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Not yet recruitingNCT07049445Updated Jul 3, 2025

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

An interventional study of Music Activity Program in Depression, Sleep Quality and Frailty, sponsored by National Chung Hsing University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by National Chung Hsing University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study summary

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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Conditions studied

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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 80 is close to the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

National Chung Hsing University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    Behavioral: Music Activity Program

  • No intervention
    Control Group

Interventions

  • BehavioralMusic 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.

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What researchers measure

Primary outcomes

  1. Geriatric Depression Scale-15 (GDS-15)

    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.

    Time frame: At baseline, week 4, and week 8

  2. Pittsburgh Sleep Quality Index (PSQI)

    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.

    Time frame: At baseline, week 4, and week 8

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Study locations

1 site
  • huajiale Day Care Center
    Taipei, Taiwan
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References and documents

Publications

  • Chu H, Yang CY, Lin Y, Ou KL, Lee TY, O'Brien AP, Chou KR. The impact of group music therapy on depression and cognition in elderly persons with dementia: a randomized controlled study. Biol Res Nurs. 2014 Apr;16(2):209-17. doi: 10.1177/1099800413485410. Epub 2013 May 2. PubMed 23639952 ↗
  • Chen CY, Wu SC, Chen LJ, Lue BH. The prevalence of subjective frailty and factors associated with frailty in Taiwan. Arch Gerontol Geriatr. 2010 Feb;50 Suppl 1:S43-7. doi: 10.1016/S0167-4943(10)70012-1. PubMed 20171456 ↗
  • Chen CT, Tung HH, Fang CJ, Wang JL, Ko NY, Chang YJ, Chen YC. Effect of music therapy on improving sleep quality in older adults: A systematic review and meta-analysis. J Am Geriatr Soc. 2021 Jul;69(7):1925-1932. doi: 10.1111/jgs.17149. Epub 2021 Apr 20. PubMed 33880759 ↗
  • Chen CT, Tung HH, Chen YC, Lee HF, Wang CJ, Lin WH. Depressive symptoms and nutritional status in the frail older adults. Arch Gerontol Geriatr. 2019 Jul-Aug;83:96-100. doi: 10.1016/j.archger.2019.03.023. Epub 2019 Mar 30. PubMed 30991156 ↗
  • Chen CT, Tung HH, Chen CW, Yang YR, Wang JL, Chang CM, Chen YC, Liang SH, Fan CH. Preventing functional decline in hospitalized older adults in medical ward: a best practice implementation project. JBI Evid Implement. 2024 Aug 1;22(3):271-280. doi: 10.1097/XEB.0000000000000411. PubMed 38470609 ↗
  • Chan MF, Chan EA, Mok E. Effects of music on depression and sleep quality in elderly people: A randomised controlled trial. Complement Ther Med. 2010 Jun-Aug;18(3-4):150-9. doi: 10.1016/j.ctim.2010.02.004. PubMed 20688261 ↗
  • Cervellin G, Lippi G. From music-beat to heart-beat: a journey in the complex interactions between music, brain and heart. Eur J Intern Med. 2011 Aug;22(4):371-4. doi: 10.1016/j.ejim.2011.02.019. Epub 2011 Mar 22. PubMed 21767754 ↗
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PubMed 2748771 ↗
  • Bilotta C, Nicolini P, Case A, Pina G, Rossi S, Vergani C. Frailty syndrome diagnosed according to the Study of Osteoporotic Fractures (SOF) criteria and adverse health outcomes among community-dwelling older outpatients in Italy. A one-year prospective cohort study. Arch Gerontol Geriatr. 2012 Mar-Apr;54(2):e23-8. doi: 10.1016/j.archger.2011.06.037. Epub 2011 Aug 25. PubMed 21871675 ↗

Individual participant data

Plan to share: No — No plan to share individual participant data due to privacy considerations.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07049445
Lead sponsor
National Chung Hsing University
Responsible party
Chia-Te Chen (Assistant Professor, National Chung Hsing University) — Principal investigator
First posted
Jul 3, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 3, 2025

Study contacts

Chia-Te Chen
Contact
a0911395524@dragon.nchu.edu.tw
04 2284 0360-813

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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