Effect of Music Therapy in Mental Subhealth (EMTMS)

NCT05648539 | Recruiting

• 1 other identifier: 81725005-4
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety

Keywords

Music Therapy; Depression, Anxiety; Acoustic features

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

The clinical response of the music therapy

EXPERIMENTAL

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

The alterations of acoustic features in the music therapy

EXPERIMENTAL

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

Interventions

The mini apps named "SOUL GYM" on the Wechat DEVICE

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.

The alterations of acoustic features in the music therapy; The clinical response of the music therapy

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A total of \> 5 on PHQ-9 or a total of \> 5 on GAD-7

You may not qualify if:

• Acute suicidal thoughts, With a severe or potentially confounding psychiatric disorder (e.g. psychosis, substance misuse).

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Affiliated Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• Liang L, Zhu Y, Zheng Z, Ma H, Cai X, Yang H, Wang F. Music Therapy Modulates Abnormal Brain Networks and Alleviates Anxiety Symptoms in University Students: An fNIRS Study. Depress Anxiety. 2025 Nov 20;2025:7906429. doi: 10.1155/da/7906429. eCollection 2025.

  PMID: 41321481 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Fei Wang

  Affiliated Nanjing Brain Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Yue Zhu

CONTACT

02418640297059; zhuyuemiiu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: April 19, 2023
• Primary Completion: October 1, 2023
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)