- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04927026
"Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults
"Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial
The World Health Organization (WHO) reported that approximately 15% of adults aged 60 and above suffer from some form of mental disorder, with one of the most common neuropsychiatric disorders being depression. Similar trends are seen in Singapore where 11.4% of the older adults aged 65 and above had depressive symptoms. Another population survey conducted among elderly in Singapore showed that elderly with subsyndromal depression (SSD) were similar to or worse than elderly with Major Depressive Disorder (MDD). However being a multi-ethnic Asia society the mental conditions such as depression and anxiety are seen as taboo topics to be discussed more so to seek help or treatment for these conditions in Singapore. Additionally scarcity of trained psychiatrists and work load of these trained professionals in the acute care settings make it difficult to reach these needy older adults. Hence, it is imperative to support the needs of this group of community dwelling older adults to ensure that their emotional wellbeing, and their condition do not progress to MDD. As such, this is the first of its kind study that will evaluate the effectiveness of solution focused brief therapy delivered by the lay mindfulness practitioner and the nurses.
If the pilot intervention is found to be feasible and effective, the large scale community trial will be planned to reach to more elderly in Singapore to help them age in a dignified way. In addition, other countries that do not involve lay mindfulness practitioners and nurses to provide integrated personal therapy in the community may benefit from this study as well.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Singapore, Сингапур, 117597
- National University of Singapore
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Community-dwelling older adults aged between 60-95 years old
- Able to understand and speak either English and/or Mandarin
- Able to attend at least 80% (five out of seven sessions) of the intervention sessions
- Have subsyndromal depression (obtained a score between one and five on the Geriatric Depression Scale) and/or subsyndromal anxiety (obtained a score between three and 10 on the Geriatric Anxiety Scale)
Exclusion Criteria:
- Older adults aged between 60-95 years old without subsyndromal depression and/or subsyndromal anxiety
- Older adults aged between 60-95 years old who could not understand or speak either English and/or Mandarin.
- Older adults aged between 60-95 years old who were unable to attend at least 80% (five out of seven sessions) of the intervention sessions.
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 |
---|---|
Без вмешательства: Контроль
Без вмешательства
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Экспериментальный: Where-there-is-no-psychiatrist Integrated Personal Therapy (WIPT)
Solution-focused brief therapy (SFBT) involving psychoeducation and structured life review therapy, as well as mindfulness-based training
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The WIPT include weekly face-to-face group sessions including mindfulness-based training and solution focused brief therapy (SFBT) involving psychoeducation and structured life review therapy catered to the personal needs of the participants.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Symptoms of depression
Временное ограничение: Prior to start of intervention
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Measured using Geriatric Depression Scale.
15-item scale where participants select either "Yes" or "No" in response to 15 statements.
The maximum score that could be obtained was 15 points; a high score on the scale indicates severe depressive symptoms.
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Prior to start of intervention
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Symptoms of depression
Временное ограничение: 3 months post-recruitment
|
Measured using Geriatric Depression Scale.
15-item scale where participants select either "Yes" or "No" in response to 15 statements.
The maximum score that could be obtained was 15 points; a high score on the scale indicates severe depressive symptoms.
|
3 months post-recruitment
|
Symptoms of depression
Временное ограничение: 6 months post-recruitment
|
Measured using Geriatric Depression Scale.
15-item scale where participants select either "Yes" or "No" in response to 15 statements.
The maximum score that could be obtained was 15 points; a high score on the scale indicates severe depressive symptoms.
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6 months post-recruitment
|
Symptoms of anxiety
Временное ограничение: Prior to start of intervention
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Measured using Geriatric Anxiety Inventory.
20-item scale where participants select either "Agree" or "Disagree" to assess the anxiety symptoms in older adults.
The maximum score that could be obtained was 20 points; a high score indicates more anxiety symptoms.
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Prior to start of intervention
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Symptoms of anxiety
Временное ограничение: 3 months post-recruitment
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Measured using Geriatric Anxiety Inventory.
20-item scale where participants select either "Agree" or "Disagree" to assess the anxiety symptoms in older adults.
The maximum score that could be obtained was 20 points; a high score indicates more anxiety symptoms.
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3 months post-recruitment
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Symptoms of anxiety
Временное ограничение: 6 months post-recruitment
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Measured using Geriatric Anxiety Inventory.
20-item scale where participants select either "Agree" or "Disagree" to assess the anxiety symptoms in older adults.
The maximum score that could be obtained was 20 points; a high score indicates more anxiety symptoms.
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6 months post-recruitment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Life satisfaction
Временное ограничение: Prior to start of intervention
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Measured using Satisfaction with Life Scale.
5-item scale that included a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree").
The maximum score that could be obtained was 35 points; a high score indicates high level of satisfaction with life.
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Prior to start of intervention
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Life satisfaction
Временное ограничение: 3 months post-recruitment
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Measured using Satisfaction with Life Scale.
5-item scale that included a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree").
The maximum score that could be obtained was 35 points; a high score indicates high level of satisfaction with life.
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3 months post-recruitment
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Life satisfaction
Временное ограничение: 6 months post-recruitment
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Measured using Satisfaction with Life Scale.
5-item scale that included a 7-point Likert scale (1 = "Strongly Disagree"; 7 = "Strongly Agree").
The maximum score that could be obtained was 35 points; a high score indicates high level of satisfaction with life.
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6 months post-recruitment
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Social connectedness in terms of friendship
Временное ограничение: Prior to start of intervention
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Measured using Friendship Scale.
6-item where participants had to select an answer out of the five options (1 = "Not at All"; 5 = "Almost Always").
The maximum score that could be obtained was 30 points; a high score indicates high level of social connectedness.
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Prior to start of intervention
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Social connectedness in terms of friendship
Временное ограничение: 3 months post-recruitment
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Measured using Friendship Scale.
6-item where participants had to select an answer out of the five options (1 = "Not at All"; 5 = "Almost Always").
The maximum score that could be obtained was 30 points; a high score indicates high level of social connectedness.
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3 months post-recruitment
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Social connectedness in terms of friendship
Временное ограничение: 6 months post-recruitment
|
Measured using Friendship Scale.
6-item where participants had to select an answer out of the five options (1 = "Not at All"; 5 = "Almost Always").
The maximum score that could be obtained was 30 points; a high score indicates high level of social connectedness.
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6 months post-recruitment
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Quality of life
Временное ограничение: Prior to start of intervention
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Measured using World Health Organization Quality of Life-Older Adults module.
13-item scale where participants had to select an answer based on a 5-point rating scale (1 = "Not at All"; 5 = "Very Satisfied").
The maximum score was 65 points, and a high score indicates high quality of life.
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Prior to start of intervention
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Quality of life
Временное ограничение: 3 months post-recruitment
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Measured using World Health Organization Quality of Life-Older Adults module.
13-item scale where participants had to select an answer based on a 5-point rating scale (1 = "Not at All"; 5 = "Very Satisfied").
The maximum score was 65 points, and a high score indicates high quality of life.
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3 months post-recruitment
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Quality of life
Временное ограничение: 6 months post-recruitment
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Measured using World Health Organization Quality of Life-Older Adults module.
13-item scale where participants had to select an answer based on a 5-point rating scale (1 = "Not at All"; 5 = "Very Satisfied").
The maximum score was 65 points, and a high score indicates high quality of life.
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6 months post-recruitment
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Cortisol in ng/ml
Временное ограничение: Prior to start of intervention
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Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
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Prior to start of intervention
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Cortisol in ng/ml
Временное ограничение: 6 months post-recruitment
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Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
|
6 months post-recruitment
|
Annexin-A1 in ng/ml
Временное ограничение: Prior to start of intervention
|
Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
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Prior to start of intervention
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Annexin-A1 in ng/ml
Временное ограничение: 6 months post-recruitment
|
Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
|
6 months post-recruitment
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Interleukin-1-beta in pg/ml
Временное ограничение: Prior to start of intervention
|
Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
|
Prior to start of intervention
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Interleukin-1-beta in pg/ml
Временное ограничение: 6 months post-recruitment
|
Stress- and anxiety- related inflammatory outcomes.
Collected in lithium heparin tubes
|
6 months post-recruitment
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- A17-2003-B
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
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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. .
Клинические исследования Душевное здоровье
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... и другие соавторыАктивный, не рекрутирующийПрофилактические медицинские услуги (PREV HEALTH SERV)Соединенные Штаты