Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT07425119 per Disturbo da uso di tabacco è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Torna alla ricerca
Università DukeProject Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily 60 Randomizzato Remoto
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07425119 è uno studio interventistico per Disturbo da uso di tabacco, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 maggio 2026, con l'obiettivo di raggiungere 60 partecipanti. Sotto la guida di l'Università Duke, dovrebbe concludersi entro il 1 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 febbraio 2026.
Sommario breve
This study aims to test the feasibility and acceptability of a remotely delivered cue-based treatment intervention to promote smoking cessation among people who smoke lightly or non-daily. Secondary objectives include assessing preliminary efficacy on cessation and examining cue reactivity. Participants will be randomized to CBT only or CBT + cue-based treatment, with assessments at baseline, end-of-treatment, 6 mont...Mostra di più
Titolo ufficiale
Feasibility of Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly (≤10 Cigarettes Per Day) or Non-daily
Patologie
Disturbo da uso di tabaccoAltri ID dello studio
Numero NCT
Data di inizio (effettiva)
2026-05
Ultimo aggiornamento pubblicato
2026-02-20
Data di completamento (stimata)
2028-06
Arruolamento (previsto)
60
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
Smoking cessation
Cue-based treatment
Cognitive Behavioral Therapy
Cue-based treatment
Cognitive Behavioral Therapy
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoCBT only CBT delivered via telehealth sessions and supportive text messages. | Terapia cognitivo-comportamentale (TCC) CBT delivered via telehealth sessions and supportive text messages. |
SperimentaleCBT + Cue-based treatment CBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies. | Terapia cognitivo-comportamentale (TCC) CBT delivered via telehealth sessions and supportive text messages. Cue-based treatment intervention Cue-based treatment includes exposure to smoking-related cues and coping strategies. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Feasibility as measured by the number of participants who are recruited and randomized | During the recruitment period (up to 9 months) | |
Feasibility as measured by the number of participants who respond to pre-quit real-time data collection | End of treatment (up to 12 months) | |
Feasibility as measured by the number of participants who take pictures of smoking/craving situations | End of treatment (up to 12 months) | |
Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions | End of treatment (up to 12 months) | |
Feasibility as measured by the number of participants who complete all cue-based treatment sessions | End of treatment (up to 12 months) | |
Feasibility as measured by the number of participants who respond to EMA text based assessments | End of treatment (up to 12 months) | |
Feasibility as measured by the number of participants who proactively text to report cravings | End of treatment (up to 12 months) | |
Acceptability of CBT + cue-based treatment intervention compared to CBT only | We will assess acceptability quantitatively and qualitatively. We will assess message helpfulness (1=Not at all helpful to 5=extremely helpful) and whether participants would recommend the program to a friend (1=definitely would not recommend to 5=definitely would recommend). We will also assess participant fidelity to the intervention protocol (e.g., experienced cues and texted to report when experiencing a cue). Qualitative data will be used to describe barriers and facilitators to intervention uptake among participants in the CBT + cue-based treatment arm. | End of treatment (up to 12 months) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Number of participants reporting the presence of smoking cues | The brief EMA text-based assessment will include a question to assess the presence of smoking cues. | 7 days after end of each CBT session (4 sessions total) |
Craving level | The brief EMA text-based assessment will include a question to assess current craving level: "How strong was your craving on a scale from 1=None to 10=Very Strong?" | 7 days after end of each CBT session (4 sessions total) |
Stress level | The brief EMA text-based assessment will include a question to assess current stress level: "How stressed did you feel on a scale from not at all stressed=1 to extremely stressed=10?" | 7 days after end of each CBT session (4 sessions total) |
Current mood | The brief EMA text-based assessment will include a question to assess current mood: "How is your mood right now 1=Extremely bad to 10=Extremely good?" | 7 days after end of each CBT session (4 sessions total) |
Number of participants who reported 30-day point prevalence abstinence | Smoking cessation will be assessed using self-reported 30-day point prevalence abstinence (e.g., smoked any cigarettes in the past 30 days?). | End of Treatment, 6 months |
Smoking status as measured by salivary cotinine | Smoking status will be biochemically validated via salivary cotinine levels. | End of Treatment, 6 months |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Age ≥18
- Able to read and understand English or Spanish
- Smoke 1-10 cigarettes/day on at least 4 days of the past two weeks for the last year
- Willing to try quitting in next 30 days
- Access to cell phone with texting capabilities
- Current participation in another smoking cessation study
- Unable to provide consent
- Refusal to abstain from e-cigarettes or other tobacco products
- Use of medications affecting smoking cessation (e.g., Chantix, Wellbutrin)
Università Duke537 studi clinici attivi da esplorareContatti principali dello studio
Contatto: Laura Fish, PhD, 919-681-3820, [email protected]
Contatto: Lauren Hart, MSW, MPH, 919-613-2607, [email protected]
Nessun dato sulle località