Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Hollings Cancer Center,86 Jonathan Lucas St., PO Box 250955, Charleston, SC 29425, USA.
Clin Trials. 2010 Apr;7(2):157-66. doi: 10.1177/1740774510361533. Epub 2010 Mar 25.
Many smokers remain unwilling or unable to make a quit attempt. For these smokers, novel strategies to induce quit attempts are necessary to achieve further reductions in smoking prevalence.
This article describes the design and methods of an ongoing nationwide telephone-based clinical trial for cessation induction, the principal aim of which is to test the hypothesis that samples of nicotine replacement therapy (NRT), can induce quit attempts among smokers otherwise unmotivated to quit.
Smokers are recruited proactively through online channels. A 'behavioral filter' is used to identify and separate motivated versus unmotivated smokers, the latter of whom (N = 750) are formally entered into the clinical trial. Participants are randomized to one of two treatment conditions designed to promote self-efficacy and motivation to quit: (1) practice quit attempt (PQA) or (2) PQA plus NRT sampling. The primary outcome measure tested over a 6-month follow-up is the incidence of additional quit attempts as well as hypothesized mediators of treatment effects.
This study details the challenges of identifying and treating smokers who are unmotivated to quit. Strengths include a novel treatment approach, tested among a group of proactively recruited smokers nationwide, with a unique method of identifying cessation-resistant smokers.
The omission of a true control group, testing the effect of the PQA itself, is an inherent limitation to the study design. Online recruitment presents additional study challenges, all of which are discussed in detail.
The study has translational potential to guide both clinical and policy recommendations for cessation induction. Further, while the focus is on smoking, this trial may serve as an example to researchers and clinicians who focus on other health behaviors, and who themselves are challenged with motivating people who are unmotivated for change.
许多吸烟者仍然不愿意或无法尝试戒烟。对于这些吸烟者，需要新的策略来促使他们尝试戒烟，以进一步降低吸烟率。
本文描述了一项正在进行的全国性电话戒烟诱导临床试验的设计和方法，其主要目的是检验以下假设：尼古丁替代疗法（NRT）样本可以促使那些没有戒烟意愿的吸烟者尝试戒烟。
通过在线渠道主动招募吸烟者。使用“行为过滤器”来识别和区分有动机和无动机的吸烟者，后者（N=750）正式纳入临床试验。参与者被随机分配到两种旨在提高戒烟自我效能和动机的治疗条件之一：（1）练习戒烟尝试（PQA）或（2）PQA 加 NRT 样本。在 6 个月的随访中，主要的测量指标是额外戒烟尝试的发生率以及治疗效果的假设中介因素。
本研究详细介绍了识别和治疗无戒烟意愿吸烟者的挑战。研究的优势包括一种新颖的治疗方法，在全国范围内主动招募的吸烟者中进行测试，以及一种独特的识别戒烟抵抗者的方法。
该研究设计的一个固有局限性是没有真正的对照组来测试 PQA 本身的效果。在线招募带来了额外的研究挑战，所有这些挑战都在详细讨论中。
该研究具有转化潜力，可以为戒烟诱导提供临床和政策建议。此外，虽然重点是吸烟，但该试验可以为关注其他健康行为的研究人员和临床医生提供参考，他们自己也面临着激励那些没有改变意愿的人的挑战。
