Mindfulness-based Treatment to Prevent Smoking Relapse: a Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- rate of recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
usual care
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)
MBRP group
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
干预措施: MBRP group (Behavioral)
结局指标
主要结局
rate of recruitment
时间窗: 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.
the rate of retention
时间窗: 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
次要结局
- reported abstinence from smoking during the last seven days, which will be confirmed with an expired carbon monoxide level of <6 ppm(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- 7-item Generalized Anxiety Disorder Questionnaire (GAD-7)(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- 10-item Perceived Stress Scale(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- Five-Facet Mindfulness Questionnaire (FFMQ)(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- the Alcohol Use Identification Test (AUDIT)(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- 20-item Positive Affect and Negative Affect Scale(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- 9-item Patient Health Questionnaire (PHQ-9)(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- Minnesota Nicotine Withdrawal Scale(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
- Brief questionnaire of smoking urges(assessed at baseline (before class 1) and immediately after the eighth MBRP class)
研究者
Lee Kam Pui
Clinical Assistant Professor
Chinese University of Hong Kong