Мотивационное интервью для снижения употребления психоактивных веществ среди пациентов с депрессией
8 июня 2015 г. обновлено: University of California, San Francisco
Исследование направлено на оценку эффективности вмешательства по снижению употребления алкоголя и наркотиков и симптомов депрессии, улучшению функционального состояния и содействию надлежащему использованию медицинских услуг в выборке из 300 взрослых, обращающихся за лечением от депрессии, которые также сообщают об опасном употреблении алкоголя или наркотиков при депрессии. .
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
В этом исследовании рассматриваются важные вопросы, касающиеся того, как выявлять и лечить пациентов в психиатрии, которые обращаются за помощью в связи с употреблением алкоголя или наркотиков, что может усугубить депрессию.
Исследователи предлагают провести исследование краткого мотивационного вмешательства (BMI) для снижения употребления наркотиков и алкоголя среди пациентов с депрессией, а также для расширения участия в программе восстановления от химической зависимости Kaiser (CDRP) по мере необходимости.
Пациенты с депрессией, употребляющие наркотики или алкоголь даже на субдиагностическом уровне, подвержены высокому риску эскалации проблем с психоактивными веществами.
ИМТ — это инновационный, основанный на фактических данных подход, который может снизить употребление наркотиков и алкоголя и улучшить результаты.
Но это не было проверено среди пациентов с депрессией.
Эта выборка исследования будет включать 300 амбулаторных пациентов, проходящих лечение депрессии в психиатрии Kaiser Permanente Северной Калифорнии Хейворд/Фремонт.
Критерии включения основаны на употреблении наркотиков (любое незаконное употребление наркотиков и использование отпускаемых по рецепту лекарств без рецепта) и опасном употреблении алкоголя (т. симптомы депрессии при приеме внутрь.
Триста пациентов будут рандомизированы для получения одного личного сеанса ИМТ и двух телефонных сеансов ИМТ в течение 6 недель после приема (вмешательство) или брошюры о рисках употребления наркотиков и алкоголя (контроль).
Исследователи ожидают, что вмешательство будет эффективным в снижении частоты употребления наркотиков и опасного употребления алкоголя при контрольных опросах по телефону через 3, 6 и 12 месяцев; улучшение настроения и функциональных результатов; увеличение продолжительности лечения депрессии (количество посещений психиатра на основе стандартов набора данных и информации об эффективности здравоохранения (HEDIS)); и содействие пациенту в начале лечения по программе лечения химической зависимости, если это необходимо, и будет экономически эффективным.
Для улучшения ухода за пациентами это также даст важную информацию об интеграции лечения алкогольной и наркотической зависимости в психиатрию и о том, как лучше всего помочь пациентам получить доступ к специализированным услугам CDRP, когда это необходимо.
Тип исследования
Интервенционный
Регистрация (Действительный)
307
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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California
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Union City, California, Соединенные Штаты, 94545
- Kaiser Permanente Medical Center Southern Alameda County
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Критерии включения:
- Опасное употребление алкоголя (т. е. ≥ 3 доз в день для женщин и ≥ 4 доз в день для мужчин)
- Употребление наркотиков (включая любое незаконное употребление наркотиков и безрецептурное использование отпускаемых по рецепту лекарств в течение предшествующих 30 дней)
- Умеренные или более выраженные симптомы депрессии на основании оценки ≥ 5 по Опроснику здоровья пациента (PHQ-9)
Критерий исключения:
- Текущая мания или психоз
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Мотивационное интервью
Мотивационное интервьюирование (МИ) состояло из одного 45-минутного личного сеанса МИ, за которым следовали два 15-минутных телефонных «бустерных» сеанса.
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Активный компаратор: Контроль
Участники получили брошюру о рисках употребления алкоголя и наркотиков.
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Участники получили брошюру о рисках употребления алкоголя и наркотиков.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Опасное употребление алкоголя в течение предшествующих 30 дней (самооценка количества дней употребления алкоголя с опасными последствиями)
Временное ограничение: 6 месяцев
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Самооценка количества дней употребления алкоголя с опасными последствиями (3+ порций в день для женщин / 4+ порций в день для мужчин) за предшествующие 30 дней.
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6 месяцев
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Употребление наркотиков в течение предшествующих 30 дней (самооценка количества дней употребления наркотиков)
Временное ограничение: 6 месяцев
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Самооценочное количество дней употребления наркотиков (незаконное употребление наркотиков или злоупотребление отпускаемыми по рецепту лекарствами) за 30 предыдущих дней.
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6 месяцев
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Опасное употребление алкоголя в течение предшествующих 30 дней (самооценка количества дней употребления алкоголя с опасными последствиями)
Временное ограничение: 12 месяцев
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Самооценка количества дней употребления алкоголя с опасными последствиями (3+ порций в день для женщин / 4+ порций в день для мужчин) за предшествующие 30 дней.
Мы изучаем изменение между использованием в течение 6 месяцев и использованием в течение 12 месяцев, чтобы измерить долгосрочное влияние вмешательства.
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12 месяцев
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Употребление наркотиков в течение предшествующих 30 дней (самооценка количества дней употребления наркотиков)
Временное ограничение: 12 месяцев
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Самооценочное количество дней употребления наркотиков (незаконное употребление наркотиков или злоупотребление отпускаемыми по рецепту лекарствами) за 30 предыдущих дней.
Мы изучаем изменения в использовании между 6 и 12 месяцами, чтобы измерить долгосрочное влияние вмешательства.
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12 месяцев
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Симптомы депрессии (оценка по опроснику здоровья пациента (PHQ-9))
Временное ограничение: 12 месяцев
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измеряется при последующих телефонных интервью. PHQ-9 оценивает частоту 9 типов проблем за последние 2 недели; ответы варьируются от 0 (вовсе нет) до 3 (почти каждый день).
Если по крайней мере 4 из 9 >0, сумма баллов по пунктам используется для обозначения тяжести депрессии: 1-4 Минимальная; 5-9 Легкий; 10-14 Умеренный; 15-19 Умеренно тяжелый; 20-27 Тяжелая.
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12 месяцев
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Адекватное психиатрическое лечение (количество участников, получающих непрерывное 12-недельное лечение в амбулаторном психиатрическом отделении Kaiser Permanente)
Временное ограничение: 3 месяца
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Количество участников, получающих непрерывное 12-недельное лечение в амбулаторном психиатрическом отделении Kaiser Permanente
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3 месяца
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Derek D Satre, PhD, University of California, San Francisco
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Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 октября 2010 г.
Первичное завершение (Действительный)
1 августа 2014 г.
Завершение исследования (Действительный)
1 августа 2014 г.
Даты регистрации исследования
Первый отправленный
7 апреля 2015 г.
Впервые представлено, что соответствует критериям контроля качества
17 апреля 2015 г.
Первый опубликованный (Оценивать)
20 апреля 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
10 июня 2015 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 июня 2015 г.
Последняя проверка
1 июня 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 10-03323
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. .