- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
...
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Maryland
-
Bethesda, Maryland, Yhdysvallat, 20892
- National Cancer Institute (NCI)
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
- 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Active Comparator: 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.
|
|
Active Comparator: 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 Comparator: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: William M Klein, Ph.D., National Cancer Institute (NCI)
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 999917039
- 17-C-N039
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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