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NCT Number: NCT06862050

BREATHE Free: a Pilot Feasibility 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.

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Key information

Conditions

Smoking Cessation; Tobacco Dependence Behavior Chemically-Induced Disorders E-Cig Use Health Behavior Mental Disorders Nicotine Dependence, Other Tobacco Product Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30912, United States

Location status: Recruiting

Location contact

Ban A Majeed, PhD

CONTACT

[email protected]

706-721-0806

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BREATHE Free Curriculum

Behavioral

Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.

Primary outcomes

  1. Engagement

    Time frame: Weekly assessments, with first assessment in week 2 and last assessment in week 12.

    Active participation in weekly session as reflected by number of weekly accomplishments

  2. Acceptability

    Time frame: Program evaluation will be administered on last meeting (week 12).

    Program evaluation questionnaire will assess, on a 1-5 (ranging from completely disagree - completely agree) scale, participants' attitude and confidence to quit tobacco us.

  3. Acceptability

    Time frame: Program evaluation will be administered on last meeting (week 12).

    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.

Secondary outcomes

  1. Average number of cigarette smoked per day

    Time frame: Measured in baseline and weeks 12 and 16

    Number of cigarettes (or cigars) smoked per day (CPD)

  2. Smoking abstinence

    Time frame: Measured in baseline and weeks 12 and 16

    Biochemically verified point prevalence abstinence (7 days)

  3. Resilience

    Time frame: Measured in baseline and weeks 12 and 16

    Connor-Davidson Resilience Scale 10 (CD-RISC-10) score

Study contacts

Contact information is provided by the study sponsor or research team.

Ban A Majeed, PhD

CONTACT

[email protected]

7067210806

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment: a Pilot Feasibility Trial

Acronym: BF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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