Study on the Intervention of Mindfulness-integrated Volleyball Course

Not Applicable

• Conditions: Depression, Anxiety; Mindful Walking Meditation
• Interventions: Behavioral: Mindful Walking meditation; Behavioral: physical education group class

• Registration Number: NCT06600373
• Lead Sponsor: Ye Zhiyin

Brief 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. 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, the end and a follow-up questionnaire 8 weeks after 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 four time points: on the day before the intervention, at 8 weeks into the intervention, on the last day of the intervention, and 8 weeks after the intervention concludes.

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, Mindfulness 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 four time points: T1 pre-test (before the start), T2 after 8 weeks of intervention, T3 after 16 weeks of intervention, and T4 eight weeks after the intervention concludes, for a total of four 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 Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Study Start: 2024-09-20
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-03-02
• Study Completion: 2025-03-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 420

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Mindful Walking meditation	Conduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class.
Control group	physical education group class	120 minutes regular physical education group class.

Primary Outcome Measures

Name	Time	Method
anxiety	From enrollment to 8 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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
depression	From enrollment to 8 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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
sleep	From enrollment to 8 weeks after the end of treatment.	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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).

Secondary Outcome Measures

Name	Time	Method
positive and negative affect	From enrollment to 8 weeks after the end of treatment.	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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
life satisfactory	From enrollment to 8 weeks after the end of treatment.	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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
self-esteem	From enrollment to 8 weeks after the end of treatment.	Using WFI-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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
self perception	From enrollment to 8 weeks after the end of treatment.	Using WFI-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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
mindfulness	From enrollment to 8 weeks after the end of treatment.	Using FFMQ-20 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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
self-compassion	From enrollment to 8 weeks after the end of treatment.	Using SCS-12 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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
loneliness	From enrollment to 8 weeks after the end of treatment.	Using Revised UCLA Loneliness 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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
social anxiety	From enrollment to 8 weeks after the end of treatment.	Using Mini-SPIN 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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
social support	From enrollment to 8 weeks after the end of treatment.	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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).
self-efficacy	From enrollment to 8 weeks after the end of treatment.	Using GPSS-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 8 weeks of intervention), T3 (after 16 weeks of intervention), and T4 (8 weeks after the end).

Trial Locations

Locations (1)

Central University of Finance and Economics; 🇨🇳 Beijing, Beijing, China