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BREATHE Free: a Pilot Feasibility Trial

NCT06862050 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-03-06

No results posted yet for this study

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

Interventions

BEHAVIORAL

BREATHE Free Curriculum

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

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-12-25
Completion
2026-12-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862050 on ClinicalTrials.gov