Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

Study Overview
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Brief Summary
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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.

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

Conditions
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Depressive Symptoms, Depression, Adolescent Behavior

Intervention / Treatment
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* Behavioral: Behavioral Activation Therapy app
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal2QuitVaping<br>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<br>* 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.<br>|
| Other: Treatment as Usual<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 4 weeks | 
| E-cigarette use episodes per day and per week | Assessed using the Timeline Followback at baseline for the last 6 months and during each weekly assessment. | Up to 4 weeks | 
| E-cigarette dependence | Assessed at baseline via the 10-item Penn State Electronic Cigarette Dependence Index (ECDI) | Up to 4 weeks | 
| Number/duration of quit attempts | Assessed during the Timeline Followback | Up to 4 weeks | 
| 7-day point prevalence abstinence | Assessed during the Timeline Followback | Week 4 |