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

NCT07049445 | Not Yet Recruiting

• 1 other identifier: B-ER-114-152
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Sleep Quality; Frailty

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline, week 4, and week 8

• 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.

  At baseline, week 4, and week 8

Study Arms (2)

Experimental Group

EXPERIMENTAL

Behavioral: Music Activity Program

Control Group

NO INTERVENTION

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Chung Hsing University: lead

Study Sites (1)

huajiale Day Care Center

Taipei, Taiwan

Location

Related Publications (9)

• 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.

  PMID: 23639952 BACKGROUND

• 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.

  PMID: 20171456 BACKGROUND

• 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.

  PMID: 33880759 BACKGROUND

• 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.

  PMID: 30991156 BACKGROUND

• 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.

  PMID: 38470609 BACKGROUND

• 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.

  PMID: 20688261 BACKGROUND

• 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.

  PMID: 21767754 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 21871675 BACKGROUND

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders; Frailty

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chia-Te Chen

CONTACT

04 2284 0360-813; a0911395524@dragon.nchu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)