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

NCT07024979 | Recruiting

• 1 other identifier: EA240556
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety; Stress

Outcome Measures

Primary Outcomes (5)

• Change of Baseline Depression Anxiety Stress Level after 4 Sessions

  English and administration of the Chinese translated version of The Depression Anxiety and Stress Scale-21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Scores of depression, anxiety, and stress are calculated by summing the scores for the relevant items.

  Baseline (day 1), and the last session (up to 2 weeks, the 4th session)

• Change of Baseline Social Connection Level after 4 Sessions

  English and administration of the Chinese translated version of the UCLA-Loneliness Scale (ULS-8). ULS-8 has been used to evaluated severity of feelings of loneliness in individuals, from adolescence to adulthood. Scale consists of 8 items which were loaded into a single factor. ULS-8 is a Likert-type scale with 4 options "(1) Never, (2) Rarely, (3) Sometimes and (4) Always". "I am an extrovert person" and " I can find friends when I want" items are reverse-scored. Sum of 8 items reveal general loneliness score, minimum and maximum possible scores are 8 and 32, respectively, higher scores from USL-8 correspond to severe loneliness in adolescents and young adults.

  Baseline (day 1), and the last session (up to 2 weeks, the 4th session)

• Interbrain Synchrony Level During 4 Sessions (EEG-based)

  The interbrain synchronization level between the participant and music therapist in 4 sessions. EEG will be simultaneously recorded from both participants using two electrode caps with 16 Ag/AgCl electrode each. The electrode placement will follow the international 10-20 system guidelines. The EEG LAB toolbox and in-house scripts for MATLAB will be used for data processing. Specifically, phase locking value (PLV) and partial directed coherence (PDC)will be used to examine the magnitude of phase synchrony and its directionality, respectively during sessions. The connectivity analysis will be performed with the FieldTrip toolbox. The PLV quantified the degree of IBS between individuals.

  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

  English and administration of the Chinese translated version of the Hospital Anxiety and Depression Scale (HAD-14) is a 14-item self-report questionnaire designed to screen for symptoms of anxiety and depression in non-psychiatric medical settings. It consists of two subscales (7 items measuring anxiety and 7 items measuring depression). Each item is rated on a 4-point scale (0 = not at all, 3 = nearly every day), with subscale scores ranging from 0 to 21 for each domain. Higher score indicates more severe symptoms.

  Baseline (day 1), and the last session (up to 2 weeks, the 4th session)

• Change of Baseline Perceived Stress Level

  English and administration of the Chinese translated version of the Perceived Stress Scale (PSS-10) will be used in this study. PSS-10 has been widely used to assess the degree to which individuals perceived their lives as unpredictable, uncontrollable, and overloaded in the past month. Comprising 10 items rated on a 5-point Liker scale (0 = never to 4 = very often). Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.

  Baseline (day 1) and the last session (up to 2 weeks, the 4th session)

Secondary Outcomes (3)

• Work Alliance After Each Session

  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

  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

  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

Study Arms (2)

Music Therapy Songwriting Intervention

EXPERIMENTAL

This arm of participants will be receiving individual music therapy songwriting intervention as intervention.

Behavioral: Music Therapy Songwriting Intervention

Non-therapeutic Music Listening and Discussion

NO INTERVENTION

This arm of participants will receive non-therapeutic music listening and discussion (non-therapeutic topics/techniques) sessions as the control condition. This active control condition matches the experimental intervention in format and include musical element, but excludes therapeutic components. The music therapist will ask the participant to provide 3 to 4 their preferred songs. Then they will listen to these songs through standardized equipment. Following each song, the therapist facilitates a structured discussion focused on normal domains and non-therapeutic topics, such as music styles, tempos, and factual information about artists and genres.

Interventions

Music Therapy Songwriting Intervention BEHAVIORAL

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: discussion of song meaning and emotional connections between the participant and music therapist.

Music Therapy Songwriting Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

2/F., The Hong Kong Jockey Club Building for Interdisciplinary Research

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Wanru Zhao

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanru Zhao

CONTACT

(852)59745737; wanru@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the intervention's inherent characteristics, complete blinding is not feasible for music therapists and investigators. The therapeutic nature of songwriting requires therapist awareness, while control condition procedures maintain equivalent therapist presence without therapeutic techniques. All analyses will be conducted with assessors maintain blinding until completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Randomized Controlled Trial

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 17, 2025
• Study Start: February 10, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol will be shared upon trial completion or concurrent with the first results publication. The statistical analysis plan will be shared before database lock and shared with manuscript submission.
• Access Criteria: Academic researchers affiliated with recognized institutions (universities, hospitals, NGOs) with reasonable requests.

Locations

HK (1)