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临床试验/NCT04754867
NCT04754867撤回不适用

Pre-Test of For the Future Self: A Behavioral Intervention to Increase Success in a Smoking Cessation Program

Carnegie Mellon University0 个研究点开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Adherence at two weeks

研究概览

简要总结

The goal of this experimental research is to increase adherence to a smoking cessation patch among Pittsburgh residents who are trying to quit smoking. The literature on smoking cessation shows that there is a significant problem with adherence when using a transdermal patch as a nicotine replacement treatment. Less than half of patients use the patch as prescribed and adherence suffers a rapid decline during the first six weeks of treatment (Waldroup, Gifford, & Kalra, 2006). Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images.

详细描述

Several factors are thought to be relevant to the level of adherence such as the initial level of nicotine addiction (Orleans et al., 1994), gender (Gritz, Nielsen, & Brooks, 1996), concerns over weight gain due to smoking cessation (Fagerström, 2002) and side effects (Burns & Levinson, 2008). On the other hand, combining nicotine replacement treatment with behavioral therapy has been shown to improve adherence and overall abstinence (Cooper et al., 2004) and motivation is found to be an important factor related to patch use (Alterman, Gariti, Cook, & Cnaan, 1999).

Can a more vivid connection to an individual's future self facilitate smoking cessation? While behavioral interventions that enhance connection to the future self have been proven effective at mitigating present bias, they have so far been done in domains that require self-restraint (e.g., delinquency). Smoking cessation does in part require restraint, but a cessation program utilizing the nicotine patch also requires proactive daily commitment and action. Little research has been done to establish the effectiveness of a future selves intervention on behaviors that require proactive action.

Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images. Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view; participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.); participants in the current self virtual reality condition will see their present age self in a virtual reality rendering. Participants in all conditions will write a 200-300 word letter to themselves (in the treatment condition, the letter is written to their self in 20 years; in control, the letter is written to themselves in 3 months). The investigators will measure the impact of the behavioral intervention on participants' expected efficacy with smoking cessation, self-reported patch adherence, and smoking cessation success 2 and 8 weeks later.

The investigators will collect self-reported and non-invasive physiological adherence data over the course of 8 weeks on participants' adherence to the nicotine patch (self-report) and success with smoking cessation (self-report and CO analysis). For those participants self-reporting zero cigarettes smoked in the 7 day period before lab visits, investigators will administer a breath CO assessment (a simple procedure where the participant breathes into a tube and the device analyzes how many carbon dioxide parts per million are in the breath). The investigators will also asks participants if they would be willing to receive an email invitation to an online, 3-question, 6-month follow-up survey to occur four months after their last in-person visit to the laboratory.

The data collected will not be tied to identifiers; it will be used in statistical analyses assessing the effects of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Considering enrollment or recently enrolled (within 1 week) in one of the three designated smoking cessation programs

排除标准

  • •Use of any form of tobacco other than cigarettes
  • •Use of nicotine gum
  • •History of alcohol or drug dependency

研究组 & 干预措施

"discontinued-smoker" age-progressed

Experimental

Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view.

干预措施: Future Self Virtual Reality Image - Normal Aging (Behavioral)

"discontinued-smoker" age-progressed

Experimental

Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view.

干预措施: Letter - 20 years (Behavioral)

"discontinued-smoker" + "continued smoking" age-progressed

Experimental

Participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.).

干预措施: Future Self Virtual Reality Image - Normal Aging (Behavioral)

"discontinued-smoker" + "continued smoking" age-progressed

Experimental

Participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.).

干预措施: Future Self Virtual Reality Image - Smoking Consequences Aging (Behavioral)

"discontinued-smoker" + "continued smoking" age-progressed

Experimental

Participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.).

干预措施: Letter - 20 years (Behavioral)

Current self virtual reality images

Experimental

Participants in the current self virtual reality condition will see their present age self in a virtual reality rendering.

干预措施: Current Self Virtual Reality Image (Behavioral)

Current self virtual reality images

Experimental

Participants in the current self virtual reality condition will see their present age self in a virtual reality rendering.

干预措施: Letter - 3 months (Behavioral)

结局指标

主要结局

Adherence at two weeks

时间窗: Two weeks after initial intervention

In the past 2 weeks, how often did you wear a nicotine patch?

Adherence at eight weeks

时间窗: Eight weeks after initial intervention

In the past 2 weeks, how often did you wear a nicotine patch?

次要结局

  • CO ppm at eight weeks(Eight weeks after initial intervention)
  • Abstinence at eight weeks(Eight weeks after initial intervention)
  • Abstinence at two weeks(Two weeks after initial intervention)
  • CO ppm at two weeks(Two weeks after initial intervention)

研究者

申办方类型
Other
责任方
Sponsor

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