Randomized Controlled Trial of Dyadic Financial Incentive Treatment for Dual Smoker Couples: Evaluation of Efficacy, Mechanisms, and Cost Effectiveness

双烟夫妇二元经济激励治疗的随机对照试验：疗效、机制和成本效益评估

• 批准号: 10734422
• 负责人: Michelle Renee vanDellen
• 金额: $ 60.68万
• 依托单位: UNIVERSITY OF GEORGIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-08 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10734422
• 关键词: Abstinence; Address; Aftercare; Biochemical; Categories; Characteristics; Cigarette; Clinical; Communication; Cost Analysis; Cost Effectiveness Analysis; Cotinine; Couples; Data; Effectiveness; Enrollment; Evidence based intervention; Financial Support; Financial cost; High Prevalence; Incentives; Individual; Intervention; Maintenance; Motivation; Outcome; Outcome Study; Participant; Phase; Pilot Projects; Population; Prevalence; Prognosis; Protocols documentation; Randomized; Randomized, Controlled Trials; Refractory; Relapse; Reporting; Research; Resistance; Resources; Smoker; Smoking; Smoking Cessation Intervention; Smoking treatment; Subgroup; Target Populations; Testing; Time; Underserved Population; Variant; behavior change; clinical risk; contingency management; cost; cost effectiveness; cost-effectiveness evaluation; design; efficacy evaluation; efficacy outcomes; efficacy testing; efficacy trial; experience; financial incentive; follow-up; high risk; improved outcome; long term abstinence; member; nicotine replacement; pilot trial; predicting response; psychoeducation; psychoeducational; relative cost; response; secondary endpoint; secondary outcome; smoking abstinence; smoking cessation; standard care; success; treatment as usual; treatment comparison; treatment effect; treatment strategy

Project Summary/Abstract Smokers partnered with other smokers (i.e., dual-smoker couples) represent ~2/3 of all smokers. Dual- smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates; and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed randomized controlled trial (RCT) will systematically examine two adaptations of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these FITs for smoking abstinence in DSCs, we will examine mechanisms of change, secondary endpoints and outcomes, and the cost effectiveness of each adaptation. We will address these questions in a three-group RCT that is informed by a highly supportive pilot trial we have completed on FITs for DSCs (R21CA241570). In all conditions, treatment-seeking smokers who are part of a DSC (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two experimental conditions (single FIT and dyadic FIT, SFT and DFIT), participants will receive incentives for abstinence at three time points (1-, 3-, and 6-months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner in a couple will be offered incentives. Primary efficacy outcome is biochemically-verified abstinence at 6-months post-baseline among targets. We will concurrently evaluate candidate mechanisms of change (e.g., partner support, individual and partner motivation) to understand how FITs confer benefits and inform optimization. Secondary outcomes are point-prevalence abstinence at 1- and 3-months during the treatment and 6-months post-treatment (12-months post-baseline), as well as partner smoking outcomes. As FITs inherently rely on financial resources, cost-effectiveness analysis will quantify the cost and relative cost of positive outcomes within and across conditions. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population.

项目概要/摘要 与其他吸烟者（即双吸烟者夫妇）合作的吸烟者约占所有吸烟者的 2/3。双重的- 吸烟者夫妇 (DSC) 不太可能尝试戒烟，并且更有可能在戒烟尝试期间复吸， 降低总体戒烟率并代表高危临床人群。尽管他们的高 持续吸烟的患病率和风险，但是，有关戒烟干预措施的数据有限 DSC 之间。之前的研究表明：a) 财务激励措施 (FIT) 是有效的 戒烟率不断上升； b) FIT 的二元调整对于在 DSC 中实施是可行的，建议 随机对照试验 (RCT) 将系统地检验 FIT 的两种改进措施以促进吸烟 DSC 之间的停止。除了确定这些 FIT 对 DSC 戒烟的功效外， 我们将研究变革机制、次要终点和结果，以及每个目标的成本效益 适应。我们将在三组随机对照试验中解决这些问题，该试验由高度支持的试点提供信息 我们已经完成了 DSC 的 FIT 试验（R21CA241570）。在所有情况下，寻求治疗的吸烟者 属于 DSC 的一部分（即目标）将接受常规护理（快效和慢效尼古丁替代品的组合） 治疗+戒烟资源）。在两种实验条件下（单一 FIT 和二元 FIT、SFT 和 DFIT）， 参与者将在三个时间点（基线后 1、3 和 6 个月）获得禁欲奖励。在 SFIT条件，只有情侣中的目标才会获得激励；在 DFIT 条件下，目标和合作伙伴均 一对夫妇将获得奖励。主要疗效结果是 6 个月时经生化验证的戒断 目标之间的基线后。我们将同时评估候选变革机制（例如，合作伙伴 支持、个人和合作伙伴动机）以了解 FIT 如何带来好处并为优化提供信息。 次要结局是治疗期间 1 个月和 3 个月以及 6 个月时的点流行率戒断率 治疗后（基线后 12 个月）以及伴侣吸烟结果。由于散客本质上依赖于 财务资源，成本效益分析将量化成本和积极成果的相对成本 以及跨条件。这些关于 DSC 的 FIT 的功效、机制和成本的数据将提供信息 在人群层面实施并促进难治性人群成功戒烟。