Anxiety, Depressive Disorder, Randomised Controlled Trial
Conditions
Keywords
Depressive Disorders, Anxiety, Chinese Five-Element Music, Male Inpatients, Randomised Controlled Trial
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.
Detailed description
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.
Interventions
OTHERResonance-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.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) | 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. |
Countries
China
Contacts
STUDY_CHAIRWen Fen Beh, PhD
University of Malaya
Outcome results
None listed