Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

Not Applicable

Completed

• Conditions: Adolescent Behavior; Depression; Depressive Symptoms

• Registration Number: NCT04951193
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The purpose of this study is to evaluate a mobile application (app) called "Goal2QuitVaping" to help adolescents quit vaping nicotine. Goal2QuitVaping was developed by our research team to assist with quitting vaping. Participants will be randomly assigned to either download the mobile app, "Goal2QuitVaping", or not. If provided with Goal2QuitVaping, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 4 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-06
• Primary Completion: 2023-05-24
• Study Completion: 2023-06-21
• Results First Submitted: 2024-04-04
• Results First Submitted QC: 2024-06-05
• Results First Posted: 2024-06-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. age 16-20
2. vaped nicotine on ≥20 days out of the last 30
3. elevated depressive symptoms, defined as a score of ≥10 on Patient Health Questionnaire-8 (PHQ-8) during preliminary screening and the Adolescent Patient Health Questionnaire-9 (PHQ-9A) at final eligibility
4. currently own an iOS or Android smartphone
5. report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)
6. have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)
7. ability to read the consent form
8. has been seen (in person or remotely) by a primary care physician within the last year

Exclusion Criteria

1. smoked cigarettes or used other tobacco products on ≥9 days out of the last 30
2. severe visual impairment
3. currently receiving treatment for vaping or tobacco use
4. current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II
5. household member currently enrolled in the study
6. inability to read the consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number/Duration of Quit Attempts	Across all 4 weeks	Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks
Mean Score of Depressive Symptoms	Up to 4 weeks	Patients will self report depressive symptoms weekly for 4 weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression. This outcome will measure change from baseline at week 4.
Average Vapes Per Day at Week 4	Week 4	Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.
E-cigarette Dependence	Up to 4 weeks	Assessed at baseline via the 10-item Penn State Electronic Cigarette Dependence Index (ECDI). Change from baseline at week 4. The scores range from 0-20 with 0-3= not dependent, 4-8 low dependence, 9-12 medium dependence, 13+ = high dependence.
7-day Point Prevalence Abstinence	At any point during the study	Assessed during the Timeline Followback. At any point during the study across all 4 weeks.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States