Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951193
• Other study ID #: 00108733
• Secondary ID: 1R41DA053856-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 21, 2023

Study information

• Verified date: June 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 21, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Behavioral Activation Therapy app
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
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number/Duration of Quit Attempts	Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks	Across all 4 weeks
Primary	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