Effect of Music Therapy in Mental Subhealth (EMTMS)

Jiangsu Province Nanjing Brain Hospital

Status: Enrolling

Conditions: Depression, Anxiety

Treatments: Device: The mini apps named "SOUL GYM" on the Wechat

Study type: Interventional

Funder types: Other

Identifiers

NCT05648539

81725005-4

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16 to 35 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

The clinical response of the music therapy

Experimental group

Description:

To assessthe efficacy of music therapy of MT group compared to Waiting group in mental subhealth.

Treatment:

Device: The mini apps named "SOUL GYM" on the Wechat

The alterations of acoustic features in the music therapy

Experimental group

Description:

To understand the possible biological mechanism underlying the efficacy of music therapy by analyzing alterations of acoustic features.

Treatment:

Device: The mini apps named "SOUL GYM" on the Wechat