Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.

Официальное название

Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.

Обзор

Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?

Подробное описание

This protocol provides the recommended treatment to achieve smoking cessation (i.e., counseling and nicotine replacement therapy) and randomly assigns individuals to a high-intensity exercise or low-intensity exercise intervention as a strategy to engage the mechanisms relevant to high anxiety sensitive smokers to improve smoking cessation outcomes.

Вмешательства

• Поведенческое Aerobic Exercise
  Participants will select a YMCA branch and will be assigned a personal fitness instructor who will oversee a 15-week exercise intervention. The weekly exercise prescription is 75 minutes of aerobic training.
• Поведенческое Counseling
  Participants will receive the standard tobacco cessation package of up to 5 proactive interactions from the Texas Tobacco Quitline (TTQ). Interactions are typically phone calls, but can be chat or live text if the participant prefers. Interaction 1 is for assessment and quit date planning, Interaction 2 occurs prior to the quit date and can be a group session, Interaction 3 occurs shortly following the quit date, and Interactions 4 and 5 are for relapse prevention if the smoker has quit or probl
• Препарат Nicotine patch
  On the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches \[TNP\]).

Первичные конечные точки

• 7-day point prevalence abstinence (PPA) at 6-month follow-up [Срок оценки: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)]

Вторичные конечные точки (2)

• 7-day point prevalence abstinence (PPA) at 12-month follow-up [Срок оценки: Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)]
• 7-day point prevalence abstinence (PPA) at 9-month follow-up [Срок оценки: Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)]

Критерии участия

Критерии включения

• Adult (age ≥ 18);
• High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]);
• Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
• Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
• Body mass index < 40;
• Medical clearance to participate.
• Located near a participating YMCA site (within 50 miles)

Критерии исключения

• Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months
• Receiving current intervention for smoking cessation.
• Outstanding debt to the YMCA
• Listed as a sex offender on the National Sex Offender Registry

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas at Austin — Austin

Идентификаторы

NCT: NCT06053567 · 2016120049 · R01CA273221

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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