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NCT Number: NCT07049445

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Music Activity Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Te Chen

CONTACT

[email protected]

04 2284 0360-813

Sponsors and collaborators

Lead sponsor

National Chung Hsing University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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