NCT06464328

Brief Summary

This study aims to investigate the effects of Tai Chi combined with music therapy on alleviating depression and anxiety among college students. Depression and anxiety are prevalent among college students and have a significant impact on their lives and academic performance. Therefore, exploring effective interventions is crucial for promoting the mental health of college students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 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

February 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 2, 2024

Last Update Submit

June 12, 2024

Conditions

Keywords

Tai Chi combined with music therapydepressionanxietycollege students

Outcome Measures

Primary Outcomes (2)

  • Change from the Self-Rating Depression Scale (SDS) at week 12

    The SDS, developed by American researchers Zung (1965), is specifically designed to evaluate the degree of depression in participants. The survey comprises 20 items, and participants express their feelings using a Likert scale ranging from 1 (Never) to 4 (Always). The SDS has been widely utilized worldwide to measure depression levels, demonstrating strong internal consistency and validity (Cronbach's Alpha = 0.832), and has been well-established in clinical and research settings (Campo-Arias et al., 2006).

    12 weeks

  • Change from the Self-Rating Anxiety Scale (SAS) at week 12

    The SAS developed by American researchers Zung, (2013), is tailored to assess the anxiety level of participants. This instrument consists of a concise 20-item questionnaire, and participants use a Likert scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) to express their emotions. The SAS exhibits robust psychometric properties in assessing participants' anxiety levels, with acceptable reliability values. The internal consistency, measured through Cronbach's Alpha, is 0.897, and the test-retest reliability, represented by the intra-class correlation coefficient (ICC), is 0.913 (Samakouri et al., 2012).

    12 weeks

Study Arms (3)

Tai Chi Combined with Music Therapy Intervention

EXPERIMENTAL

Tai Chi combined with music therapy Intervention, the effect was achieved by replacing the school's physical education classes with Tai Chi of the researchers' choice, and then by playing music of the researchers' choice during class.

Behavioral: Tai Chi Combined with Music Therapy Intervention

Music intervention only

EXPERIMENTAL

Music only (the fast tempo of 120-130 bpm music will be selected) The effect was achieved by playing music selected by the researchers during originally physical education classes in school.

Behavioral: Music intervention only

Tai Chi intervention only

EXPERIMENTAL

Tai Chi intervention only The effect was achieved by replacing the school's originally physical education classes with Tai Chi of the researchers' choice.

Behavioral: Tai Chi intervention only

Interventions

Tai Chi combined with music therapy Intervention, the effect was achieved by replacing the school's physical education classes with Tai Chi of the researchers' choice, and then by playing music of the researchers' choice during class; twice a week for twelve weeks

Tai Chi Combined with Music Therapy Intervention

Music only (120-130 bpm) The effect was achieved by playing music selected by the researchers during originally physical education classes in school; twice a week for twelve weeks

Music intervention only

Tai Chi intervention only The effect was achieved by replacing the school's originally physical education classes with Tai Chi of the researchers' choice; twice a week for twelve weeks

Tai Chi intervention only

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • This study were being enrolled as a student at Tianjin University of Sport
  • aged between 18 and 25 years
  • proficient in reading and communicating in Chinese.

You may not qualify if:

  • Students with visual impairments
  • Students with auditory
  • Students with other impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2024

First Posted

June 18, 2024

Study Start

February 5, 2023

Primary Completion

June 5, 2023

Study Completion

September 5, 2023

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations