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Trial registered on ANZCTR


Registration number
ACTRN12619001555145
Ethics application status
Approved
Date submitted
11/10/2019
Date registered
12/11/2019
Date last updated
12/11/2019
Date data sharing statement initially provided
12/11/2019
Date results information initially provided
12/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain Changes after brief meditation
Scientific title
Functional Brain Changes Associated with EcoMeditation: A comparison to brief meditation in healthy volunteers.
Secondary ID [1] 299533 0
none
Universal Trial Number (UTN)
U1111-1241-9238
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 314786 0
Condition category
Condition code
Mental Health 313116 313116 0 0
Other mental health disorders
Neurological 313256 313256 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be called for through community advertising, and must be over 18 years (for consent issues). Both women and men will be eligible for treatment and both meditators and non-meditators will be included. You cannot participate if you have a previous or current mental health diagnosis (as diagnosed previously), a prior head trauma, current recreational drug usage or current medication that affects the central nervous system.

Some of the main mental health diagnosis groups are:

• mood disorders (such as depression or bipolar disorder)
• anxiety disorders.
• personality disorders.
• psychotic disorders (such as schizophrenia)
• eating disorders.
• trauma-related disorders (such as post-traumatic stress disorder)
• substance abuse disorders.

Suitable participants will be sent a package of questionnaires to complete online before they attend a brain scanning session (fMRI). They will be scanned for 10 minutes and then engage in a 4 week meditation trial where they will be asked to listen to either a brief 22 minute Ecomeditation track (daily) or a comparison brief meditation track. Everyone will be asked to keep a daily log of whether they completed the track for that day - the Ecomeditation or comparison track will be randomly allocated (via computer generator) after they have been assigned their first scan time. Both meditations are delivered by a meditation expert (recorded voice on the track).

There will be 2 groups: experienced meditators and in-experienced meditators (defined below).

EcoMeditation is a novel form of meditation designed to address this issue. Rather than relying on a spiritual, religious or cognitive framework, it uses physical cues (e.g. “Slow your breathing to 6 seconds per inbreath”) to induce transcendent states. This makes its practice relatively easy for both novices and experienced meditation practitioners. Preliminary evidence indicates that EcoMeditation is able to induce a sustained alpha brain wave state in under 5 minutes, a time period much briefer than that measured in studies of other methods.
The actual script of the Ecomeditation is as follows:

1. Mindful Breathing.
0:00: Instruction: Feel the natural rhythm of your own breath. Imagine your breath coming in and out of your heart.

2. Heart Tapping.
1:00: Instruction: Imagine crossing hands over heart and tapping with fingertips.

3. Stress Release Visualization.
1:30: Instruction: Imagine tapping on heart, visualize stress leaving your body.

4. Reversal Point Tapping.
2:00: Instruction: Imagine tapping on the side of your hand.

5. Affirmation of Inner Peace.
2:30: Instruction: Affirm that I release any and every obstacle to inner peace. I fill myself with inner peace and release everything else.

6. Parasympathetic Activation of Vagus via Hypoglossal Nerve.
3:07: Instruction: Relax your tongue on the floor of your mouth.

7. Alpha Brain Wave Induction.
3:45: Instruction: Feel the space inside your hands, feet, body, head, and between your eyes.

8. Heart Coherence Induction.
5:00: Instruction: Slow your breathing down to six seconds in and six seconds out.

9. Heart Mindfulness.
6:20: Instruction: Feel the energy of love, kindness and compassion inside your own heart

10. Deep Coherence Induction.
6:45: Instruction: Send a beam of heart energy to a person or place.
7:20: Instruction: Visualize details of heart energy beam.

11. Compassion for Others Visualization.
11:10: Instruction: In your heart energy beam, feel the love and compassion, and send it to that person or place.

12. Universal Compassion Visualization.
13:00: Instruction: Imagine your compassion flowing to every part of the universe.

13. Intensity Induction.
14:00: Instruction: Intensify the experience.

14. Compassion for Self Visualization.
16:15: Instruction: Draw energy beam back into your own body. Feel compassion and love within.

15. Body Mindfulness Eyes Closed.
17:10: Instruction: Send a beam of your compassionate heart energy with to a part of your own body that is suffering.

16. Orientation to Present.
20:00: Return to the Present: Instruction: Feel your hands and feet. With the next three breaths bring yourself fully into the present.

17. Return to Present Time and Space.
20:30: Open Eyes. Instruction: Open your eyes, look around you with soft eyes. Notice objects in environment.

18. Body Mindfulness Eyes Open.
21:15: Instruction: Notice peace in body.

19. Anchoring Wellbeing in Body.
21:30: Instruction: Heart tapping

20. Anchoring Wellbeing in Mind.
21:45: Instruction: Affirm that I deserve to feel good.

22:35: End.


Inclusion criteria: Ability to follow instructions and fill out forms. 18 years or older. Both meditators and non-meditators will be included.

Exclusion: No previous or current DSM-5 (as diagnosed previously). No prior head trauma. No current recreational drug usage. No current medication that affects the central nervous system.

Functional Magnetic Resonance Imaging (fMRI) is widely used to map brain activity. fMRI exploits the local increase in blood flow and hence blood volume and blood oxygenation that occur to support the resulting increase in metabolic demand, instead of detecting neuronal activity directly. Brain imaging is a powerful technique that is enhancing neuroscience research. Most conventional fMRI studies are based on the BOLD effect, which is the term used to describe the increase in fMRI signal due to the change in blood oxygenation and blood volume secondary to the increase in blood flow. BOLD fMRI has been used to map the primary cortical representation of taste and odour in humans and to study responses to pleasant and aversive stimuli.

The fMRI scans will be examined for intracranial structural abnormalities by the Radiologist expert who works at the service - Queensland Diagnostic Imaging (Dr Craig Buchan). During the fMRI scanning the participants will be passive. The scan will be 10 minutes at baseline. Afterwards they will engage in listening to a meditation track daily for 4 weeks and then be scanned again at post. Teh scans will be compared.

Participants will be scanned on a Skyra 3T system on NUMARIS/4 Version Syngo MR E11A, using a 20ch head neck coil combination. A ep2d_pace_moco sequence will be used. This is a single shot Echo planar sequence that has prospective motion correction built within the sequence to correct in real time for motion. In addition, real time monitoring of the amount of motion is possible via the 3D neuro card utilizing the inline features.

Post processing will be completed on the scanner using the Neuro 3D platform.

Meditator definitions: experienced meditators are defined as those participants who report a meditation frequency and duration of at least twice a week, thirty minutes or more, for a year or more.

Non-meditators: are those who a meditation frequency of less than once a week over the previous year.
Intervention code [1] 315789 0
Behaviour
Intervention code [2] 315863 0
Treatment: Other
Comparator / control treatment
The comparison meditation to the Ecomeditation being tested is a meditation of the same length. It has had the steps in Ecomeditation removed (this is 1-21) - instead the participants will listen to a guided visualization about a previous holiday they have had, just to relax. There are no steps of the ecomeditation in the comparison meditation.
Control group
Active

Outcomes
Primary outcome [1] 321657 0
Composite primary outcome is Brain changes - deactivation of the brain’s Default Mode Network (PCC / MPFC) and amygdala. This is measured through the fMRI scan analysis.
Timepoint [1] 321657 0
After 4 weeks (post)
Secondary outcome [1] 375791 0
Change in psychological symptomology of stress as measured by the Patient Health Questionnaire
Timepoint [1] 375791 0
Post (after 4 weeks)
Secondary outcome [2] 376101 0
Measurement of mystical experiences (mystical experience, defined as “the experience of profound unity with all that exists, a felt sense of sacredness, a sense of the experience of truth and reality at a fundamental level (noetic quality), deeply felt positive mood, transcendence of time and space, and difficulty explaining the experience in words.”), as measured by the Revised Mystical Experiences Questionnaire
Timepoint [2] 376101 0
4 weeks (post)

Eligibility
Key inclusion criteria
Inclusion criteria: Ability to follow instructions and fill out forms. 18 years or older. Both meditators and non-meditators will be included.


Meditator definitions: Experienced Meditators are defined as those participants who report a meditation frequency and duration of at least twice a week, thirty minutes or more, for a year or more.
Non-meditators are those who a meditation frequency of less than once a week over the previous year.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No previous or current DSM-5 (as diagnosed previously and examples below). No prior head trauma. No current recreational drug usage. No current medication that affects the central nervous system.

Some of the main mental health diagnosis groups are_ •mood disorders (such as depression or bipolar disorder)•anxiety disorders.•personality disorders.•psychotic disorders (such as schizophrenia)•eating disorders.•trauma-related disorders (such as post-traumatic stress disorder)•substance abuse disorders

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
central randomisation by computer
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
Data for the psychological questionnaires will be analysed using MANOVA or t-test.

The average percent signal change (± SD) in fMRI data will be analysed pre-post.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304025 0
Commercial sector/Industry
Name [1] 304025 0
The National Institute for Integrative Healthcare (NIIH) in USA
Address [1] 304025 0
3340 Fulton Rd, #442, Fulton, California USA 95404
Country [1] 304025 0
United States of America
Primary sponsor type
University
Name
Bond University
Address
School of Psychology
University Rd
Bond University
Robina Queensland 4229
Country
Australia
Secondary sponsor category [1] 304201 0
None
Name [1] 304201 0
Address [1] 304201 0
Country [1] 304201 0
Other collaborator category [1] 280988 0
Other Collaborative groups
Name [1] 280988 0
Queensland Diagnostic Imaging
Address [1] 280988 0
2 Lake Street, Varsity Lakes, Queensland Australia 4227
Country [1] 280988 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304516 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 304516 0
School of Psychology
University Rd
Bond University
Robina Queensland 4229
Ethics committee country [1] 304516 0
Australia
Date submitted for ethics approval [1] 304516 0
15/03/2019
Approval date [1] 304516 0
05/04/2019
Ethics approval number [1] 304516 0
PS00116

Summary
Brief summary
This research is being conducted to investigate the impact of a brief meditation on brain function using a functional MRI process. The benefits of this study will include determining the impact of Ecomeditation (a brief 22 minute meditation) on neural brain changes - participants will be asked to have a 10 minute brain scan then engage in listening to a meditation track for 4 weeks (daily) and then have another brain scan to see if there are any changes. Validating brief meditation as a physiological method of meditation that can be rapidly and reliably induced, may make brief meditation accessible to many who have found it difficult in the past. We will compare both experienced meditators and non-meditators (in order to ascertain whether non-meditators are able to achieve sustaining a meditative state over the 4 weeks and to see any changes it has on brain regions indicative of deep meditative states, such as the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, the thymus, and the hippocampus. It is hypothesized that changes in activity patterns and maybe connectivity will be observed).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97226 0
A/Prof Peta Stapleton
Address 97226 0
School of Psychology
Bond University
University Drive
Robina Queensland 4227
Country 97226 0
Australia
Phone 97226 0
+61 7 55952515
Fax 97226 0
Email 97226 0
pstaplet@bond.edu.au
Contact person for public queries
Name 97227 0
A/Prof Peta Stapleton
Address 97227 0
School of Psychology
Bond University
University Drive
Robina Queensland 4227
Country 97227 0
Australia
Phone 97227 0
+61 755952515
Fax 97227 0
Email 97227 0
pstaplet@bond.edu.au
Contact person for scientific queries
Name 97228 0
A/Prof Peta Stapleton
Address 97228 0
School of Psychology
Bond University
University Drive
Robina Queensland 4227
Country 97228 0
Australia
Phone 97228 0
+61 755952515
Fax 97228 0
Email 97228 0
pstaplet@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary