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

December 4, 2023 updated by: Washington University School of Medicine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

189

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Patricia Cavazos-Rehg, PhD
  • Phone Number: 314-362-2152
  • Email: pcavazos@wust.edu

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaping cessation
Time Frame: Baseline, 6 weeks, 3 months
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
Time Frame: Baseline, 6 weeks, 3 months
Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).
Baseline, 6 weeks, 3 months
Intervention engagement
Time Frame: Baseline, 6 weeks, 3 months
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
Risk perception related to vaping
Time Frame: Baseline, 6 weeks, 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34DA054725-01A1 (U.S. NIH Grant/Contract)
  • R34DA054725 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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