ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000134426

Ethics application status

Approved

Date submitted

17/01/2025

Date registered

6/02/2025

Date last updated

6/02/2025

Date data sharing statement initially provided

6/02/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of Transcendental Meditation (TM) on Mental and Cardiometabolic Health among staff at RMIT University, Australia: A Randomised Controlled Trial

Scientific title

Effects of Transcendental Meditation (TM) on Mental and Cardiometabolic Health among staff at RMIT University, Australia: A Randomised Controlled Trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Mental Health

Cardiometabolic Health

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Cardiovascular

Normal development and function of the cardiovascular system

Mental Health

Depression

Public Health

Health promotion/education

Mental Health

Studies of normal psychology, cognitive function and behaviour

Mental Health

Anxiety

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This will be a two-arm, parallel-group randomised controlled trial.

Transcendental Meditation (TM) program includes a 5-day training provided by a trained TM teacher, with sessions lasting 1 hour/day for the first two days and 1.5 hours/day for the following three days.

Day one will be the introduction about the TM, this can be joined in-person or online.
Day two will be an in-person personal instruction, where teacher will select a personalised mantra (mental word) and teaches how to use it properly. Rest of the three days will be in-person individual or group (2-8) training depending upon the number of participants. These last four days of training will be in consecutive days. This training will be provided in quite room. The session attendance will be recorded.

Thereafter, follow-up discussions and check-in meetings (in-person or online in Teams) will be held fortnightly for 2 months and then monthly for the remaining 10 months. These check-in sessions will be in-person or online (Teams) and run for about an hour. Participants will be asked to meditate twice daily for 15-20 minutes at a time and place convenient for them. Meditation adherence will be recorded using a brief survey questionnaire (adapted) at two weeks interval for 12-month post-intervention.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

The control group will follow the lifestyle-as-usual (LAU) and continue the currently available wellbeing resources currently accessible to all staff at the university (e.g brisk walking, engaging in sports and fitness activities etc.). Special arrangements will not be made to encourage wellbeing activities. The control group will get the TM training at the end of the trial.

Control group

Placebo

Outcomes

Primary outcome [1]

Perceived stress

Timepoint [1]

Baseline, and 3-month, 6-month (primary end-point), and 12-month post-commencement of the intervention

Secondary outcome [1]

Sleep quality measured by smartwatch (Biostrap Kairos)

Timepoint [1]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [2]

Insulin resistance (HOMA-IR)

Timepoint [2]

Baseline and 6-month and 12-month post-commencement of the intervention

Secondary outcome [3]

Health-related quality of life (HRQoL)

Timepoint [3]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [4]

Anxiety symptoms

Timepoint [4]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [5]

Body mass index (BMI)

Timepoint [5]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [6]

Emotion Regulation

Timepoint [6]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [7]

Systolic and Diastolic Blood Pressure (SBP and DBP)

Timepoint [7]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [8]

Burnout

Timepoint [8]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [9]

waist circumference

Timepoint [9]

Baseline, 3-month, 6-month, 12-month post-commencement of intervention

Secondary outcome [10]

Lipid profile

Timepoint [10]

Baseline and 6 month and 12-month post-commencement of intervention

Secondary outcome [11]

Antihypertensive drug or other drug use, if any

Timepoint [11]

Baseline and 3-month, 6-month, and 12-month post-commencement of intervention

Secondary outcome [12]

Depression symptoms

Timepoint [12]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [13]

Work Productivity and Activity Impairment

Timepoint [13]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [14]

Mental wellbeing

Timepoint [14]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [15]

Sleep Quality

Timepoint [15]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [16]

Daily meditation practice (intervention group only)

Timepoint [16]

At two weeks interval after completion of the TM training

Secondary outcome [17]

Perceived benefit of meditation, barriers and facilitators. These outcomes will be assessed as a composite outcome.

Timepoint [17]

At 6-month post-commencement of intervention

Secondary outcome [18]

Alcohol, smoking use, and coffee use (composite)

Timepoint [18]

Baseline and 3-month, 6-month, and 12-month post-commencement of intervention

Secondary outcome [19]

Heart Rate Variability (HRV)

Timepoint [19]

Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention

Secondary outcome [20]

Salivary cortisol

Timepoint [20]

Baseline and 6 month and 12-month post-commencement of intervention

Secondary outcome [21]

Inflammatory markers

Timepoint [21]

Baseline and 6-month and 12-month post-commencement of intervention

Secondary outcome [22]

Physical activity

Timepoint [22]

Baseline and 3-month, 6-month, and 12-month post-commencement of intervention

Secondary outcome [23]

Fasting blood sugar

Timepoint [23]

Baseline and 6-month and 12-month post-commencement of the intervention

Secondary outcome [24]

Telomere length

Timepoint [24]

Baseline and 6-month and 12-month post-commencement of intervention

Secondary outcome [25]

Daily steps

Timepoint [25]

Baseline and 3-month, 6-month, and 12-month post-commencement of intervention

Secondary outcome [26]

Number of sick leaves over the past month

Timepoint [26]

Baseline, and at monthly interval post-commencement of the intervention

Secondary outcome [27]

Training satisfaction questionnaire

Timepoint [27]

After meditation training

Secondary outcome [28]

Sympathetic arousal

Timepoint [28]

Baseline, 3-month, 6-month and 12-month post-commencement of intervention

Secondary outcome [29]

percentage body fat

Timepoint [29]

Baseline and 3-month, 6-month, and 12-month post-commencement of intervention

Secondary outcome [30]

Cost-effectiveness analysis

Timepoint [30]

6 and 12-month post-commencement of the intervention

Secondary outcome [31]

Cost-effectiveness analysis

Timepoint [31]

6 and 12-month post-commencement of the intervention

Secondary outcome [32]

Cost-effectiveness analysis

Timepoint [32]

6 and 12-month post-commencement of the intervention

Eligibility

Key inclusion criteria

• Any academic/non-academic staff of RMIT University, Australia
• Age: 18+ years
• Expressed intent not to leave RMIT over the next 12 months from the beginning of the data collection period
• Completion of Informed Consent
• Have access to computer or smartphone devices
• Have Medicare or equivalent health insurance in Australia

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Suffering from severe psychological distress (assessed by Kessler-10 scale), severe depression, or suicidal ideation.
• Self-reported current meditation practice

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participants will be randomised (after completion of baseline data) either to treatment or control group using computer-generated random sequence numbers, by a researcher not involved in the data collection and study implementation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation by using computer-generated random sequence numbers

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

Statisticians will be blinded to the study group allocation.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

17/10/2024

Date of last participant enrolment

Anticipated

22/08/2025

Actual

Date of last data collection

Anticipated

30/11/2026

Actual

Sample size

Target

122

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

David Lynch Foundation (DLF), philanthropic donations received by RMIT University

Address [1]

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Philia Labs (PL)-will provide the smartwatch at no cost with technical support

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

RMIT 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]

Royal Melbourne Institute of Technology Human Research Ethics Committee

Ethics committee address [1]

https://www.rmit.edu.au/research/our-research/ethics-and-integrity/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/11/2023

Approval date [1]

12/08/2024

Ethics approval number [1]

Summary

Brief summary

Transcendental Meditation (TM) may help prevent psychological distress while promoting mental and cardiometabolic health, but its effects remain underexplored among university staff in Australia. This two-arm, parallel-group randomised controlled trial at RMIT University will compare the effects of TM with access to the university's wellbeing program on psychological and cardiometabolic outcomes. Over 12 months, data will be collected three to four times through surveys, physical measurements (e.g., blood pressure, anthropometry), tracking using Biostrap Kairos watches (e.g. heart rate, sleep), biochemical assessments (e.g., lipid profiles, salivary cortisol, markers of insulin resistance and inflammation, telomere length), and interviews. The study aims to provide empirical evidence of TM's role in enhancing the mental and cardiometabolic health of university staff.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Barbora de Courten

Address

Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia

Country

Australia

Phone

+61 3 9925 6474

Fax

[email protected]

Contact person for public queries

Name

Barbora de Courten

Address

Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia

Country

Australia

Phone

+61 3 9925 6474

Fax

[email protected]

Contact person for scientific queries

Name

Barbora de Courten

Address

Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia

Country

Australia

Phone

+61 3 9925 6474

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: This is a high-risk study involving data on biospecimen analysis, including telomere assessment. Therefore, IPD will not be available.

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					Letter.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