Clinical trial NCT05949736: Effect of Music Therapy in Medical Students (EMTMS)
Official title: Effect of Telemedicine Music Therapy in Medical Students With Depression, Anxiety, or Insomnia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Insomnia
Keywords: Telemedicine
Music Therapy
Mental sub-health
Acoustic features
Wearable devices
Functional near-infrared evaluation
Lead sponsor: Jiangsu Province Nanjing Brain Hospital
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Baseline, 4th week, 8th week, and 28th week.
measure: 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.
timeFrame: Baseline, 4th week, 8th week, and 28th week.
measure: Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at week 4, week 8, and week 28.
timeFrame: Baseline, 4th week, 8th week, and 28th week.
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 4th week, 8th week, and 28th week.
measure: 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.
timeFrame: Baseline, 4th week, 8th week, and 28th week.
measure: Change from baseline in behavioral data measured by wearable devices (WD) during treatment.
timeFrame: Baseline to 4th week.
measure: Change from baseline in acoustic features.
timeFrame: Baseline, 4th week, 8th week, and 28th week.
measure: The neuro-changes resulting from the MT intervention.
timeFrame: Baseline, 2th week, and 4th week.
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Medical College
state: Hainan
city: Xinxiang
country: China
facility: Xinxiang Medical University
state: Henan
city: Nanjing
country: China
facility: Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Affiliated Nanjing Brain Hospital, Nanjing Medical University
name: Fei Wang, Ph.D
role: STUDY_CHAIR
References: