DepressionNCT06472154
The Effect of Chinese Five-element Music
A study testing Experimental in people with Depression and Anxiety, run by University of Malaya at 1 site in China.
Trial summary
Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants' HAM-D scores should be greater than 8 and HAM-A scores should be greater than 7.
- Patients should be older than or equal to 60 years of age.
- Patients have no other psychiatric disorders and are not taking psychotropic medication to improve symptoms.
- They participate voluntarily in this experiment.
Who cannot join
- People who did not meet the diagnostic criteria. .
- Who have participated in other clinical trials within the last four weeks.
- Graduates of music studies or workers who are involved in music.
- People suffering from hearing impairment or other severe chronic psychiatric disorders.
- People who are under psychotropic medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: he Effect of Chinese Five-element Music Based on Midnight-noon Ebb-flow Theory on Depression and Anxiety Among Older Adults
Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults.
Read the detailed description
Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults. This study intervened in music-based intervention for 86 older adults with depression and anxiety, and divided the 86 subjects into an experimental group (with Chinese five elements music based on midnight-noon ebb-flow theory) and a control group (with Chinese five elements music). This study used the Hamilton Depression Scale, Hamilton Anxiety Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire as assessment instruments after the intervention. According to the evaluation results, it was found that compared with traditional Chinese five elements music, the intervention of Chinese five elements music with midnight-noon ebb-flow theory is more effective in alleviating depression in the older adults. This study will provide a scientific basis for further study of the timing mechanism of the five elements theory and further advance the benefits of Traditional Chinese Time Medicine.
- Conditions
- Depression, Anxiety
- Being tested
- Experimental, Control
- Keywords
- Depression, Anxiety, older adults, Chinese five elements music-based intervention, Midnight-noon ebb-flow
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
The experimental group intervened based on the midnight-noon ebb-flow theory, listening to music corresponding to the five organs at different time periods.
ControlOther
The control group listened to Chinese five elements music pieces from 13:00 to 18:00 p.m., each music piece for within 30 minutes for, 5 days per week, 4 weeks for a cycle, 3 cycles in total.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | with Chinese five elements music based on midnight-noon ebb-flow theory Receives: Other: Experimental |
| control group | Placebo comparator | with Chinese five elements music Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D)
The 17 items of the original HAM-D measure the degree of depression, feelings of guilt, suicidal thoughts, insomnia, ability to work and be active, language and cognitive retardation, agitation, anxiety (psychological and somatic), gastrointestinal, genital or general symptoms, hypochondriasis, weight loss and awareness of illness. Similar to the HAM-A, more than half of the items have values between 0 and 4. All other values are between 0 and 2, with the exception of weight loss (0-3). Individuals who score between 0 and 7 are considered normal or in remission. According to UF Health (2011b), a total score of more than 20 is considered an indication of at least moderate to severe depression
Measured: 12 months
Hamilton Anxiety Rating Scale (HAM-A)
The 14 items of the HAM-A relate to psychological and somatic symptoms such as tension, insomnia, nervousness, depression and somatic symptoms. They also cover behavioral problems identified during the interview, such as restlessness or fidgeting, as well as problems with the respiratory tract, gastrointestinal tract, cardiovascular system, genitourinary system or autonomic system. With a total score of 0-56, each element is rated on a scale from 0 (not present) to 4 (extremely severe). According to UF Health (2011a), individuals who score between 0 and 7 are considered normal or in remission, a total score of less than 17 more than 7 indicates low anxiety, 18-24 indicates mild to moderate anxiety, and 25-30 indicates moderate to severe anxiety.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study intervened in music-based intervention for 86 older adults with depression and anxiety, and divided the 86 subjects into an experimental group (with Chinese five elements music based on midnight-noon ebb-flow theory) and a control group (with Chinese five elements music).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wen fen beh, Phd, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472154
- Sponsor's protocol ID
- Depression and Anxiety
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Beh WF, Wang IT, Wu Y. The effect of Chinese 5-element music with midnight-noon ebb-flow theory on depression, anxiety, quality of life satisfaction among older adults: A randomized controlled trial. Medicine (Baltimore). 2025 Jan 3;104(1):e41224. doi: 10.1097/MD.0000000000041224.
PubMed 40184117
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Effect of Chinese Five-element Music Based on Midnight-noon Ebb-flow Theory on Depression and Anxiety Among Older Adults
- ClinicalTrials.gov ID
- NCT06472154
- Acronym / sponsor ID
- Depression and Anxiety
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, older adults, Chinese five elements music-based intervention, Midnight-noon ebb-flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Jun 2024 (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.
Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults.
Detailed description
Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults. This study intervened in music-based intervention for 86 older adults with depression and anxiety, and divided the 86 subjects into an experimental group (with Chinese five elements music based on midnight-noon ebb-flow theory) and a control group (with Chinese five elements music). This study used the Hamilton Depression Scale, Hamilton Anxiety Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire as assessment instruments after the intervention. According to the evaluation results, it was found that compared with traditional Chinese five elements music, the intervention of Chinese five elements music with midnight-noon ebb-flow theory is more effective in alleviating depression in the older adults. This study will provide a scientific basis for further study of the timing mechanism of the five elements theory and further advance the benefits of Traditional Chinese Time Medicine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study intervened in music-based intervention for 86 older adults with depression and anxiety, and divided the 86 subjects into an experimental group (with Chinese five elements music based on midnight-noon ebb-flow theory) and a control group (with Chinese five elements music).
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Experimentalwith Chinese five elements music based on midnight-noon ebb-flow theory |
| control group | Placebo comparator | Other: Controlwith Chinese five elements music |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants' HAM-D scores should be greater than 8 and HAM-A scores should be greater than 7.
- Patients should be older than or equal to 60 years of age.
- Patients have no other psychiatric disorders and are not taking psychotropic medication to improve symptoms.
- They participate voluntarily in this experiment.
Key exclusion criteria (5 listed)
- People who did not meet the diagnostic criteria. .
- Who have participated in other clinical trials within the last four weeks.
- Graduates of music studies or workers who are involved in music.
- People suffering from hearing impairment or other severe chronic psychiatric disorders.
- People who are under psychotropic medication.
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 |
|---|---|---|
| ExperimentalThe experimental group intervened based on the midnight-noon ebb-flow theory, listening to music corresponding to the five organs at different time periods. | Other | experimental group |
| ControlThe control group listened to Chinese five elements music pieces from 13:00 to 18:00 p.m., each music piece for within 30 minutes for, 5 days per week, 4 weeks for a cycle, 3 cycles in total. | Other | control group |
Primary outcome
Hamilton Depression Rating Scale (HAM-D)
Time frame: 12 months
The 17 items of the original HAM-D measure the degree of depression, feelings of guilt, suicidal thoughts, insomnia, ability to work and be active, language and cognitive retardation, agitation, anxiety (psychological and somatic), gastrointestinal, genital or general symptoms, hypochondriasis, weight loss and awareness of illness. Similar to the HAM-A, more than half of the items have values between 0 and 4. All other values are between 0 and 2, with the exception of weight loss (0-3). Individuals who score between 0 and 7 are considered normal or in remission. According to UF Health (2011b), a total score of more than 20 is considered an indication of at least moderate to severe depression
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 12 months
The 14 items of the HAM-A relate to psychological and somatic symptoms such as tension, insomnia, nervousness, depression and somatic symptoms. They also cover behavioral problems identified during the interview, such as restlessness or fidgeting, as well as problems with the respiratory tract, gastrointestinal tract, cardiovascular system, genitourinary system or autonomic system. With a total score of 0-56, each element is rated on a scale from 0 (not present) to 4 (extremely severe). According to UF Health (2011a), individuals who score between 0 and 7 are considered normal or in remission, a total score of less than 17 more than 7 indicates low anxiety, 18-24 indicates mild to moderate anxiety, and 25-30 indicates moderate to severe anxiety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 40184117Li J, Beh WF, Wang IT, Wu Y. The effect of Chinese 5-element music with midnight-noon ebb-flow theory on depression, anxiety, quality of life satisfaction among older adults: A randomized controlled trial. Medicine (Baltimore). 2025 Jan 3;104(1):e41224. doi: 10.1097/MD.0000000000041224.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
wen fen beh, Phd principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Depression and Anxiety, run by University of Malaya at 1 site in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jun 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D) (time frame: 12 months). 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 NCT06472154, which also lists 1 linked publication.
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 24 Jun 2024.