Clinical trial NCT03930329: Mindfulness-based Treatment to Prevent Smoking Relapse
Official title: Mindfulness-based Treatment to Prevent Smoking Relapse: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tung Wah Group for Hospital Integrated Centre
First posted: 2019-04-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: the rate of retention
timeFrame: recruitment and thoughout the 8-week program
measure: rate of recruitment
timeFrame: from recruitment to the start of the 8-week program
Secondary outcomes:
measure: reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: 7-item Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: the Alcohol Use Identification Test (AUDIT)
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: 10-item Perceived Stress Scale
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: 20-item Positive Affect and Negative Affect Scale
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: Five-Facet Mindfulness Questionnaire (FFMQ)
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
measure: Brief questionnaire of smoking urges
timeFrame: assessed at baseline (before class 1) and immediately after the eighth MBRP class
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tung Wah Group of Hospitals, Integrated Centre on Smoking Cessation, Tuen Mun Centre
Study officials:
References: