An interventional study of Behavioral Activation Therapy app and Treatment as Usual in Depressive Symptoms, Depression and Adolescent Behavior, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 16 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 106 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
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
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
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
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
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
| Milestone | Goal2QuitVaping | Treatment as Usual |
|---|---|---|
| Started | 56 | 50 |
| Completed | 49 | 45 |
| Not completed | 7 | 5 |
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.
| score on a scale | Goal2QuitVaping | Treatment as Usual |
|---|---|---|
| Mean Score of Depressive Symptoms | -9.50 ± 9.54 | -8.30 ± 9.72 |
Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.
| vapes per day | Goal2QuitVaping | Treatment as Usual |
|---|---|---|
| Average Vapes Per Day at Week 4 | 9.42 ± 16.11 | 10.17 ± 11.89 |
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.
| score on a scale | Goal2QuitVaping | Treatment as Usual |
|---|---|---|
| E-cigarette Dependence | -2.19 ± 3.30 | -2.38 ± 2.86 |
Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks
| number of quit attempts | Goal2QuitVaping | Treatment as Usual |
|---|---|---|
| Number/Duration of Quit Attempts | 5.00 ± 4.35 | 4.00 ± 4.11 |
Assessed during the Timeline Followback. At any point during the study across all 4 weeks.
| Participants | Goal2QuitVaping | Treatment as Usual |
|---|---|---|
| 7-day Point Prevalence Abstinence | 14 | 15 |
Collected over 4 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Goal2QuitVaping | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Treatment as Usual | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | Goal2QuitVaping | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 4 | 1 | 5 |
| Between 18 and 65 years | 52 | 49 | 101 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Goal2QuitVaping | Treatment as Usual | Total |
|---|---|---|---|
| Female | 34 | 35 | 69 |
| Male | 22 | 15 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Goal2QuitVaping | Treatment as Usual | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 8 | 13 |
| Not Hispanic or Latino | 51 | 42 | 93 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Goal2QuitVaping | Treatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 42 | 40 | 82 |
| More than one race | 8 | 2 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jun 2021 to primary completion in May 2023, 23 months.
Results were first posted in Jun 2024, 1 year after primary completion.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 23 months is close to that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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