Utilizing Augmented Reality as an Adjunct for Smoking Cessation

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: Augmented Reality 2; Behavioral: Augmented Reality 3; Behavioral: Augmented Reality 1; Behavioral: Augmented Reality 4

• Registration Number: NCT04101422
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-24
• Study Start: 2019-10-07
• Primary Completion: 2022-02-14
• Study Completion: 2022-02-14
• Results First Submitted: 2023-02-06
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Results First Posted: 2023-05-22
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laboratory Validation of AR Stimuli Session 1: Cue Reactivity	Augmented Reality 2	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.
Testing AR Application	Augmented Reality 3	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.
Pilot Testing of AR Application	Augmented Reality 1	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.
Laboratory Validation of AR Stimuli Session 2: Extinction	Augmented Reality 4	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.

Primary Outcome Measures

Name	Time	Method
Urge to Smoke - Pilot Testing	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	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	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	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).

Secondary Outcome Measures

Name	Time	Method
Reality/Co-Existence - Pilot Testing	Day 1, immediately following cue presentation	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).
Reality/Co-Existence - AR Stimuli Session 1	Day 1, immediately following cue presentation	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).
Reality/Co-Existence - AR Stimuli Session 2	Day 1, immediately following cue presentation	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).

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States