Sleep as a Mechanism of Change in Alcohol Use
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: Cognitive Behavioral Therapy for Insomnia.
- Кому может быть актуально
- Состояния в реестре: Insomnia, Alcohol; Harmful Use. Базовые параметры: 18 лет — 49 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 →
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Официальное название
Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults
Обзор
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Подробное описание
Heavy alcohol use is prevalent in the United States and results in significant physical and psychological burden. One in 10 adults in the United States reports binge drinking on a weekly basis, and few are willing to seek mental health treatment. Thus, additional strategies are needed to engage and treat individuals at risk for alcohol-related harm. Half of those who screen positive for hazardous drinking report clinically significant symptoms of insomnia. Insomnia tends to be less stigmatized than other mental health disorders, and it is one condition for which the field has highly efficacious treatment. Thus, one potential strategy to engage individuals in mental health treatment and reduce the burden of alcohol use in the United States is to target insomnia. This project aims (1) to examine change in insomnia as a mediator of insomnia treatment effects on alcohol use outcomes and sex as a moderator of those effects and (2) to identify mechanisms linking change in insomnia to alcohol use outcomes. Adults who drink alcohol and have insomnia will be randomly assigned to Cognitive Behavioral Therapy for Insomnia (CBT-I, n=112) or waitlist control (WLC, n=112). Outcomes will be assessed weekly during treatment, at the end of the active intervention period (post-treatment), and at 1-, 3-, and 6-month follow-ups.
Вмешательства
- Поведенческое Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical ni
Первичные конечные точки
- Insomnia Symptoms [Срок оценки: Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Drinking quantity [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Alcohol-related consequences [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
Вторичные конечные точки (9)
- Treatment willingness (alcohol) [Срок оценки: Change from baseline to post-treatment (week 6)]
- Alcohol craving [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Negative emotionality [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Response inhibition [Срок оценки: Change from baseline to post (week 6) to 3-month follow-up]
- Working memory [Срок оценки: Change from baseline to post (week 6) to 3-month follow-up]
- Delay discounting [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Alcohol to help with sleep [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Heartrate variability [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
- Dysfunctional Beliefs and Attitudes about Sleep Scale [Срок оценки: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups]
Критерии участия
Критерии включения
- report heavy drinking in a typical week in the past month
- meet DSM-5 criteria for Alcohol Use Disorder
- meet DSM-5 and research diagnostic criteria for Insomnia Disorder
Критерии исключения
- ≥50 years
- unable to provide informed consent
- report contraindications for CBT-I (mania or seizure disorder)
- moderate to severe sleep apnea that is untreated
- have symptoms requiring immediate clinical attention (e.g., psychosis, suicide plan)
- are already receiving behavioral treatment for insomnia or alcohol use
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Missouri-Columbia — Columbia
Идентификаторы
NCT: NCT06286774 · 2096884