- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ankie Tan Cheung, PhD, MPhil, BN
- Numer telefonu: +852 39430515
- E-mail: ankiecheung@cuhk.edu.hk
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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 |
|
Komparator 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Resilience
Ramy czasowe: 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).
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Anxiety and depressive symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Ankie Tan Cheung, PhD, MPhil, BN, Chinese University of Hong Kong
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Procesy patologiczne
- Objawy behawioralne
- Choroby Układu Oddechowego
- Zaburzenia oddychania
- Stany patologiczne, oznaki i objawy
- Zachowanie
- Satysfakcja osobista
- Zaburzenia lękowe
- Depresja
- Aspiracja oddechowa
- Samopoczucie psychiczne
- Techniki śledcze
- Projekt badań epidemiologicznych
- Metody epidemiologiczne
- Projekt badań
- Metody
- Grupy kontrolne
Inne numery identyfikacyjne badania
- 2025.394
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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