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Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents

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ClinicalTrials.gov Identifier: NCT04951193
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : July 6, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jennifer Dahne, Medical University of South Carolina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Depression Adolescent Behavior Behavioral: Behavioral Activation Therapy app Behavioral: Treatment as Usual Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean score of depressive symptoms [ Time Frame: Up to 4 weeks ]
    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.

  2. E-cigarette use episodes per day and per week [ Time Frame: Up to 4 weeks ]
    Assessed using the Timeline Followback at baseline for the last 6 months and during each weekly assessment.

  3. E-cigarette dependence [ Time Frame: Up to 4 weeks ]
    Assessed at baseline via the 10-item Penn State Electronic Cigarette Dependence Index (ECDI)

  4. Number/duration of quit attempts [ Time Frame: Up to 4 weeks ]
    Assessed during the Timeline Followback

  5. 7-day point prevalence abstinence [ Time Frame: Week 4 ]
    Assessed during the Timeline Followback


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951193


Contacts
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Contact: Jennifer Dahne, PhD 843-876-2280 dahne@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jennifer Dahne, PhD    843-876-2280    dahne@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Jennifer Dahne, PhD Medical University of South Carolina
More Information
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Responsible Party: Jennifer Dahne, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04951193    
Other Study ID Numbers: 00108733
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms