Clinical trial NCT06600373: Study on the Intervention of Mindfulness-integrated Volleyball Course
Official title: Study on the Intervention of Mindfulness-integrated Volleyball Course
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression, Anxiety
Mindful Walking Meditation
Keywords: mindfulness walking
volleyball
sport therapy
Lead sponsor: Central University of Finance and Economics, China
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 420
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#39; 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.

Eligibility criteria: 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.

Primary outcomes:
measure: anxiety
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: depression
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: sleep
timeFrame: From enrollment to 8 weeks after the end of treatment.
Secondary outcomes:
measure: positive and negative affect
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: life satisfactory
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: self-esteem
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: self perception
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: mindfulness
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: self-compassion
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: loneliness
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: social anxiety
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: social support
timeFrame: From enrollment to 8 weeks after the end of treatment.
measure: self-efficacy
timeFrame: From enrollment to 8 weeks after the end of treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Central University of Finance and Economics
state: Beijing
Study officials:
References: