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Clinical Trials in China / NCT07653113
Enrolling by invitation Not applicable

Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients

NCT07653113 · tracked via the Priya Life Science China tracker
Sponsor
University of Malaya
Phase
Not applicable
Started
2026-06-05
Last updated
2026-06-17

Condition(s) studied

Depressive DisorderAnxietyRandomised Controlled Trial

Investigational drug(s) / intervention(s)

Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy groupResonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group

Resonance-Based Chinese Five-Element Music Intervention(RFEMI) plus pharmacotherapy group: 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 group: received standard pharmacotherapy plus RFEMI. RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery.

Study 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. 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
44 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Hamilton Depression Rating Scale (HAM-D) — 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.

Trial sites (1)

FacilityCityRegionStatus
Datong Maternal and Child Health Hospital (formerly Datong First People's Hospital), Shanxi, China Shanxi Shanxi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07653113 on ClinicalTrials.gov ↗ ← All trials in China