BREATHE Free: a Pilot Feasibility Trial (BF)

March 3, 2025 updated by: Ban Majeed, Augusta University

BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BREATHE Free
Attend 12 in-person weekly meetings and go through Breathe Free curriculum.
Behavioral: BREATHE Free Curriculum
Curriculum will teach practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamworking, perseverance, gratitude, and joy.
No Intervention: Control
This group will serve as a control group and will receive usual care, referral to tobacco quit line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
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
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.
Program evaluation will be administered on last meeting (week 12).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Measured in baseline and weeks 12 and 16
Smoking abstinence
Time Frame: Measured in baseline and weeks 12 and 16
Biochemically verified point prevalence abstinence (7 days)
Measured in baseline and weeks 12 and 16
Resilience
Time Frame: Measured in baseline and weeks 12 and 16
Connor-Davidson Resilience Scale 10 (CD-RISC-10) score
Measured in baseline and weeks 12 and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2051137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on E-Cig Use

Clinical Trials on BREATHE Free Curriculum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe