Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

NCT04951193 | Completed Results

• 2 other identifiers: 001087331R41DA053856-01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Depression; Adolescent Behavior

Outcome Measures

Primary Outcomes (5)

• Mean Score of Depressive Symptoms

  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.

  Up to 4 weeks

• Average Vapes Per Day at Week 4

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

  Week 4

• E-cigarette Dependence

  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.

  Up to 4 weeks

• Number/Duration of Quit Attempts

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

  Across all 4 weeks

• 7-day Point Prevalence Abstinence

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

  At any point during the study

Study Arms (2)

Goal2QuitVaping

EXPERIMENTAL

Participants 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.

Behavioral: Behavioral Activation Therapy app

Treatment as Usual

OTHER

Participants 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.

Behavioral: Treatment as Usual

Interventions

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.

Goal2QuitVaping

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.

Treatment as Usual

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Depression; Adolescent Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Jennifer Dahne
• Organization: MUSC

dahne@musc.edu

843-876-2280

Study Officials

• Jennifer Dahne, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: June 1, 2021
• Primary Completion: May 24, 2023
• Study Completion: June 21, 2023
• Last Updated: August 21, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)