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.

项目总结/摘要 吸烟者与其他吸烟者合作（即，双吸烟者夫妇）占所有吸烟者的约2/3。双- 吸烟夫妇（DSC）不太可能尝试戒烟，更有可能在戒烟尝试中复发， 降低总体戒烟率，代表高风险临床人群。尽管他们的高 持续吸烟的患病率和风险，然而，关于戒烟干预措施的数据有限 在DSC中。基于先前的研究表明：a）财务激励治疗（FIT）是有效的 戒烟率不断增加;和B）FIT的二元调整对于在DSC中实施是可行的，建议 一项随机对照试验（RCT）将系统地研究两种适应性的FIT，以提高吸烟 停止供应链。除了确定这些FIT在DSC中戒烟的功效外， 我们将研究变化机制、次要终点和结果，以及每种方法的成本效益。 适应我们将在一个三组随机对照试验中解决这些问题，该试验由一个高度支持的试点提供信息 我们已完成的DSC FIT试验（R21 CA 241570）。在所有情况下，寻求治疗的吸烟者 是DSC的一部分（即，目标）将接受常规护理（快速和缓慢作用尼古丁替代品组合 治疗+戒烟资源）。在两种实验条件下（单FIT和双FIT，SFT和DFIT）， 参与者将在三个时间点（基线后1个月、3个月和6个月）接受禁欲奖励。在 在SFIT条件下，只有一对夫妇中的目标将获得奖励;在DFIT条件下，目标和伴侣都将获得奖励。 会得到奖励主要疗效结局是6个月时经生化验证的禁欲 目标之间的基线后。我们将同时评估候选的变更机制（例如，伙伴 支持、个人和合作伙伴激励），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个月时的点患病率禁欲率。 治疗后（基线后12个月）以及伴侣吸烟结果。由于散客固有地依赖于 成本效益分析将量化成本和积极成果的相对成本， 和各种条件。这些关于FIT治疗DSCs的疗效、机制和成本的数据将为我们提供信息， 人群水平实施并促进该治疗难治性人群的成功戒烟。