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临床试验/NCT04101422
NCT04101422已完成不适用

Utilizing Augmented Reality as an Adjunct for Smoking Cessation; Development and Initial Validation

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2019年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
197
试验地点
1
主要终点
Urge to Smoke - Pilot Testing

研究概览

简要总结

The purpose of the study is to develop an preliminary test a tobacco smoking-related augmented reality (AR) paradigm for eventual development as an adjunctive tobacco cessation 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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Currently smoking ≥ 3 cigarettes per day for the past year
  • •Breath carbon monoxide (CO) level ≥ 5 ppm
  • •Motivated to quit smoking
  • •Aim 1 & 2 Only: Valid home address in the Tampa Bay area
  • •Functioning telephone number
  • •Can speak, read, and write in English
  • •Aim 3: Must have a smartphone that participant is willing to use during the study
  • •Aim 3: Motivated to quit smoking within the next month

排除标准

  • •Regular use (e.g., no more than 1/3 of month) of other tobacco products (cigars)
  • •Household member already enrolled in the study

研究组 & 干预措施

Development of Augmented Reality (AR) Application

No Intervention

Investigators will collaborate with an AR software specialist to develop AR stimuli that are embedded within a basic digital application.

Pilot Testing of AR Application

Experimental

AR stimuli (smoking, e.g, cigarette, ashtray, lighter; and non-smoking, e.g., pen, notebook, eraser) will be piloted on a small group of smokers to receive feedback and modify as needed. Participants will answer questions from a 10 point Likert scale that will asses urge from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke) and reality/co-existence (how realistic the item looks, and it's integration into the environment), from 1 (Not at all) to 10 (Very Much). Participants will then be asked additional open-ended questions about the quality of the images following the ratings of the images.

干预措施: Augmented Reality 1 (Behavioral)

Laboratory Validation of AR Stimuli Session 1: Cue Reactivity

Experimental

Participants will attend 1st lab based session that will test cue-reactivity. Participant will be randomized to view either AR images, or in vivo items first. Order of presentation of items will also be randomized within the type (AR or in vivo).Session 1 should last under 1 hour.

干预措施: Augmented Reality 2 (Behavioral)

Laboratory Validation of AR Stimuli Session 2: Extinction

Experimental

Participants will be randomized into either the extinction or control group. 28 trials of AR cues will be presented for each group. Both groups will receive the same neutral cue in Trial 1 (to establish baseline urge) and the same smoking cue in Trial 2 (for pre-test cue-reactivity). The extinction group will receive smoking cues for trials 3-26, whereas the control group will receive neutral cues. Both groups will receive matched smoking cues for trial (27) followed by matched neutral cues for the final trial (28), for post-test cuereactivity. Each cue will be presented for 1 minute and will be shown 4 times in trials 3-26. Following each cue, participants will complete the single-item measure of urge. Following the final trial (28) for both groups, participants will be presented with one of their own cigarettes and asked to take at least one puff. Latency to smoke will later be determined using time stamps on the video recording. Session 2 is expected to last 1.25 hours.

干预措施: Augmented Reality 4 (Behavioral)

Testing AR Application

Experimental

Participants will be instructed to use the AR app that presents smoking-related stimuli (cigarette, ashtray, lighter) in locations/situations where they typically smoke with the goal of at least 5 uses per day for 7 days. Usage and rating data will be collected in real-time. Participants will also be asked to rate their urge to smoke on the smartphone app at selected times. Participants will complete a telephone interview to provide additional feedback on the app, answer questions related to smoking behavior, and receive an in-person interview on their perceptions of the app as a potential cessation tool. Participants will use the smart phone application for 7 days.

干预措施: Augmented Reality 3 (Behavioral)

结局指标

主要结局

Urge to Smoke - Pilot Testing

时间窗: Post-cue presentation on Day 1, immediately following cue presentation

Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).

Urge to Smoke - AR Stimuli Session 2

时间窗: Post-cue presentation on Day 1, immediately following cue presentation

Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).

Urge to Smoke - Testing AR Application

时间窗: Up to Day 7 - Last Day of App Use, immediately following cue presentation

Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).

Urge to Smoke - AR Stimuli Session 1

时间窗: Post-cue presentation on Day 1, immediately following cue presentation

Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).

Urge to Smoke - Testing AR Application

时间窗: Day 1 - First Day of App Use, immediately following cue presentation

Participants will rate their urge to smoke on a 10-point Likert scale from 1 (absolutely no urge to smoke) to 10 (strongest urge to smoke).

次要结局

  • Reality/Co-Existence - AR Stimuli Session 2(Day 1, immediately following cue presentation)
  • Reality/Co-Existence - Pilot Testing(Day 1, immediately following cue presentation)
  • Reality/Co-Existence - AR Stimuli Session 1(Day 1, immediately following cue presentation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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