- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06600373
Study on the Intervention of Mindfulness-integrated Volleyball Course
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100875
- Central University of Finance and Economics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Disagree to consistently participate in each mindfulness-integrated volleyball course.
- Individuals unable to commit to participating in each mindfulness-integrated volleyball course.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Conduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class.
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Conduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class.
|
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Active Comparator: Control group
120 minutes regular physical education group class.
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120 minutes physical education group class about volleyball.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
self-esteem
Time Frame: From enrollment to the end of treatment at 16 weeks
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
self-efficacy
Time Frame: From enrollment to the end of treatment at 16 weeks
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
self compassion
Time Frame: From enrollment to the end of treatment at 16 weeks
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
loneliness
Time Frame: From enrollment to the end of treatment at 16 weeks
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
|
perceived support
Time Frame: From enrollment to the end of treatment at 16 weeks
|
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).
|
From enrollment to the end of treatment at 16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUFinanceEcon
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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