- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04754867
Pre-Test of For the Future Self and Smoking Cessation
Pre-Test of For the Future Self: A Behavioral Intervention to Increase Success in a Smoking Cessation Program
Обзор исследования
Статус
Условия
Подробное описание
Several factors are thought to be relevant to the level of adherence such as the initial level of nicotine addiction (Orleans et al., 1994), gender (Gritz, Nielsen, & Brooks, 1996), concerns over weight gain due to smoking cessation (Fagerström, 2002) and side effects (Burns & Levinson, 2008). On the other hand, combining nicotine replacement treatment with behavioral therapy has been shown to improve adherence and overall abstinence (Cooper et al., 2004) and motivation is found to be an important factor related to patch use (Alterman, Gariti, Cook, & Cnaan, 1999).
Can a more vivid connection to an individual's future self facilitate smoking cessation? While behavioral interventions that enhance connection to the future self have been proven effective at mitigating present bias, they have so far been done in domains that require self-restraint (e.g., delinquency). Smoking cessation does in part require restraint, but a cessation program utilizing the nicotine patch also requires proactive daily commitment and action. Little research has been done to establish the effectiveness of a future selves intervention on behaviors that require proactive action.
Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images. Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view; participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.); participants in the current self virtual reality condition will see their present age self in a virtual reality rendering. Participants in all conditions will write a 200-300 word letter to themselves (in the treatment condition, the letter is written to their self in 20 years; in control, the letter is written to themselves in 3 months). The investigators will measure the impact of the behavioral intervention on participants' expected efficacy with smoking cessation, self-reported patch adherence, and smoking cessation success 2 and 8 weeks later.
The investigators will collect self-reported and non-invasive physiological adherence data over the course of 8 weeks on participants' adherence to the nicotine patch (self-report) and success with smoking cessation (self-report and CO analysis). For those participants self-reporting zero cigarettes smoked in the 7 day period before lab visits, investigators will administer a breath CO assessment (a simple procedure where the participant breathes into a tube and the device analyzes how many carbon dioxide parts per million are in the breath). The investigators will also asks participants if they would be willing to receive an email invitation to an online, 3-question, 6-month follow-up survey to occur four months after their last in-person visit to the laboratory.
The data collected will not be tied to identifiers; it will be used in statistical analyses assessing the effects of the intervention.
Тип исследования
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Considering enrollment or recently enrolled (within 1 week) in one of the three designated smoking cessation programs
Exclusion Criteria:
- Use of any form of tobacco other than cigarettes
- Use of nicotine gum
- History of alcohol or drug dependency
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: "discontinued-smoker" age-progressed
Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view.
|
Using software developed for this purpose, a current photograph of the subject will be aged and presented through a visual medium.
The image (face) will be rendered as a 3D virtual reality avatar.
Participants will write a 200-300 word letter to the self they see in that image in 20 years' time.
The instructions will read: "Think about who you will be in 20 years from now, and write about the person you are now.
What things are important and dear to you, and how do you see your life?"
|
|
Экспериментальный: "discontinued-smoker" + "continued smoking" age-progressed
Participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.).
|
Using software developed for this purpose, a current photograph of the subject will be aged and presented through a visual medium.
The image (face) will be rendered as a 3D virtual reality avatar.
Participants will write a 200-300 word letter to the self they see in that image in 20 years' time.
The instructions will read: "Think about who you will be in 20 years from now, and write about the person you are now.
What things are important and dear to you, and how do you see your life?"
Using software developed for this purpose, a current photograph of the participant will be aged showing the results of continued smoking and presented through a visual medium.
The image (face) will be rendered as a 3D virtual reality avatar.
|
|
Экспериментальный: Current self virtual reality images
Participants in the current self virtual reality condition will see their present age self in a virtual reality rendering.
|
Using software developed for this purpose, a current photograph of the participant will be rendered as a 3D virtual reality avatar.
Participants will write a 200-300 word letter to the self they see in that image.
The instructions will read: "Think about who you will be in 3 months from now, and write about the person you are now.
What things are important and dear to you, and how do you see your life?"
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Adherence at two weeks
Временное ограничение: Two weeks after initial intervention
|
In the past 2 weeks, how often did you wear a nicotine patch?
|
Two weeks after initial intervention
|
|
Adherence at eight weeks
Временное ограничение: Eight weeks after initial intervention
|
In the past 2 weeks, how often did you wear a nicotine patch?
|
Eight weeks after initial intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Abstinence at two weeks
Временное ограничение: Two weeks after initial intervention
|
In the past 2 weeks, how often did you smoke a cigarette?
|
Two weeks after initial intervention
|
|
Abstinence at eight weeks
Временное ограничение: Eight weeks after initial intervention
|
In the past 2 weeks, how often did you smoke a cigarette?
|
Eight weeks after initial intervention
|
|
CO ppm at two weeks
Временное ограничение: Two weeks after initial intervention
|
Subjects will blow into CO analyzer.
|
Two weeks after initial intervention
|
|
CO ppm at eight weeks
Временное ограничение: Eight weeks after initial intervention
|
Subjects will blow into CO analyzer.
|
Eight weeks after initial intervention
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Ожидаемый)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
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
Другие идентификационные номера исследования
- STUDY2016_00000551
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.
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