Utilizing Augmented Reality as an Adjunct for Smoking Cessation

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Augmented Reality 1
* Behavioral: Augmented Reality 2
* Behavioral: Augmented Reality 3
* Behavioral: Augmented Reality 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Regular use (e.g., no more than 1/3 of month) of other tobacco products (cigars) Household member already enrolled in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Development of Augmented Reality (AR) Application<br>Investigators will collaborate with an AR software specialist to develop AR stimuli that are embedded within a basic digital application. | |
| Experimental: Pilot Testing of AR Application<br>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. | Behavioral: Augmented Reality 1<br>* Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) and non-smoking related stimuli (pens, notebook, eraser).<br>|
| Experimental: Laboratory Validation of AR Stimuli Session 1: Cue Reactivity<br>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. | Behavioral: Augmented Reality 2<br>* Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of smoking related AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.). They will also be presented with real smoking (e.g., ashtray) and non-smoking (e.g., pencil) items. Their urge to smoke rating following each presentation will be compared for AR images vs. vivo items, and smoking-related vs. non-smoking related.<br>|
| Experimental: Laboratory Validation of AR Stimuli Session 2: Extinction<br>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. | Behavioral: Augmented Reality 4<br>* Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.) Their urge to smoke rating following each presentation will be compared from baseline urge to smoke. The post-test urge to smoke will be compared between control group and extinction group.<br>|
| Experimental: Testing AR Application<br>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. | Behavioral: Augmented Reality 3<br>* Participants will use an Augmented Reality )AR) application on smart phones in locations and situations where they typically smoke. the application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays). Participants will have a goal of using application at least 5 times per day for 7 days. Usage and rating data will be collected in real-time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urge to Smoke - Pilot Testing | 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). | Post-cue presentation on Day 1, immediately following cue presentation | 
| Urge to Smoke - AR Stimuli Session 1 | 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). | Post-cue presentation on Day 1, immediately following cue presentation | 
| Urge to Smoke - AR Stimuli Session 2 | 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). | Post-cue presentation on Day 1, immediately following cue presentation | 
| Urge to Smoke - Testing AR Application | 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). | Day 1 - First Day of App Use, immediately following cue presentation | 
| Urge to Smoke - Testing AR Application | 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). | Up to Day 7 - Last Day of App Use, immediately following cue presentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reality/Co-Existence - Pilot Testing | Three items will be used to assess the quality of the AR experience. Reality (How real did the object seem to you?) Environment Co-Existence (How well did the the object appear to be part of the scene?) and User Co-Existence (How much did you feel the object was right there in front of you?). These 3 items will be assessed using a 10 point Likert Scale from from 1 (Not at all) to 10 (Very much). | Day 1, immediately following cue presentation | 
| Reality/Co-Existence - AR Stimuli Session 1 | Three items will be used to assess the quality of the AR experience. Reality (How real did the object seem to you?) Environment Co-Existence (How well did the the object appear to be part of the scene?) and User Co-Existence (How much did you feel the object was right there in front of you?). These 3 items will be assessed using a 10 point Likert Scale from from 1 (Not at all) to 10 (Very much). | Day 1, immediately following cue presentation | 
| Reality/Co-Existence - AR Stimuli Session 2 | Three items will be used to assess the quality of the AR experience. Reality (How real did the object seem to you?) Environment Co-Existence (How well did the the object appear to be part of the scene?) and User Co-Existence (How much did you feel the object was right there in front of you?). These 3 items will be assessed using a 10 point Likert Scale from from 1 (Not at all) to 10 (Very much). | Day 1, immediately following cue presentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quit Smoking, Augmented Reality, Smoking