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

Официальное название

Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients: A Randomised Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Hamilton Depression Rating Scale (HAM-D) [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Hamilton Anxiety Rating Scale (HAM-A) [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Datong Maternal and Child Health Hospital (formerly Datong First People's Hospital), Shanx — Shanxi

Публикации

• 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. PMID 29144545
• 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
• 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 PMID 29477251
• 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

Идентификаторы

NCT: NCT07653113 · Chinese 5 Elements

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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