- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07631845
Music Breathing in Enhancing Resilience Among Elders at Risk of Mental Health Problems
Effects of a Mindfulness-based Music Breathing Intervention in Enhancing Resilience Among Community-dwelling Elders at Risk of Mental Health Problems: A Pilot Randomised Controlled Trial
The goal of this pilot randomised controlled trial is to examine the effects of a mindfulness-based music breathing intervention in enhancing resilience (primary outcome), and in reducing anxiety, depressive symptoms, loneliness, and improving health-related quality of life (secondary outcomes) among community-dwelling older adults at risk of mental health problems.
It is hypothesised that compared with the control group, participants in the intervention group will report enhanced resilience, reduced anxiety, depressive symptoms, and loneliness, and improved health-related quality of life immediately post-intervention.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Background:
Evidence shows that community-dwelling elders experience a myriad of life challenges related to psychosocial well-being, including loneliness, social isolation, and reduced social participation, which are associated with anxiety, depressive symptoms, jeopardising their overall quality of life. Resilience, the capacity to adapt and maintain psychological well-being in stressful events, is a protective factor against emotional dysregulation and negative emotions. Music and mindfulness-based interventions have emerged as promising strategies for promoting psychological well-being among diverse populations. However, no research has yet been conducted to assess the effectiveness of an integrated music and mindfulness-based breathing intervention in enhancing resilience among elders at risk of mental health problems.
Design and subjects: A single-blind, two-arm parallel-group, prospective randomised controlled trial of a mindfulness-based music breathing intervention will be conducted in accordance with the CONSORT guidelines. 40 community-dwelling elders aged 65 years or above who has mild to moderate anxiety and/or depressive symptoms, based on the Hospital Anxiety and Depression Scale (HADS) (i.e., a score of 8 or higher on either the anxiety or depression subscale) will be randomised 1:1 to intervention and control groups.
Instruments: Validated questionnaires, including the Chinese version of the Connor-Davidson Resilience Scale (CD-RISC-25), the Chinese version of HADS, the Chinese version of the EQ-5D-3L and the Chinese version of the 3-item UCLA Loneliness Scale.
Interventions: Participants in the intervention group will receive a 4-week music plus mindfulness-based breathing program, consisting of one 60-minute face-to-face session per week. The sessions will be delivered in small groups (8-10 older adults per group) by a qualified music breathing practitioner. The intervention will follow a structured protocol developed by the research team and reviewed by a certified music-breathing therapist. Participants in the control group will receive usual care, which may include access to existing community-based services, health education, or leisure activities.
Main outcome measure: Data collection will be conducted at baseline (T0) and immediately post-intervention (T1). The primary outcome is levels of resilience. Secondary outcomes include anxiety levels and depressive symptoms, loneliness, and health-related quality of life.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ankie Tan Cheung, PhD, MPhil, BN
- Номер телефона: +852 39430515
- Электронная почта: ankiecheung@cuhk.edu.hk
Места учебы
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Hong Kong, Гонконг
- Рекрутинг
- The Chinese University of Hong Kong
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Контакт:
- Ankie Tan Cheung, PhD, MPhil, BN
- Номер телефона: 852 39430515
- Электронная почта: ankiecheung@cuhk.edu.hk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Aged 65 years or above
- Able to read Chinese and communicate in Cantonese/Mandarin.
- Has mild to moderate anxiety and/or depressive symptoms, based on the - Hospital Anxiety and Depression Scale (HADS) (i.e., a score of 8 or higher on either the anxiety or depression subscale)
Exclusion Criteria:
- Partcipants will be excluded if they have cognitive impairment, hearing loss, severe depression, known mental illness, or chronic illness.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Mindfulness-based music breathing intervention
Participants in the intervention group will receive a 4-week music plus mindfulness-based breathing program, consisting of one 60-minute face-to-face session per week.
The sessions will be delivered in small groups (8-10 older adults per group) by a qualified music breathing practitioner.
The intervention will follow a structured protocol developed by the research team and reviewed by a certified music-breathing therapist.
|
Participants in the intervention group will receive a 4-week music plus mindfulness-based breathing program, consisting of one 60-minute face-to-face session per week. The sessions will be delivered in small groups by a qualified music breathing practitioner. The intervention will follow a structured protocol developed by the research team and reviewed by a certified trained music-breathing therapist. Each session will consist of four progressive breathing phases, including: I. Discovery Breathing - to increase awareness of breath and bodily sensations II. Triangular Breathing - to cultivate control and balance through rhythm III. Silent Breathing - to promote stillness and internal reflection IV. Music Breathing - to combine guided music listening with mindful breathing for emotional regulation |
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Плацебо Компаратор: Control group
Participants in the control group will receive usual care, which may include access to existing community-based services, health education, or leisure activities, but will not involve any structured music or mindfulness-based intervention.
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Participants in the control group will receive usual care, which may include access to existing community-based services, health education, or leisure activities, but will not involve any structured music or mindfulness-based intervention.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Resilience
Временное ограничение: Change from baseline to post-intervention (at 4-week follow-up).
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Elders' resilience will be measured by the Chinese version of the Connor-Davidson Resilience Scale (CD-RISC).
Total scores range from 0 to 100, with higher scores indicating higher level of resilience.
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Change from baseline to post-intervention (at 4-week follow-up).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Anxiety and depressive symptoms
Временное ограничение: Change from baseline to post-intervention (at 4-week follow-up).
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The Chinese version of the Hospital Anxiety and Depression Scale (HADS) will be employed to evaluate anxiety and depressive symptoms.
Total scores range from 0 to 41, with higher scores indicating high levels of anxiety and depressive symptoms.
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Change from baseline to post-intervention (at 4-week follow-up).
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Health-related quality of life
Временное ограничение: Change from baseline to post-intervention (at 4-week follow-up).
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The European Quality of Life-5 Dimensions questionnaire (EQ-5D-3L) will be used to evaluate the participants' health-related quality of life.
The visual analogue scale will be used to measure the participant's perception of their overall health status from 0 to 100, with 0 being the worst imaginable health and 100 the best health.
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Change from baseline to post-intervention (at 4-week follow-up).
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Loneliness
Временное ограничение: Change from baseline to post-intervention (at 4-week follow-up).
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The UCLA Loneliness Scale will be used to assess elders' levels of loneliness.
Total score ranges from 20 to 80.
A higher total score indicates a greater degree of subjective loneliness and social isolation.
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Change from baseline to post-intervention (at 4-week follow-up).
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Ankie Tan Cheung, PhD, MPhil, BN, Chinese University of Hong Kong
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Ключевые слова
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Патологические процессы
- Поведенческие симптомы
- Заболевания дыхательных путей
- Нарушения дыхания
- Патологические состояния, признаки и симптомы
- Поведение
- Личное удовлетворение
- Тревожные расстройства
- Депрессия
- Респираторная аспирация
- Психологическое благополучие
- Следственные методы
- Эпидемиологический дизайн исследований
- Эпидемиологические методы
- Расширение исследования
- Методы
- Контрольные группы
Другие идентификационные номера исследования
- 2025.394
Планирование данных отдельных участников (IPD)
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