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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] 313565 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 336076 0
Cardiometabolic Health 336077 0
Condition category
Condition code
Cardiovascular 332624 332624 0 0
Normal development and function of the cardiovascular system
Mental Health 332625 332625 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 332626 332626 0 0
Anxiety
Mental Health 332627 332627 0 0
Depression
Metabolic and Endocrine 332628 332628 0 0
Normal metabolism and endocrine development and function
Public Health 332629 332629 0 0
Health promotion/education
Mental Health 332631 332631 0 0
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] 330155 0
Behaviour
Intervention code [2] 330156 0
Lifestyle
Intervention code [3] 330157 0
Prevention
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] 340139 0
Perceived stress
Assessment method [1] 340139 0
Perceived Stress Scale (PSS-10)
Timepoint [1] 340139 0
Baseline, and 3-month, 6-month (primary end-point), and 12-month post-commencement of the intervention
Secondary outcome [1] 442929 0
Anxiety symptoms
Assessment method [1] 442929 0
Generalised anxiety disorder (GAD-7) scale
Timepoint [1] 442929 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [2] 442930 0
Depression symptoms
Assessment method [2] 442930 0
Center for Epidemiological Studies-Depression (CES-D, 10)
Timepoint [2] 442930 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [3] 442931 0
Burnout
Assessment method [3] 442931 0
Burnout assessment tool (BAT-23)
Timepoint [3] 442931 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [4] 442932 0
Health-related quality of life (HRQoL)
Assessment method [4] 442932 0
36-Item Short Form Survey Instrument (SF-36)
Timepoint [4] 442932 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [5] 442933 0
Mental wellbeing
Assessment method [5] 442933 0
Warwick Edinburgh Mental Wellbeing Scale (WEMWBS-7), satisfaction with life- single item
Timepoint [5] 442933 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [6] 442934 0
Emotion Regulation
Assessment method [6] 442934 0
Emotion regulation questionnaire (ERQ-6)
Timepoint [6] 442934 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [7] 442935 0
Sleep Quality
Assessment method [7] 442935 0
Measured by PROMIS SD and SRI
Timepoint [7] 442935 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [8] 442936 0
Work Productivity and Activity Impairment
Assessment method [8] 442936 0
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
Timepoint [8] 442936 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [9] 442938 0
Systolic and Diastolic Blood Pressure (SBP and DBP)
Assessment method [9] 442938 0
Office BP measurement
Timepoint [9] 442938 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [10] 442939 0
Heart Rate Variability (HRV)
Assessment method [10] 442939 0
Wearable smart device (Biostrap Kairos)
Timepoint [10] 442939 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [11] 442940 0
Sleep quality measured by smartwatch (Biostrap Kairos)
Assessment method [11] 442940 0
Wearable smart device (Biostrap Kairos)
Timepoint [11] 442940 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [12] 442941 0
Body mass index (BMI)
Assessment method [12] 442941 0
Anthropometric measurement: height using stadiometer, weight (Digital weighing machine: Withings bodyscan)
Timepoint [12] 442941 0
Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
Secondary outcome [13] 442942 0
Insulin resistance (HOMA-IR)
Assessment method [13] 442942 0
Insulin resistance measurement using HOMA-IR.
Timepoint [13] 442942 0
Baseline and 6-month and 12-month post-commencement of the intervention
Secondary outcome [14] 442943 0
Lipid profile
Assessment method [14] 442943 0
Biochemical assessment of fasting blood sample
Timepoint [14] 442943 0
Baseline and 6 month and 12-month post-commencement of intervention
Secondary outcome [15] 442944 0
Salivary cortisol
Assessment method [15] 442944 0
By saliva sample (measured four times a day: 6-8 am, 12 pm, 4 pm and 8 pm)
Timepoint [15] 442944 0
Baseline and 6 month and 12-month post-commencement of intervention
Secondary outcome [16] 442945 0
Perceived benefit of meditation, barriers and facilitators. These outcomes will be assessed as a composite outcome.
Assessment method [16] 442945 0
In-depth interview among selected participants. The interview will be semi-structured, one-on-one interview (face-to-face or online in Teams) with a member of the research team.
Timepoint [16] 442945 0
At 6-month post-commencement of intervention
Secondary outcome [17] 442946 0
Physical activity
Assessment method [17] 442946 0
Short form of physical activity (IPAQ)- single item
Timepoint [17] 442946 0
Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
Secondary outcome [18] 442947 0
Alcohol, smoking use, and coffee use (composite)
Assessment method [18] 442947 0
Self-reported questionnaires adapted from WHO steps questionnaires
Timepoint [18] 442947 0
Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
Secondary outcome [19] 442948 0
Inflammatory markers
Assessment method [19] 442948 0
Such as high sensitivity C-reactive protein, interleukins (IL) IL-1beta, IL-6, IL-8, IL-10, tumor necrosis factor-alpha, and adipokines (such as adiponectin, resistin, adipsin) using biochemical assessment of fasting blood sample
Timepoint [19] 442948 0
Baseline and 6-month and 12-month post-commencement of intervention
Secondary outcome [20] 442949 0
Telomere length
Assessment method [20] 442949 0
From peripheral blood mononuclear cells (PBMC)
Timepoint [20] 442949 0
Baseline and 6-month and 12-month post-commencement of intervention
Secondary outcome [21] 442950 0
Number of sick leaves over the past month
Assessment method [21] 442950 0
Self-reported scales adapted for this study
Timepoint [21] 442950 0
Baseline, and at monthly interval post-commencement of the intervention
Secondary outcome [22] 442951 0
Daily meditation practice (intervention group only)
Assessment method [22] 442951 0
Self-reported questionnaires (adapted)
Timepoint [22] 442951 0
At two weeks interval after completion of the TM training
Secondary outcome [23] 442952 0
Training satisfaction questionnaire
Assessment method [23] 442952 0
Self-reported tool (adapted)
Timepoint [23] 442952 0
After meditation training
Secondary outcome [24] 444315 0
Sympathetic arousal
Assessment method [24] 444315 0
Wearable smart device (Biostrap Kairos)
Timepoint [24] 444315 0
Baseline, 3-month, 6-month and 12-month post-commencement of intervention
Secondary outcome [25] 444316 0
waist circumference
Assessment method [25] 444316 0
Non elastic measuring tape
Timepoint [25] 444316 0
Baseline, 3-month, 6-month, 12-month post-commencement of intervention
Secondary outcome [26] 444317 0
percentage body fat
Assessment method [26] 444317 0
Withings bodyscan
Timepoint [26] 444317 0
Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
Secondary outcome [27] 444318 0
Fasting blood sugar
Assessment method [27] 444318 0
Biochemical assessment of fasting blood sample
Timepoint [27] 444318 0
Baseline and 6-month and 12-month post-commencement of the intervention
Secondary outcome [28] 444319 0
Daily steps
Assessment method [28] 444319 0
Daily steps count measured by Biostrap Kairos smartwatch.
Timepoint [28] 444319 0
Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
Secondary outcome [29] 444320 0
Antihypertensive drug or other drug use, if any
Assessment method [29] 444320 0
Self-reported questionnaire (designed for this study)
Timepoint [29] 444320 0
Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
Secondary outcome [30] 444569 0
Cost-effectiveness analysis
Assessment method [30] 444569 0
Cost-effectiveness analysis in terms of changes in wellbeing (WEMWBS-7)
Timepoint [30] 444569 0
6 and 12-month post-commencement of the intervention
Secondary outcome [31] 444570 0
Cost-effectiveness analysis
Assessment method [31] 444570 0
Cost-effectiveness analysis in terms of changes in health-related quality of life (HRQoL)
Timepoint [31] 444570 0
6 and 12-month post-commencement of the intervention
Secondary outcome [32] 444571 0
Cost-effectiveness analysis
Assessment method [32] 444571 0
Cost-effectiveness analysis in terms of changes in and satisfaction with life (SWL-1).
Timepoint [32] 444571 0
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
54
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318028 0
Charities/Societies/Foundations
Name [1] 318028 0
David Lynch Foundation (DLF), philanthropic donations received by RMIT University
Country [1] 318028 0
Australia
Funding source category [2] 318029 0
Commercial sector/Industry
Name [2] 318029 0
Philia Labs (PL)-will provide the smartwatch at no cost with technical support
Country [2] 318029 0
Australia
Primary sponsor type
University
Name
RMIT University
Country
Australia
Secondary sponsor category [1] 320373 0
None
Name [1] 320373 0
Country [1] 320373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316686 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 316686 0
Ethics committee country [1] 316686 0
Australia
Date submitted for ethics approval [1] 316686 0
17/11/2023
Approval date [1] 316686 0
12/08/2024
Ethics approval number [1] 316686 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138666 0
Prof Barbora de Courten
Address 138666 0
Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia
Country 138666 0
Australia
Phone 138666 0
+61 3 9925 6474
Email 138666 0
barbora.decourten@rmit.edu.au
Contact person for public queries
Name 138667 0
Barbora de Courten
Address 138667 0
Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia
Country 138667 0
Australia
Phone 138667 0
+61 3 9925 6474
Email 138667 0
barbora.decourten@rmit.edu.au
Contact person for scientific queries
Name 138668 0
Barbora de Courten
Address 138668 0
Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia
Country 138668 0
Australia
Phone 138668 0
+61 3 9925 6474
Email 138668 0
barbora.decourten@rmit.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24457Ethical approval    Letter.pdf



Results publications and other study-related documents

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

Documents added automatically
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