Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Mental Health Center
About this trial
The goal of this clinical trial is to learn if Five-Elements Music Therapy works to treat depression disorder. It will also learn about the mechanism of action of Five-Elements Music Therapy of Traditional Chinese Medicine (TCM) for depression disorder. The main questions it aims to answer is: Can Five-Elements Music Therapy, primarily using Gong-mode and Zhi-mode tones, improve Hamilton Depression Rating Scale (HAMD) scale scores in patients with depression disorder by regulating prefrontal cortex function?
Researchers will compare customized five-element music 1 (featuring Gong-mode and Zhi-mode as the predominant tones) to customized five-element music 2 (featuring Shang-mode and Yu-mode as the predominant tones, with identical rhythm and pitch to music 1), while simultaneously observing electroencephalogram (EEG), eye movement, and pulse diagnostic data from a healthy control group, to see if customized five-element music 1 featuring Gong-mode and Zhi-mode as the predominant tones can significantly improve depressive states in patients with depressive disorder.
Participants will:
1. Undergo Five-Element Music 1 or Five-Element Music 2 therapy twice daily for 4 weeks (28 days), with each session consisting of 30 minutes of music listening followed by 10 minutes of rest. 2. Concurrently receive antidepressant therapy with fluoxetine hydrochloride. 3. Undergo relevant examinations once every two weeks and record their levels of depression and anxiety (Hamilton Depression Rating Scale (HAMD) \& Hamilton Anxiety Rating Scale (HAMA)). 4. Undergo and record their post-intervention electroencephalogram (EEG), eye movement, and pulse characteristics after the 4-week period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Meet the diagnostic criteria for depressive episodes of ICD-10;
Hamilton Depression Scale -17 items score ≥14 points;
The diagnosis should be confirmed by at least two physicians with the title of attending physician or above.
Have sufficient visual and auditory levels to ensure that the necessary checks and experiments for the research can be completed;
Disqualifiers
There are serious heart, liver and kidney diseases, organic brain diseases, serious cardiovascular diseases, tumors, blood history, rheumatism, malnutrition and neurodegenerative diseases, etc.
Depressive episodes secondary to other mental or physical illnesses;
There is a history of abuse of tobacco, alcohol and other psychoactive substances;
Those with comorbidities of other mental disorders;
Trial design
Design model
Parallel
Treatments tested in this trial
Five-Element Music 1 combined with antidepressant medication
Combination productThe self-composed musical piece Five Elements Music 1 was selected to intervene with the patients, with the songs primarily based on the Gong tone and Zhi tone in traditional Chinese music. On this basis, the intervention was combined with fluoxetine hydrochloride treatment
Five-Element Music 2 combined with antidepressant medication
Combination productThe self-composed musical piece Five Elements Music 2 was selected to intervene with the patients, with the songs primarily based on the Shang mode (A) and Yu (E) mode in traditional Chinese music. On this basis, the intervention was combined with fluoxetine hydrochloride treatment
No Intervention: Observational Cohort
Other interventionNo intervention will be applied to healthy people
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Five-Element Music 1 Primarily in Gong and Zhi modes combined with antidepressant medicationExperimental treatment 1 intervention
Group B: Five-Element Music 2 Primarily in Shang and Yu modes combined with antidepressant medicationActive comparator 1 intervention
Group C: health controlOther 1 intervention
Trial outcomes
Primary outcomes
1
The reduction rate of Hamilton Depression Rating Scale-17（HAMD-17） after treatment
Reduction rate = (Baseline HAMD-17 score - Week 4 HAMD-17 score) / Baseline HAMD-17 score. A HAMD-17 response rate ≥50% is defined as an effective treatment
Time frame
From enrollment to the end of the treatment at 4 weeksSecondary outcomes
1
Hamilton Anxiety Rating Scale（HAMA）
HAMA scale is used to assess the severity of anxiety symptoms in patients with neurotic disorders and other conditions. Previous studies have reported good reliability and validity for this scale. According to the evaluation criteria provided by the Chinese Psychiatric Rating Scale Cooperative Group: 1. A total score above 29 indicates severe anxiety; 2. Above 21 indicates definite marked anxiety; 3. Above 14 indicates definite anxiety; 4. Above 7 suggests possible anxiety; 5. Below 7 signifies no anxiety symptoms. Previous studies have commonly used 14 as the cut-off score, with higher total scores indicating more severe anxiety symptoms.
Time frame
From enrollment to the end of treatment at 4 weeks2
Repeatable Battery for the Assessment of Neuropsychological Status（RBANS）
This scale is used to assess participants' cognitive function. It offers advantages in clinical applications including concise administration, user-friendly operation, and sensitive/responsive results. Patients experiencing depressive episodes demonstrate high compliance with completion. The RBANS includes five domain scores: * Immediate Memory: Reflects the participant's ability to retain information immediately after presentation; * Visuospatial/Constructional: Reflects the participant's ability to perceive spatial relationships and accurately reproduce drawings; * Language: Reflects the participant's verbal fluency and naming abilities; ④ Attention: Reflects the participant's working memory capacity and ability to access short-term memory stores through visual and verbal modalities; ⑤ Delayed Memory: Reflects the participant's anterograde memory capacity.
Time frame
From enrollment to the end of treatment at 4 weeks3
Treatment Emergent Symptom Scale（TESS）
Among comparable scales, it provides the most comprehensive item coverage-assessing both common adverse symptoms/signs and multiple laboratory findings. The Treatment Emergent Symptom Scale (TESS) requires clinicians to evaluate each symptom across three dimensions: Severity, Relationship to Intervention, and Action Taken. Severity is rated on a 0-4 scale: 0 = Absence of the symptom; 1. = Occasional presence of the symptom; 2. = Mild severity, no impairment to routine functioning; 3. = Moderate severity, producing some impairment to routine functioning; 4. = Severe, causing significant impairment or disability to routine functioning.
Time frame
From enrollment to the end of treatment at 4 weeks4
Event-related potential（ERP）
ERP data acquisition in the laboratory was performed using the Curry system with an internationally standard 64-channel electrode cap. The right mastoid (M2) served as the reference electrode. Electrodes were attached above and below the left orbit to record vertical electro-oculogram (VEOG), and electrodes were placed at the outer canthi of both eyes to record horizontal electro-oculogram (HEOG). ERP data acquisition commenced once all electrode impedances were reduced below 5 kΩ. For ERP data analysis, the recorded signals were band-pass filtered between 0.1 Hz and 30 Hz and continuously sampled at 500 Hz. The data were segmented into epochs of 1700 ms duration, including a 200-ms pre-stimulus baseline period and a 1500-ms post-stimulus period. The peak amplitudes of ERP components were calculated separately for each experimental group.
Time frame
From enrollment to the end of treatment at 4 weeksLocations
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Source ClinicalTrials.gov
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