Department of Psychology, University of Missouri-Kansas City, Kansas City, MO 64110, USA.
BMC Public Health. 2012 Jun 19;12:456. doi: 10.1186/1471-2458-12-456.
Although the current Clinical Practice Guideline 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/DESIGN: 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.
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 also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline.
ClinicalTrials.gov NCT01188018.
尽管目前的临床实践指南建议对尚未准备戒烟的吸烟者使用动机性访谈，但该方法的证据强度被评为并不理想。本研究的目的是通过确保动机性访谈干预措施的传递保持保真度、使用注意力匹配的对照组，并专注于那些元分析表明可能最受益于动机性访谈的缺乏动机的吸烟者，来解决以前研究中的关键方法学局限性。研究假设 MI 将比简短戒烟建议和强度匹配的健康教育条件更有效地诱导戒烟尝试和 6 个月随访时的戒烟。
方法/设计：正在使用 2:2:1 的治疗分配（动机性访谈、健康教育或简短建议）对报告低动机和准备戒烟的成年社区居民吸烟者（N=255）进行随机分组。在 6 个月内，动机性访谈和健康教育组的参与者接受 4 次个体咨询，简短建议组的参与者在基线时接受一次简短的面对面个体咨询。严格监测和独立验证保真度将确保咨询方法明显不同，并按计划进行。参与者在基线、第 12 周和 6 个月随访时完成调查，以评估人口统计学、吸烟特征和吸烟结果。决定戒烟的参与者将获得戒烟自助指南、戒烟计划帮助和免费药物治疗。主要结局是在随机化和 6 个月随访之间自我报告至少持续 24 小时的一次或多次戒烟尝试。次要结局是在 6 个月随访时通过生物化学确认 7 天点流行率戒烟。假设对戒烟尝试的假定治疗效果的中介变量是更强的自主性支持和自主动机。药物治疗的使用是动机性访谈对戒烟效果的假设中介。
这项试验将对动机性访谈鼓励缺乏动机的吸烟者戒烟尝试的功效进行迄今为止最严格的评估。它还将提供 MI 对戒烟影响的效应大小估计，以为未来的临床试验提供信息，并为临床实践指南提供信息。
ClinicalTrials.gov NCT01188018。
