Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

描述(由申请人提供)：戒烟电话是美国烟草控制计划中不可或缺的组成部分。但增加他们的成功是非常必要的。即使在传统认知行为疗法和药物疗法(通常是尼古丁替代疗法；NRT)的标准干预下，使用Quigline的吸烟者中平均有86%会重新吸烟(即14%保持戒烟状态)。目前还没有新的、被证明有效的咨询方法来提高戒烟药物的戒烟成功率。我们通过试点测试一种被称为接受与承诺疗法(ACT)的有前景的方法来解决这一关键需求，作为电话传递的戒烟干预。我们最近完成了一项对社区招募的参与者进行的小型(n=14)单臂可行性研究，该研究表明，通过电话提供戒烟治疗是可行的，并且参与者接受干预。在治疗后12个月(93%的保留率)，意向治疗的长期戒断率为29%。虽然结果很有希望，但没有对照组，样本量只有14个，参与者不是放弃电话的人，也没有提供NRT。为了建立在这些结果的基础上，现在需要一个试点随机对照试验，其中包括更大的样本量，从QuiLine呼叫者那里招募，以及NRT规定，以提供全面的R01随机试验的设计。因此，这项建议的目的是进行一项试点随机试验，比较电话提供的ACT咨询+NRT和电话提供的CBT咨询+NRT，以：(1)证明ACT的实施结果至少与传统的CBT一样好；(2)证明与CBT相比，ACT有更高的戒烟和相关行为改变率的趋势；(3)证明ACT的戒烟结果，而不是传统的CBT，是由两个心理测量调节的，这两个测量是ACT理论模型的核心：(A)接受吸烟的内在线索(感觉、情感和思想)和(B)戒烟的承诺。关键的创新是戒烟咨询的新概念模型。这项研究将这一新模型应用于戒烟这一极其重要的公共健康问题，并在广泛传播的戒烟热线的背景下测试了该模型。这项研究提出了一种研究范式的转变，以增加戒烟咨询内容的创新。该提案显示出令人振奋的前景，可以提高戒烟治疗的成功率，从而降低医疗成本，减少与烟草相关的过早死亡。 公共卫生相关性：这项为期两年的R21随机试验将试点测试一种新出现的咨询方法，称为接受与承诺疗法(ACT)，作为电话传递的戒烟干预。如果ACT后来在一项全面的试验中被证明是有效的，并传播到50%到100%的美国戒烟者，那么每年可能会有3.1万到6.1万烟民戒烟。

DESCRIPTION (provided by applicant): Smoking cessation telephone quitlines are an integral component in the US tobacco control program. But increasing their success is greatly needed. Even with quitlines' standard intervention of traditional Cognitive Behavioral Therapy combined with pharmacotherapy (typically nicotine replacement therapy; NRT), an average of 86% of smokers using quitlines will relapse to smoking (i.e., 14% stay quit). There are no new, proven-effective counseling approaches to improve the smoking cessation success rates of quitlines. We address this critical need by pilot testing a promising approach, called Acceptance & Commitment Therapy (ACT), as a telephone-delivered smoking cessation intervention. We recently completed a small (n =14) single- arm feasibility study of community-recruited participants which demonstrated that ACT for smoking cessation was feasibly-delivered by telephone and that participants were receptive to the intervention. At 12 months post- treatment (93% retention), the intent-to-treat prolonged abstinence rate was 29%. While results were promising, there was no control group, the sample size was only 14, participants were not quitline callers, and no NRT was provided. To build on these results, a pilot randomized controlled trial that includes a larger sample size, recruitment from quitline callers, and NRT provision is now needed to inform the design of a full- scale R01 randomized trial. Accordingly, the aims of this proposal are to conduct a pilot randomized trial comparing telephone-delivered ACT counseling plus NRT to telephone-delivered CBT counseling plus NRT, in order to: (1) Demonstrate that ACT's implementation outcomes are at least as good as those of traditional CBT; (2) Demonstrate that ACT, as compared to CBT, has a trend toward higher smoking cessation and related behavior change rates; (3) Demonstrate that the smoking cessation outcomes of ACT, but not traditional CBT, are mediated by two psychological measures that are central to the theoretical model underlying ACT: (a) acceptance of internal cues to smoke (sensations, emotions, and thoughts) and (b) commitment to quitting smoking. The key innovation is a new conceptual model for quitline counseling. The study applies this new model to the highly important public health problem of smoking cessation and tests the model in the widely disseminable context of a quitline. The study proposes a research paradigm shift toward increasing innovations in quitline counseling content. The proposal shows exciting promise for improving the success rates of quitlines and thereby lowering healthcare costs and reducing premature tobacco-related deaths. PUBLIC HEALTH RELEVANCE: This two-year R21 randomized trial will pilot test a newly emerging counseling approach, called Acceptance & Commitment Therapy (ACT), as a telephone-delivered smoking cessation intervention. If ACT is later proven effective in a full-scale trial and disseminated to 50% to 100% of US quitlines, it is possible that 31,000 to 61,000 more smokers could quit each year.