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Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

Not Applicable
Completed
Conditions
Adolescent Behavior
Depression
Depressive Symptoms
Interventions
Behavioral: Behavioral Activation Therapy app
Behavioral: Treatment as Usual
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

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
Arm && Interventions
GroupInterventionDescription
Goal2QuitVapingBehavioral Activation Therapy appParticipants in the Goal2QuitVaping group will be asked to download the Goal2QuitVaping app to their smartphone. Goal2QuitVaping focuses on mood management as well as on quitting vaping nicotine. Participants will be asked to use Goal2QuitVaping regularly, at least once per day, for the study duration. Participants will also be asked to complete questionnaires weekly for 4 weeks.
Treatment as UsualTreatment as UsualParticipants in the treatment as usual group will be provided with educational material about quitting vaping nicotine and it will be suggested that they discuss any questions about mood management and about quitting vaping with their primary care provider. The educational material is from the National Cancer Institute's SmokeFree Teen website and includes information on recognizing reasons for quitting vaping, avoiding dual use of e-cigarettes and other tobacco products, setting a quit date, understanding triggers, and accessing social support.
Primary Outcome Measures
NameTimeMethod
Number/Duration of Quit AttemptsAcross all 4 weeks

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

Mean Score of Depressive SymptomsUp 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 4Week 4

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

E-cigarette DependenceUp 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 AbstinenceAt any point during the study

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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