- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00536406
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)
BE-ACTIV: Treating Depression in Nursing Homes
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Depression is a common mental disorder that affects nearly half of all older people living in nursing homes. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affect people's sleep patterns, concentration, and energy levels. In addition, nursing homes are often understaffed and very busy, making it difficult for older people with depression to receive a proper diagnosis and adequate treatment. Recent studies have shown that an increase in pleasurable activities among residents in nursing homes can improve symptoms of depression. The purpose of this study is to determine whether symptoms of depression can be reduced by increasing opportunities for nursing home residents to engage in pleasant events and build better relationships with nursing home staff members.
Participating nursing homes will be randomly assigned to have their residents receive behavioral activity treatment (BE-ACTIV) or treatment as usual for 12 weeks. Potential participating nursing home residents will complete two brief tests regarding memory, attention, and symptoms of depression. An hour-long interview will then be conducted during which eligible participating residents will discuss their symptoms of depression, rate their health and level of functioning, and assess the quality of their relationship with a staff member. Residents receiving BE-ACTIV will meet with a therapist for weekly 30-minute sessions for 10 weeks. During these sessions, residents will discuss their activity participation and any pleasant events that they recently experienced. Therapists and nursing home activities staff will work together to incorporate more activities of interest into each resident's schedule. Residents of nursing homes assigned to receive treatment as usual will be asked to rate their mood once a week for 10 weeks. Researchers will observe each resident, regardless of treatment group, for 5-minute intervals at various times during the study to assess mood and activity levels. All participating residents will undergo a second interview after 10 weeks to discuss any changes or improvements in mood, symptoms of depression, activity level, or their relationship with staff members. All participating residents will be assessed after 3 months and again after 6 months post-treatment to determine whether the BE-ACTIV program was successful in improving symptoms of depression.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Kentucky
-
Louisville, Kentucky, Соединенные Штаты, 40292
- University of Louisville
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Nursing home residents in long-term care beds with an expected stay of 3 months or more
- Geriatric Depression Scale score of at least 11
- Meets DSM-IV criteria for major depressive disorder or research diagnostic criteria for minor depressive disorder
Exclusion Criteria:
- Mini Mental State Exam score below 14
- Referred to hospice care for a terminal condition
- Current unstable or terminal medical condition
- Suicidal
- Meets DSM-IV criteria for bipolar disorder
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: A
Participants will receive the BE-ACTIV treatment
|
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
|
|
Активный компаратор: B
Participants will receive treatment as usual
|
TAU includes usual treatment in nursing care facility.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
Временное ограничение: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
Временное ограничение: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Staff attention
Временное ограничение: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Positive affect
Временное ограничение: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Activity participation
Временное ограничение: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Behavior problems
Временное ограничение: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Resident satisfaction
Временное ограничение: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Suzanne Meeks, PhD, University of Louisville
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- R01MH074865 (Грант/контракт NIH США)
- DATR A4-GPS
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. .