BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Augusta University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of participants who stopped smoking completely
Study Overview
Brief Summary
The purpose of this study is to evaluate whether BREATHE Free, an in-person faith-based smoking cessation program, can help people quit using tobacco products, including cigarettes, cigars, cigarillos, and e-cigarettes/vapes.
The program consists of 12 weekly group sessions that teach character strengths and resilience-based skills, such as hope, love, and spirituality, using the BREATHE Free curriculum. Participants will also receive free nicotine patches and complete surveys about their tobacco use, character strengths, and resilience.
The study will help us improve the program and determine whether it can reduce or eliminate tobacco use. Success will be measured through participant surveys and verified using expired carbon monoxide (CO) testing, a standard method for confirming smoking cessation.
The main question is: Can participation in the BREATHE Free program help people reduce or quit tobacco use?
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Current use of one or more tobacco products
- •Valid home address in Augusta or the CSRA and able to attend sessions in person held in Augusta, Ga
- •Functioning telephone number
- •Speak, read, write in English
Exclusion Criteria
- •Current use of tobacco cessation medications
- •Enrolled in tobacco treatment program
Arms & Interventions
BREATHE Free
Attend 12 in-person weekly meetings and go through Breathe Free curriculum.
Intervention: BREATHE Free Curriculum (Behavioral)
Outcomes
Primary Outcomes
Number of participants who stopped smoking completely
Time Frame: Measured at week 12
Biochemically verified point prevalence abstinence (7 days)
Number of participants who achieved a ≥50% reduction in tobacco use from baseline
Time Frame: Measured in baseline and weeks 12
Number of participants who achieved a ≥50% reduction in tobacco use from baseline, defined as a reduction of at least 50% in the number of cigarettes smoked per day or the number of vaping episodes per day, measured at Week 12 compared with baseline.
Secondary Outcomes
- Number of participants who rated the intervention positively at week 12(Program evaluation will be administered on last meeting (week 12))
Investigators
Ban Majeed
Associate Professor
Augusta University