Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Depressive Symptoms; Depression; Adolescent Behavior

Treatments: Behavioral: Treatment as Usual; Behavioral: Behavioral Activation Therapy app

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04951193

1R41DA053856-01 (U.S. NIH Grant/Contract)

00108733

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 16 to 20 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Goal2QuitVaping

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Activation Therapy app

Treatment as Usual

Other group

Description:

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.

Treatment:

Behavioral: Treatment as Usual