Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

NCT ID: NCT04951193

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-06-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Goal2QuitVaping

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.

Group Type: EXPERIMENTAL

Behavioral Activation Therapy app

Intervention Type: 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

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.

Group Type: OTHER

Treatment as Usual

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Dahne

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Dahne, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R41DA053856-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00108733

Identifier Type: -

Identifier Source: org_study_id