BREATHE Free for Smoking Addiction

(BF Trial)

Overseen By Ban A Majeed, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Must not be taking: Tobacco cessation medications

Disqualifiers: Tobacco treatment program, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called BREATHE Free, designed to help people quit using tobacco products like cigarettes and vapes. Participants will either attend 12 weekly group meetings using this program or receive usual care with a referral to a tobacco quit line. The researchers aim to determine if the program is engaging, acceptable, and effective in reducing tobacco use. This trial may suit individuals who use tobacco daily, live in Augusta or the CSRA, and have a functioning phone. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future tobacco cessation programs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using tobacco cessation medications.

What prior data suggests that the BREATHE Free curriculum is safe?

Research shows that educational programs like the BREATHE Free curriculum are safe and easy for participants. These programs teach skills and build personal strengths to help individuals quit smoking. Without the use of medication or medical procedures, there are no reports of physical side effects. Participants typically find these programs engaging and helpful. The main goal is to reduce tobacco use by offering support and guidance through regular meetings. Thus, joining this type of program is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BREATHE Free curriculum because it offers a fresh approach to smoking addiction through structured, in-person support. Unlike standard treatments like nicotine replacement therapy or medication that focus on reducing withdrawal symptoms, BREATHE Free emphasizes behavioral change and community support. Participants attend 12 weekly meetings designed to build skills and strategies for quitting smoking, fostering a supportive environment that could lead to more sustainable results. This method has the potential to address the psychological and social aspects of addiction more robustly than existing options.

What evidence suggests that the BREATHE Free curriculum is effective for smoking addiction?

Research has shown that the faith-based BREATHE Free program can help people quit smoking. In one study, 58.4% of participants in the program stopped smoking, compared to 30.9% in a group not using the program. This trial will evaluate the effectiveness of the BREATHE Free program, with participants attending 12 in-person weekly meetings. The program helps individuals develop personal strengths and resilience, crucial for resisting the urge to smoke. Additionally, many people participate in similar programs, indicating that this approach is both engaging and accessible. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who are trying to quit using tobacco products, including cigarettes, cigarillos, little filtered cigars, and e-cigarettes. Participants should be interested in a faith-based program and willing to attend 12 weekly meetings on a university campus.

Inclusion Criteria

Daily use of one or more tobacco products

Valid home address in Augusta or the CSRA

Ability to speak, read, and write in English

Exclusion Criteria

Enrolled in a tobacco treatment program

I am currently using medication to help me stop smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 12 weekly in-person meetings to go through the BREATHE Free curriculum designed to teach character strengths and promote resilience.

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for smoking behavior and resilience after the intervention.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BREATHE Free Curriculum

Trial Overview

The BREATHE Free pilot study is testing the effectiveness of a faith-based curriculum designed to help people stop tobacco use. It involves attending group meetings and comparing this approach with usual care that includes information and referral services.

How Is the Trial Designed?

Group I: BREATHE Free Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

This group will serve as a control group and will receive usual care, referral to tobacco quit line.

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Published Research Related to This Trial

A 6-month outpatient rehabilitation program for patients with severe COPD led to significant improvements in walking distance, exercise capacity, muscle strength, and quality of life, with these benefits lasting up to 18 months after the program ended.

The training group showed a mean increase of 52 meters in 6-minute walking distance and a 14-point improvement in quality of life, both of which exceeded the minimal clinically-important difference, indicating meaningful health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Troosters, T., Gosselink, R., Decramer, M.[2022]

A dedicated improvement team successfully increased the documentation of tobacco use status in hospitalized patients to 80-90%, ensuring better identification of those who need cessation support.

Counseling rates for tobacco cessation among patients admitted with heart failure or pneumonia improved significantly to 82-96%, highlighting the effectiveness of standardized processes and community resources in supporting hospitalized tobacco users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the quality of care for the hospitalized tobacco user--one institution's transformational journey. Liu, SK., Prior, E., Warren, C., et al.[2021]

A randomized controlled trial involving 614 active smokers showed that providing detailed spirometry results significantly increased prolonged smoking abstinence rates to 7.8% compared to 2.6% in the control group, indicating the effectiveness of this intervention.

The intervention, which included brief counseling and spirometry feedback, was identified as an independent factor for smoking cessation, with a 2.8 times higher odds of quitting smoking for those receiving the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial. Martín-Luján, F., Santigosa-Ayala, A., Pallejà-Millán, M., et al.[2023]

The WeBREATHe program, a 3-hour web-based tobacco cessation education course, significantly improved tobacco cessation intervention behaviors among pediatric respiratory therapists, registered nurses, and nurse practitioners, with 215 participants in the study.

Participants who completed the training were more likely to advise, assess, and assist patients with tobacco cessation compared to those who received delayed training, indicating the program's effectiveness and high consumer satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of a web-based tobacco cessation education program. Gordon, JS., Mahabee-Gittens, EM., Andrews, JA., et al.[2022]

The systematic review included seven studies focusing on family-oriented smoking cessation interventions for individuals with chronic obstructive pulmonary disease (COPD), but no definitive conclusions about their effectiveness could be drawn.

While some studies provided data on family dynamics and support related to smoking cessation, further research is necessary to explore how integrating family-focused strategies with existing treatments could enhance smoking cessation success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation interventions in chronic obstructive pulmonary disease and the role of the family: a systematic literature review. Luker, KA., Chalmers, KI., Caress, AL., et al.[2018]

Tobacco abuse significantly contributes to chronic obstructive pulmonary disease (COPD), which is a leading cause of death in the U.S., highlighting the need for effective tobacco cessation programs.

Combining pharmacologic treatments with counseling and support greatly increases the chances of successfully quitting smoking, emphasizing the critical role of respiratory therapists in guiding patients through tobacco cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco treatment and prevention: what works and why. Goodfellow, LT., Waugh, JB.[2015]

A train-the-trainer program for respiratory therapy faculty significantly improved their confidence and ability to teach tobacco cessation, with 97.4% of participants finding the training format effective for learning.

The initiative reached 270 faculty members from 248 respiratory therapy schools, leading to an anticipated median of 3 hours of tobacco cessation training for 1,248 students in the following academic year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Interprofessional Tobacco Cessation Train-the-Trainer Program for Respiratory Therapy Faculty. Hudmon, KS., Vitale, FM., Elkhadragy, N., et al.[2023]

Confronting smokers with undetected chronic obstructive pulmonary disease (COPD) did not significantly increase smoking cessation rates compared to regular counselling, with both groups showing similar prolonged abstinence rates around 11%.

While the confrontational approach resulted in a higher abstinence rate compared to usual care (5.9%), this difference was not statistically significant, indicating that simply confronting smokers with their health status may not be an effective strategy for increasing long-term smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of confronting smokers with airflow limitation for smoking cessation. Kotz, D., Wesseling, G., Huibers, MJ., et al.[2022]

A systematic review of 37 studies involving over 9,000 smokers showed that interventions during smoke-free stays significantly improve the chances of maintaining abstinence from smoking after discharge, with a risk ratio of 1.27 favoring the interventions.

Nine promising behavior change techniques, such as pharmacological support and social support, were identified as effective in helping individuals maintain smoking abstinence for up to 18 months post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting smoking cessation and preventing relapse following a stay in a smoke-free setting: a meta-analysis and investigation of effective behaviour change techniques. Shoesmith, E., Huddlestone, L., Lorencatto, F., et al.[2021]

A study involving 90 smokers showed that providing personalized feedback on exhaled carbon monoxide and lung function significantly increased the likelihood of quitting smoking, with 40% of those receiving the intervention reporting cessation compared to only 16% in the control group.

At the 12-month mark, 33% of the intervention group achieved verified smoking cessation through carbon monoxide testing, compared to just 10% in the control group, highlighting the effectiveness of personalized motivational strategies in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial. Risser, NL., Belcher, DW.[2022]

The DIMENSIONS: Tobacco Free Program, implemented in Arkansas for justice-involved populations, successfully engaged over 1,100 individuals in tobacco cessation efforts, demonstrating that this vulnerable group is willing to participate in support programs.

Participants showed significant reductions in tobacco use, along with increased knowledge, confidence, and intent to quit, indicating the program's effectiveness in promoting tobacco cessation among those on probation, parole, or in drug court.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Statewide Tobacco Cessation Program Among Individuals Involved With Arkansas Community Correction. Garver-Apgar, C., Young, S., Howard, B., et al.[2019]

The American Lung Association's Freedom From Smoking Online program achieved a 55% quit rate among participants who reported not smoking in the previous 24 hours, indicating its effectiveness in helping individuals quit smoking.

Sustained abstinence rates were 28.8% at 3 months and 16.3% at 12 months post-program, suggesting that while initial success is high, long-term cessation rates may need further support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the Freedom From Smoking Online cessation program among Wisconsin residents. Thieleke, J., McMahon, J., Meyer, G., et al.[2015]

Citations

1.

augusta.edu

augusta.edu/research/studies/trial.php?study=2051137

BREATHE Free: Character Strength and Resilience-Based ...

This curriculum is a 12-week spirituality and faith-based curriculum designed to develop and enhance character strengths, and in turn resilience, through weekly ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9732762/

Outcomes of a Comprehensive Mobile Smoking Cessation ...

At 3 months, Average Treatment Effects weighted abstinence rates were 4.2% for those who did not use the web-based community, 15.1% for those ...

3.

tobaccopreventioncessation.com

tobaccopreventioncessation.com/Participation-in-a-workplace-smoking-cessation-program-nincentivized-by-lowering,118237,0,2.html

Participation in a workplace smoking cessation program ...

Results: In the LLUH BREATHE cohort, we found a very high rate of participation (72.7%; 95% CI: 69–77%) in workplace smoking cessation that was ...

4.

prchn.org

prchn.org/breathe-free/

Breathe Free: We Share Air

Breathe Free used a multi-level approach to tobacco prevention and cessation by increasing adoption of 100% tobacco-free worksite policies and smoke-free home ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10236936/

The effectiveness of tobacco cessation programs for ...

Smoking abstinence rate was 58.4% (80/137) in intervention group and 30.9% (42/136) in control group (RR=1.89; 95% CI: 1.42–2.52, p<0.001). The ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11403683/

The CATCH My Breath Vaping Prevention Curriculum

This report describes the implementation and evaluation of a school-based e-cigarette prevention program, CATCH My Breath (CMB), in 8 central Appalachian ...

7.

dconc.gov

dconc.gov/Public-Health1/Documents/YouthTobaccoResources-July-2024.pdf

Youth-Centered Tobacco Educational Resources FREE ...

This free, downloadable toolkit covers topics like the health and safety risks of vaping, how vapes work, and the signs and symptoms of nicotine addiction.

8.

education.ohio.gov

education.ohio.gov/Topics/Student-Supports/School-Wellness/Prevention-Education/Updates-to-Health-Education-Instruction

Harms of Electronic Smoking Devices | Ohio Department of ...

An online course with four lessons on the dangers associated with using e-cigarettes and resources to help young people quit if they already ...

9.

dph.ncdhhs.gov

dph.ncdhhs.gov/chronic-disease-and-injury/tobacco-prevention-and-control/youthtobaccoresourcespdf/open

Youth-Centered Tobacco Educational Resources Mostly ...

This free, downloadable toolkit covers topics like the health and safety risks of vaping, how vapes work, and the signs and symptoms of nicotine addiction.

10.

education.ky.gov

education.ky.gov/school/sdfs/Pages/Evidence-based-Prevention-and-Cessation-Materials.aspx

Evidence-based Prevention and Cessation Materials

The following resources for schools have been compiled by the Tobacco Prevention & Cessation Program at the Kentucky Department for Public Health.