BREATHE Free: a Pilot Feasibility Trial

NCT06862050 | Recruiting

• 1 other identifier: 2051137
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Tobacco Dependence; E-Cig Use; Nicotine Dependence, Other Tobacco Product

Outcome Measures

Primary Outcomes (3)

• Engagement

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

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

• 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.

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

• 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.

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

Secondary Outcomes (3)

• Average number of cigarette smoked per day

  Measured in baseline and weeks 12 and 16

• Smoking abstinence

  Measured in baseline and weeks 12 and 16

• Resilience

  Measured in baseline and weeks 12 and 16

Study Arms (2)

BREATHE Free

EXPERIMENTAL

Attend 12 in-person weekly meetings and go through Breathe Free curriculum.

Behavioral: BREATHE Free Curriculum

Control

NO INTERVENTION

This group will serve as a control group and will receive usual care, referral to tobacco quit line.

Interventions

BREATHE Free Curriculum BEHAVIORAL

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

BREATHE Free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daily use of one or more tobacco products
• Valid home address in Augusta or the CSRA
• Functioning telephone number
• Speak, read, write in English

You may not qualify if:

• Current use of tobacco cessation medications
• Enrolled in tobacco treatment program

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking

Central Study Contacts

Ban A Majeed, PhD

CONTACT

7067210806; bmajeed@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

US (1)