BREATHE Free: a Pilot Feasibility Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BREATHE Free Curriculum.
- Who it may be relevant to
- Registry conditions: Smoking Cessation; Tobacco Dependence, E-Cig Use, Nicotine Dependence, Other Tobacco Product. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment: a Pilot Feasibility Trial
Overview
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.
Interventions
- Behavioral BREATHE Free Curriculum
Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.
Primary outcome measures
- Engagement [Time frame: Weekly assessments, with first assessment in week 2 and last assessment in week 12.]
- Acceptability [Time frame: Program evaluation will be administered on last meeting (week 12).]
- Acceptability [Time frame: Program evaluation will be administered on last meeting (week 12).]
Secondary outcome measures (3)
- Average number of cigarette smoked per day [Time frame: Measured in baseline and weeks 12 and 16]
- Smoking abstinence [Time frame: Measured in baseline and weeks 12 and 16]
- Resilience [Time frame: Measured in baseline and weeks 12 and 16]
Eligibility criteria
Inclusion criteria
- Daily use of one or more tobacco products
- Valid home address in Augusta or the CSRA
- Functioning telephone number
- Speak, read, write in English
Exclusion criteria
- Current use of tobacco cessation medications
- Enrolled in tobacco treatment program
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Augusta University — Augusta
Identifiers
NCT: NCT06862050 · 2051137