Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02037360
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Mindfulness Training for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Point prevalence abstinence at 6 months', 'timeFrame': '6 months after beginning treatment', 'description': 'Subjects will be assessed for smoking abstinence at a 6-month follow-up.'}], 'secondaryOutcomes': [{'measure': 'Point prevalence abstinence at 3 months', 'timeFrame': '3 months after beginning treatment', 'description': 'Subjects will be assessed for smoking abstinence at a 3-month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking', 'Cessation'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '35420700', 'type': 'DERIVED', 'citation': 'Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.'}], 'seeAlsoLinks': [{'url': 'http://www.umassmed.edu/cfm/Research/Participate-in-Study/', 'label': 'Click here for more information and to sign up for the study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years.', 'detailedDescription': 'In this study, a pilot phase will be carried out first to test feasibility and engagement of the tested intervention. Then in the randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains mindfulness for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must be (a) 18-65 years of age; (b) smoke 5+ cigarettes/day, (c) \\< 3 months abstinence in the past year; (d) have a smartphone; and motivated to quit smoking.\n\nExclusion Criteria:\n\nThere are no exclusion criteria. We aim to recruit a heterogeneous group, representative of the general population.'}, 'identificationModule': {'nctId': 'NCT02037360', 'briefTitle': 'Mobile Mindfulness Training for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'orgStudyIdInfo': {'id': '1305012015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator App/Training', 'description': 'This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.', 'interventionNames': ['Behavioral: Active Comparator App/Training']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental App/Training', 'description': 'This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.', 'interventionNames': ['Behavioral: Experimental App/Training']}], 'interventions': [{'name': 'Active Comparator App/Training', 'type': 'BEHAVIORAL', 'description': 'This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones', 'armGroupLabels': ['Active Comparator App/Training']}, {'name': 'Experimental App/Training', 'type': 'BEHAVIORAL', 'description': 'It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.', 'armGroupLabels': ['Experimental App/Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts, Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Judson Brewer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Center for Mindfulness', 'investigatorFullName': 'Judson Brewer', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}