DepressionNCT07049445
Effect of Music Activities on Depression and Sleep Quality in Frail Older Adults
A study testing Music Activity Program in people with Depression and Sleep Quality, run by National Chung Hsing University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Sleep Quality, Frailty
- What is being tested?
- Music Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe hearing or visual impairments.
- Diagnosed with severe psychiatric disorders or dementia.
- Unable to participate in group activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
huajiale Day Care Center
Taipei
shih che Chen, +886 975123123, a915633322@gmail.com
About this study
Official title: 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.
- Conditions
- Depression, Sleep Quality, Frailty
- Being tested
- Music Activity Program
- Medical subject headings
- Depression, Sleep Initiation and Maintenance Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Activity ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Behavioral: Music Activity Program |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline, week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Chung Hsing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Te Chen, National Chung Hsing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049445
- Sponsor's protocol ID
- B-ER-114-152
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data due to privacy considerations.
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 23639952Chen 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 20171456Chen 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 33880759Chen 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 30991156Chen 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 38470609Chan 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 20688261Cervellin 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 21767754Buysse 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 2748771Bilotta 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Music Activities on Depression and Sleep Quality in Frail Older Adults
- ClinicalTrials.gov ID
- NCT07049445
- Acronym / sponsor ID
- B-ER-114-152
- Conditions
- Depression, Sleep Quality, Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Chung Hsing UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Music Activity Program |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (3 listed)
- Severe hearing or visual impairments.
- Diagnosed with severe psychiatric disorders or dementia.
- Unable to participate in group activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Activity ProgramParticipants 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. | Behavioural | Experimental Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 23639952Chu 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.
- Background: PubMed 20171456Chen 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.
- Background: PubMed 33880759Chen 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.
- Background: PubMed 30991156Chen 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.
- Background: PubMed 38470609Chen 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.
- Background: PubMed 20688261Chan 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.
- Background: PubMed 21767754Cervellin 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 21871675Bilotta 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.
- Individual participant dataSharing planned: No. No plan to share individual participant data due to privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Activity Program in people with Depression and Sleep Quality, run by National Chung Hsing University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Te Chen (04 2284 0360-813, a0911395524@dragon.nchu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Depression Scale-15 (GDS-15) (time frame: At baseline, week 4, and week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07049445, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.