Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors

Study Overview
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Brief Summary
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Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults. With limited information on the long-term effects of vaping products, health information about vaping has been somewhat unclear in regards to associated health risks. Teens and young adults may be reluctant to disclose their use of vaping products to parents or health providers and instead turn to social media to share and seek out information regarding vaping risks and cessation supports. Thus, our current proposal outlines the use of social media to identify teens and young adults socially networking about vaping, the use of an online chatbot screen to evaluate individual cessation support needs, and the use of a digital intervention system to support vaping cessation. The mobile intervention used in this study is based on a widely-used evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been adapted for vaping and young adults to include an in-app chatbot to guide users to tailored content and to motivate and encourage their cessation efforts. We aim to integrate our social media recruitment and online screening approach to connect individuals with this mobile app intervention, and will conduct a randomized controlled trial to evaluate user engagement with and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens and young adults.

Official Title
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Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors

Conditions
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Nicotine Vaping, Nicotine Use Disorder

Intervention / Treatment
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* Device: quitSTART Mobile Application
* Behavioral: Chatbot Feature in quitSTART Mobile Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: US Resident English Speaking Have daily access to a smartphone Current vaping product user (P30D) Identified as socially networking about a desire to quit vaping and/or experiencing negative health outcomes due to vaping Vaping product user only (i.e., not using vaping as a means to support combustible smoking cessation)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Nationwide resource referral and intervention waitlist | |
| Experimental: Experimental Group A: Mobile App Intervention<br>quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults | Device: quitSTART Mobile Application<br>* Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.<br>|
| Experimental: Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature<br>quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Including Embedded Chatbot Feature | Device: quitSTART Mobile Application<br>* Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.<br>Behavioral: Chatbot Feature in quitSTART Mobile Application<br>* In-App chatbot feature emedded into quitSTART mobile application to motivate vaping cessation and support app navigation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaping cessation | Vaping cessation as assessed by 7 day self-reported vaping abstinence at follow-up. Timeline follow back procedures will be used to establish abstinence or if participants lapsed (their first instance of vaping post quit) or relapsed (vaped on 7 consecutive days) at each follow up time point. | Baseline, 6 weeks, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine dependence | Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS). | Baseline, 6 weeks, 3 months | 
| Risk perception related to vaping | Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020. How harmful, if at all, do you think vaping/using an e-cigarette is to a user's health? (general) and Imagine you vaped/used e-cigarettes daily for the next 10 years and used no other tobacco product. How harmful do you think this vaping would be to your health? (conditional), both using a five-point response scale (not at all-extremely harmful). | Baseline, 6 weeks, 3 months | 
| Intervention engagement | Data automatically captured within the chatbot, and app platform will be used to calculate a composite measure of engagement for those randomized to each of these intervention components and will be examined as a predictor of outcomes. We will use a modified version of an app Engagement Index (EI). | Baseline, 6 weeks, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaping, mobile app intervention, youth, young adults, chatbot, nicotine, social media