Depressive SymptomsNCT07024979
Music Therapy's Impact on University Students' Social and Mental Health
A study testing Music Therapy Songwriting Intervention in people with Depressive Symptoms and Anxiety, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Stress
- What is being tested?
- Music Therapy Songwriting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (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).
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
2/F., The Hong Kong Jockey Club Building for Interdisciplinary Research
Hong Kong
Wanru Zhao, (852)59745737, wanru@connect.hku.hk
About this study
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
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.
Read the 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.
- Conditions
- Depressive Symptoms, Anxiety, Stress
- Being tested
- Music Therapy Songwriting Intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy Songwriting InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy Songwriting Intervention | Experimental | This arm of participants will be receiving individual music therapy songwriting intervention as intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (day 1) and the last session (up to 2 weeks, the 4th session)
Secondary outcomes (3)
Work Alliance After Each Session
English and administration of the Chinese translated version of the Work Alliance Inventory-Short Revised (WAI-SR).
The WAI-SR is a 12-item measure for the assessment of the therapeutic alliance. It assesses three key aspects of the therapeutic alliance (1) agreement on the tasks of therapy, (2) agreement on the goals of therapy and (3) development of an affective bond.
Measured: 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
English and administration of the Chinese translated version of the Session Rating Scale (SRS).
The SRS is a simple, 4-item visual analogue scale designed to assess key dimensions of effective therapeutic relationships.
The SRS translates what is known about the alliance into four visual analogue scales each 10cm long to assess the clients' perceptions of: (1) respect and understanding, (2) relevance of the goals and topics, (3) client-practitioner fit and (4) overall alliance.
Measured: 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
The participant's state anxiety will be assessed after each session with the English and Chinese version of State-Trait Anxiety Inventory (STAI)-State Anxiety Subscale (Form Y-1). The STAI for Y-1 is a 20-item self-report measure designed to evaluate transient feelings of anxiety experience in the moment. Each item is rated on a 4-point Liker scale (1 = not at all to 4 = very much to), with statements reflecting current emotional states. Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start10 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Model description
- Parallel Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanru Zhao, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024979
- Sponsor's protocol ID
- EA240556
- Status last verified
- Dec 2024
- First submitted
- 12 May 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is committed to transparent and ethical data sharing to advance scientific collaboration while protecting participant confidentiality. The sharing data include assess to the study protocol, statistical analysis plan, and de-identified participant data. 1. Full study protocol will be shared or published as a supplement to the primary trial manuscript in a public registry. It will available upon trial completion or concurrent with the first results publication. 2. Primary and secondary outcome analyses data will be upload to journal supplementary materials. Finalize before database lock and shared with manuscript submission. 3. De-identified participant data will be shared to researchers with reasonable requests, such as meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07024979
- Acronym / sponsor ID
- EA240556
- Conditions
- Depressive Symptoms, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jun 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Songwriting Intervention | Experimental | Behavioral: Music Therapy Songwriting InterventionThis arm of participants will be receiving individual music therapy songwriting intervention as 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- (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).
Key exclusion criteria (4 listed)
- (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.
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 |
|---|---|---|
| Music Therapy Songwriting InterventionThe 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. | Behavioural | Music Therapy Songwriting Intervention |
Primary outcome
Change of Baseline Depression Anxiety Stress Level after 4 Sessions
Time frame: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)
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.
Change of Baseline Social Connection Level after 4 Sessions
Time frame: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)
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.
Interbrain Synchrony Level During 4 Sessions (EEG-based)
Time frame: 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 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.
Change of Baseline Hospital Anxiety and Depression Scale
Time frame: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)
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.
Change of Baseline Perceived Stress Level
Time frame: Baseline (day 1) and the last session (up to 2 weeks, the 4th session)
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.
3 secondary outcomes
Work Alliance After Each Session
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Yes. This study is committed to transparent and ethical data sharing to advance scientific collaboration while protecting participant confidentiality. The sharing data include assess to the study protocol, statistical analysis plan, and de-identified participant data. 1. Full study protocol will be shared or published as a supplement to the primary trial manuscript in a public registry. It will available upon trial completion or concurrent with the first results publication. 2. Primary and secondary outcome analyses data will be upload to journal supplementary materials. Finalize before database lock and shared with manuscript submission. 3. De-identified participant data will be shared to researchers with reasonable requests, such as meta-analysis.
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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.
Wanru Zhao principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy Songwriting Intervention in people with Depressive Symptoms and Anxiety, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanru Zhao ((852)59745737, wanru@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Baseline Depression Anxiety Stress Level after 4 Sessions (time frame: Baseline (day 1), and the last session (up to 2 weeks, the 4th session)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.