Effect of Music Therapy in Mental Subhealth (EMTMS)

Study Overview
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Brief Summary
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Mental health is increasingly at the forefront of concerns, especially since the start of COVID-19 pandemic. However, not all individuals under mental subhealth need pharmaceutical treatment. Music Therapy (MT) can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety. This study adopted randomized clinical trials design, with two groups of MT group and Waiting group both under mental subhealth. The MT group received music therapy and routine activities, while the Waiting group received music therapy after the therapy of MT group. Data collections were performed by trained, certified, and qualified personnel. The study aims to provide that MT is an effective intervention way to alleviate the mental subhealth state in the future.

Detailed Description
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This study is a double-blind randomized controlled trial aiming at assessing the efficacy of MT compared to Waiting group in mental subhealth. Participants will be assigned randomly (1:1) to MT group and Waiting group. All the participants will be treated with 12 sessions (3 sessions per week), 30 minutes each time, and conducted for 4 weeks. The MT group received music therapy between 1st-4th week, and the Waiting group received music therapy between 5th-8th week. Pre-MT (baseline) and post-MT (4th week), two group performed symptom assessment and voice data collection (poetry readings). The MT is mainly divided into three stages, and each stage has a topic. The topic of each stage as follow: ① physical and mental relaxation stage: learning the whole body and mind relaxation mode from breathing to muscle; ② nature imagination stage: guiding music imagination; ③ internal self-exploration: excavating the positive experience and positive potential of the listener and adopting resource orientation for psychological intervention. The purposes of the present study are to: 1) evaluate the clinical response the MT in mental subhealth. 2) further understand the possible biological mechanism underlying the efficacy of MT by analyzing alterations of acoustic features.

Official Title
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Effect of Music Therapy in Mental Subhealth: A Randomized Controlled Trial

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Device: The mini apps named SOUL GYM on the Wechat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A total of > 5 on PHQ-9 or a total of > 5 on GAD-7 Exclusion Criteria: Acute suicidal thoughts, With a severe or potentially confounding psychiatric disorder (e.g. psychosis, substance misuse).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The clinical response of the music therapy<br>To assessthe efficacy of music therapy of MT group compared to Waiting group in mental subhealth. | Device: The mini apps named SOUL GYM on the Wechat<br>* Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety.<br>|
| Experimental: The alterations of acoustic features in the music therapy<br>To understand the possible biological mechanism underlying the efficacy of music therapy by analyzing alterations of acoustic features. | Device: The mini apps named SOUL GYM on the Wechat<br>* Music Therapy can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | Baseline and week 4. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music Therapy, Depression, Anxiety, Acoustic features