Clinical trial NCT07024979: Music Therapy's Impact on University Students' Social and Mental Health
Official title: The Effects and Hyperscanning-Based Neural Mechanisms of Music Therapy on Social Relationships and Mental Wellness in University Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Stress
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: In recent years, university education has become more challenging due to increased academic competition. A rising number of university students globally are currently being diagnosed with mental health problems, and previous research suggests that insufficient social support plays a significant role in the development of mental illnesses, such as symptoms of depression and anxiety. Music Therapy has been widely used in emotional regulation, offering a promising solution for people struggling with anxiety, depression, and social isolation. Research on the neural mechanisms underlying music therapy represents rapidly growing field of study. Hyperscanning is one of the useful neuroscience study methods, which is widely-used for study interbrain synchronization, refers to the simultaneous measurement of brain activity in two or more individuals who are interacting with each other. This study aims to investigate the effectiveness of music therapy intervention in enhancing mental health and social skills of university students with depressed, anxious, and stress symptoms. This current study will adopt a 2-arm randomized controlled design comparing therapeutic songwriting (experimental condition) with non-therapeutic music listening and discussion (control condition). Upon screening for inclusion criteria, baseline data will be collected; and eligible participants will be randomized into either 4 individual music therapy sessions or non-therapeutic music listening and discussion sessions.

Detailed description: A rising number of university students globally are currently being diagnosed with mental health problems, and previous research suggests that insufficient social support plays a significant role in the development of mental illnesses, such as symptoms of depression and stress. Recent research indicates that 2.6% of young people worldwide experience depression, which is often associated with insufficient social interactions, challenges in emotional regulation, and unhealthy social relationships. These challenges may further impact their educational attainment, mental well-being, and quality of life. To address the impairment of mental health problems and its related influence on youths and their families, researchers, psychiatrists, and clinical therapists have been exploring innovative treatment approaches. Music therapy is one of these approaches.

In recent years, researchers have shifted their focus from simply demonstrating the effectiveness of music therapy treatment toward a deeper exploration of the underlying mechanisms of music used in these interventions. The field of research on Interbrain Synchronization (IBS) offers valuable insights into the intricate neural activities occurring across different brains and brain regions during human interaction. Hyperscanning, a widely-used method for studying interbrain synchronization, refers to the simultaneous measurement of brain activity in two or more individuals who are interacting with each other through various techniques, such as functional magnetic response imaging (fMRI), electroencephalography (EEG), magnetoencephalography (MEG), and functional near-infrared spectroscopy (fNIRS). The use of hyperscaning methods during clinical music therapy sessions may provide the opportunity to understand how music interventions affect the neural connections between therapist and client during a real clinical environment. However, a limited number of studies specifically examine this phenomenon within the unique setting of music therapy.

This study aims to bridge the gap between neuroscience, clinical music therapy, social relationships, and mental health by investigating the effects of EEG interbrain synchronization in undergraduate students. It seeks to explore further the connections between music, the brain, and psychological well-being, aiming to understand the underlying neurological mechanism.

This current study will adopt a 2-arm randomized controlled design comparing therapeutic songwriting (experimental condition) with non-therapeutic music listening and discussion (control condition). To address the research objectives, this study will track psychological and neurophysiological changes across four individual sessions through a combination of repeated measures. Participants and music therapists will wear synchronized EEG caps during each session to capture interbrain dynamics, while participants complete post-session therapeutic relationship and satisfaction ratings. Mental health outcomes will be assessed using standardized questionnaires administered at baseline (pre-intervention) and immediately following the final session (post-intervention). This multi-method approach integrates: 1) temporal tracking of psychological changes (both immediate session-level effects and cumulative intervention effects), 2) objective neurophysiological data on therapeutic rapport, and 3) subjective evaluations of the therapeutic process, collectively provide a multidimensional understanding of music therapy mechanisms.

Eligibility criteria: Inclusion Criteria:

* (1) adults who aged between 18-40
* (2) without any mental diagnosis
* (3) able to speak and read Mandarin, Cantonese, or English
* (4) moderate stress or problems in academic activities, problems in interpersonal relationships, or adaptability to college life.
* (5) participants DASS-21 score \>= "Moderate" severity on each subscale (Depression \>= 14; Anxiety \>= 10; Stress \>= 19).

Exclusion Criteria:

* (1) has more than 10 consecutive years professional music training
* (2) with chronic illness and taking medication
* (3) with prior history of brain trauma or brain surgery
* (4) wearing metal piercings or implants.

Primary outcomes:
measure: Change of Baseline Depression Anxiety Stress Level after 4 Sessions
timeFrame: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)
measure: Change of Baseline Social Connection Level after 4 Sessions
timeFrame: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)
measure: Interbrain Synchrony Level During 4 Sessions (EEG-based)
timeFrame: Baseline (day 1), the 2nd session (3 days after the first session), the 3rd session (at the beginning of the second week) , the 4th session (3 days after the 3rd session, up to two weeks).
Secondary outcomes:
measure: Work Alliance After Each Session
timeFrame: Baseline (day 1), the 2nd session (3 days after the first session), the 3rd session (at the beginning of the second week) , the 4th session (3 days after the 3rd session, up to two weeks).
measure: Therapeutic Rapport After Each Session
timeFrame: Baseline (day 1), the 2nd session (3 days after the first session), the 3rd session (at the beginning of the second week) , the 4th session (3 days after the 3rd session, up to two weeks).
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: 2/F., The Hong Kong Jockey Club Building for Interdisciplinary Research
Study officials:
affiliation: The University of Hong Kong
name: Wanru Zhao
role: PRINCIPAL_INVESTIGATOR
References: