Depression Anxiety DisorderNCT06658431
Study on Music Intervention of Non-clinical College Students
A study testing music group therapy in people with Depression Anxiety Disorder, run by Ye Zhiyin at 1 site in China.
Trial summary
The purpose of this trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students. The main questions it aims to answer is: Does the music group effectively intervene in the participants' mental health levels, including… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression Anxiety Disorder
- What is being tested?
- music group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants aged 16 years or older.
- Able to communicate in Mandarin and voluntarily participate in the study.
- Agree to consistently participate in each session.
Who cannot join
- Disagree to consistently participate in each mindfulness-integrated volleyball course.
- Individuals unable to commit to participating in each mindfulness-integrated volleyball course.
Trial locations and contacts
1 site in 1 country.
China1 site
Central University of Finance and Economics
Beijing, Beijing Municipality, 100875
About this study
The purpose of this trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students. The main questions it aims to answer is:
Does the music group effectively intervene in the participants' mental health levels, including indicators such as anxiety and depression?
Participants will:
Attend a music group once a week for 1.5 hours each session, for a total of 6 weeks.
Complete a psychological questionnaire every 3 weeks and a follow-up questionnaire every 2 weeks after the program concludes for twice.
- Conditions
- Depression Anxiety Disorder
- Being tested
- music group therapy
- Keywords
- music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music group therapyBehavioural
90 minutes music group therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 90 minutes music group therapy Receives: Behavioral: music group therapy |
| control group | No intervention | Without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
Using GAD-7 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end)， and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
anxiety
Using PHQ-9 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
perceived stress
Using PSS-10 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
Secondary outcomes (8)
sleep
Using ISI-7 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
positive and negative affective
Using PANAS-10 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
life satisfaction
Using SWLS-5 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
burnout
Using MBI-SS-15 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
emotion regulation
Using ERQ-10 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
loneliness and social anxiety
Using UCLA Scale to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
self acceptance
Using SAQ-16 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
perceived support
Using MSPSS-6 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
Measured: From enrollment to 4 weeks after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start24 Oct 2024
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ye Zhiyin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ye Zhiyin, Central University of Finance and Economics, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658431
- Sponsor's protocol ID
- CUFE2
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Music Intervention of Non-clinical College Students
- ClinicalTrials.gov ID
- NCT06658431
- Acronym / sponsor ID
- CUFE2
- Conditions
- Depression Anxiety Disorder
- Keywords
- music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ye ZhiyinUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 26 Oct 2024 (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.
The purpose of this trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students. The main questions it aims to answer is:
Does the music group effectively intervene in the participants' mental health levels, including indicators such as anxiety and depression?
Participants will:
Attend a music group once a week for 1.5 hours each session, for a total of 6 weeks.
Complete a psychological questionnaire every 3 weeks and a follow-up questionnaire every 2 weeks after the program concludes for twice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: music group therapy90 minutes music group therapy |
| control group | No intervention | –Without any intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 16 years or older.
- Able to communicate in Mandarin and voluntarily participate in the study.
- Agree to consistently participate in each session.
Key exclusion criteria (2 listed)
- Disagree to consistently participate in each mindfulness-integrated volleyball course.
- Individuals unable to commit to participating in each mindfulness-integrated volleyball course.
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 group therapy90 minutes music group therapy | Behavioural | Experimental group |
Primary outcome
depression
Time frame: From enrollment to 4 weeks after the end of treatment.
Using GAD-7 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end)， and T5 (4 weeks after the end).
anxiety
Time frame: From enrollment to 4 weeks after the end of treatment.
Using PHQ-9 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
perceived stress
Time frame: From enrollment to 4 weeks after the end of treatment.
Using PSS-10 to investigate the psychological variables of participants, a total of four assessments will be conducted, including T1 pre-test (before the start), with measurement time points at T2 (after 3 weeks of intervention), T3 (after 6 weeks of intervention), T4 (2 weeks after the end) and T5 (4 weeks after the end).
8 secondary outcomes
sleep
Time frame: From enrollment to 4 weeks after the end of treatment.
positive and negative affective
Time frame: From enrollment to 4 weeks after the end of treatment.
life satisfaction
Time frame: From enrollment to 4 weeks after the end of treatment.
burnout
Time frame: From enrollment to 4 weeks after the end of treatment.
emotion regulation
Time frame: From enrollment to 4 weeks after the end of treatment.
loneliness and social anxiety
Time frame: From enrollment to 4 weeks after the end of treatment.
self acceptance
Time frame: From enrollment to 4 weeks after the end of treatment.
perceived support
Time frame: From enrollment to 4 weeks after the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 group therapy in people with Depression Anxiety Disorder, run by Ye Zhiyin at 1 site in China.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jan 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression (time frame: From enrollment to 4 weeks after the end of treatment.). The study lists 3 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 17 Jan 2025.