- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
...
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Maryland
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Bethesda, Maryland, Stany Zjednoczone, 20892
- National Cancer Institute (NCI)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 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
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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.
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Aktywny 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
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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.
|
Aktywny 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.
|
Komparator placebo: 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)
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
Ramy czasowe: 1 month and 3 months
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Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
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1 month and 3 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
Ramy czasowe: 1 month and 3 months follow-up
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Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
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1 month and 3 months follow-up
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Type of Tobacco Products
Ramy czasowe: 1 month and 3 months follow-up
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Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
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1 month and 3 months follow-up
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: William M Klein, Ph.D., National Cancer Institute (NCI)
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 999917039
- 17-C-N039
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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