Depressive symptom is a common symptom that can be present in various psychiatric conditions, including depression and bipolar disorder. If left untreated, moderate to severe depressive symptoms can lead to serious health complications and are closely linked with suicide. Music therapy (MT)interventions have emerged as an important non-pharmacological approach to treating psychiatric and behavioral disorders, and have been observed to effectively alleviate depressive symptoms. Through its impact on the cerebral cortex, hypothalamus, and limbic system, music helps to regulate an individual's psychological state and can alleviate depressive symptoms. This study utilized a randomized clinical trial design involving two groups: the MT group and the control group, both of which exhibited depressive symptoms. The MT group received MT in addition to routine clinical treatment, while the control group received only routine clinical treatment. The objective of this study was to demonstrate that MT is an effective intervention for alleviating depressive symptoms and to elucidate the neurobiological mechanisms of MT.
This study is a double-blind randomized controlled trial aimed at evaluating the effectiveness of MT compared to a control group for major depressive disorder. Participants will be randomly assigned in a 1:1 ratio to the MT group or control group. All participants will receive 12 sessions (3 sessions per week), each lasting 30 minutes, over a 4-week period. The MT group will receive music therapy during the first 4 weeks, while the control group will receive music therapy during the subsequent 4 weeks (weeks 5-8). Prior to the start of the study (baseline) and after the 4-week intervention, both groups will undergo symptom assessments and brain imaging (MRI) to collect data. The MT intervention consists of three stages, each with a specific focus: 1) physical and mental relaxation, which involves learning relaxation techniques from breathing to muscle relaxation; 2) nature imagination, which includes guided music imagery; and 3) internal self-exploration, which involves identifying positive experiences and potential resources for psychological intervention. The study aims to: 1) assess the clinical efficacy of MT in reducing depressive symptoms, and 2) examine possible biological mechanisms underlying the effectiveness of MT through multidimensional analysis of neuroimaging data and acoustic feature alterations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The clinical symptoms will be evaluated before and after MT intervention.
Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The acoustic features will be evaluated before and after MT intervention.
Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals. The neuroimaging features will be evaluated before and after MT intervention.
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at week 4.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.
Time frame: Baseline and week 4
Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 4
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 7 or higher indicate mild, moderate, severe, or very severe depression.
Time frame: Baseline and week 4
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) at week 4.
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Time frame: Baseline and week 4
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at week 4
MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.
Time frame: Baseline and week 4
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at week 4.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.
Time frame: Baseline and week 4
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4.
The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.
Time frame: Baseline and week 4
Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4
The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).
Time frame: Baseline and week 4
Change from baseline in the amplitude of low-frequency fluctuation (ALFF) values measured by resting-state functional magnetic resonance imaging (fMRI) at week 4
Participants will undergo fMRI scans prior to beginning music treatment (baseline) and after completing music treatment (week 4). ALFF is a fMRI indicator that reflects the spontaneous neural activity. After data acquisition, whole-brain voxel-wise analysis of ALFF values will be performed to detect the change from baseline in brain functional activity at baseline and week 4.
Time frame: Baseline and week 4
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