Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-21 @ 9:08 AM
Study NCT ID:
NCT03027466
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kleinwm@mail.nih.gov', 'phone': '2402766972', 'title': 'William Klein', 'organization': 'National Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Study start to study completion date, approximately 17 months and 26 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Baseline Affirmation and Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.', 'otherNumAtRisk': 2027, 'deathsNumAtRisk': 2027, 'otherNumAffected': 0, 'seriousNumAtRisk': 2027, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.', 'otherNumAtRisk': 1984, 'deathsNumAtRisk': 1984, 'otherNumAffected': 0, 'seriousNumAtRisk': 1984, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'No Baseline Affirmation and Affirmation Texts', 'description': 'Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.', 'otherNumAtRisk': 1903, 'deathsNumAtRisk': 1903, 'otherNumAffected': 0, 'seriousNumAtRisk': 1903, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.', 'otherNumAtRisk': 1985, 'deathsNumAtRisk': 1985, 'otherNumAffected': 0, 'seriousNumAtRisk': 1985, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'OG000'}, {'value': '1984', 'groupId': 'OG001'}, {'value': '1903', 'groupId': 'OG002'}, {'value': '1985', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Affirmation and Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG001', 'title': 'Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG002', 'title': 'No Baseline Affirmation and Affirmation Texts', 'description': 'Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG003', 'title': 'No Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}], 'classes': [{'title': 'Past Week Cessation at 1 Month', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}]}, {'title': 'Past Month Cessation at 1 Month', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}]}]}, {'title': 'Past Week Cessation at 3 Months', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'Past Month Cessation at 3 Months', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month and 3 months', 'description': 'Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Affirmation and Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG001', 'title': 'Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG002', 'title': 'No Baseline Affirmation and Affirmation Texts', 'description': 'Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG003', 'title': 'No Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}], 'timeFrame': '1 month and 3 months follow-up', 'description': 'Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because there was too little variability, and the data could not be analyzed due to high levels of attrition. The former Principal Investigator left the institute and no data are available or will ever become available for this Outcome.'}, {'type': 'SECONDARY', 'title': 'Type of Tobacco Products', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Affirmation and Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG001', 'title': 'Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG002', 'title': 'No Baseline Affirmation and Affirmation Texts', 'description': 'Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'OG003', 'title': 'No Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}], 'timeFrame': '1 month and 3 months follow-up', 'description': 'Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not done because type of tobacco products were not collected from participants at 1 month and 3 months follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Baseline Affirmation and Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition).Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'FG001', 'title': 'Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'FG002', 'title': 'No Baseline Affirmation and Affirmation Texts', 'description': 'Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'FG003', 'title': 'No Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2027'}, {'groupId': 'FG001', 'numSubjects': '1984'}, {'groupId': 'FG002', 'numSubjects': '1903'}, {'groupId': 'FG003', 'numSubjects': '1985'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1869'}, {'groupId': 'FG001', 'numSubjects': '1819'}, {'groupId': 'FG002', 'numSubjects': '1743'}, {'groupId': 'FG003', 'numSubjects': '1821'}]}], 'dropWithdraws': [{'type': 'Opting out of the app', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1869'}, {'groupId': 'FG001', 'numSubjects': '1819'}, {'groupId': 'FG002', 'numSubjects': '1743'}, {'groupId': 'FG003', 'numSubjects': '1821'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Baseline Affirmation and Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'BG001', 'title': 'Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'BG002', 'title': 'No Baseline Affirmation and Affirmation Texts', 'description': 'Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'BG003', 'title': 'No Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)\n\nSelf-affirmation induction: Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '30.6', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '30.5', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '30.5', 'spread': '8.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '799', 'groupId': 'BG000'}, {'value': '759', 'groupId': 'BG001'}, {'value': '765', 'groupId': 'BG002'}, {'value': '786', 'groupId': 'BG003'}, {'value': '3109', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1228', 'groupId': 'BG000'}, {'value': '1225', 'groupId': 'BG001'}, {'value': '1138', 'groupId': 'BG002'}, {'value': '1199', 'groupId': 'BG003'}, {'value': '4790', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants Currently Using Cessation Aid', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '446', 'groupId': 'BG000'}, {'value': '401', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}, {'value': '440', 'groupId': 'BG003'}, {'value': '1721', 'groupId': 'BG004'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1581', 'groupId': 'BG000'}, {'value': '1583', 'groupId': 'BG001'}, {'value': '1469', 'groupId': 'BG002'}, {'value': '1545', 'groupId': 'BG003'}, {'value': '6178', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Desire to Smoke', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '3.1', 'spread': '1.4', 'groupId': 'BG003'}, {'value': '3.2', 'spread': '1.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Desire to smoke: 1 = not at all; 5 = a lot.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quit Attempts in Past Year', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2027', 'groupId': 'BG000'}, {'value': '1984', 'groupId': 'BG001'}, {'value': '1903', 'groupId': 'BG002'}, {'value': '1985', 'groupId': 'BG003'}, {'value': '7899', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '22.8', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '20.7', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '19.6', 'groupId': 'BG002'}, {'value': '7.9', 'spread': '27.5', 'groupId': 'BG003'}, {'value': '7.9', 'spread': '27.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Past year cessation attempts were assessed as a write-in question; all values from 0 to 365 were considered valid cases. All responses outside of this range were excluded from analysis of past year cessation attempts but were included in all subsequent analyses.', 'unitOfMeasure': 'Attempts', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-06', 'size': 268371, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-22T14:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7899}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-22', 'studyFirstSubmitDate': '2017-01-18', 'resultsFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-22', 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months', 'timeFrame': '1 month and 3 months', 'description': 'Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.'}], 'secondaryOutcomes': [{'measure': 'Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up', 'timeFrame': '1 month and 3 months follow-up', 'description': 'Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.'}, {'measure': 'Type of Tobacco Products', 'timeFrame': '1 month and 3 months follow-up', 'description': 'Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quitting Smoking', 'Phone Application'], 'conditions': ['Number of Quit Attempts']}, 'referencesModule': {'references': [{'pmid': '18298234', 'type': 'BACKGROUND', 'citation': 'Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.'}, {'pmid': '25720333', 'type': 'BACKGROUND', 'citation': 'Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2.'}, {'pmid': '19372432', 'type': 'BACKGROUND', 'citation': 'Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769.'}, {'pmid': '33666561', 'type': 'RESULT', 'citation': 'Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nQuitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior.\n\nObjective:\n\nTo explore people s values, smoking attitudes, and smoking behavior.\n\nEligibility:\n\nPeople ages 18 and older who smoke\n\nDesign:\n\nThe study takes place entirely on a mobile device.\n\nParticipants will give their age, gender, data about their smoking habits, and desired quit date.\n\nThen they will get different texts about quitting.\n\nParticipants will answer follow-up surveys 1 and 3 months later.\n\n...', 'detailedDescription': 'Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to smoke as threatening if they think it suggests that they are unable to meet the challenges of cessation. When individuals experience such a threat to their sense of self-identity (e.g., to their sense that they have integrity and/ or competence), they often respond defensively. Individuals have a tendency to react defensively to information that informs them that their behavior increases risk for a particular disease or negative health consequences. Self-affirmation a process through which individuals focus on their strengths and values can offset threats to the self and promote healthier behaviors, including smoking cessation. To the extent that relapse or difficulty quitting is perceived as a threat to self-identity, when individuals are presented with the opportunity to self-affirm they may perceive failure as less threatening, mitigating the motivation to downplay the importance of quitting. Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an existing smoking cessation text message-based intervention, and may bolster cessation rates among users motivated to quit smoking. Here, we propose to extend that research by examining whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing app content only). Importantly, self-affirmation material will be incorporated into the current app and will not change the goals or nature of the original texting program. We predict that the individuals in the self-affirmation condition will be more likely to report being smoke-free at the 1-month and 3-month follow-ups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION/EXCLUSION:\n* Because the app is designed to assist with smoking cessation, all smokers are eligible to participate.\n* Subjects are eligible if they are 18+ years of age.'}, 'identificationModule': {'nctId': 'NCT03027466', 'briefTitle': 'Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging', 'orgStudyIdInfo': {'id': '999917039'}, 'secondaryIdInfos': [{'id': '17-C-N039'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baseline Affirmation and Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study', 'interventionNames': ['Behavioral: Self-affirmation induction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study', 'interventionNames': ['Behavioral: Self-affirmation induction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Baseline Affirmation and Affirmation Texts', 'description': 'Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study', 'interventionNames': ['Behavioral: Self-affirmation induction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Baseline Affirmation and No Affirmation Texts', 'description': 'Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)', 'interventionNames': ['Behavioral: Self-affirmation induction']}], 'interventions': [{'name': 'Self-affirmation induction', 'type': 'BEHAVIORAL', 'description': 'Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.', 'armGroupLabels': ['Baseline Affirmation and Affirmation Texts', 'Baseline Affirmation and No Affirmation Texts', 'No Baseline Affirmation and Affirmation Texts', 'No Baseline Affirmation and No Affirmation Texts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute (NCI)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'William M Klein, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William Klein, Ph.D.', 'investigatorAffiliation': 'National Cancer Institute (NCI)'}}}}