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Trial registered on ANZCTR


Registration number
ACTRN12624000821594
Ethics application status
Approved
Date submitted
27/05/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tai Chi Stress Reduction Program for University/College Students
Scientific title
Tai Chi-based Stress Reduction program for students in higher education settings: A pilot clinical trial
Secondary ID [1] 312073 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 333907 0
Stress 333908 0
Depression 333909 0
Condition category
Condition code
Mental Health 330582 330582 0 0
Anxiety
Mental Health 330583 330583 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tai Chi-based Stress Reduction program include:
(1) Two mental health workshops at baseline and 4 weeks before the Tai Chi class, 60min for the first one, and 90min for the second one.
o The first workshop lasts 60min. It includes 10min introduction (welcome & overview of the workshop goals and objectives), 40min of four topics (to understand stress, anxiety and depression, stress management methods, and lifestyle behaviors), and 10min of Q&A, closing and summary.
o The second workshop lasts 90min. It includes 10min of introduction (reflection and overview of the goals), discussion of practical skills (20min), 50min of interactive activities (group discussion, role-playing, and case studies), and 10min of Q&A, closing and summary.

(2) A Tai Chi class, one in-person and one online live session per week for 8 weeks.
o The in-person Tai Chi class will be held outdoor (delivered indoor if weather does not permit) at the Westmead campus of Western Sydney University during lunchtime or in the afternoon (TBC).
o The online class will be held after regular business hours (TBC – either morning or evening) via zoom meetings. Participants will be encouraged to attend both the in-person and online live classes, but the online live one is optional. The content covered in both session within the same week is identical.
o The contents include a warm-up exercise (10min), standing posture (5min), Tai Chi movements (cloud hands and 8-form Chen-style Tai Chi) (35min), meditation (5min), Q&A and summary (5min). Each session will follow the structured plan of intervention.

Procedures and Activities:
Two mental health educational workshops focusing on stress management and healthy lifestyle behaviors.
An 8-week Tai Chi training program combining in-person and online sessions.

Delivery Personnel:
Mental health workshops are co-facilitated by a member of the research team and experienced facilitators from Headspace Castle Hill and Parramatta.
Tai Chi classes are conducted by an experienced instructor with over 16 years of teaching experience.

Mode of Delivery:
Workshops are delivered in person.
Tai Chi classes are conducted both in-person at the Westmead campus of Western Sydney University and online via Zoom. Classes are offered once per week in-person and once per week online, each lasting 60 minutes.

Frequency and Duration:
The first workshop is 60 minutes and occurs at baseline.
The second workshop is 90 minutes and takes place six weeks later.
Tai Chi classes occur weekly for 8 weeks, with each session lasting 60 minutes.

Location:
Workshops and in-person Tai Chi classes are held at the Westmead campus of Western Sydney University.
Online Tai Chi classes are delivered via Zoom.

Personalisation and Adaptation:
The intervention is standardised; however, participants can choose to attend online sessions optionally to accommodate personal schedules.

Fidelity Assessment:
Attendance at each Tai Chi session is recorded by the instructor.
Follow-up phone calls are made to track reasons for any missed sessions.
Strategies to maintain engagement include reminder emails and optional session attendance.
Intervention code [1] 328669 0
Prevention
Intervention code [2] 328670 0
Treatment: Other
Comparator / control treatment
Waitlist Control Group.
Participants in the waitlist control group will not receive the Tai Chi-based Stress Reduction program during the active phase of the study. They will continue with their usual activities without any additional intervention from the study. This group serves to provide a comparison to evaluate the effectiveness of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 338336 0
Recruitment Rate
Timepoint [1] 338336 0
Calculated monthly during the active recruitment period and at the end of the recruitment phase (3 months).
Primary outcome [2] 338337 0
Retention Rate
Timepoint [2] 338337 0
At the conclusion of the 8-week intervention period.
Primary outcome [3] 338338 0
Adherence Rate
Timepoint [3] 338338 0
Weekly attendance recorded throughout the 8-week intervention, with the final calculation at the end of the 8 weeks.
Secondary outcome [1] 435474 0
Quality of life
Timepoint [1] 435474 0
At baseline and at 8 weeks post-intervention commencement.
Secondary outcome [2] 435475 0
Self- Efficacy
Timepoint [2] 435475 0
Completed at baseline and 8 weeks post-intervention commencement via REDCap database.
Secondary outcome [3] 435476 0
Social Support
Timepoint [3] 435476 0
Completed at baseline and 8 weeks post-intervention commencement via REDCap database.
Secondary outcome [4] 435477 0
Physical Activity
Timepoint [4] 435477 0
Measured over 7 days (Week 1) at baseline and 8 weeks post-intervention commencement.
Secondary outcome [5] 435478 0
Weight
Timepoint [5] 435478 0
At baseline and 8 weeks post-intervention commencement
Secondary outcome [6] 435479 0
Stress
Timepoint [6] 435479 0
At baseline and 8 weeks post-intervention commencement
Secondary outcome [7] 435480 0
Health Behaviour Change
Timepoint [7] 435480 0
At baseline, 4 weeks, and 8 weeks post-intervention commencement
Secondary outcome [8] 435481 0
Motivation
Timepoint [8] 435481 0
At baseline during the assessment stage
Secondary outcome [9] 435482 0
Participant Satisfaction
Timepoint [9] 435482 0
Post-trial (Week 8) upon completion or withdrawal from the study.
Secondary outcome [10] 435562 0
Depression
Timepoint [10] 435562 0
At baseline and 8 weeks post-intervention commencement
Secondary outcome [11] 435563 0
Anxiety
Timepoint [11] 435563 0
At baseline and 8 weeks post-intervention commencement
Secondary outcome [12] 435564 0
Sleep quality
Timepoint [12] 435564 0
At baseline and 8 weeks post-intervention commencement
Secondary outcome [13] 436452 0
Blood-pressure
Timepoint [13] 436452 0
At baseline and 8 weeks post-intervention commencement
Secondary outcome [14] 436453 0
Heart rate
Timepoint [14] 436453 0
At baseline and 8 weeks post-intervention commencement
Secondary outcome [15] 436454 0
Health Behaviour Change
Timepoint [15] 436454 0
At baseline, 4 weeks, and 8 weeks post-intervention commencement
Secondary outcome [16] 436455 0
Attitude
Timepoint [16] 436455 0
At baseline during the assessment stage
Secondary outcome [17] 436456 0
Expectation
Timepoint [17] 436456 0
At baseline during the assessment stage

Eligibility
Key inclusion criteria
Participants will be included if they:
- Aged 16 years old or above.
- Students, who are undertaking tertiary or higher education, including undergraduate students, honors students, master’s students, doctoral students, regardless of domestic or international students, full-time or part-time students.
- Meet any of the following diagnostic criteria:
a. With elevated levels of stress-related symptoms and DASS-21 stress score greater than or equal to 19; elevated levels of anxiety-related symptoms and DASS-21 anxiety score greater than or equal to 10; or elevated depression-related symptoms, and DASS-21 depression score greater than or equal to 14.
b. With elevated levels of depression diagnosed by a validated clinician-based or self-reported depression symptom questionnaire, such as Hamilton Rating-Scale for Depression, the Beck Depression Inventory, or the Center for Epidemiological Studies Depression Scale,
c. With a diagnosis of depressive disorders in accordance with the Diagnostic and Statistical Manual, Third Edition (DSM-III or DSM-III-R), Fourth Edition or Fifth Edition (DSM-IV or DSM-V), or the International Classification of Disease 10 (ICD-10),
d. With a diagnosis of anxiety disorders in accordance with the Diagnostic and Statistical Manual Fourth Edition or Fifth Edition (DSM-IV or DSM-V), or
e. have been diagnosed with an anxiety disorder and/or a depressive disorder by a medical doctor (e.g., general practitioner (GP), psychologist, or psychiatrist).
- Are willing and able to give written informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
- Are unable to speak and read English,
- refuse or are unwilling to engage in Tai Chi group class or mental health educational workshops,
- are regular Tai Chi practitioner or have practiced Tai Chi within the past 6 months,
- are currently enrolled in any other stress reduction program,
- are pregnant or lactating,
- have any physical limitations that would significantly limit Tai Chi participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is maintained via a central randomisation controlled by our REDCap database system. After obtaining informed consent and assigning each participant a unique study ID, the REDCap system, which is managed by an independent administrator off-site, automatically randomises participants to their respective groups. This system ensures that the allocation sequence is not accessible to the researchers enrolling participants, thereby preventing any potential selection bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a computer-generated randomisation table.
We employ a computerised sequence generation method facilitated by our REDCap database. This system uses a complex algorithm to generate a random order, ensuring that the allocation of participants to the intervention or control groups is entirely random and unbiased.
No stratification is used in this study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/05/2024
Date of last participant enrolment
Anticipated
16/08/2024
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
40
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316433 0
University
Name [1] 316433 0
Western Sydney University Research Theme Grant Assistance Scheme 2024
Country [1] 316433 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 318602 0
None
Name [1] 318602 0
Address [1] 318602 0
Country [1] 318602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315225 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 315225 0
Ethics committee country [1] 315225 0
Australia
Date submitted for ethics approval [1] 315225 0
28/02/2024
Approval date [1] 315225 0
15/04/2024
Ethics approval number [1] 315225 0
H15903

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134046 0
Dr Guoyan Yang
Address 134046 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145
Country 134046 0
Australia
Phone 134046 0
+61 421 718 592
Fax 134046 0
Email 134046 0
e.yang@westernsydney.edu.au
Contact person for public queries
Name 134047 0
Guoyan Yang
Address 134047 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145
Country 134047 0
Australia
Phone 134047 0
+61 421 718 592
Fax 134047 0
Email 134047 0
e.yang@westernsydney.edu.au
Contact person for scientific queries
Name 134048 0
Guoyan Yang
Address 134048 0
NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145
Country 134048 0
Australia
Phone 134048 0
+61 421 718 592
Fax 134048 0
Email 134048 0
e.yang@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data, after de-identification, underlying published results only. It is estimated that the data will be available from 15 November 2025 and available for 5 years after publication.
When will data be available (start and end dates)?
When relevant papers are published. It is estimated that the data will be available from 15 November 2025.
Available to whom?
Principal investigator: Dr Guoyan Yang
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator Dr Guoyan Yang (email: e.yang@westernsydney.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23787Ethical approval    387747-(Uploaded-24-05-2024-15-00-17)-H15903 - Human Ethics Approval - Apr 2024.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.