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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmacotherapy-only | Placebo Comparator | received standard antidepressant pharmacotherapy once daily for four weeks. Medication classes included SSRIs, SNRIs, benzodiazepines, and other antidepressants. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group | Other | received standard pharmacotherapy plus RFEMI. RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen Fen Beh, PhD | University of Malaya | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Datong Maternal and Child Health Hospital (formerly Datong First People's Hospital), Shanxi, China | Shanxi | Shanxi | 037010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 29144545 | Background | 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. | |
| 36535295 |
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Confidential until the journal is published.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2026 | Jun 5, 2026 |
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| Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group | Other | received standard pharmacotherapy plus RFEMI. RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery. |
|
| Background |
| Marwaha 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. |
| 29477251 | Background | Cipriani 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. |
| 30396512 | Result | Malhi GS, Mann JJ. Depression. Lancet. 2018 Nov 24;392(10161):2299-2312. doi: 10.1016/S0140-6736(18)31948-2. Epub 2018 Nov 2. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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