Trial Outcomes & Findings for Utilizing Augmented Reality as an Adjunct for Smoking Cessation (NCT NCT04101422)
NCT ID: NCT04101422
Last Updated: 2023-05-22
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
Post-cue presentation on Day 1, immediately following cue presentation
Results posted on
2023-05-22
Participant Flow
The 17 participants in the Laboratory Validation of AR Stimuli Session 1: Cue Reactivity group were then randomized into either the Laboratory Validation of AR Stimuli Session 2: Extinction group or Control group.
Participant milestones
| Measure |
Pilot Testing of AR Application
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.
Augmented Reality 1: 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).
|
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity
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.
Augmented Reality 2: 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.
|
Laboratory Validation of AR Stimuli Session 2: Extinction or Control
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.
Augmented Reality 4: 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.
|
Testing AR Application
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.
Augmented Reality 3: 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
17
|
126
|
43
|
|
Overall Study
Extinction Group
|
0
|
10
|
59
|
0
|
|
Overall Study
Control Group
|
0
|
7
|
67
|
0
|
|
Overall Study
COMPLETED
|
10
|
17
|
112
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
14
|
20
|
Reasons for withdrawal
| Measure |
Pilot Testing of AR Application
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.
Augmented Reality 1: 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).
|
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity
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.
Augmented Reality 2: 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.
|
Laboratory Validation of AR Stimuli Session 2: Extinction or Control
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.
Augmented Reality 4: 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.
|
Testing AR Application
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.
Augmented Reality 3: 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.
|
|---|---|---|---|---|
|
Overall Study
Ineligible
|
1
|
0
|
9
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Not attending to the stimuli
|
0
|
0
|
4
|
0
|
|
Overall Study
Did not download app
|
0
|
0
|
0
|
17
|
|
Overall Study
Did not use app on 4 or more occasions per protocol
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Utilizing Augmented Reality as an Adjunct for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Pilot Testing of AR Application
n=11 Participants
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.
Augmented Reality 1: 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).
|
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity
n=17 Participants
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.
Augmented Reality 2: 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.
|
Laboratory Validation of AR Stimuli Session 2: Extinction or Control
n=126 Participants
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.
Augmented Reality 4: 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.
|
Testing AR Application
n=43 Participants
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.
Augmented Reality 3: 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.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
187 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
104 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
93 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
180 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
67 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
123 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
17 participants
n=4 Participants
|
126 participants
n=27 Participants
|
43 participants
n=483 Participants
|
197 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Post-cue presentation on Day 1, immediately following cue presentationParticipants 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=10 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Urge to Smoke - Pilot Testing
Smoking Stimuli
|
4.58 score on a scale
Interval 1.0 to 10.0
|
|
Urge to Smoke - Pilot Testing
Neutral Stimuli
|
1.42 score on a scale
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: Post-cue presentation on Day 1, immediately following cue presentationParticipants 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=17 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Urge to Smoke - AR Stimuli Session 1
Smoking Related AR Images
|
7.50 score on a scale
Interval 1.0 to 10.0
|
|
Urge to Smoke - AR Stimuli Session 1
Neutral Images
|
3.33 score on a scale
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: Post-cue presentation on Day 1, immediately following cue presentationParticipants 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=129 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Urge to Smoke - AR Stimuli Session 2
Extinction condition
|
5.3 score on a scale
Standard Deviation 2.9
|
|
Urge to Smoke - AR Stimuli Session 2
Control condition
|
6.4 score on a scale
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: Day 1 - First Day of App Use, immediately following cue presentationParticipants 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=23 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Urge to Smoke - Testing AR Application
|
7.61 score on a scale
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: Up to Day 7 - Last Day of App Use, immediately following cue presentationParticipants 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=23 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Urge to Smoke - Testing AR Application
|
7.28 score on a scale
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 1, immediately following cue presentationThree 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=10 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Reality/Co-Existence - Pilot Testing
Realistic
|
6.49 score on a scale
Standard Deviation 3.11
|
|
Reality/Co-Existence - Pilot Testing
Environmental Coexistence
|
6.93 score on a scale
Standard Deviation 3.04
|
|
Reality/Co-Existence - Pilot Testing
User Coexistence
|
6.38 score on a scale
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Day 1, immediately following cue presentationThree 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=17 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Reality/Co-Existence - AR Stimuli Session 1
Realism
|
7.83 score on a scale
Interval 1.0 to 10.0
|
|
Reality/Co-Existence - AR Stimuli Session 1
Environmental Coexistence
|
7.83 score on a scale
Interval 1.0 to 10.0
|
|
Reality/Co-Existence - AR Stimuli Session 1
User Coexistence
|
7.17 score on a scale
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 1, immediately following cue presentationThree 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).
Outcome measures
| Measure |
Pilot Testing of AR Application
n=129 Participants
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.
Augmented Reality 1: 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).
|
|---|---|
|
Reality/Co-Existence - AR Stimuli Session 2
Realism
|
7.91 score on a scale
Standard Deviation 1.88
|
|
Reality/Co-Existence - AR Stimuli Session 2
Enviromental Coexistence
|
7.96 score on a scale
Standard Deviation 2.31
|
|
Reality/Co-Existence - AR Stimuli Session 2
User Coexistence
|
8.04 score on a scale
Standard Deviation 2.12
|
Adverse Events
Pilot Testing of AR Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laboratory Validation of AR Stimuli Session 2: Extinction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testing AR Application
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place