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Clinical Trials/NCT04951193
NCT04951193
Completed
Not Applicable

Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients

Medical University of South Carolina1 site in 1 country106 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
Medical University of South Carolina
Enrollment
106
Locations
1
Primary Endpoint
Number/Duration of Quit Attempts
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
June 21, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Dahne

Assistant Professor

Medical University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • vaped nicotine on ≥20 days out of the last 30
  • 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
  • currently own an iOS or Android smartphone
  • report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)
  • have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)
  • ability to read the consent form
  • has been seen (in person or remotely) by a primary care physician within the last year

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number/Duration of Quit Attempts

Time Frame: Across all 4 weeks

Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks

Mean Score of Depressive Symptoms

Time Frame: 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

Time Frame: Week 4

Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.

E-cigarette Dependence

Time Frame: 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

Time Frame: At any point during the study

Assessed during the Timeline Followback. At any point during the study across all 4 weeks.

Study Sites (1)

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