Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03405220
Status:
UNKNOWN
Last Update Posted:
2018-05-21
First Post:
2018-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing a Self-affirmation Intervention for Use in a Mobile Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-01', 'size': 354168, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-01-18T15:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Study 1 will use a 2 (self-affirmation: self-affirmation, control) X 3 (Mode of example: none, write, imagine) experimental design. In the self-affirmation condition, participants will complete the self-affirmation kindness quiz (10 questions) and in the control condition they will complete a personal opinion survey (10 questions). Depending on the mode of example condition, participants will not be asked to provide examples, asked to write examples for each of the 10 questions, or asked to imagine examples for each of the 10 questions.\n\nBased on examination of data from Study 1 (i.e., which items receive more "yes" responses and for which items examples are provided), in Study 2 we will test whether using fewer self-affirmation items influences dependent variables. Study 2 will use a 3 (Number of questions: 10, 5, 3) X 3 (Mode of example: none, write, imagine) experimental design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Defensive Avoidance', 'timeFrame': 'immediately post-intervention', 'description': 'Indicator of defensive information processing, 3 items (Witte)'}, {'measure': 'Reactance', 'timeFrame': 'immediately post-intervention', 'description': 'Indicator of defensive information processing, 27 items (Hall et al., 2016)'}, {'measure': 'Yielding', 'timeFrame': 'immediately post-intervention', 'description': 'Indicator of defensive information processing, 7 items (Brennan et al., 2011, 2014)'}, {'measure': 'Intentions to quit smoking in the next 3 months', 'timeFrame': 'immediately post-intervention', 'description': 'Intentions to quit smoking, 3 items'}], 'secondaryOutcomes': [{'measure': 'Cognitive perceived likelihood of developing smoking related disease', 'timeFrame': 'immediately post-intervention', 'description': '3 items'}, {'measure': 'Perceived severity', 'timeFrame': 'immediately post-intervention', 'description': '3 items'}, {'measure': 'Response efficacy of quitting smoking', 'timeFrame': 'immediately post-intervention', 'description': '3 items'}, {'measure': 'Self-efficacy to quit smoking', 'timeFrame': 'immediately post-intervention', 'description': '3 items'}, {'measure': 'Affective perceived likelihood', 'timeFrame': 'immediately post-intervention', 'description': '3 items'}, {'measure': 'Anticipated regret', 'timeFrame': 'immediately post-intervention', 'description': '3 items'}, {'measure': 'Worry', 'timeFrame': 'immediately post-intervention', 'description': '3 items'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoking', 'self-affirmation', 'mobile application', 'cessation'], 'conditions': ['Smoking', 'Smoking Cessation', 'Smoking, Tobacco']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Reed, M. B., & Aspinwall, L. G. (1998). Self-affirmation reduces biased processing of health-risk information. Motivation and Emotion, 22(2), 99-132.'}]}, 'descriptionModule': {'briefSummary': 'The aim of these studies is to adapt the self-affirmation kindness questionnaire for use in a mobile application. Two studies will be conducted to test hypotheses that simplifying and shortening the original questionnaire in systematic ways will result in comparable effectiveness (compared to the original version) in promoting reduced defensive avoidance, less reactance, greater yielding, and higher intentions to quit smoking among a sample of smokers.', 'detailedDescription': 'Research has shown that self-affirmation interventions, in which people are instructed to focus on their strengths and values, can offset self-threats and promote healthier behaviors, such as smoking cessation. A commonly used self-affirmation intervention is known as the "kindness quiz." The original kindness questionnaire (Reed \\& Aspinwall, 1998) consists of 10 yes/no questions, and participants are asked to think about and write down an example of each. For example, one item is "Have you ever been considerate of another person\'s feelings? \\_\\_\\_\\_ YES \\_\\_\\_\\_NO; IF YES, WRITE ABOUT A SPECIFIC EXAMPLE." The items were written so that all participants should be able to say "yes" in response to each question, which will affirm a positive view of themselves.\n\nThe purpose of these studies are to test shorter and simpler versions of this kindness questionnaire so that it can be implemented on mobile phones. In Study 1, we will test whether written examples are necessary for the effectiveness of the self-affirmation intervention (compared to no examples or imagined examples) compared to a control. In Study 2, we will again test whether written examples are necessary, as well as whether shorter questionnaires (i.e., 5 items or 3 items) are as effective as the original 10 item questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently live in the US\n* 21-65 years (several states have 21 as minimum legal age to smoke)\n* self-identified every day or some day smoker\n* no prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases\n\nExclusion Criteria:\n\n* Not currently living in the US\n* Less than 21 years of age or older than 65\n* Nonsmoker\n* Prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases'}, 'identificationModule': {'nctId': 'NCT03405220', 'briefTitle': 'Testing a Self-affirmation Intervention for Use in a Mobile Application', 'organization': {'class': 'OTHER', 'fullName': 'Kent State University'}, 'officialTitle': 'Testing a Self-affirmation Intervention for Use in a Mobile Application', 'orgStudyIdInfo': {'id': '17-544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-affirm, No examples, Study 1', 'description': 'Behavioral: Self affirmation, 10 items, no examples', 'interventionNames': ['Behavioral: Self affirmation, 10 items, no examples']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-affirm, Write examples, Study 1', 'description': 'Behavioral: Self affirmation, 10 items, written examples', 'interventionNames': ['Behavioral: Self affirmation, 10 items, written examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, Imagine examples, Study 1', 'description': 'Behavioral: Self affirmation, 10 items, imagined examples', 'interventionNames': ['Behavioral: Self affirmation, 10 items, imagined examples']}, {'type': 'NO_INTERVENTION', 'label': 'Opinion survey, No examples, Study 1', 'description': 'No intervention: control. Participants will complete the 10 item personal opinion survey and will not be asked to provide examples for any items they respond "yes" to.'}, {'type': 'NO_INTERVENTION', 'label': 'Opinion survey, Write examples, Study 1', 'description': 'No intervention: control. Participants will complete the 10 item personal opinion survey and will be asked to provide written examples for each item they respond "yes" to.'}, {'type': 'NO_INTERVENTION', 'label': 'Opinion survey, Imagine examples, Study1', 'description': 'No intervention: control. Participants will complete the 10 item personal opinion survey and will be asked to imagine examples for each item they respond "yes" to.'}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 10-item, No ex, Study 2', 'description': 'Behavioral: Self affirmation, 10 items, no examples', 'interventionNames': ['Behavioral: Self affirmation, 10 items, no examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 5-item, No ex, Study 2', 'description': 'Behavioral: Self affirmation, 5 items, no examples', 'interventionNames': ['Behavioral: Self affirmation, 5 items, no examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 3-item, No ex, Study 2', 'description': 'Behavioral: Self affirmation, 3 items, no examples', 'interventionNames': ['Behavioral: Self affirmation, 3 items, no examples']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-affirm, 10-item, Write ex, Study 2', 'description': 'Behavioral: Self affirmation, 10 items, written examples', 'interventionNames': ['Behavioral: Self affirmation, 10 items, written examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 5-item, Write ex, Study 2', 'description': 'Behavioral: Self affirmation, 5 items, written examples', 'interventionNames': ['Behavioral: Self affirmation, 5 items, written examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 3-item, Write ex, Study 2', 'description': 'Behavioral: Self affirmation, 3 items, written examples', 'interventionNames': ['Behavioral: Self affirmation, 3 items, written examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 10-item, Imagine ex, Study2', 'description': 'Behavioral: Self affirmation, 10 items, imagined examples', 'interventionNames': ['Behavioral: Self affirmation, 10 items, imagined examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 5-item, Imagine ex, Study 2', 'description': 'Behavioral: Self affirmation, 5 items, imagined examples', 'interventionNames': ['Behavioral: Self affirmation, 5 items, imagined examples']}, {'type': 'EXPERIMENTAL', 'label': 'Self-affirm, 3-item, Imagine ex, Study 2', 'description': 'Behavioral: Self affirmation, 3 items, imagined examples', 'interventionNames': ['Behavioral: Self affirmation, 3 items, imagined examples']}], 'interventions': [{'name': 'Self affirmation, 10 items, written examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete the 10 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 10-item, Write ex, Study 2', 'Self-affirm, Write examples, Study 1']}, {'name': 'Self affirmation, 10 items, no examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete the 10 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 10-item, No ex, Study 2', 'Self-affirm, No examples, Study 1']}, {'name': 'Self affirmation, 10 items, imagined examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete the 10 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 10-item, Imagine ex, Study2', 'Self-affirm, Imagine examples, Study 1']}, {'name': 'Self affirmation, 5 items, written examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a 5 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 5-item, Write ex, Study 2']}, {'name': 'Self affirmation, 5 items, no examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a 5 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 5-item, No ex, Study 2']}, {'name': 'Self affirmation, 5 items, imagined examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a 5 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 5-item, Imagine ex, Study 2']}, {'name': 'Self affirmation, 3 items, written examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a 3 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 3-item, Write ex, Study 2']}, {'name': 'Self affirmation, 3 items, no examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a 3 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 3-item, No ex, Study 2']}, {'name': 'Self affirmation, 3 items, imagined examples', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a 3 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.', 'armGroupLabels': ['Self-affirm, 3-item, Imagine ex, Study 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44242', 'city': 'Kent', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kent State University', 'geoPoint': {'lat': 41.15367, 'lon': -81.35789}}], 'overallOfficials': [{'name': 'Jennifer M Taber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kent State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data will be made available to other researchers upon request following publication of the results of the study. Alternatively, data may be posted on a site such as Open Science Framework and made publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kent State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Taber', 'investigatorAffiliation': 'Kent State University'}}}}