- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04461288
Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment
Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
Przegląd badań
Status
Szczegółowy opis
Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a Facebook-delivered smoking cessation intervention (including daily posts, and weekly live group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus, the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a usual care condition which includes referral to smokefree.gov, a federally-developed web-based intervention which includes similar digital treatment elements. All participants will have access to up to six months of nicotine replacement therapy (NRT).
Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to provide biochemical verification of smoking status using a portable carbon monoxide measurement tool. All intervention and assessment procedures will be conducted digitally.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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California
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San Francisco, California, Stany Zjednoczone, 94143
- University of California, San Francisco
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Daily smoker
- Self-identify as sexual and/or gender minority
- Interested in quitting in next 6 months
- 6 months of Facebook experience
- English-speaking
Exclusion Criteria:
- Contraindications to nicotine replacement therapy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Pride Posts
This six month intervention will be conducted on the Facebook platform.
Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+).
Weekly live sessions with a tobacco expert will be available.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
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This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers.
The intervention is group-based and includes daily posts and weekly live sessions during the initial three months.
Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette. |
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Eksperymentalny: Pride Posts Plus
This six month intervention will include all elements of the Pride Posts arm.
In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers.
The intervention is group-based and includes daily posts and weekly live sessions during the initial three months.
Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.
Gaming elements designed to encourage participation in the program and behavior change.
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Aktywny komparator: Usual Care Condition
Participants in this arm will be provided with a referral to smokefree.gov,
a federally-funded website which provides support and digital-based interventions to assist in smoking cessation activities.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
Ramy czasowe: 3 months
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Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment.
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3 months
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Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months
Ramy czasowe: 6 months
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Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment.
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6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
Ramy czasowe: 3 to 6 months
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Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment
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3 to 6 months
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Responses to the Thoughts About Abstinence Questionnaire Over Time
Ramy czasowe: 3 to 6 months
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The Thoughts About Abstinence Questionnaire is a 5 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty.
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3 to 6 months
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Frequency of social media posts
Ramy czasowe: 3 to 6 months
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Treatment engagement as measured by frequency of social media posts
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3 to 6 months
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Frequency of participation in live group sessions
Ramy czasowe: 3 to 6 months
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Treatment engagement as measured by participation in live group sessions
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3 to 6 months
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Duration of Active Participation
Ramy czasowe: 3 to 6 months
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Treatment engagement as measured by duration of active participation in intervention.
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3 to 6 months
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Gary Humfleet, PhD, University of California, San Francisco
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 (Rzeczywisty)
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
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia wywołane chemicznie
- Zaburzenia związane z substancjami
- Zaburzenia związane z używaniem tytoniu
- Fizjologiczne skutki leków
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Agenci autonomiczni
- Agenty obwodowego układu nerwowego
- Środki cholinergiczne
- Stymulatory ganglionowe
- Agoniści nikotynowi
- Agoniści cholinergiczni
- Nikotyna
Inne numery identyfikacyjne badania
- TRDRP - T29IP0461
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
produkt wyprodukowany i wyeksportowany z USA
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