Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients (RCFMI)
Adjunctive Resonance-Based Chinese Five-Element Music Intervention for Depressive Disorders and Anxiety Symptoms in Male Inpatients: A Randomised Controlled Trial
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Shanxi
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Shanxi、Shanxi、中国、037010
- Datong Maternal and Child Health Hospital (formerly Datong First People's Hospital), Shanxi, China
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：pharmacotherapy-only
received standard antidepressant pharmacotherapy once daily for four weeks.
Medication classes included SSRIs, SNRIs, benzodiazepines, and other antidepressants.
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received standard pharmacotherapy plus RFEMI.
RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery.
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有源比较器：Conventional music plus pharmacotherapy group
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.
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received standard pharmacotherapy plus RFEMI.
RFEMI was based on TCM Five-Element theory, zang-fu emotion correspondence, and resonance-informed acoustic delivery.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hamilton Depression Rating Scale (HAM-D)
大体时间：3 months
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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.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hamilton Anxiety Rating Scale (HAM-A)
大体时间：3 months
|
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.
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3 months
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合作者和调查者
调查人员
- 学习椅：Wen Fen Beh, PhD、University of Malaya
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
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首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Chinese 5 Elements
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IPD 计划说明
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