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MARS 项目:控制吸烟的移动协助 (MARS)

2026年8月6日 更新者:University of Utah

使用 mHealth 数据的新颖用途来识别 JITAI 的脆弱性和接受度状态

本研究旨在确定失误的脆弱状态,确定参与自我调节活动的接受状态,并研究利用脆弱状态和接受状态向吸烟者提供实时自我调节提示的方法。

研究概览

详细说明

目标 1:识别失误的脆弱性状态:自我报告和基于传感器的测量将用于跨多个时间尺度识别最能预测失误的基于经验和理论基础的特征。 根据预测的失误风险水平来操作脆弱性,研究人员假设 (H1) 当前的脆弱性由当前和/或最近的高负面情绪、低积极情绪、高渴望、低自我效能、低自我调节来表示容量 (SRC) 和风险环境(例如,特定位置,如酒吧;可用的香烟;其他人吸烟)。

目标 2:确定参与自我监管活动的接受状态:自我报告和基于传感器的测量将用于跨多个时间尺度识别最能预测参与的基于经验和理论基础的特征(即,使用自律活动)。 根据预测的参与可能性来操作接受度,研究人员假设 (H2) 当前接受度由高积极激活情绪(例如快乐、感激)、低消极停用情绪(例如悲伤、无聊)、低渴望、高自我效能、高 SRC 和低风险环境(例如,特定位置,如家中)。

目标 3:研究利用脆弱性和接受性状态来提供实时自我调节提示的方法。 调查促使个人参与自律活动的提示是否、何种类型以及在何种条件下(例如,当前的脆弱性和/或接受度)会增加参与度,从而降低脆弱性。

拟议的研究将有助于建立一个全面的概念、技术和经验基础,这是开发基于脆弱性和接受能力动态模型的有效即时自适应干预 (JITAI) 所必需的。 在微随机试验 (MRT) 中,生态瞬时评估 (EMA) 在 JITAIs 之前和之后进行,项目旨在衡量可能与参与者参与 JITAIs 相关的不同指数。

研究类型

介入性

注册 (实际的)

114

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Utah
      • Salt Lake City、Utah、美国、84102
        • University of Utah

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

描述

纳入标准:

  • 18岁或以上
  • 目前平均每天至少吸 3 支香烟的吸烟者
  • 有动力在接下来的 30 天内戒烟
  • 有效的家庭住址
  • 工作电话号码
  • 能说、读、写英语
  • 至少具有边缘健康素养(由 45 或更高的 REALM 素养测试确定)

排除标准:

  • 尼古丁贴片的禁忌症
  • 当前使用戒烟药物或其他辅助工具(即 安非他酮)
  • 怀孕或哺乳(如自我报告)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
Participants receive messages tailored for situations when they experiencing negative affect & cigarettes are available.
Participants receive messages tailored for situations when they are not experiencing negative affect & cigarettes are available.
Participants receive messages tailored for situations when they are experiencing negative affect & cigarettes are not available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
Smart phone app that teaches participants to practice breathing exercise.
Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
Smart phone app that teaches participants to accept their thoughts and feelings.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment
大体时间:1 hour following micro-randomization

Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy.

Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below.

The three EMA items used to operationalize PE were:

  1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No);
  2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No);
  3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No).

Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.

1 hour following micro-randomization
Proportion of Randomized Decision Points in Which the Participant Reported Proximal Engagement by Randomized Assignment.
大体时间:1 hour following micro-randomization

Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy.

Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below.

The three EMA items used to operationalize PE were:

  1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No);
  2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No);
  3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No).

Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.

1 hour following micro-randomization

次要结果测量

结果测量
措施说明
大体时间
Proximal Cigarette Use
大体时间:approximately 1 hour following the decision point

Proximal Cigarette Use (PCU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal Cigarette Use was created, coded as 1 if the response included "Cigarettes" and 0 otherwise.

This outcome measure reports the proportion that reported PCU at 1 hour following micro-randomization.

The intent of this Outcome Measures is to report overall PCU use according to participant's self-reported engagement with self-regulatory strategies.

approximately 1 hour following the decision point
Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use
大体时间:approximately 1 hour following the decision point

Proximal Nicotine-Containing Non-Cessation Product Use (NCNCP) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal NCNCP Use was created, coded as 1 if the response included "Cigarettes", "Vape pen, JUUL, or e-cigarette," "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise.

This outcome measure will report the proportion that reported NCNCP Use at 1 hour following micro-randomization.

approximately 1 hour following the decision point
Proximal Tobacco Product Use (PTPU) Use
大体时间:approximately 1 hour following the decision point

Proximal Nicotine-Containing Non-Cessation Product Use (PTPU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of PTPU was created, coded as 1 if the response included "Cigarettes", "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise.

This outcome measure will report the proportion that reported PTPU at 1 hour following micro-randomization.

approximately 1 hour following the decision point

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:David Wetter, PhD、University of Utah
  • 首席研究员:Inbal Nahum-Shani, PhD、University of Michigan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年8月27日

初级完成 (实际的)

2023年10月20日

研究完成 (实际的)

2023年10月20日

研究注册日期

首次提交

2020年1月9日

首先提交符合 QC 标准的

2020年5月5日

首次发布 (实际的)

2020年5月6日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 112287
  • U01CA229437-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

数据将与在具有联邦广泛保证 (FWA) 的机构下工作的调查人员共享。 在共享数据之前,数据将被剥离所有个人标识符和所有识别码。 根据我们对演绎披露可能性的描述,数据将被视为敏感或低风险。 将通过评估请求者的凭据和潜在风险来审查对敏感数据的请求。 请注意,我们的风险分析将基于对所有请求的数据产品的总体风险的共同考虑。

IPD 共享时间框架

PI 和研究团队将努力在收集数据并接受主要发现发表后的合理时间内提供数据。 将遵循犹他大学、密歇根大学和 NIH 的数据维护和分发规则。

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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