Меню
Набор скоро начнётся NCT07158749

Generalized and Domain-Specific Episodic Thinking for Smoking Cessation

Без фазы С лечением Cigarette Smoking Behavior

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Episodic Future Thinking (EFT), Episodic Recent Thinking (ERT), Domain-specific episodic thinking, Generalized episodic thinking.
Кому может быть актуально
Состояния в реестре: Cigarette Smoking Behavior. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Generalized and Domain-Specific Episodic Thinking for Smoking Cessation: An 8-Week Pilot and Feasibility Trial

Обзор

Cigarette smoking remains common, particularly in rural areas, despite ample evidence that smoking causes cancer and respiratory disease. Successful smoking cessation yields the majority of its health benefits (e.g., avoidance of lung cancer) after years of sustained behavioral change; however, people who smoke cigarettes tend to show elevated rates of delay discounting (i.e., devaluation of delayed outcomes) and a bias for immediate gratification. The overall goal of this project is to develop different versions of an episodic future thinking intervention (i.e., visualization of the future) and test their feasibility and efficacy for smoking cessation in rural and urban populations.

Подробное описание

Cigarette smoking causes more than a dozen cancers, including cancers of the head and neck, colon, bladder, and lung. Although quitting smoking drastically reduces the risk of cancer mortality, rates of cessation are low, particularly in rural areas and other communities. Current evidence-based treatments for smoking cessation have made progress, but substantial room for innovation remains and novel strategies are needed. Successful smoking cessation may be considered, in part, an intertemporal choice between continuing to smoke and achieving the delayed health benefits associated with quitting (e.g., avoidance of lung cancer). Thus, quitting requires one's behavior to be sufficiently motivated by future outcomes. Unfortunately, robust cross-sectional and longitudinal evidence indicates that people who smoke cigarettes show elevated delay discounting, or a bias for immediate gratification. Prior research shows that delay discounting predicts treatment failure and relapse in smoking cessation. These findings suggest that delay discounting often prevents successful quitting because the health benefits of cessation (e.g., avoiding cancer) are too delayed to motivate sustained behavioral change. Thus, delay discounting is a therapeutic target in smoking cessation, where interventions that increase valuation of future outcomes may facilitate quitting. Episodic future thinking (EFT) is one such scalable intervention that is designed to shift time perspective and reduce bias for immediate gratification by promoting vivid and frequent visualization of a broad range of personally significant future events (e.g., weddings, birthdays, spending time with loved ones). In laboratory studies, research has shown that this form of generalized EFT in cigarette smokers reduces delay discounting and motivation to smoke (i.e., cigarette consumption, craving, and valuation). Moreover, strong preliminary evidence suggests that cancer-related EFT, a novel form of the intervention that involves visualizing the future experience of smoking-related lung cancer, may be more efficacious for reducing urges to smoke than the generalized form. The proposed trial will adapt both forms of EFT (generalized and cancer-related) for clinical use in smoking cessation. Remote intervention delivery and outcomes assessment (breath carbon monoxide and number of cigarettes smoked per day) will be used to minimize clinical burden and increase intervention reach and access, including in rural populations who often lack access to evidence-based treatments for smoking cessation. In an eight-week proof-of-concept trial, participants will be prompted to engage in EFT or control episodic thinking multiple times per day and during acute craving episodes. Specific Aims 1 and 2 will examine the feasibility and efficacy, respectively, of generalized and cancer-related EFT to reduce smoking. An Exploratory Aim will investigate the potential moderating role of income, education, sex, and other characteristics (e.g., baseline delay discounting, cigarettes/day) in the effects of EFT on smoking outcomes.

Вмешательства

  • Поведенческое Episodic Future Thinking (EFT)
    Participants will engage in EFT for 8 weeks, three times a day. Participants will receive three daily text messages. Each prompt will link to a custom web interface that guides participants to read and vividly imagine one of their cues, chosen randomly. Visit times and durations will be recorded.
  • Поведенческое Episodic Recent Thinking (ERT)
    Participants will engage in ERT for 8 weeks, three times a day. Participants will receive three daily text messages. Each prompt will link to a custom web interface that guides participants to read and vividly imagine one of their cues, chosen randomly. Visit times and durations will be recorded.
  • Поведенческое Domain-specific episodic thinking
    Content of the episodic thinking intervention will experiencing the symptoms of lung cancer during a broad range of personally meaningful, otherwise positive, events (e.g., social events, celebrations, spending times with friends and family).
  • Поведенческое Generalized episodic thinking
    Content of the episodic thinking intervention will include a broad range of personally meaningful, positive, events (e.g., social events, celebrations, spending times with friends and family).

Первичные конечные точки

  • Cigarettes smoked per day [Срок оценки: From Week 0 to the end of treatment at 8 weeks]
Вторичные конечные точки (2)
  • Other tobacco/nicotine product use per day [Срок оценки: From Week 0 to the end of treatment at 8 weeks]
  • 7-day point prevalence cigarette abstinence [Срок оценки: Week 8]

Критерии участия

Критерии включения

  • smoked cigarettes daily for the last 30 days;
  • salivary cotinine > 30 ng/mL, consistent with tobacco use;
  • plan to quit smoking in the next 30 days

Критерии исключения

  • prior diagnosis with a smoking-related illness (e.g., respiratory disease);
  • past 30-day use any smoking cessation treatment;
  • anxiety or mood disorders; and
  • medical contraindications for use of nicotine replacement therapy (e.g. pregnancy).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Fralin Biomedical Research Institute at VTC — Roanoke

Идентификаторы

NCT: NCT07158749 · 24-1183 · 1R21CA294049

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗