Effect of Music Therapy in Medical Students (EMTMS)

Depression Clinical Trial

Official title:

Effect of Telemedicine Music Therapy in Medical Students With Depression, Anxiety, or Insomnia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949736
• Other study ID #: 81725005-6
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: July 2023
• Source: Jiangsu Province Nanjing Brain Hospital
• Contact: Yue Zhu, Ph.D
• Phone: 18640197059
• Email: zhuyuemiiu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Internet intervention study is a double-blind randomized controlled trial designed to assess the efficacy of Internet-based Music Therapy (MT) compared to a waiting control group for individuals experiencing mental sub-health. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (MT group) or the waiting group (CON group).

Participants in the MT group will receive 12 sessions, spread over a 3-4 week period, with 3-4 sessions per week, each lasting 20-30 minutes. The MT group will undergo music therapy during the first 4 weeks. Clinical symptom assessments and related data will be collected from participants before MT (baseline) and after MT (at the 3rd or 4th week, 1 month, and 6 months). The MT sessions will be divided into three stages, each focusing on a specific topic: Physical and mental relaxation stage: Participants will learn relaxation techniques encompassing the whole body and mind, including breathing and muscle relaxation. Nature imagination stage: Guided music imagination will be utilized during this stage. Internal self-exploration: Participants will explore positive experiences and potential within themselves, adopting a resource-oriented approach for psychological intervention. Participants in the CON group will not receive any intervention during the treatment of the MT group.

Throughout the study, all participants will undergo symptom assessment, poetry reading, voice collection, functional near-infrared evaluation (fNIRS), and wearable devices monitoring to collect data.

The study aims to achieve the following objectives: Evaluate changes in clinical symptoms, such as depression, anxiety, or insomnia, after the telemedicine MT intervention for individuals experiencing mental sub-health. Gain deeper insights into the possible biological mechanisms underlying the efficacy of tele-MT intervention by analyzing digital biomarkers. Explore the predictive effect of objective biomarkers on the treatment outcomes of tele-MT. The study's ultimate goal is to contribute to the understanding and effectiveness of telemedicine-based MT interventions for individuals facing mental sub-health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2025
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. Participants with self-reported lifetime suicide attempt, active self-harm, or active suicidal ideation with intent will be excluded from the study.

2. Participants with a clinician-diagnosed bipolar disorder, substance use disorder, or any psychotic disorder, including schizophrenia, will not be eligible to participate.

3. 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• The Online intervention platform
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.

Locations

Country	Name	City	State
China	Hainan Medical College	Haikou	Hainan
China	Nanjing Medical University	Nanjing	Jiangsu
China	Xinxiang Medical University	Xinxiang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Nanjing Brain Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.	The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).	Baseline, 4th week, 8th week, and 28th week.
Secondary	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.	The total scores of these questionnaires were interpreted as follows: no or low suicidal ideation (0-8), moderate suicidal ideation (9-16), high suicidal ideation (17-38).	Baseline, 4th week, 8th week, and 28th week.
Secondary	Change from baseline in behavioral data measured by wearable devices (WD) during treatment.	The behavioral data include heart rate (bpm), blood oxygen (SaO2), sleep time (s), and the number of steps.	Baseline to 4th week.
Secondary	Change from baseline in acoustic features.	Participants will record videos prior to beginning intervention (baseline) and after completing intervention (week 4, week 8, and week 28). Acoustic features (Hz) are a set of indicators that can reflect an individual's emotional state.	Baseline, 4th week, 8th week, and 28th week.
Secondary	The neuro-changes resulting from the MT intervention.	The functional near-infrared spectroscopy (fNIRS) data will be collected at three time points: before MT intervention, at the end of intervention section 6, and after the entire intervention treatment. The fNIRS can collect the oxygenated hemoglobin and deoxyhemoglobin during brain activity.	Baseline, 2th week, and 4th week.