Depressive DisorderRCFMINCT07653113
Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients
A study testing Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group in people with Depressive Disorder and Anxiety, run by University of Malaya at 1 site in China.
Trial summary
This randomized controlled trial will evaluate the effectiveness of Resonance-Based Chinese Five-Element Music Intervention (RFEMI) as an adjunct to pharmacotherapy in male inpatients with depressive disorders. Read more about this study
- Who is it for?
- Ages 18 to 44 years, men only
- Conditions the study is for
- Depressive Disorder, Anxiety, Randomised Controlled Trial
- What is being tested?
- Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2026to 31 Aug 2026
- 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 18 to 44 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- meeting both the ICD-11 diagnostic criteria for depressive episode or recurrent depressive disorder and the TCM diagnostic criteria for Yu disease
- diagnosis confirmed by two senior clinical physicians
- planned inpatient stay longer than six weeks
- no antidepressant medication in the previous six months and no music therapy in the previous year
- male sex, age 18-44 years, junior secondary education or above, clear consciousness, and ability to communicate effectively
- no other major physical disease or mental disorder
- voluntary written informed consent and complete clinical records.
Who cannot join
- depression due to organic mental disorder, psychoactive substance use, or non-addictive substance use
- serious organic disease or unstable vital signs
- suicidal or violent tendency, or refusal to cooperate with treatment
- hearing impairment
- inability to follow the intervention protocol
- incomplete scale data or clinical records.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Datong Maternal and Child Health Hospital (formerly Datong First People's Hospital), Shanxi, China
Shanxi, Shanxi, 037010
About this study
Official title: Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients: A Randomised Controlled Trial
This randomized controlled trial will evaluate the effectiveness of Resonance-Based Chinese Five-Element Music Intervention (RFEMI) as an adjunct to pharmacotherapy in male inpatients with depressive disorders. Based on Traditional Chinese Medicine Five-Element tone theory and resonance-informed acoustic delivery, RFEMI will be compared with conventional music intervention plus pharmacotherapy and pharmacotherapy alone over a four-week intervention period. The study will assess changes in depressive and anxiety symptoms, TCM syndrome characteristics, neuroendocrine biomarkers, cerebral oxygenation, and autonomic nervous system regulation.
Read the detailed description
Depressive disorders are among the most prevalent psychiatric conditions worldwide and are frequently accompanied by anxiety symptoms, chronic stress, and disturbances in autonomic nervous system regulation. Although pharmacotherapy remains a standard treatment, interest has increased in complementary non-pharmacological interventions that may enhance clinical outcomes and improve patient well-being.
Resonance-Based Chinese Five-Element Music Intervention (RFEMI) is a structured receptive music intervention developed from Traditional Chinese Medicine (TCM) Five-Element tone theory and resonance-informed acoustic principles. The intervention will aim to provide individualized auditory stimulation through carefully selected musical materials aligned with TCM syndrome differentiation.
Participants will be randomly assigned to one of three groups: (1) pharmacotherapy only, (2) conventional music intervention combined with pharmacotherapy, or (3) RFEMI combined with pharmacotherapy. The intervention period will last four weeks. All participants will continue receiving routine psychiatric care and prescribed antidepressant medications throughout the study period.
The study will investigate whether RFEMI, when used as an adjunctive intervention, can influence psychological symptoms, TCM syndrome manifestations, neuroendocrine biomarkers, cerebral oxygenation, and autonomic nervous system activity in hospitalized patients with depressive disorders.
- Conditions
- Depressive Disorder, Anxiety, Randomised Controlled Trial
- Being tested
- Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group
- Keywords
- Depressive Disorders, Anxiety, Chinese Five-Element Music, Male Inpatients, Randomised Controlled Trial
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy groupOther
received standard pharmacotherapy plus RFEMI. RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery.
Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy groupOther
received standard pharmacotherapy plus RFEMI. RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery.
| Study group | Role | What they receive |
|---|---|---|
| pharmacotherapy-only | Placebo comparator | received standard antidepressant pharmacotherapy once daily for four weeks. Medication classes included SSRIs, SNRIs, benzodiazepines, and other antidepressants. Receives: Other: Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group |
| Conventional music plus pharmacotherapy group | Active comparator | received standard pharmacotherapy plus receptive music listening. SThe music was comfortable, slow, and stable in rhythm, and was selected as general relaxing music rather than Five-Element music. Receives: Other: Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D)
A widely used clinician-administered questionnaire used to assess the severity of depressive symptoms and monitor changes in patients diagnosed with depression. The lowest possible score is 0 (indicating the absence of depressive symptoms), and the highest score on the most commonly used 17-item scale is 52.
Measured: 3 months
Secondary outcomes (1)
Hamilton Anxiety Rating Scale (HAM-A)
one of the first rating scales developed to measure the severity of anxiety symptoms. Its lowest possible score is 0 (no anxiety present), and its highest possible score is 56.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start5 Jun 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Fen Beh, PhD, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653113
- Sponsor's protocol ID
- Chinese 5 Elements
- Acronym
- RCFMI
- Status last verified
- May 2026
- First submitted
- 7 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential until the journal is published.
Publications
Windle E, Hickling LM, Jayacodi S, Carr C. Patient experiences in the Synchrony group-music-therapy trial for long-term depression. Arts Psychother. 2020;67:101580. doi:10.1016/j.aip.2019.101580
Aalbers S, Fusar-Poli L, Freeman RE, Spreen M, Ket JC, Vink AC, Maratos A, Crawford M, Chen XJ, Gold C. Music therapy for depression. Cochrane Database Syst Rev. 2017 Nov 16;11(11):CD004517. doi: 10.1002/14651858.CD004517.pub3.
PubMed 29144545Marwaha S, Palmer E, Suppes T, Cons E, Young AH, Upthegrove R. Novel and emerging treatments for major depression. Lancet. 2023 Jan 14;401(10371):141-153. doi: 10.1016/S0140-6736(22)02080-3. Epub 2022 Dec 16.
PubMed 36535295Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, Leucht S, Ruhe HG, Turner EH, Higgins JPT, Egger M, Takeshima N, Hayasaka Y, Imai H, Shinohara K, Tajika A, Ioannidis JPA, Geddes JR. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018 Apr 7;391(10128):1357-1366. doi: 10.1016/S0140-6736(17)32802-7. Epub 2018 Feb 21.
PubMed 29477251Malhi GS, Mann JJ. Depression. Lancet. 2018 Nov 24;392(10161):2299-2312. doi: 10.1016/S0140-6736(18)31948-2. Epub 2018 Nov 2.
PubMed 30396512
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07653113
- Acronym / sponsor ID
- RCFMI / Chinese 5 Elements
- Conditions
- Depressive Disorder, Anxiety, Randomised Controlled Trial
- Keywords
- Depressive Disorders, Anxiety, Chinese Five-Element Music, Male Inpatients, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 17 Jun 2026 (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 randomized controlled trial will evaluate the effectiveness of Resonance-Based Chinese Five-Element Music Intervention (RFEMI) as an adjunct to pharmacotherapy in male inpatients with depressive disorders. Based on Traditional Chinese Medicine Five-Element tone theory and resonance-informed acoustic delivery, RFEMI will be compared with conventional music intervention plus pharmacotherapy and pharmacotherapy alone over a four-week intervention period. The study will assess changes in depressive and anxiety symptoms, TCM syndrome characteristics, neuroendocrine biomarkers, cerebral oxygenation, and autonomic nervous system regulation.
Detailed description
Depressive disorders are among the most prevalent psychiatric conditions worldwide and are frequently accompanied by anxiety symptoms, chronic stress, and disturbances in autonomic nervous system regulation. Although pharmacotherapy remains a standard treatment, interest has increased in complementary non-pharmacological interventions that may enhance clinical outcomes and improve patient well-being.
Resonance-Based Chinese Five-Element Music Intervention (RFEMI) is a structured receptive music intervention developed from Traditional Chinese Medicine (TCM) Five-Element tone theory and resonance-informed acoustic principles. The intervention will aim to provide individualized auditory stimulation through carefully selected musical materials aligned with TCM syndrome differentiation.
Participants will be randomly assigned to one of three groups: (1) pharmacotherapy only, (2) conventional music intervention combined with pharmacotherapy, or (3) RFEMI combined with pharmacotherapy. The intervention period will last four weeks. All participants will continue receiving routine psychiatric care and prescribed antidepressant medications throughout the study period.
The study will investigate whether RFEMI, when used as an adjunctive intervention, can influence psychological symptoms, TCM syndrome manifestations, neuroendocrine biomarkers, cerebral oxygenation, and autonomic nervous system activity in hospitalized patients with depressive disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmacotherapy-only | Placebo comparator | Other: Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy groupreceived standard antidepressant pharmacotherapy once daily for four weeks. Medication classes included SSRIs, SNRIs, benzodiazepines, and other antidepressants. |
| Conventional music plus pharmacotherapy group | Active comparator | Other: Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy groupreceived standard pharmacotherapy plus receptive music listening. SThe music was comfortable, slow, and stable in rhythm, and was selected as general relaxing music rather than Five-Element music. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- meeting both the ICD-11 diagnostic criteria for depressive episode or recurrent depressive disorder and the TCM diagnostic criteria for Yu disease
- diagnosis confirmed by two senior clinical physicians
- planned inpatient stay longer than six weeks
- no antidepressant medication in the previous six months and no music therapy in the previous year
- male sex, age 18-44 years, junior secondary education or above, clear consciousness, and ability to communicate effectively
Key exclusion criteria (6 listed)
- depression due to organic mental disorder, psychoactive substance use, or non-addictive substance use
- serious organic disease or unstable vital signs
- suicidal or violent tendency, or refusal to cooperate with treatment
- hearing impairment
- inability to follow the intervention protocol
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 |
|---|---|---|
| Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy groupreceived standard pharmacotherapy plus RFEMI. RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery. | Other | Conventional music plus pharmacotherapy group |
| Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy groupreceived standard pharmacotherapy plus RFEMI. RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery. | Other | pharmacotherapy-only |
Primary outcome
Hamilton Depression Rating Scale (HAM-D)
Time frame: 3 months
A widely used clinician-administered questionnaire used to assess the severity of depressive symptoms and monitor changes in patients diagnosed with depression. The lowest possible score is 0 (indicating the absence of depressive symptoms), and the highest score on the most commonly used 17-item scale is 52.
1 secondary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 3 months
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 17 Jun 2026.
- BackgroundWindle E, Hickling LM, Jayacodi S, Carr C. Patient experiences in the Synchrony group-music-therapy trial for long-term depression. Arts Psychother. 2020;67:101580. doi:10.1016/j.aip.2019.101580
- Background: PubMed 29144545Aalbers S, Fusar-Poli L, Freeman RE, Spreen M, Ket JC, Vink AC, Maratos A, Crawford M, Chen XJ, Gold C. Music therapy for depression. Cochrane Database Syst Rev. 2017 Nov 16;11(11):CD004517. doi: 10.1002/14651858.CD004517.pub3.
- Background: PubMed 36535295Marwaha S, Palmer E, Suppes T, Cons E, Young AH, Upthegrove R. Novel and emerging treatments for major depression. Lancet. 2023 Jan 14;401(10371):141-153. doi: 10.1016/S0140-6736(22)02080-3. Epub 2022 Dec 16.
- Background: PubMed 29477251Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, Leucht S, Ruhe HG, Turner EH, Higgins JPT, Egger M, Takeshima N, Hayasaka Y, Imai H, Shinohara K, Tajika A, Ioannidis JPA, Geddes JR. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018 Apr 7;391(10128):1357-1366. doi: 10.1016/S0140-6736(17)32802-7. Epub 2018 Feb 21.
- Results publication: PubMed 30396512Malhi GS, Mann JJ. Depression. Lancet. 2018 Nov 24;392(10161):2299-2312. doi: 10.1016/S0140-6736(18)31948-2. Epub 2018 Nov 2.
- Individual participant dataSharing planned: No. Confidential until the journal is published.
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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.
Wen Fen Beh, PhD study chair
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 Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group in people with Depressive Disorder 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 7 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. 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?
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?
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: 3 months). 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 NCT07653113, which also lists 5 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 17 Jun 2026.