动机访谈鼓励无戒烟动机的吸烟者戒烟:随机、对照、有效性临床试验研究方法
2012/08/28
摘要
背景:虽然当前临床实践指南推荐,对于不打算戒烟的吸烟者可采用动机访谈,但有关该推荐的证据强度尚未达到最佳。为确保动机访谈的保真度,本研究采用注意力匹配对照环境,关注无戒烟动机的吸烟者(荟萃分析显示后者能从动机访谈中获益),阐述前期研究中方法学的缺陷。我们认为,与戒烟建议和强度匹配的健康教育相比,动机访谈能更加有效的诱导吸烟者在6个月随访期内的戒烟意愿和戒烟。
方法:社区成人吸烟者(n=255)以2:2:1比例分为动机访谈组、健康教育组和简短建议组,这些吸烟者具有较低的戒烟动机和意愿。在6个月的随访期内,动机访谈组和健康教育组受试者接受4次个人咨询,简短建议组受试者接受一次个人简短咨询。严格检测和独立验证保真性,以确保咨询方法的不同和咨询按计划进行。参与者在基础状态下、12周和6个月的随访期内完成调查,评价人口统计学、吸烟特征和吸烟转归。给决定戒烟的参与者提供自助式指导来戒烟、帮助制定戒烟计划和免费提供戒烟药物。主要转归为自随机分组至6个月随访期结束之间自我主诉的持续至少24 h的一次或多次戒烟意愿。次要转归为6个月随访期内生化方法确定的7天点戒断。治疗对戒烟意愿影响的假定介质为自主支持和自主动机。采用药物治疗是动机访谈对戒烟影响的一个假定介质。
讨论:本试验是目前研究动机访谈促进无戒烟动机吸烟者戒烟的最为严格的评价研究。该研究将对动机访谈对戒烟的影响提供影响-大小评估,为未来临床试验和临床实践提供证据。
(陈欣 审校)
BMC Public Health. 2012 Jun 19;12(1):456. [Epub ahead of print]
Motivational Interviewing for encouraging quit attempts among unmotivated smokers: Study protocol of a randomized, controlled, efficacy trial.
Catley D, Harris KJ, Goggin K, Richter K, Williams K, Patten C, Resnicow K, Ellerbeck E, Bradley-Ewing A, Malomo D, Liston R.
Abstract
BACKGROUND: Although current clinical practice guidelines recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition.
METHODS: A sample of adult community resident smokers (N= 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing’s effect on cessation.
DISCUSSION: This trial will provide the most rigorous evaluation to date of Motivational Interviewing’s efficacy for encouraging unmotivated smokers to make a quit attempt. It will provide also provide effect-size estimates of MI’s impact on smoking cessation to inform future clinical trials and inform the clinical practice guidelines. Trial registration ClinicalTrials.gov NCT01188018
BMC Public Health. 2012 Jun 19;12(1):456. [Epub ahead of print]
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