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

14. juni 2026 opdateret af: University of Malaya

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

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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shanxi
      • Shanxi, Shanxi, Kina, 037010
        • Datong Maternal and Child Health Hospital (formerly Datong First People's Hospital), Shanxi, China

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: pharmacotherapy-only
received standard antidepressant pharmacotherapy once daily for four weeks. Medication classes included SSRIs, SNRIs, benzodiazepines, and other antidepressants.
Andet: 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.
Aktiv komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hamilton Depression Rating Scale (HAM-D)
Tidsramme: 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.
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hamilton Anxiety Rating Scale (HAM-A)
Tidsramme: 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.
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaya

Efterforskere

  • Studiestol: Wen Fen Beh, PhD, University of Malaya

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

5. juni 2026

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

31. august 2026

Datoer for studieregistrering

Først indsendt

7. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Chinese 5 Elements

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Confidential until the journal is published.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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