Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT04951193
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2021-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dahne@musc.edu', 'phone': '843-876-2280', 'title': 'Dr. Jennifer Dahne', 'organization': 'MUSC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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.", 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Score of Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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."}], 'classes': [{'categories': [{'measurements': [{'value': '-9.50', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '-8.30', 'spread': '9.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 weeks', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Average Vapes Per Day at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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."}], 'classes': [{'categories': [{'measurements': [{'value': '9.42', 'spread': '16.11', 'groupId': 'OG000'}, {'value': '10.17', 'spread': '11.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.', 'unitOfMeasure': 'vapes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'E-cigarette Dependence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.19', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '2.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 weeks', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number/Duration of Quit Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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."}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '4.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Across all 4 weeks', 'description': 'Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks', 'unitOfMeasure': 'number of quit attempts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '7-day Point Prevalence Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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."}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any point during the study', 'description': 'Assessed during the Timeline Followback. At any point during the study across all 4 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.'}, {'id': 'FG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Goal2QuitVaping', 'description': '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.\n\nBehavioral 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.'}, {'id': 'BG001', 'title': 'Treatment as Usual', 'description': "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.\n\nTreatment 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."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-09', 'size': 498001, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-01T13:14', 'hasProtocol': True}, {'date': '2023-05-09', 'size': 319492, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-21T16:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2021-06-25', 'resultsFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-05', 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Score of Depressive Symptoms', 'timeFrame': 'Up to 4 weeks', 'description': '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.'}, {'measure': 'Average Vapes Per Day at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the Timeline Followback during each weekly assessment. Average vapes per day at week 4.'}, {'measure': 'E-cigarette Dependence', 'timeFrame': 'Up to 4 weeks', 'description': '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.'}, {'measure': 'Number/Duration of Quit Attempts', 'timeFrame': 'Across all 4 weeks', 'description': 'Assessed during the Timeline Followback. Total number of quit attempts across all 4 weeks'}, {'measure': '7-day Point Prevalence Abstinence', 'timeFrame': 'At any point during the study', 'description': 'Assessed during the Timeline Followback. At any point during the study across all 4 weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Symptoms', 'Depression', 'Adolescent Behavior']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 16-20\n2. vaped nicotine on ≥20 days out of the last 30\n3. 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\n4. currently own an iOS or Android smartphone\n5. report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)\n6. have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)\n7. ability to read the consent form\n8. has been seen (in person or remotely) by a primary care physician within the last year\n\nExclusion Criteria:\n\n1. smoked cigarettes or used other tobacco products on ≥9 days out of the last 30\n2. severe visual impairment\n3. currently receiving treatment for vaping or tobacco use\n4. current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II\n5. household member currently enrolled in the study\n6. inability to read the consent form'}, 'identificationModule': {'nctId': 'NCT04951193', 'briefTitle': 'Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients', 'orgStudyIdInfo': {'id': '00108733'}, 'secondaryIdInfos': [{'id': '1R41DA053856-01', 'link': 'https://reporter.nih.gov/quickSearch/1R41DA053856-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Goal2QuitVaping', 'description': '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.', 'interventionNames': ['Behavioral: Behavioral Activation Therapy app']}, {'type': 'OTHER', 'label': 'Treatment as Usual', 'description': "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.", 'interventionNames': ['Behavioral: Treatment as Usual']}], 'interventions': [{'name': 'Behavioral Activation Therapy app', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Goal2QuitVaping']}, {'name': 'Treatment as Usual', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Jennifer Dahne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Dahne', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}