NCT05583695

Brief Summary

This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

October 12, 2022

Last Update Submit

June 22, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difficulties in Emotion Regulation Scale (DERS)

    Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.

    at baseline

  • Difficulties in Emotion Regulation Scale (DERS)

    Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.

    In the 8th week from baseline

Secondary Outcomes (4)

  • Depression Anxiety Stress Scales-21 (DASS-21)

    at baseline

  • Depression Anxiety Stress Scales-21 (DASS-21)

    In the 8th week from baseline

  • Geriatric Depression Scale (GDS)

    at baseline

  • Geriatric Depression Scale (GDS)

    In the 8th week from baseline

Study Arms (3)

mindfulness-based music therapy

EXPERIMENTAL
Behavioral: mindfulness-based music therapy

mindfulness-based therapy

EXPERIMENTAL
Behavioral: mindfulness-based therapy

routine care

ACTIVE COMPARATOR
Behavioral: routine care

Interventions

eight weekly sessions with a combination of both mindfulness and music therapy

mindfulness-based music therapy

eight weekly sessions of mindfulness

mindfulness-based therapy
routine careBEHAVIORAL

eight weekly sessions of routine care

routine care

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • female
  • blind with visual acuity (the best eye) of 20/400 or below
  • aged 65 years or above
  • cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12
  • able to speak Cantonese

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Society for the Blind

Kowloon, Hong Kong

Location

Related Publications (1)

  • Chan SHW, Cheung MYC, Chiu ATS, Leung MHT, Kuo MCC, Yip DYC, Hui CCY, Kam SWI, Yeung K, Mui DSP, Wang SM, Yip CCK. Clinical effectiveness of mindfulness-based music therapy on improving emotional regulation in blind older women: A randomized controlled trial. Integr Med Res. 2023 Dec;12(4):100993. doi: 10.1016/j.imr.2023.100993. Epub 2023 Aug 26.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 18, 2022

Study Start

June 1, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations