BREATHE Free: a Pilot Feasibility Trial

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Augusta University
Study ID
NCT06862050
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Mar 2025
Primary completion
Dec 25, 2026
Completion
Dec 25, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BREATHE Free
    Attend 12 in-person weekly meetings and go through Breathe Free curriculum.
  • No Intervention: Control
    This group will serve as a control group and will receive usual care, referral to tobacco quit line.

Primary Outcome Measure

Engagement [ Time Frame: Weekly assessments, with first assessment in week 2 and last assessment in week 12. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Augusta UniversityAugustaGeorgia30912
Ban A Majeed, PhD
[email protected]
706-721-0806

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Augusta University· Augusta, GA

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