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Completed

NCT Number: 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central University of Finance and Economics

Beijing, Beijing Municipality, 100875, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindful Walking meditation

Behavioral

Conduct approximately 10 minutes of mindful walking after the 110-minute regular physical education group class.

physical education group class

Behavioral

120 minutes physical education group class about volleyball.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Ye Zhiyin

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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