Trial Outcomes & Findings for Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents (NCT NCT04951193)
NCT ID: NCT04951193
Last Updated: 2024-08-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2024-08-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
50
|
|
Overall Study
COMPLETED
|
49
|
45
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents
Baseline characteristics by cohort
| Measure |
Goal2QuitVaping
n=56 Participants
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.
|
Treatment as Usual
n=50 Participants
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.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPatients 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.
Outcome measures
| Measure |
Goal2QuitVaping
n=50 Participants
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.
|
Treatment as Usual
n=49 Participants
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.
|
|---|---|---|
|
Mean Score of Depressive Symptoms
|
-9.50 score on a scale
Standard Deviation 9.54
|
-8.30 score on a scale
Standard Deviation 9.72
|
PRIMARY outcome
Timeframe: Week 4Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.
Outcome measures
| Measure |
Goal2QuitVaping
n=50 Participants
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.
|
Treatment as Usual
n=49 Participants
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.
|
|---|---|---|
|
Average Vapes Per Day at Week 4
|
9.42 vapes per day
Standard Deviation 16.11
|
10.17 vapes per day
Standard Deviation 11.89
|
PRIMARY outcome
Timeframe: Up to 4 weeksAssessed 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.
Outcome measures
| Measure |
Goal2QuitVaping
n=50 Participants
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.
|
Treatment as Usual
n=49 Participants
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.
|
|---|---|---|
|
E-cigarette Dependence
|
-2.19 score on a scale
Standard Deviation 3.30
|
-2.38 score on a scale
Standard Deviation 2.86
|
PRIMARY outcome
Timeframe: Across all 4 weeksAssessed during the Timeline Followback. Total number of quit attempts across all 4 weeks
Outcome measures
| Measure |
Goal2QuitVaping
n=50 Participants
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.
|
Treatment as Usual
n=49 Participants
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.
|
|---|---|---|
|
Number/Duration of Quit Attempts
|
5.00 number of quit attempts
Standard Deviation 4.35
|
4.00 number of quit attempts
Standard Deviation 4.11
|
PRIMARY outcome
Timeframe: At any point during the studyAssessed during the Timeline Followback. At any point during the study across all 4 weeks.
Outcome measures
| Measure |
Goal2QuitVaping
n=50 Participants
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.
|
Treatment as Usual
n=49 Participants
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.
|
|---|---|---|
|
7-day Point Prevalence Abstinence
|
14 Participants
|
15 Participants
|
Adverse Events
Goal2QuitVaping
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place