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临床试验/NCT04967885
NCT04967885已完成不适用

Evaluation of an Ecological Momentary Intervention of Implementation Intentions Delivered by Text Message to Reduce Cigarette Smoking

Trustees of Dartmouth College2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Percent of Participants Completing Intervention Period

研究概览

简要总结

This study will develop an ecological momentary implementation intentions intervention (EMI-II) for cigarette smoking, which will link critical situations where smoking is likely to occur with alternative responses to support avoidance of cigarette use. Using ecological momentary assessment (EMA) for data collection, this project will evaluate the feasibility, acceptability, and initial effectiveness of a micro-randomized trial (MRT) of EMI-II targeting cigarette smoking reduction in a sample of adults who smoke a minimum of 15 cigarettes per day (n=100).

详细描述

Cigarette smoking accounts for nearly 1 in 5 preventable deaths in the United States, and reducing cigarette smoking has been suggested for those not yet ready to quit. Cigarette reduction has been shown to longitudinally predict eventual cessation. Evidence suggests that smoking is highly sensitive to environmental stimuli, so ecological momentary interventions (EMI) embedded within daily life may help reduce cigarette smoking. Within the context of EMIs, researchers have explored different strategies to support smoking cessation and reduction. Implementation interventions (II) is a novel self-regulatory strategy that may help individuals reduce smoking. In II, individuals identify critical situations where smoking is likely to occur, then develop and plan appropriate alternative responses to avoid cigarette use. When II is delivered as a brief, single session intervention, II increases cessation rates relative to control conditions. Although II is well-suited for EMI because the brief messages are designed to be contextually relevant, no known research has evaluated whether repeated administration of II delivered by EMI reduces cigarette use. EMI-II may be beneficial with greater exposure and when delivered in the contexts where a behavior, such as smoking, is likely to occur.

This randomized controlled trial aims to test an ecological momentary implementation intentions intervention (EMI-II) to reduce cigarette smoking. This research seeks to identify in-the-moment intervention components that target momentary contextual and personal variables to effectively reduce cigarette smoking. Adults who smoke and are interested in reducing their cigarette use will be randomized to either the immediate intervention condition, or to a waitlist control. All participants will be followed for one month and will complete weekly surveys. Intervention participants will receive two weeks of the EMI-II with daily ecological momentary assessments (EMAs) in the two weeks post-randomization. Waitlist control participants will complete the weekly surveys for two weeks, then have access to the EMI-II with daily EMAs for two weeks. The daily EMAs are brief surveys in which participants report their current context and recent behavior and events.

This project consists of two primary aims:

Aim 1. To test the feasibility and acceptability of a customized, micro-randomized trial using EMI-II for smoking reduction.

The investigators hypothesize that at least 75% of participants who start the EMI-II component will complete the two-week active study period. Also, the investigators hypothesize that participants will rate the acceptability of the EMI-II at least a 3.5 out of 5, on average.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • English-language proficient
  • Located in the United States
  • Self-reports smoking 15 or more cigarettes per day in the past week
  • Expresses interest in quitting or reducing smoking
  • Has a cell phone with access to text messaging
  • Willing to send and receive text messages related to smoking

排除标准

  • Currently pregnant or plans to become pregnant
  • Currently on psychotropic medications for smoking cessation
  • Currently receiving behavioral treatment/therapy for smoking cessation

结局指标

主要结局

Percent of Participants Completing Intervention Period

时间窗: 2 weeks

To evaluate the feasibility of this customized EMI-II intervention, the investigators will examine the proportion of study participants completing the two-week intervention period, Week 2 in the Immediate Intervention arm and week 4 in the Waitlist arm.

Rate of Self-reported Cigarette Smoking

时间窗: 2 weeks

Self-reported cigarette smoking will be assessed five times per day (morning, late morning, early afternoon, late afternoon, evening) during the intervention period. Participants will respond via text messaging to the question, "Since the last prompt, how many cigarettes have you smoked?"

Average Acceptability of the EMI-II Intervention

时间窗: 2 weeks

To examine the acceptability of the EMI-II intervention, participants will rate the acceptability of the intervention on a Likert scale ranging from 1 (low acceptability) to 5 (high acceptability) on the two weekly surveys completed during the intervention period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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