ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Stress

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Prevention

Intervention code [2]

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]

Recruitment Rate

Timepoint [1]

Calculated monthly during the active recruitment period and at the end of the recruitment phase (3 months).

Primary outcome [2]

Retention Rate

Timepoint [2]

At the conclusion of the 8-week intervention period.

Primary outcome [3]

Adherence Rate

Timepoint [3]

Weekly attendance recorded throughout the 8-week intervention, with the final calculation at the end of the 8 weeks.

Secondary outcome [1]

Quality of life

Timepoint [1]

At baseline and at 8 weeks post-intervention commencement.

Secondary outcome [2]

Self- Efficacy

Timepoint [2]

Completed at baseline and 8 weeks post-intervention commencement via REDCap database.

Secondary outcome [3]

Social Support

Timepoint [3]

Completed at baseline and 8 weeks post-intervention commencement via REDCap database.

Secondary outcome [4]

Physical Activity

Timepoint [4]

Measured over 7 days (Week 1) at baseline and 8 weeks post-intervention commencement.

Secondary outcome [5]

Weight

Timepoint [5]

At baseline and 8 weeks post-intervention commencement

Secondary outcome [6]

Stress

Timepoint [6]

At baseline and 8 weeks post-intervention commencement

Secondary outcome [7]

Health Behaviour Change

Timepoint [7]

At baseline, 4 weeks, and 8 weeks post-intervention commencement

Secondary outcome [8]

Motivation

Timepoint [8]

At baseline during the assessment stage

Secondary outcome [9]

Participant Satisfaction

Timepoint [9]

Post-trial (Week 8) upon completion or withdrawal from the study.

Secondary outcome [10]

Depression

Timepoint [10]

At baseline and 8 weeks post-intervention commencement

Secondary outcome [11]

Anxiety

Timepoint [11]

At baseline and 8 weeks post-intervention commencement

Secondary outcome [12]

Sleep quality

Timepoint [12]

At baseline and 8 weeks post-intervention commencement

Secondary outcome [13]

Blood-pressure

Timepoint [13]

At baseline and 8 weeks post-intervention commencement

Secondary outcome [14]

Heart rate

Timepoint [14]

At baseline and 8 weeks post-intervention commencement

Secondary outcome [15]

Health Behaviour Change

Timepoint [15]

At baseline, 4 weeks, and 8 weeks post-intervention commencement

Secondary outcome [16]

Attitude

Timepoint [16]

At baseline during the assessment stage

Secondary outcome [17]

Expectation

Timepoint [17]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Western Sydney University Research Theme Grant Assistance Scheme 2024

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Western Sydney University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Western Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.westernsydney.edu.au/research/research_ethics_and_integrity/human_ethics/apply_for_human_research_ethics_review

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/02/2024

Approval date [1]

15/04/2024

Ethics approval number [1]

H15903

Summary

Brief summary

This study assesses whether a Tai Chi-based stress reduction program, including two educational workshops on stress management and healthy lifestyle and 8-week Tai Chi, can reduce the stress, anxiety, and depression levels among university students. Participants will be randomly assigned to either the Tai Chi program or a waitlist control group, 20 in each group. We hypothesize that those in the Tai Chi group will report lower stress levels and enhanced overall health compared to the control group. Questionnaires and other vital measures will be tested at baseline and 8 weeks. We will also perform interviews with participants in the beginning and at the end of this study to understand their expectation and satisfaction towards this stress reduction program.

Trial website

https://www.westernsydney.edu.au/nicm/research/clinical_trials/tai_chi-based_stress_reduction_for_higher_education_students

Trial related presentations / publications

Public notes

Are you feeling overwhelmed by the demands of college/university life? It’s time to take control of your stress and enhance your wellbeing!

Researchers from Western Sydney University’s NICM Health Research Institute have co-designed a Tai Chi-based Stress Reduction program for higher education students with health professionals, Tai Chi instructors, and students. A pilot randomised controlled trial will be held to explore the feasibility, effects, and cost-effectiveness of the stress reduction program in reducing stress, anxiety, and depression among students. 

How to get involved? Visit https://www.westernsydney.edu.au/nicm/research/clinical_trials/tai_chi-based_stress_reduction_for_higher_education_students

Contacts

Principal investigator

Name

Dr Guoyan Yang

Address

NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145

Country

Australia

Phone

+61 421 718 592

Fax

[email protected]

Contact person for public queries

Name

Guoyan Yang

Address

NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145

Country

Australia

Phone

+61 421 718 592

Fax

[email protected]

Contact person for scientific queries

Name

Guoyan Yang

Address

NICM Health Research Institute, 158 Hawkesbury Rd, Westmead NSW 2145

Country

Australia

Phone

+61 421 718 592

Fax

[email protected]

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: [email protected]).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23787	Ethical 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.

Trial Review

Documents added manually

Documents added automatically