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Completed

NCT Number: NCT04951193

Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

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.

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Key information

Conditions

Depressive Symptoms Adolescent Behavior Behavior Behavioral Symptoms Depression

Age range

16 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 16-20
  • 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

Treatment and study plan

Behavioral Activation Therapy App

Behavioral

Goal2QuitVaping focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.

Treatment as Usual

Behavioral

Participants will be provided educational material about quitting vaping nicotine with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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