- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ankie Tan Cheung, PhD, MPhil, BN
- Número de telefone: +852 39430515
- E-mail: ankiecheung@cuhk.edu.hk
Locais de estudo
-
-
-
Hong Kong, Hong Kong
- Recrutamento
- The Chinese University of Hong Kong
-
Contato:
- Ankie Tan Cheung, PhD, MPhil, BN
- Número de telefone: 852 39430515
- E-mail: ankiecheung@cuhk.edu.hk
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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 |
|
Comparador de Placebo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Resilience
Prazo: Change from baseline to post-intervention (at 4-week follow-up).
|
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.
|
Change from baseline to post-intervention (at 4-week follow-up).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anxiety and depressive symptoms
Prazo: Change from baseline to post-intervention (at 4-week follow-up).
|
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.
|
Change from baseline to post-intervention (at 4-week follow-up).
|
|
Health-related quality of life
Prazo: Change from baseline to post-intervention (at 4-week follow-up).
|
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.
|
Change from baseline to post-intervention (at 4-week follow-up).
|
|
Loneliness
Prazo: Change from baseline to post-intervention (at 4-week follow-up).
|
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.
|
Change from baseline to post-intervention (at 4-week follow-up).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ankie Tan Cheung, PhD, MPhil, BN, Chinese University of Hong Kong
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Processos Patológicos
- Sintomas Comportamentais
- Doenças Respiratórias
- Distúrbios Respiratórios
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Satisfação pessoal
- Transtornos de ansiedade
- Depressão
- Aspiração Respiratória
- Bem-estar psicológico
- Técnicas de investigação
- Design de pesquisa epidemiológica
- Métodos epidemiológicos
- Design de pesquisa
- Métodos
- Grupos de controle
Outros números de identificação do estudo
- 2025.394
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .