search
Back to results

Effect of Music Therapy in Mental Subhealth (EMTMS)

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The mini apps named "SOUL GYM" on the Wechat
Sponsored by
Jiangsu Province Nanjing Brain Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety focused on measuring Music Therapy, Depression, Anxiety, Acoustic features

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesAccepts 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).

Sites / Locations

  • Affiliated Nanjing Brain Hospital, Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The clinical response of the music therapy

The alterations of acoustic features in the music therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
April 13, 2023
Sponsor
Jiangsu Province Nanjing Brain Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05648539
Brief Title
Effect of Music Therapy in Mental Subhealth (EMTMS)
Official Title
Effect of Music Therapy in Mental Subhealth: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Nanjing Brain Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Music Therapy, Depression, Anxiety, Acoustic features

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The clinical response of the music therapy
Arm Type
Experimental
Arm Description
To assessthe efficacy of music therapy of MT group compared to Waiting group in mental subhealth.
Arm Title
The alterations of acoustic features in the music therapy
Arm Type
Experimental
Arm Description
To understand the possible biological mechanism underlying the efficacy of music therapy by analyzing alterations of acoustic features.
Intervention Type
Device
Intervention Name(s)
The mini apps named "SOUL GYM" on the Wechat
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at week 4.
Description
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.
Title
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at week 4.
Description
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.
Title
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4.
Description
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.
Title
Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Zhu
Phone
02418640297059
Email
zhuyuemiiu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Wang
Organizational Affiliation
Affiliated Nanjing Brain Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Nanjing Brain Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Wang
Phone
86-025-83295957
Email
fei.wang@yale.edu
First Name & Middle Initial & Last Name & Degree
Yue Zhu
Phone
86-18640297059
Email
zhuyuemiiu@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Music Therapy in Mental Subhealth (EMTMS)

We'll reach out to this number within 24 hrs