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BREATHE Free: a Pilot Feasibility Trial

BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment: a Pilot Feasibility Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06862050
Acronym
BF
Enrollment
90
Registered
2025-03-06
Start date
2025-03-01
Completion date
2026-12-25
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E-Cig Use, Nicotine Dependence, Other Tobacco Product, Smoking Cessation; Tobacco Dependence

Brief summary

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). The 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. The main questions it aims to answer are: * Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use? * Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day? Researchers will assign participants to either BREATHE Free curriculum or usual care. Participants will: * Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line * BREATHE Free group will attend 12 group meetings held on the university campus * All participants will answer interview questions related to tobacco use, character strengths and resilience * Expired Carbon Monoxide (CO) will be assessed in all participants.

Interventions

BEHAVIORALBREATHE Free Curriculum

Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Daily use of one or more tobacco products * Valid home address in Augusta or the CSRA * Functioning telephone number * Speak, read, write in English

Exclusion criteria

* Current use of tobacco cessation medications * Enrolled in tobacco treatment program

Design outcomes

Primary

MeasureTime frameDescription
EngagementWeekly assessments, with first assessment in week 2 and last assessment in week 12.Active participation in weekly session as reflected by number of weekly accomplishments
AcceptabilityProgram evaluation will be administered on last meeting (week 12).Program evaluation questionnaire will assess, on a 1-5 (ranging from completely disagree - completely agree) scale, participants' attitude and confidence to quit tobacco us.

Secondary

MeasureTime frameDescription
Average number of cigarette smoked per dayMeasured in baseline and weeks 12 and 16Number of cigarettes (or cigars) smoked per day (CPD)
Smoking abstinenceMeasured in baseline and weeks 12 and 16Biochemically verified point prevalence abstinence (7 days)
ResilienceMeasured in baseline and weeks 12 and 16Connor-Davidson Resilience Scale 10 (CD-RISC-10) score

Countries

United States

Contacts

Primary ContactBan A Majeed, PhD
bmajeed@augusta.edu7067210806

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026