DepressionNCT05949736
Effect of Music Therapy in Medical Students (EMTMS)
A study testing The Online intervention platform in people with Depression and Anxiety, run by Jiangsu Province Nanjing Brain Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Depression, Anxiety, Insomnia
- What is being tested?
- The Online intervention platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2021to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
Hainan Medical College
Haikou, Hainan
Lijuan Liang, Phd., hy0203043@hainmc.edu.cn
- Recruiting
Nanjing Medical University
Nanjing, Jiangsu
Yue Zhu, PhD, 18640197059, zhuyuemiiu@163.com
- Recruiting
Xinxiang Medical University
Xinxiang, Henan
Yue Zhu, zhuyuemiiu@163.com
About this study
Official title: Effect of Telemedicine Music Therapy in Medical Students With Depression, Anxiety, or Insomnia.
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.
Read the detailed 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.
- Conditions
- Depression, Anxiety, Insomnia
- Being tested
- The Online intervention platform
- Keywords
- Telemedicine, Music Therapy, Mental sub-health, Acoustic features, Wearable devices, Functional near-infrared evaluation
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Online intervention platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: The Online intervention platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).
Measured: 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.
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).
Measured: Baseline, 4th week, 8th week, and 28th week.
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.
Measured: Baseline to 4th week.
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.
Measured: Baseline, 4th week, 8th week, and 28th week.
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.
Measured: Baseline, 2th week, and 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Mar 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Wang, Ph.D, Study chair, Affiliated Nanjing Brain Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949736
- Sponsor's protocol ID
- 81725005-6
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Y, Tang R, Zhang H, Wang Y, Yu Y, Qin S, Zhang Q, Tu J, Liu R, Wang F. The Mediating Effects of Digital Music Therapy on Depressive Symptoms in Youth During the COVID-19 Pandemic: A Randomized Controlled Trial. Stress Health. 2026 Feb;42(1):e70156. doi: 10.1002/smi.70156.
PubMed 41736248
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telemedicine Music Therapy in Medical Students With Depression, Anxiety, or Insomnia.
- ClinicalTrials.gov ID
- NCT05949736
- Acronym / sponsor ID
- 81725005-6
- Conditions
- Depression, Anxiety, Insomnia
- Keywords
- Telemedicine, Music Therapy, Mental sub-health, Acoustic features, Wearable devices, Functional near-infrared evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Clinical Symptom Changes of Music Therapy in a Randomized Controlled Study. | Experimental | Device: The Online intervention platformThis 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. |
| The changes of objective markers of the music therapy. | Experimental | Device: The Online intervention platformThis 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. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Online intervention platformMusic 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. | Device | The Clinical Symptom Changes of Music Therapy in a Randomized Controlled Study., The changes of objective markers of the music therapy. |
Primary outcome
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.
Time frame: Baseline, 4th week, 8th week, and 28th week.
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, week 8, and week 28.
Time frame: Baseline, 4th week, 8th week, and 28th week.
TThe 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, week 8, and week 28.
Time frame: Baseline, 4th week, 8th week, and 28th week.
The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.
5 secondary outcomes
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.
Time frame: 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.
Time frame: Baseline, 4th week, 8th week, and 28th week.
Change from baseline in behavioral data measured by wearable devices (WD) during treatment.
Time frame: Baseline to 4th week.
Change from baseline in acoustic features.
Time frame: Baseline, 4th week, 8th week, and 28th week.
The neuro-changes resulting from the MT intervention.
Time frame: Baseline, 2th week, and 4th week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 41736248Zhu Y, Tang R, Zhang H, Wang Y, Yu Y, Qin S, Zhang Q, Tu J, Liu R, Wang F. The Mediating Effects of Digital Music Therapy on Depressive Symptoms in Youth During the COVID-19 Pandemic: A Randomized Controlled Trial. Stress Health. 2026 Feb;42(1):e70156. doi: 10.1002/smi.70156.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Wang, Ph.D study chair
Affiliated Nanjing Brain Hospital, Nanjing Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Online intervention platform in people with Depression and Anxiety, run by Jiangsu Province Nanjing Brain Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Zhu, Ph.D (18640197059, zhuyuemiiu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline, 4th week, 8th week, and 28th week.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05949736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.