Effect of Music Therapy in Medical Students (EMTMS)

NCT05949736 | Unknown

• 1 other identifier: 81725005-6
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Mental health has become an increasingly pressing concern, especially since the onset of the COVID-19 pandemic. However, not all individuals experiencing mental suboptimal states require pharmacological treatment. Telemedicine offers psychological interventions like Music Therapy (MT), which utilizes remote network technology to provide effective psychological services. MT achieves its therapeutic effect by improving the brain's internal network activation patterns, thus promoting self-regulation. With relaxing and soothing music, MT gradually helps individuals unwind and regulates their psychological emotions by influencing the cerebral cortex, hypothalamus, and limbic system, leading to an improved daily mood and reduced tension and anxiety. The study was designed as a randomized clinical trial, comprising a telemedicine intervention group (MT) and a waiting control group (CON group), both of whom were in a state of mental sub-health. The MT group received music therapy, while the Waiting group received the MT intervention after the treatment of the MT group. The aim of this study was to collect mental health symptom data, behavioral data, and voice expression data using mobile phone, wearable devices (WD) and neuroimaging techniques (fNIRS). These indicators were used as objective measures to assess the long-term and short-term efficacy of telep-sychological interventions. Analyzing digital biomarkers allowed for a deeper understanding of the potential biological and neurobiological mechanisms underlying the effectiveness of tele-psychological interventions.

Conditions

Depression; Anxiety; Insomnia

Keywords

Telemedicine; Music Therapy; Mental sub-health; Acoustic features; Wearable devices; Functional near-infrared evaluation

Outcome Measures

Primary Outcomes (3)

• Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at week 4, week 8, and week 28.

  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, 4th week, 8th week, and 28th week.

• Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at week 4, week 8, and week 28.

  TThe total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.

  Baseline, 4th week, 8th week, and 28th week.

• Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4, week 8, and week 28.

  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, 4th week, 8th week, and 28th week.

Secondary Outcomes (5)

• Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at week 4, week 8, and week 28.

  Baseline, 4th week, 8th week, and 28th week.

• Change from baseline in suicidal ideation assessed by the Beck Scale for Suicide (BSS-14; range: 0-38) at week 4, week 8, and week 28.

  Baseline, 4th week, 8th week, and 28th week.

• Change from baseline in behavioral data measured by wearable devices (WD) during treatment.

  Baseline to 4th week.

• Change from baseline in acoustic features.

  Baseline, 4th week, 8th week, and 28th week.

• The neuro-changes resulting from the MT intervention.

  Baseline, 2th week, and 4th week.

Study Arms (2)

The Clinical Symptom Changes of Music Therapy in a Randomized Controlled Study.

EXPERIMENTAL

This study investigates the clinical symptom changes of the Music Therapy (MT) group through a randomized controlled trial, aiming to explore the short- and long-term efficacy of MT for individuals experiencing mental sub-health. The study includes one-month and six-month post-treatment follow-ups to assess the lasting effects of MT intervention.

Device: The Online intervention platform

The changes of objective markers of the music therapy.

EXPERIMENTAL

This study examines the changes in objective markers resulting from Music Therapy (MT) intervention. It explores alterations in behavior, biological features, and neuroimaging data to understand the potential biological mechanism underlying the efficacy of music therapy. By analyzing these objective markers, the study aims to gain valuable insights into the impact of MT on individuals' mental well-being.

Device: The Online intervention platform

Interventions

The Online intervention platform DEVICE

Music Therapy (MT) is known to have a calming effect on individuals by using relaxing and soothing music, gradually inducing a state of relaxation. Moreover, it can effectively regulate individual psychological emotions through its influence on specific brain regions such as the cerebral cortex, hypothalamus, and limbic system. This regulation of emotional responses can lead to an improvement in daily mood, reducing feelings of tension and anxiety.

The Clinical Symptom Changes of Music Therapy in a Randomized Controlled Study.; The changes of objective markers of the music therapy.

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants with a total score of PHQ-9 \>5 or a total score of GAD-7 \>5 or a total score of ISI \>7 will be eligible to participate in the study.

You may not qualify if:

• Participants with self-reported lifetime suicide attempt, active self-harm, or active suicidal ideation with intent will be excluded from the study.
• Participants with a clinician-diagnosed bipolar disorder, substance use disorder, or any psychotic disorder, including schizophrenia, will not be eligible to participate.
• Individuals who are incapable of understanding or completing study procedures and digital intervention, as determined by the participant, patient/legal guardian, healthcare provider, or clinical research team, will be excluded.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (3)

Hainan Medical College

Haikou, Hainan, China

NOT YET RECRUITING

Xinxiang Medical University

Xinxiang, Henan, China

RECRUITING

Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Fei Wang, Ph.D

  Affiliated Nanjing Brain Hospital, Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Yue Zhu, Ph.D

CONTACT

18640197059; zhuyuemiiu@163.com

Study Design

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

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: March 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: May 1, 2025
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)