BREATHE Free: a Pilot Feasibility Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAugusta University
About 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 accepts healthy volunteersQualifiers
Daily use of one or more tobacco products
Valid home address in Augusta or the CSRA
Functioning telephone number
Speak, read, write in English
Disqualifiers
Current use of tobacco cessation medications
Enrolled in tobacco treatment program
Trial design
Design model
Parallel
Treatments tested in this trial
BREATHE Free Curriculum
BehavioralCurriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: BREATHE FreeExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Engagement
Active participation in weekly session as reflected by number of weekly accomplishments
Time frame
Weekly assessments, with first assessment in week 2 and last assessment in week 12.2
Acceptability
Program evaluation questionnaire will assess, on a 1-5 (ranging from completely disagree - completely agree) scale, participants' attitude and confidence to quit tobacco us.
Time frame
Program evaluation will be administered on last meeting (week 12).3
Acceptability
Program evaluation questionnaire will assess, on a 1-10 (rated from 1=not at all helpful to 10=extremely helpful) scale, perceived helpfulness of BREATHE Free curriculum in helping participants stop tobacco use.
Time frame
Program evaluation will be administered on last meeting (week 12).Secondary outcomes
1
Average number of cigarette smoked per day
Number of cigarettes (or cigars) smoked per day (CPD)
Time frame
Measured in baseline and weeks 12 and 162
Smoking abstinence
Biochemically verified point prevalence abstinence (7 days)
Time frame
Measured in baseline and weeks 12 and 163
Resilience
Connor-Davidson Resilience Scale 10 (CD-RISC-10) score
Time frame
Measured in baseline and weeks 12 and 16Sponsors and contacts
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Source ClinicalTrials.gov