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Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging

2021年7月22日 更新者:William Klein, Ph.D.、National Cancer Institute (NCI)

Background:

Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior.

Objective:

To explore people s values, smoking attitudes, and smoking behavior.

Eligibility:

People ages 18 and older who smoke

Design:

The study takes place entirely on a mobile device.

Participants will give their age, gender, data about their smoking habits, and desired quit date.

Then they will get different texts about quitting.

Participants will answer follow-up surveys 1 and 3 months later.

...

研究概览

详细说明

Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to smoke as threatening if they think it suggests that they are unable to meet the challenges of cessation. When individuals experience such a threat to their sense of self-identity (e.g., to their sense that they have integrity and/ or competence), they often respond defensively. Individuals have a tendency to react defensively to information that informs them that their behavior increases risk for a particular disease or negative health consequences. Self-affirmation a process through which individuals focus on their strengths and values can offset threats to the self and promote healthier behaviors, including smoking cessation. To the extent that relapse or difficulty quitting is perceived as a threat to self-identity, when individuals are presented with the opportunity to self-affirm they may perceive failure as less threatening, mitigating the motivation to downplay the importance of quitting. Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an existing smoking cessation text message-based intervention, and may bolster cessation rates among users motivated to quit smoking. Here, we propose to extend that research by examining whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing app content only). Importantly, self-affirmation material will be incorporated into the current app and will not change the goals or nature of the original texting program. We predict that the individuals in the self-affirmation condition will be more likely to report being smoke-free at the 1-month and 3-month follow-ups.

研究类型

介入性

注册 (实际的)

7899

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

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Cancer Institute (NCI)

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 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

  • INCLUSION/EXCLUSION:
  • Because the app is designed to assist with smoking cessation, all smokers are eligible to participate.
  • Subjects are eligible if they are 18+ years of age.

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:并行分配
  • 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:Baseline Affirmation and Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
有源比较器:Baseline Affirmation and No Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
有源比较器:No Baseline Affirmation and Affirmation Texts
Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
安慰剂比较:No Baseline Affirmation and No Affirmation Texts
Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.

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
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
大体时间:1 month and 3 months
Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
1 month and 3 months

次要结果测量

结果测量
措施说明
大体时间
Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
大体时间:1 month and 3 months follow-up
Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
1 month and 3 months follow-up
Type of Tobacco Products
大体时间:1 month and 3 months follow-up
Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
1 month and 3 months follow-up

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:William M Klein, Ph.D.、National Cancer Institute (NCI)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2018年3月6日

初级完成 (实际的)

2019年9月1日

研究完成 (实际的)

2019年9月1日

研究注册日期

首次提交

2017年1月18日

首先提交符合 QC 标准的

2017年1月20日

首次发布 (估计)

2017年1月23日

研究记录更新

最后更新发布 (实际的)

2021年7月23日

上次提交的符合 QC 标准的更新

2021年7月22日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 999917039
  • 17-C-N039

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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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