Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment
Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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California
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San Francisco, California, Соединенные Штаты, 94143
- University of California, San Francisco
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
|
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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Экспериментальный: 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.
|
|
Активный компаратор: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
Временное ограничение: 3 to 6 months
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 3 to 6 months
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Treatment engagement as measured by participation in live group sessions
|
3 to 6 months
|
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Duration of Active Participation
Временное ограничение: 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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Соавторы и исследователи
Следователи
- Главный следователь: Gary Humfleet, PhD, University of California, San Francisco
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Химически индуцированные расстройства
- Расстройства, связанные с употреблением психоактивных веществ
- Расстройство, связанное с употреблением табака
- Физиологические эффекты лекарств
- Нейротрансмиттерные агенты
- Молекулярные механизмы фармакологического действия
- Автономные агенты
- Агенты периферической нервной системы
- Холинергические агенты
- Ганглиозные стимуляторы
- Никотиновые агонисты
- Холинергические агонисты
- Никотин
Другие идентификационные номера исследования
- TRDRP - T29IP0461
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .