NCT07631845

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Aug 2026

First Submitted

Initial submission to the registry

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 1, 2026

Last Update Submit

June 7, 2026

Conditions

Keywords

MindfulnessMsuicBreathingCommunity-dwelling eldersResilienceMental health

Outcome Measures

Primary Outcomes (1)

  • Resilience

    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).

Secondary Outcomes (3)

  • Anxiety and depressive symptoms

    Change from baseline to post-intervention (at 4-week follow-up).

  • Health-related quality of life

    Change from baseline to post-intervention (at 4-week follow-up).

  • Loneliness

    Change from baseline to post-intervention (at 4-week follow-up).

Study Arms (2)

Mindfulness-based music breathing intervention

EXPERIMENTAL

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.

Behavioral: Mindfulness-based music breathing intervention

Control group

PLACEBO COMPARATOR

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.

Behavioral: control group

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 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

Mindfulness-based music breathing intervention
control groupBEHAVIORAL

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.

Control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Partcipants will be excluded if they have cognitive impairment, hearing loss, severe depression, known mental illness, or chronic illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepressionRespiratory AspirationPsychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ankie Tan Cheung, PhD, MPhil, BN

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankie Tan Cheung, PhD, MPhil, BN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 8, 2026

Study Start

June 8, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations