BREATHE Free Curriculum

NCT06862050 | Active Not Recruiting

• 1 other identifier: 2051137
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of participants who stopped smoking completely

  Biochemically verified point prevalence abstinence (7 days)

  Measured at week 12

• Number of participants who achieved a ≥50% reduction in tobacco use from baseline

  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.

  Measured in baseline and weeks 12

Secondary Outcomes (1)

• Number of participants who rated the intervention positively at week 12

  Program evaluation will be administered on last meeting (week 12)

Study Arms (1)

BREATHE Free

EXPERIMENTAL

Attend 12 in-person weekly meetings and go through Breathe Free curriculum.

Behavioral: BREATHE Free Curriculum

Interventions

BREATHE Free Curriculum BEHAVIORAL

The curriculum teaches 12 character strengths and resilience practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamwork, perseverance, gratitude, and joy. Each weekly session includes music and movement activities, instruction and discussion focused on one practice, goal setting, and meditation exercises including deep breathing, mindfulness, prayer, gratitude, and forgiveness.

BREATHE Free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): December 25, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

US (1)