Effect of Music Activities on Depression and Sleep Quality in Frail Older Adults

July 1, 2025 updated by: Chia-Te Chen, National Chung Hsing University

A Randomized Controlled Trial on the Effect of Music Activities on Depression and Sleep Quality in Frail Older Adults

This study aims to examine the effects of music activities on depression and sleep quality among frail older adults, and to develop a standardized music activity protocol suitable for use in adult day care centers. A randomized controlled trial (RCT) design will be used. Participants will be recruited from 4 to 5 adult day care centers and randomly assigned to either an intervention group (receiving music activities twice per week, one hour per session, for eight weeks) or a control group (receiving only routine activities). Depression and sleep quality will be measured at baseline, week 4, and week 8. Assessments will include validated questionnaires and the index of osteoporotic fractures. Data analysis will evaluate the effectiveness of music activities in improving depression and enhancing sleep quality.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inclusion Criteria:

    1. Aged 60 years or older.
    2. Currently receiving services at an adult day care center.
    3. Frailty score ≥1 based on the Study of Osteoporotic Fractures (SOF) index.
    4. Geriatric Depression Scale (GDS-15) score ≥5 or Pittsburgh Sleep Quality Index (PSQI) score ≥5.
    5. Clear consciousness and able to communicate in Mandarin or Taiwanese.

Exclusion Criteria:

  1. Severe hearing or visual impairments.
  2. Diagnosed with severe psychiatric disorders or dementia.
  3. Unable to participate in group activities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Behavioral: Music Activity Program
Participants in the experimental group will receive the standard day care center activities plus a music activity intervention. The music activity consists of pre-recorded video sessions conducted twice a week, each lasting one hour, for a total duration of 8 weeks.
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geriatric Depression Scale-15 (GDS-15)
Time Frame: At baseline, week 4, and week 8
The Geriatric Depression Scale-15 (GDS-15) is a self-report questionnaire used to assess depressive symptoms in older adults. It consists of 15 yes/no questions. Total scores range from 0 to 15, with higher scores indicating more severe depressive symptoms. A score of ≥5 is suggestive of depression. The scale is widely used and validated for older populations.
At baseline, week 4, and week 8
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At baseline, week 4, and week 8
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month interval. It includes 19 items generating 7 component scores (e.g., sleep latency, sleep duration), which are summed to yield a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. A global score >5 suggests significant sleep disturbances.
At baseline, week 4, and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Chung Hsing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 22, 2025

First Submitted That Met QC Criteria

July 1, 2025

First Posted (Actual)

July 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-ER-114-152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data due to privacy considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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