- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03027466
Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging
Background:
Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior.
Objective:
To explore people s values, smoking attitudes, and smoking behavior.
Eligibility:
People ages 18 and older who smoke
Design:
The study takes place entirely on a mobile device.
Participants will give their age, gender, data about their smoking habits, and desired quit date.
Then they will get different texts about quitting.
Participants will answer follow-up surveys 1 and 3 months later.
...
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20892
- National Cancer Institute (NCI)
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
- INCLUSION/EXCLUSION:
- Because the app is designed to assist with smoking cessation, all smokers are eligible to participate.
- Subjects are eligible if they are 18+ years of age.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Baseline Affirmation and Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
|
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|
Aktiv komparator: Baseline Affirmation and No Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
|
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|
Aktiv komparator: No Baseline Affirmation and Affirmation Texts
Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
|
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|
Placebo komparator: No Baseline Affirmation and No Affirmation Texts
Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
|
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Tidsramme: 1 month and 3 months
|
Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
|
1 month and 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
Tidsramme: 1 month and 3 months follow-up
|
Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
|
1 month and 3 months follow-up
|
|
Type of Tobacco Products
Tidsramme: 1 month and 3 months follow-up
|
Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
|
1 month and 3 months follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: William M Klein, Ph.D., National Cancer Institute (NCI)
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.
- Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2.
- Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769.
- Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Nøkkelord
Andre studie-ID-numre
- 999917039
- 17-C-N039
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .