BREATHE Free for Smoking Addiction
(BF Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Augusta University
Must not be taking: Tobacco cessation medications
Disqualifiers: Tobacco treatment program, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
16789What 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.
68101112Eligibility 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
+1 more
Exclusion Criteria
Enrolled in a tobacco treatment program
I am currently using medication to help me stop smoking.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: BREATHE FreeExperimental Treatment1 Intervention
Attend 12 in-person weekly meetings and go through Breathe Free curriculum.
Group II: ControlActive Control1 Intervention
This group will serve as a control group and will receive usual care, referral to tobacco quit line.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Augusta UniversityAugusta, GA
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Who Is Running the Clinical Trial?
Augusta UniversityLead Sponsor
References
Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial. [2023]The effectiveness of providing feedback on spirometry results for smoking cessation remains inconclusive according to the current evidence.
Improving the quality of care for the hospitalized tobacco user--one institution's transformational journey. [2021]Hospitalization represents an ideal time to address tobacco cessation. For a variety of reasons, current users do not always receive appropriate support or treatment during the hospitalization. An improvement team was created to improve the care for the hospitalized tobacco user. The team's aim was to develop a standardized process to increase the assessment, documentation, and delivery of cessation counseling, and increase community referrals upon discharge. After implementation of the project, percentages of hospitalized patients who had their tobacco use status documented in the electronic medical record increased to 80-90%. The percentage of patients admitted with heart failure or pneumonia had their rates of tobacco cessation counseling improved to 82-96%. The care of the hospitalized tobacco user can be improved and sustained by utilizing community resources and creating a team of motivated care providers. This improvement work stimulated the creation of a smoke-free institution and other preventive health measures throughout the institution.
Short- and long-term effects of outpatient rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. [2022]Pulmonary rehabilitation programs are effective in patients with severe chronic obstructive pulmonary disease (COPD) in the short term, but their long-term effects are not known. We investigated the short- and long-term effects of a 6-month outpatient rehabilitation program in patients with severe COPD.
Smoking cessation interventions in chronic obstructive pulmonary disease and the role of the family: a systematic literature review. [2018]This paper is a report of a systematic review to assess the effectiveness of family-focused smoking cessation interventions for people with chronic obstructive pulmonary disease and to determine what data on families are documented in studies of smoking cessation interventions.
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]Admission to a smoke-free setting presents a unique opportunity to encourage smokers to quit. However, risk of relapse post-discharge is high, and little is known about effective strategies to support smoking cessation following discharge. We aimed to identify interventions that maintain abstinence following a smoke-free stay and determine their effectiveness, as well as the probable effectiveness of behaviour change techniques (BCTs) used in these interventions.
A randomized clinical trial of a web-based tobacco cessation education program. [2022]We report the results of a randomized clinical trial of a 3-hour, web-based, tobacco cessation education program, the Web-Based Respiratory Education About Tobacco and Health (WeBREATHe) program, for practicing pediatric respiratory therapists (RTs), registered nurses (RNs), and nurse practitioners (NPs).
Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial. [2022]Smokers are often advised to quit in a discussion of future health risks. The authors tested whether adding information about personal effects of smoking would motivate hospital outpatients to stop smoking more than advice about potential hazards would. Ninety smokers in a general screening clinic were randomized to receive education alone or education plus an additional motivational intervention that contained immediate feedback about the smoker's exhaled carbon monoxide (CO) values, spirometry results, and pulmonary symptoms. A self-report of smoking status was obtained one, four, and 12 months after the intervention. In addition, at 12 months, exhaled CO measurements were made. Smokers who received the additional motivational intervention were more than twice as likely to report quitting some time during the 12-month follow-up (40% vs. 16%, p = 0.015). At 12 months, 33% of the intervention group and 10% of the control group smokers tested had achieved CO-validated cessation (p = 0.03). Counting all patients not contacted as continuing to smoke, the percentages were 20% vs. 7% (p = 0.06). These practical feedback methods to motivate cessation deserve testing in other settings.
Evaluation of an Interprofessional Tobacco Cessation Train-the-Trainer Program for Respiratory Therapy Faculty. [2023]Although tobacco use is the leading cause of numerous preventable diseases, including respiratory illnesses, respiratory therapy students historically have received inadequate education for treating tobacco use and dependence. To address this gap, a respiratory-specific tobacco cessation training program was created and disseminated via a train-the-trainer approach for faculty in respiratory therapy and respiratory care programs across the United States. The purpose of this study was to estimate the impact of the live, web-based, train-the-trainer programs on participating faculty, and to assess changes in the extent of adoption of tobacco cessation content in respiratory therapy curricula across institutions in the United States.
Efficacy of confronting smokers with airflow limitation for smoking cessation. [2022]The objective of the present study was to test whether confronting smokers with previously undetected chronic obstructive pulmonary disease (COPD) increases the rate of smoking cessation. In total, 296 smokers with no prior diagnosis of COPD were detected with mild-to-moderate airflow limitation by means of spirometry and randomly allocated to: confrontational counselling by a nurse with nortriptyline for smoking cessation (experimental group); regular counselling by a nurse with nortriptyline (control group 1); or "care as usual" for smoking cessation by the general practitioner (control group 2). Only the experimental group was confronted with their abnormal spirometry (mean forced expiratory volume in one second (FEV(1)) post-bronchodilator 80.5% predicted, mean FEV(1)/forced vital capacity post-bronchodilator 62.5%). There was no difference in cotinine-validated prolonged abstinence rate between the experimental group (11.2%) and control group 1 (11.6%) from week 5-52 (odds ratio (OR) 0.96, 95% confidence interval (CI) 0.43-2.18). The abstinence rate was approximately twice as high in the experimental group compared with control group 2 (5.9%), but this difference was not statistically significant (OR 2.02, 95% CI 0.63-6.46). The present study did not provide evidence that the confrontational approach increases the rate of long-term abstinence from smoking compared with an equally intensive treatment in which smokers were not confronted with spirometry. The high failure rates (> or =88%) highlight the need for treating tobacco addiction as a chronic relapsing disorder.
Tobacco treatment and prevention: what works and why. [2015]Tobacco abuse is one of the main reasons that chronic obstructive pulmonary disease is the fourth leading cause of death in the United States. Many people kick the habit easily, while others struggle through a difficult cycle of addiction. Respiratory therapists often have contact with patients with chronic lung disease who want to quit smoking but do not know where to begin. Smoking bans and clean air laws are in place across the United States, but this is not enough for a complete tobacco treatment and prevention program. For any successful disease-management program, tobacco-control education and support must be included. Studies show that when pharmacologic interventions are used along with the appropriate counseling and other resources, the success of tobacco cessation increases. This must be understood, because if the regulatory efforts of our governing bodies are not enough and if patients do not receive the care that is essential for disease management and rehabilitation, then how will our role as respiratory therapist matter in any health-care system of the future? The respiratory therapist plays a key role in asking patients, especially newly diagnosed patients with chronic lung disease, if they are smokers and if they are interested in tobacco use interventions. This is a role that should not be taken lightly.
Effects of a Statewide Tobacco Cessation Program Among Individuals Involved With Arkansas Community Correction. [2019]In response to a critical need for tobacco cessation services among justice-involved populations, Arkansas Community Correction (ACC) partnered with the University of Colorado's Behavioral Health & Wellness Program in 2013 to implement the DIMENSIONS: Tobacco Free Program within all probation, parole, and drug court units. In the first 2 years of this statewide, evidence-based program, more than 1,100 individuals from 33 ACC area office locations attended tobacco-free group sessions and provided data on tobacco use and readiness to quit. Results demonstrated a significant reduction in tobacco use among participants as well as increased knowledge, confidence, and intent to quit. This study provides some of the first evidence that members of this vulnerable population will attend tobacco-free group sessions with regularity and make progress toward tobacco cessation.
An evaluation of the Freedom From Smoking Online cessation program among Wisconsin residents. [2015]To study the effectiveness of the American Lung Association's Freedom From Smoking Online cessation program in assisting Wisconsin residents to quit smoking.