Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Patricia Cavazos-Rehg, PhD
- Phone Number: 314-362-2152
- Email: pcavazos@wust.edu
Study Contact Backup
- Name: Erin Kasson, MSW
- Phone Number: 314-362-9003
- Email: erinmkasson@wustl.edu
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Recruiting
- Washington University in St. Louis, School of Medicine
-
Contact:
- Erin Kasson
- Phone Number: 314-246-9156
- Email: ichasmresearch@wustl.edu
-
Principal Investigator:
- Patricia Cavazos-Rehg, PhD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
|
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
|
Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.
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
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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