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Идёт набор NCT07024979

Music Therapy's Impact on University Students' Social and Mental Health

Без фазы С лечением Depressive Symptoms Anxiety Stress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Music Therapy Songwriting Intervention.
Кому может быть актуально
Состояния в реестре: Depressive Symptoms, Anxiety, Stress. Базовые параметры: 18 лет — 35 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effects and Hyperscanning-Based Neural Mechanisms of Music Therapy on Social Relationships and Mental Wellness in University Students: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Music Therapy Songwriting Intervention
    The music therapy songwriting intervention is an active, client-centered music therapy approach in which the participant collaboratively create an original song with a professional music therapist. This evidence-based method combines: 1) lyric writing: the participant can express personal experience/emotions through guided lyric creation; 2) musical composition: the participant will choose or improvise their favorite melody, harmony, and rhythm with a music therapist; 3) therapeutic processing:

Первичные конечные точки

  • Change of Baseline Depression Anxiety Stress Level after 4 Sessions [Срок оценки: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)]
  • Change of Baseline Social Connection Level after 4 Sessions [Срок оценки: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)]
  • Interbrain Synchrony Level During 4 Sessions (EEG-based) [Срок оценки: 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).]
  • Change of Baseline Hospital Anxiety and Depression Scale [Срок оценки: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)]
  • Change of Baseline Perceived Stress Level [Срок оценки: Baseline (day 1) and the last session (up to 2 weeks, the 4th session)]
Вторичные конечные точки (3)
  • Work Alliance After Each Session [Срок оценки: 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).]
  • Therapeutic Rapport After Each Session [Срок оценки: 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).]
  • The Participant's State Anxiety After Each Session [Срок оценки: It will be used to assess the participant's anxiety levels before and after each session, so the assessment will occur at the beginning and after each session, pre and post session 1, pre and post session 2, pre and post session 3, pre and post session 4]

Критерии участия

Критерии включения

  • (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).

Критерии исключения

  • (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • 2/F., The Hong Kong Jockey Club Building for Interdisciplinary Research — Гонконг

Идентификаторы

NCT: NCT07024979 · EA240556

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗