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

NCT07653113 | Enrolling By Invitation DMC

• 1 other identifier: Chinese 5 Elements
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder; Anxiety; Randomised Controlled Trial

Keywords

Depressive Disorders; Anxiety; Chinese Five-Element Music; Male Inpatients; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAM-A)

  3 months

Study Arms (2)

pharmacotherapy-only

PLACEBO COMPARATOR

received standard antidepressant pharmacotherapy once daily for four weeks. Medication classes included SSRIs, SNRIs, benzodiazepines, and other antidepressants.

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.

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

Interventions

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.

Conventional music plus pharmacotherapy group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

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

Shanxi, Shanxi, 037010, China

Location

Related Publications (5)

• 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

  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.

  PMID: 29144545 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.

  PMID: 36535295 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.

  PMID: 29477251 BACKGROUND

• 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.

  PMID: 30396512 RESULT

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Wen Fen Beh, PhD

  University of Malaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 17, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)