- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ankie Tan Cheung, PhD, MPhil, BN
- 전화번호: +852 39430515
- 이메일: ankiecheung@cuhk.edu.hk
참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
위약 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Resilience
기간: 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).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anxiety and depressive symptoms
기간: 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
기간: 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
기간: 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).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ankie Tan Cheung, PhD, MPhil, BN, Chinese University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025.394
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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