NCT06837649

Brief Summary

The goal of this clinical trial is to investigate whether an 8-week mindfulness-based Tai Chi intervention can improve cognitive and executive functions, particularly inhibitory control, and reduce mobile phone addiction in male university students. It will also explore the potential mechanisms by which mindfulness-based Tai Chi affects mobile phone addiction behaviors. The main questions it aims to answer are: Does mindfulness-based Tai Chi improve inhibitory control and reduce mobile phone addiction in male university students? Does mindfulness-based Tai Chi enhance overall executive functions, including inhibition, updating, and shifting abilities? Researchers will compare the experimental group (receiving mindfulness-based Tai Chi intervention) to the control group (maintaining their usual routine without intervention) to see if mindfulness-based Tai Chi leads to greater improvements in cognitive and executive functions and reduces mobile phone addiction. Participants will: Practice mindfulness-based Tai Chi for 8 weeks Complete pre- and post-intervention assessments of mobile phone addiction, mindfulness levels, and executive function Engage in weekly Tai Chi practice sessions Complete self-report diaries of mobile phone usage and mindfulness experiences

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 15, 2025

Last Update Submit

February 19, 2025

Conditions

Keywords

Mobile Phone Addiction BehaviorExecutive FunctionCognitive Function

Outcome Measures

Primary Outcomes (3)

  • Mobile Phone Addiction Index

    Measurement of mobile phone addiction used the Mobile Phone Addiction Index (MPAI) developed by Y.K. Leung, which is suitable for measuring mobile phone addiction in college students with a good reliability of 0.87. There are four dimensions in the scale, namely loss of control, withdrawal, avoidance, and ineffectiveness. It is rated from 1 to 5 with 17 questions.

    From enrollment to the end of treatment at 8 weeks.

  • Mindfulness level

    The Mindful Attention Awareness Scale (MAAS) was used to measure the mindfulness level. It developed by Brown and Ryan in 2003, which was introduced and revised by domestic scholars in 2012. Besides, it has high validity, structure validity and retest reliability of 0.87 0.89. The scale of single dimension scale, score from 1 to 6 points, are all positive ratings, which includes 15 problem. The higher the total score is, the higher levels one's mindful awareness and attention are.

    From enrollment to the end of treatment at 8 weeks.

  • Executive Functions

    Executive function was measured by the executive function test instrument developed by Chen Aiguo, whose reliability has been tested in numerous studies. The test consisted of a Flanker task (inhibition function), a 2-back task (updating function), and a More-odd shifting task (shifting function).

    From enrollment to the end of treatment at 8 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

The exercise time lasts 40 min each time, including 5 min of wuji pile practice with positive thoughts, 30 min of eight styles of Tai Chi Chuan practice (4 min\*6 sets, 1 min interval between sets), and 5 min of relaxation part of wuji pile with music. The exercise frequency is 3 times a week.

Behavioral: The mindfulness-based Tai Chi Chuan

Control group

NO INTERVENTION

The control group maintained their normal physical activity levels without any additional intervention.

Interventions

Studies have shown that compared with the Tai Chi Chuan, MTCC is more relaxing to practitioner. The Tai Chi Chuan section is based on the Yang's movements, which not only conform to the basic technical characteristics, such as the steps, stance, techniques, movement of the center of gravity, and the coordination of the whole body between the movements, but also are clear, smooth, simple, easy to learn, and beautiful. The mindfulness section is complemented by soothing, soft music to guide the practitioner to focus on himself and return to inner peace. The essence of the program is to help practitioners focus their attention and achieve inner peace during practice. Through the practice of MTCC, practitioners are encouraged to face the difficulties they encounter in reality and to develop a positive and open mind to deal with negative emotions and thoughts in daily life.

Experimental group

Eligibility Criteria

Age18 Years - 21 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male university students not majoring in physical education. Aged 18 years or older. A moderate level of dependence on mobile phones, with a score above 40 on the Mobile Phone Addiction Index (MPAI).
  • No regular exercise habits in daily academic life. Willing to participate in an 8-week mindfulness-based Tai Chi training program and provide informed consent.
  • No serious medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital University Of Physical Education And Sports, School of Kinesiology and Health

Beijing, Beijing Municipality, 100080, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will select male university students. Inclusion criteria include: Male students not majoring in physical education. Aged 18 years or older. Moderate mobile phone dependence, with a score above 40 on the Mobile Phone Addiction Index (MPAI). No regular exercise habits. Willing to participate in an 8-week mindfulness-based Tai Chi training and sign informed consent. No serious medical conditions. The control group will not receive any special exercise intervention, while the experimental group will undergo an 8-week mindfulness-based Tai Chi intervention. Participants' mobile phone addiction, mindfulness levels, and executive functions will be assessed before and after the intervention. The study will explore the potential mechanisms by which mindfulness-based Tai Chi improves mobile phone addiction.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 15, 2025

First Posted

February 20, 2025

Study Start

April 1, 2023

Primary Completion

June 3, 2023

Study Completion

June 3, 2023

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

all IPD collected throughout the trial,We are willing to share the following data from the participants in the experiment: mobile phone addiction index, mindfulness level, executive functions, and other related information.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The IPD will be made publicly available 6 months after the publication of the paper. The data will be shared on the China National Center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/) for other researchers to access and use. The shared data will include all experimental data that is not related to personal privacy, adhering to data confidentiality and ethical standards.
Access Criteria
After data collection, the data will be entered into the China National Center (https:/ngdc.cncb.ac.cn/gsub/), which is an internet-based electronic data capture and management system. It is used for storing, organizing, and managing research data to ensure the security, accuracy, and traceability of the data
More information

Locations