Depression, AnxietyNCT06600373
Study on the Intervention of Mindfulness-integrated Volleyball Course
A study testing Mindful Walking meditation and physical education group class in people with Depression, Anxiety and Mindful Walking Meditation, run by Ye Zhiyin at 1 site in China.
Trial summary
The purpose of this clinical trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students, and whether it has better intervention effects compared to a regular volleyball team sports program. 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, Mindful Walking Meditation
- What is being tested?
- Mindful Walking meditation and physical education group class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 2 Mar 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 mindfulness-integrated volleyball course.
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 clinical trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students, and whether it has better intervention effects compared to a regular volleyball team sports program. The main questions it aims to answer are:
Does the mindfulness-integrated volleyball team sports program effectively intervene in the participants\' mental health levels, including indicators such as anxiety and depression? The researchers will compare the mindfulness-integrated volleyball team sports program with the regular volleyball team sports program to see if the intervention effects are more effective.
Read more
Participants will:
Attend a mindfulness-integrated volleyball team sports program once a week for 2 hours each session, for a total of 16 weeks.
Complete a psychological questionnaire at the beginning and the end of the program concludes.
Read the detailed description
The study will focus on a non-clinical population of college students, using an exploratory parallel randomized controlled trial design. Based on the inclusion criteria, participants will be allocated to the experimental group and control group according to their registration time. The experimental group will receive the mindfulness-integrated volleyball program, while the control group will participate in a regular volleyball program. The intervention will last for a total of 16 weeks, with sessions held once a week for 120 minutes each. Relevant assessments will be conducted at two time points: on the day before the intervention, and on the last day of the intervention.
Primary indicators: Youth version of the Patient Health Questionnaire, Generalized Anxiety Disorder Scale.
Secondary indicators: Insomnia Severity Index, Self-Efficacy Scale, Positive and Negative Affect Scale, Life Satisfaction Scale, Self-Esteem Scale, Self-Compassion Scale, Loneliness Scale, Social Anxiety Scale, Perceived Social Support Scale.
All of the above indicators will be measured using the corresponding questionnaires at two time points: T1 pre-test (before the start), T2 after 16 weeks of intervention, for a total of two assessments.
Inclusion criteria: (1) Participants aged ≥16 years; (2) Able to communicate in Mandarin and willing to voluntarily participate in this study; (3) Agree to consistently attend each mindfulness-integrated volleyball session.
Exclusion criteria: (1) Individuals with language communication barriers or unwilling to cooperate in this study; (2) Individuals unable to commit to attending each mindfulness-integrated volleyball session.
- Conditions
- Depression, Anxiety, Mindful Walking Meditation
- Being tested
- Mindful Walking meditation, physical education group class
- Keywords
- mindfulness walking, volleyball, sport therapy
- 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.
Mindful Walking meditationBehavioural
Conduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class.
physical education group classBehavioural
120 minutes physical education group class about volleyball.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Conduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class. Receives: Behavioral: Mindful Walking meditation |
| Control group | Active comparator | 120 minutes regular physical education group class. Receives: Behavioral: physical education group class |
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 two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
anxiety
Using PHQ-9 to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2 (after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
social anxiety
Using Mini-SPIN to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
insomnia
Using ISI-7 to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
positive and negative affects
Using PANAS to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
life satisfaction
Using SWLS to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (5)
self-esteem
Using WFI to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
self-efficacy
Using GSES to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
self compassion
Using SCS-SF to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
loneliness
Using Revised ULS-3 to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
perceived support
Using BPSSQ to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024
- Primary completion2 Mar 2025
- Study completion2 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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
- 55 participants (actual)
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
- NCT06600373
- Sponsor's protocol ID
- CUFinanceEcon
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2024
- Last updated
- 3 Jul 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Intervention of Mindfulness-integrated Volleyball Course
- ClinicalTrials.gov ID
- NCT06600373
- Acronym / sponsor ID
- CUFinanceEcon
- Conditions
- Depression, Anxiety, Mindful Walking Meditation
- Keywords
- mindfulness walking, volleyball, sport therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ye ZhiyinUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 2 Mar 2025 (actual)
- Study completion
- 2 Mar 2025 (actual)
- First posted
- 19 Sep 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 clinical trial is to understand whether a mindfulness-integrated volleyball team sports program can effectively intervene in the mental health of college students, and whether it has better intervention effects compared to a regular volleyball team sports program. The main questions it aims to answer are:
Does the mindfulness-integrated volleyball team sports program effectively intervene in the participants\' mental health levels, including indicators such as anxiety and depression? The researchers will compare the mindfulness-integrated volleyball team sports program with the regular volleyball team sports program to see if the intervention effects are more effective.
Participants will:
Attend a mindfulness-integrated volleyball team sports program once a week for 2 hours each session, for a total of 16 weeks.
Complete a psychological questionnaire at the beginning and the end of the program concludes.
Detailed description
The study will focus on a non-clinical population of college students, using an exploratory parallel randomized controlled trial design. Based on the inclusion criteria, participants will be allocated to the experimental group and control group according to their registration time. The experimental group will receive the mindfulness-integrated volleyball program, while the control group will participate in a regular volleyball program. The intervention will last for a total of 16 weeks, with sessions held once a week for 120 minutes each. Relevant assessments will be conducted at two time points: on the day before the intervention, and on the last day of the intervention.
Primary indicators: Youth version of the Patient Health Questionnaire, Generalized Anxiety Disorder Scale.
Secondary indicators: Insomnia Severity Index, Self-Efficacy Scale, Positive and Negative Affect Scale, Life Satisfaction Scale, Self-Esteem Scale, Self-Compassion Scale, Loneliness Scale, Social Anxiety Scale, Perceived Social Support Scale.
All of the above indicators will be measured using the corresponding questionnaires at two time points: T1 pre-test (before the start), T2 after 16 weeks of intervention, for a total of two assessments.
Inclusion criteria: (1) Participants aged ≥16 years; (2) Able to communicate in Mandarin and willing to voluntarily participate in this study; (3) Agree to consistently attend each mindfulness-integrated volleyball session.
Exclusion criteria: (1) Individuals with language communication barriers or unwilling to cooperate in this study; (2) Individuals unable to commit to attending each mindfulness-integrated volleyball session.
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: Mindful Walking meditationConduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class. |
| Control group | Active comparator | Behavioral: physical education group class120 minutes regular physical education group class. |
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 mindfulness-integrated volleyball course.
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 |
|---|---|---|
| Mindful Walking meditationConduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class. | Behavioural | Experimental group |
| physical education group class120 minutes physical education group class about volleyball. | Behavioural | Control group |
Primary outcome
depression
Time frame: From enrollment to the end of treatment at 16 weeks
Using GAD-7 to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
anxiety
Time frame: From enrollment to the end of treatment at 16 weeks
Using PHQ-9 to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2 (after 16 weeks of intervention).
social anxiety
Time frame: From enrollment to the end of treatment at 16 weeks
Using Mini-SPIN to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
insomnia
Time frame: From enrollment to the end of treatment at 16 weeks
Using ISI-7 to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
positive and negative affects
Time frame: From enrollment to the end of treatment at 16 weeks
Using PANAS to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
life satisfaction
Time frame: From enrollment to the end of treatment at 16 weeks
Using SWLS to investigate the psychological variables of participants, a total of two assessments will be conducted, including T1 pre-test (before the start) and T2(after 16 weeks of intervention).
5 secondary outcomes
self-esteem
Time frame: From enrollment to the end of treatment at 16 weeks
self-efficacy
Time frame: From enrollment to the end of treatment at 16 weeks
self compassion
Time frame: From enrollment to the end of treatment at 16 weeks
loneliness
Time frame: From enrollment to the end of treatment at 16 weeks
perceived support
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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 Mindful Walking meditation and physical education group class in people with Depression, Anxiety and Mindful Walking Meditation, 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: finished, as of the sponsor's last update on 3 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the end of treatment at 16 weeks). The study lists 6 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 3 Jul 2025.