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

Trial Summary

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 data supports the effectiveness of the BREATHE Free Curriculum treatment for smoking addiction?

The research highlights that hospitalization and smoke-free settings can be effective times to encourage smoking cessation, with increased rates of counseling and community referrals improving outcomes. This suggests that structured support and behavior change techniques, similar to those potentially used in the BREATHE Free Curriculum, can be effective in helping people quit smoking. ^{1 2 3 4 5}

Is the BREATHE Free program safe for humans?

The available research does not provide specific safety data for the BREATHE Free program or similar interventions, but there are no reported safety concerns in the studies related to tobacco cessation education programs. ^{1 6 7 8 9}

What makes the BREATHE Free Curriculum treatment unique for smoking addiction?

The BREATHE Free Curriculum is unique because it focuses on a structured educational approach to help individuals quit smoking, potentially incorporating elements from successful programs like the DIMENSIONS: Tobacco Free Program, which showed effectiveness in group settings for vulnerable populations. This treatment may emphasize education and support rather than relying solely on medication, making it distinct from pharmacological interventions. ^{6 8 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Improving the quality of care for the hospitalized tobacco user--one institution's transformational journey. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Smoking cessation interventions in chronic obstructive pulmonary disease and the role of the family: a systematic literature review. [2018]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of a web-based tobacco cessation education program. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an Interprofessional Tobacco Cessation Train-the-Trainer Program for Respiratory Therapy Faculty. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of confronting smokers with airflow limitation for smoking cessation. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Tobacco treatment and prevention: what works and why. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of a Statewide Tobacco Cessation Program Among Individuals Involved With Arkansas Community Correction. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

An evaluation of the Freedom From Smoking Online cessation program among Wisconsin residents. [2015]