- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06862050
BREATHE Free Curriculum
BREATHE Free: Character Strength and Resilience-Based Curriculum for Successful Tobacco Treatment
The purpose of this study is to evaluate whether BREATHE Free, an in-person faith-based smoking cessation program, can help people quit using tobacco products, including cigarettes, cigars, cigarillos, and e-cigarettes/vapes.
The program consists of 12 weekly group sessions that teach character strengths and resilience-based skills, such as hope, love, and spirituality, using the BREATHE Free curriculum. Participants will also receive free nicotine patches and complete surveys about their tobacco use, character strengths, and resilience.
The study will help us improve the program and determine whether it can reduce or eliminate tobacco use. Success will be measured through participant surveys and verified using expired carbon monoxide (CO) testing, a standard method for confirming smoking cessation.
The main question is: Can participation in the BREATHE Free program help people reduce or quit tobacco use?
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Georgia
-
Augusta, Georgia, Forente stater, 30912
- Augusta University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Current use of one or more tobacco products
- Valid home address in Augusta or the CSRA and able to attend sessions in person held in Augusta, Ga
- Functioning telephone number
- Speak, read, write in English
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BREATHE Free
Attend 12 in-person weekly meetings and go through Breathe Free curriculum. |
The curriculum teaches 12 character strengths and resilience practices: love, perspective, prudence, hope, humility, forgiveness, spirituality, self-control, teamwork, perseverance, gratitude, and joy. Each weekly session includes music and movement activities, instruction and discussion focused on one practice, goal setting, and meditation exercises including deep breathing, mindfulness, prayer, gratitude, and forgiveness. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants who stopped smoking completely
Tidsramme: Measured at week 12
|
Biochemically verified point prevalence abstinence (7 days) |
Measured at week 12
|
|
Number of participants who achieved a ≥50% reduction in tobacco use from baseline
Tidsramme: Measured in baseline and weeks 12
|
Number of participants who achieved a ≥50% reduction in tobacco use from baseline, defined as a reduction of at least 50% in the number of cigarettes smoked per day or the number of vaping episodes per day, measured at Week 12 compared with baseline. |
Measured in baseline and weeks 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants who rated the intervention positively at week 12
Tidsramme: Program evaluation will be administered on last meeting (week 12)
|
Number of participants who rated the BREATHE Free intervention favorably (scores of 4 or 5) on the following acceptability and perceived effectiveness items. Participants will rate their agreement with each statement using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree): BREATHE Free gave me confidence that I can quit tobacco use. BREATHE Free made me think that quitting tobacco is worthwhile. BREATHE Free made me feel that someone cared whether I quit smoking. BREATHE Free helped me understand the right steps to quit smoking. |
Program evaluation will be administered on last meeting (week 12)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2051137
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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