Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT06862050
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2025-03-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BREATHE Free: a Pilot Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012907', 'term': 'Smoking'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engagement', 'timeFrame': 'Weekly assessments, with first assessment in week 2 and last assessment in week 12.', 'description': 'Active participation in weekly session as reflected by number of weekly accomplishments'}, {'measure': 'Acceptability', 'timeFrame': 'Program evaluation will be administered on last meeting (week 12).', 'description': "Program evaluation questionnaire will assess, on a 1-5 (ranging from completely disagree - completely agree) scale, participants' attitude and confidence to quit tobacco us."}, {'measure': 'Acceptability', 'timeFrame': 'Program evaluation will be administered on last meeting (week 12).', 'description': 'Program evaluation questionnaire will assess, on a 1-10 (rated from 1=not at all helpful to 10=extremely helpful) scale, perceived helpfulness of BREATHE Free curriculum in helping participants stop tobacco use.'}], 'secondaryOutcomes': [{'measure': 'Average number of cigarette smoked per day', 'timeFrame': 'Measured in baseline and weeks 12 and 16', 'description': 'Number of cigarettes (or cigars) smoked per day (CPD)'}, {'measure': 'Smoking abstinence', 'timeFrame': 'Measured in baseline and weeks 12 and 16', 'description': 'Biochemically verified point prevalence abstinence (7 days)'}, {'measure': 'Resilience', 'timeFrame': 'Measured in baseline and weeks 12 and 16', 'description': 'Connor-Davidson Resilience Scale 10 (CD-RISC-10) score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation; Tobacco Dependence', 'E-Cig Use', 'Nicotine Dependence, Other Tobacco Product']}, 'descriptionModule': {'briefSummary': 'The overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL).\n\nThe intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit.\n\nThe main questions it aims to answer are:\n\n* Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use?\n* Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day?\n\nResearchers will assign participants to either BREATHE Free curriculum or usual care.\n\nParticipants will:\n\n* Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line\n* BREATHE Free group will attend 12 group meetings held on the university campus\n* All participants will answer interview questions related to tobacco use, character strengths and resilience\n* Expired Carbon Monoxide (CO) will be assessed in all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Daily use of one or more tobacco products\n* Valid home address in Augusta or the CSRA\n* Functioning telephone number\n* Speak, read, write in English\n\nExclusion Criteria:\n\n* Current use of tobacco cessation medications\n* Enrolled in tobacco treatment program'}, 'identificationModule': {'nctId': 'NCT06862050', 'acronym': 'BF', 'briefTitle': 'BREATHE Free: a Pilot Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment: a Pilot Feasibility Trial', 'orgStudyIdInfo': {'id': '2051137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BREATHE Free', 'description': 'Attend 12 in-person weekly meetings and go through Breathe Free curriculum.', 'interventionNames': ['Behavioral: BREATHE Free Curriculum']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will serve as a control group and will receive usual care, referral to tobacco quit line.'}], 'interventions': [{'name': 'BREATHE Free Curriculum', 'type': 'BEHAVIORAL', 'description': 'Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.', 'armGroupLabels': ['BREATHE Free']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ban A Majeed, PhD', 'role': 'CONTACT', 'email': 'bmajeed@augusta.edu', 'phone': '706-721-0806'}], 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Ban A Majeed, PhD', 'role': 'CONTACT', 'email': 'bmajeed@augusta.edu', 'phone': '7067210806'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ban Majeed', 'investigatorAffiliation': 'Augusta University'}}}}