoking Relapse: a Pilot Randomized Controlled Study
Background: Smoking causes a variety of health problems and causes burden to healthcare systems. Even when support is provided, local data suggest that around 50% of biochemically confirmed quitters resume smoking within 6 months of participating in a smoking cessation program. Mindfulness-based intervention is a promising option because accumulating evidence from randomized controlled trials support its use among smokers. Our team aims to determine if mindfulness-based interventions can prevent relapse in smokers who recently quit smoking. A pilot trial is needed to determine the feasibility of recruitment, randomisation and acceptability of the intervention in these patients Method: Forty participants, who just quitted smoking, will be randomised in a 1:1 ratio to the 8week mindfulness-based relapse prevention (MBRP) program and to usual care.
- Conditions
- Smoking Cessation
- Being tested
- MBRP group
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBRP groupBehavioural
same as arm description
| Study group | Role | What they receive |
|---|---|---|
| MBRP group | Experimental | The mindfulness-based relapse prevention program consists of eight weekly 2-hour sessions. It combines mindfulness with evidence-based cognitive behavioural techniques that help participants to recognize internal and external triggers of their substance abuse, including smoking. Each session consists of mindful practices with cognitive exercises. The standardized treatment manual was published Receives: Behavioral: MBRP group |
| usual care | No intervention | All participants in this trial will receive usual care, which consists of 8-12 weeks of counselling and drug treatment to help smokers quit. Data from the centre shows that approximately 50% of smokers are successfully abstinent from smoking at end of the program, as confirmed by the carbon monoxide breath test. This trial will only recruit those who successfully quitted smoking. During this 8-12 week program, written information about relapse prevention is given, including information for maintaining healthy lifestyles (e.g. diet/sleep/exercise/emotional control). Participants will receive follow-up phone interviews by trained smoking cessation counsellors at end of the program (week 8-12) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of retention
As a pilot study to test the feasibility of the future RCT, the primary outcomes will include the rates of recruitment and retention. The amount of homework completed will be self-reported using a homework diary
Measured: recruitment and thoughout the 8-week program
rate of recruitment
As a pilot study to test the feasibility of the future RCT, the primary outcomes will include the rates of recruitment and retention.
Measured: from recruitment to the start of the 8-week program
Secondary outcomes (9)
reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm
reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
9-item Patient Health Questionnaire (PHQ-9)
validated instrument for depressive symptoms
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
7-item Generalized Anxiety Disorder Questionnaire (GAD-7)
validated instrument for anxiety symptoms
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
the Alcohol Use Identification Test (AUDIT)
validated instrument for alcohol use
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
10-item Perceived Stress Scale
validated instrument for stress level; there are two factors: (i) perceived helplessness and (ii) perceived efficacy; each subscales' score can be calculated by adding up scored from individual questions; Perceived helplessness subscale score: 0-24 (higher is worse); perceived efficacy subscale score 0-16 (higher the better) total score calculation: reverse scoring for questions in 'self-efficacy' sub-scale, total score can be calculated by adding all the scores together; Theoretical rage: 0 to 40; The higher the score, the higher the perceived stress
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
20-item Positive Affect and Negative Affect Scale
validated instrument for positive and negative affect; 10 item for positive items and 10 for negative items; score range from 10-50 for both items. For total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Minnesota Nicotine Withdrawal Scale
no subscale; total score is the sum of the score of individual item; possible score: 0-36; the higher the score, the more severe the withdrawal symptoms
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Five-Facet Mindfulness Questionnaire (FFMQ)
validated instrument to assess the level of mindfulness; 5 subscale; each subscale score is calucated by adding score from individual items; the protocol had included reverse scoring for item 3, 5, 8, 10, 12, 13, 14, 16, 17, 18, 22, 23, 25, 28, 30, 34, 35, 38, 39. Subscale score: observing (8-40), describe (8-40), act with awareness (8-40), nonjudge (8-40), nonreact (7-35); the higher the score, the higher the degree of mindfulness in each subscale
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Brief questionnaire of smoking urges
subscale 1 - intention/desire to smoke; subscale 2 - relief of negative affect \& urgent desire to smoke; the score of each subscale is calculated by adding the score from individual items; possible scores for each subscale = 5-35; the higher the score, the higher the smoking urge
Measured: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start24 Jul 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Group for Hospital Integrated Centre
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930329
- Sponsor's protocol ID
- NTEC-2019-smoke
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will make available on request of investigators
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Treatment to Prevent Smoking Relapse: a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03930329
- Acronym / sponsor ID
- NTEC-2019-smoke
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Tung Wah Group for Hospital Integrated Centre
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 29 Apr 2019 (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.
Background: Smoking causes a variety of health problems and causes burden to healthcare systems. Even when support is provided, local data suggest that around 50% of biochemically confirmed quitters resume smoking within 6 months of participating in a smoking cessation program. Mindfulness-based intervention is a promising option because accumulating evidence from randomized controlled trials support its use among smokers. Our team aims to determine if mindfulness-based interventions can prevent relapse in smokers who recently quit smoking. A pilot trial is needed to determine the feasibility of recruitment, randomisation and acceptability of the intervention in these patients Method: Forty participants, who just quitted smoking, will be randomised in a 1:1 ratio to the 8week mindfulness-based relapse prevention (MBRP) program and to usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBRP group | Experimental | Behavioral: MBRP groupThe mindfulness-based relapse prevention program consists of eight weekly 2-hour sessions. It combines mindfulness with evidence-based cognitive behavioural techniques that help participants to recognize internal and external triggers of their substance abuse, including smoking. Each session consists of mindful practices with cognitive exercises. The standardized treatment manual was published |
| usual care | No intervention | –All participants in this trial will receive usual care, which consists of 8-12 weeks of counselling and drug treatment to help smokers quit. Data from the centre shows that approximately 50% of smokers are successfully abstinent from smoking at end of the program, as confirmed by the carbon monoxide breath test. This trial will only recruit those who successfully quitted smoking. During this 8-12 week program, written information about relapse prevention is given, including information for maintaining healthy lifestyles (e.g. diet/sleep/exercise/emotional control). Participants will receive follow-up phone interviews by trained smoking cessation counsellors at end of the program (week 8-12) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 years
- self-reported smokers
- can speak and read Cantonese and Chinese
- willing to participate in at least 7 of the 8 sessions of the MBRP program
Key exclusion criteria (7 listed)
- pregnancy (they will have different motivations for quitting smoking)
- significant physical illness or severe cognitive impairment that prevents communication, such as blindness or severe hearing loss, because mindfulness exercise instructions are given verbally and reading materials are given out after each class
- history of psychotic disorders or symptoms, because MBRP is not confirmed safe or effective in this group of patients
- suicidal tendency as detected by PHQ-9 (see below)
- we will not exclude participants with mood disorders for the reasons stated in the introduction, but participants with drug changes for their mood disorders in the last 3 months will be excluded (ethics approval and informed consent will be obtained for assessing patients' medical records, CMS of the hospital authority or e-health, to confirm drug information)
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 |
|---|---|---|
| MBRP groupsame as arm description | Behavioural | MBRP group |
Primary outcome
the rate of retention
Time frame: recruitment and thoughout the 8-week program
As a pilot study to test the feasibility of the future RCT, the primary outcomes will include the rates of recruitment and retention. The amount of homework completed will be self-reported using a homework diary
rate of recruitment
Time frame: from recruitment to the start of the 8-week program
As a pilot study to test the feasibility of the future RCT, the primary outcomes will include the rates of recruitment and retention.
9 secondary outcomes
reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
9-item Patient Health Questionnaire (PHQ-9)
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
7-item Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
the Alcohol Use Identification Test (AUDIT)
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
10-item Perceived Stress Scale
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
20-item Positive Affect and Negative Affect Scale
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Minnesota Nicotine Withdrawal Scale
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Five-Facet Mindfulness Questionnaire (FFMQ)
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Brief questionnaire of smoking urges
Time frame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: Undecided. will make available on request of investigators
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBRP group in people with Smoking Cessation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 7 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 31 Aug 2021. 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 Hong Kong. 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?
the rate of retention (time frame: recruitment and thoughout the 8-week program). The study lists 2 primary outcomes in all. 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 31 Aug 2021.