Adolescent Behavior, Depression, Depressive Symptoms
Conditions
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALTreatment 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 20 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Depressive Symptoms | 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. This outcome will measure change from baseline at week 4. |
| Average Vapes Per Day at Week 4 | Week 4 | Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4. |
| E-cigarette Dependence | Up to 4 weeks | 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. |
| Number/Duration of Quit Attempts | Across all 4 weeks | Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks |
| 7-day Point Prevalence Abstinence | At any point during the study | Assessed during the Timeline Followback. At any point during the study across all 4 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 56 |
| 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.
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. | 50 |
| Total | 106 |
Baseline characteristics
| Characteristic | Goal2QuitVaping | Treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 49 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 42 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 40 Participants | 82 Participants |
| Sex: Female, Male Female | 34 Participants | 35 Participants | 69 Participants |
| Sex: Female, Male Male | 22 Participants | 15 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 50 |
| other Total, other adverse events | 0 / 56 | 0 / 50 |
| serious Total, serious adverse events | 0 / 56 | 0 / 50 |
Outcome results
Primary
7-day Point Prevalence Abstinence
Assessed during the Timeline Followback. At any point during the study across all 4 weeks.
Time frame: At any point during the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal2QuitVaping | 7-day Point Prevalence Abstinence | 14 Participants |
| Treatment as Usual | 7-day Point Prevalence Abstinence | 15 Participants |
Primary
Average Vapes Per Day at Week 4
Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal2QuitVaping | Average Vapes Per Day at Week 4 | 9.42 vapes per day | Standard Deviation 16.11 |
| Treatment as Usual | Average Vapes Per Day at Week 4 | 10.17 vapes per day | Standard Deviation 11.89 |
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.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal2QuitVaping | E-cigarette Dependence | -2.19 score on a scale | Standard Deviation 3.3 |
| Treatment as Usual | E-cigarette Dependence | -2.38 score on a scale | Standard Deviation 2.86 |
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.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal2QuitVaping | Mean Score of Depressive Symptoms | -9.50 score on a scale | Standard Deviation 9.54 |
| Treatment as Usual | Mean Score of Depressive Symptoms | -8.30 score on a scale | Standard Deviation 9.72 |
Primary
Number/Duration of Quit Attempts
Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks
Time frame: Across all 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Goal2QuitVaping | Number/Duration of Quit Attempts | 5.00 number of quit attempts | Standard Deviation 4.35 |
| Treatment as Usual | Number/Duration of Quit Attempts | 4.00 number of quit attempts | Standard Deviation 4.11 |