Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000184774
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
15/02/2013
Date last updated
18/07/2019
Date data sharing statement initially provided
18/07/2019
Date results information initially provided
18/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcendental Meditation for Carers of Dementia Sufferers Trial [TRANSCENDENT]
Scientific title
Improving the health and wellbeing of community-dwelling carers of dementia sufferers – a randomised controlled trial of structured meditation training.
Secondary ID [1] 281954 0
Nil
Universal Trial Number (UTN)
Trial acronym
TRANSCENDENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological stress 288372 0
Condition category
Condition code
Alternative and Complementary Medicine 288717 288717 0 0
Other alternative and complementary medicine
Mental Health 288745 288745 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcendental Meditation [Registered Trademark] (TM): The twelve-week TM training program comprises a one-hour introductory session, four one-and-a-half-hour training sessions (over the first week), followed by three weekly one-hour classes and four fortnightly one-hour classes, held in groups, under the guidance of experienced TM instructors. The initial sessions will comprise content on the health effects of stress, the theory of TM, training of the TM technique, and assessment and refining of the technique. The weekly and fortnightly sessions will focus on assessing, refining and mastering the TM technique.
Intervention code [1] 286521 0
Treatment: Other
Intervention code [2] 286539 0
Behaviour
Comparator / control treatment
Wait-list control: Participants assigned to wait-list control will receive twelve-weeks of no intervention, followed by four-weeks of a healthy lifestyle education program. The lifestyle program comprises four weekly ninety-minute sessions. These group sessions will be facilitated by an experienced TM instructor. Sessions will be focussed on developing skills and knowledge that foster a healthy diet and lifestyle, including yoga, preparing healthy meals, and stress management.
Control group
Active

Outcomes
Primary outcome [1] 288860 0
Mean health-related quality of life index score, as measured by the Assessment of Quality of Life 8-dimension (AQoL-8D) instrument
Timepoint [1] 288860 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24).
Primary outcome [2] 288861 0
Mean stress score, as measured by the depression, anxiety and stress scale within the WebNeuro test battery.
Timepoint [2] 288861 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24).
Secondary outcome [1] 301192 0
Mean emotional resilience score, as measured by the WebNeuro test battery
Timepoint [1] 301192 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [2] 301195 0
Mean depression score, as measured by the depression, anxiety and stress scale within the WebNeuro test battery.
Timepoint [2] 301195 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [3] 301196 0
Mean anxiety score, as measured by the depression, anxiety and stress scale within the WebNeuro test battery.
Timepoint [3] 301196 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [4] 301197 0
Mean psychomotor response speed, as measured by the WebNeuro test battery.
Timepoint [4] 301197 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [5] 301198 0
Mean impulsivity score, as measured by the WebNeuro test battery.
Timepoint [5] 301198 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [6] 301199 0
Mean attention and concentration score, as measured by the WebNeuro test battery.
Timepoint [6] 301199 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [7] 301200 0
Mean information processing efficiency score, as measured by the WebNeuro test battery.
Timepoint [7] 301200 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [8] 301201 0
Mean working memory score, as measured by the WebNeuro test battery.
Timepoint [8] 301201 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)
Secondary outcome [9] 301202 0
Mean executive function score, as measured by the WebNeuro test battery.
Timepoint [9] 301202 0
This will be assessed at baseline (week 0), post-intervention (week 12) and at follow-up (week 24)

Eligibility
Key inclusion criteria
(i) Is a non-professional, community-dwelling carer of a person with diagnosed dementia,
(ii) Has not received previous instruction on the TM technique,
(iii) Is able to provide written consent,
(iv) Is able to speak, read and understand English,
(v) Is available and willing to complete all TM / healthy lifestyle program sessions and baseline, post-intervention and follow-up assessments, and
(vi) Is able to arrange respite for the dementia sufferer when away for the TM / healthy lifestyle program sessions and assessments.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) Has a history of any condition causing moderate to severe cognitive impairment,
(ii) Has begun or ceased psychotropic medication within the past six weeks,
(iii) Has participated in a clinical trial within the past 30 days, where psychological outcomes and quality of life were outcomes of interest,
(iv) Practices some form of mind-body therapy on a regular basis,
(v) Consults a psychologist or psychiatrist at least once a week, and
(vi) Has taken a recreational drug in the past 15 days.

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)
Randomisation codes will be held in sequentially numbered opaque sealed envelopes. Each envelope will be selected in consecutive order at the time of participant enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to TM or wait-list control at a ratio of 1:1. Block randomisation will be used with computer-generated randomly permuted blocks of four; this will be performed by a researcher not involved in the implementation of the project, and blinded to the identity of the participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
- Measures of central tendency and variability will be used for descriptive data that is normally distributed.
- Medians and the interquartile ranges will be used to describe data that is not normally distributed.
- Frequency distributions and percentages will be used to describe categorical data.
- Differences between groups at baseline will be examined using the t-test for independent groups.
- Outcome differences between groups, differences over time and any differential treatment effect at different points in time will be examined using repeated measures analysis of variance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2013
Actual
8/04/2013
Date of last participant enrolment
Anticipated
Actual
4/04/2014
Date of last data collection
Anticipated
Actual
4/09/2014
Sample size
Target
36
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286735 0
Charities/Societies/Foundations
Name [1] 286735 0
Alzheimer's Australia Dementia Research Foundation
Country [1] 286735 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 285511 0
None
Name [1] 285511 0
Address [1] 285511 0
Country [1] 285511 0
Other collaborator category [1] 277281 0
Charities/Societies/Foundations
Name [1] 277281 0
Maharishi Invincibility Centre
Address [1] 277281 0
190 Greenhill Road, Parkside, SA, 5063
Country [1] 277281 0
Australia
Other collaborator category [2] 277282 0
University
Name [2] 277282 0
RMIT University
Address [2] 277282 0
200 Ballarat Road, Hamilton, VIC, 3300
Country [2] 277282 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288808 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 288808 0
GPO Box 2471, Adelaide, SA, 5001
Ethics committee country [1] 288808 0
Australia
Date submitted for ethics approval [1] 288808 0
Approval date [1] 288808 0
27/05/2011
Ethics approval number [1] 288808 0

Summary
Brief summary
The impact of dementia on family caregivers is substantial. Building on growing clinical interest in the capacity for Transcendental Meditation [Registered Trademark] (TM; a deep relaxation technique) to reduce stress and anxiety in healthy workers, this pilot RCT will examine whether similar improvements could be experienced by dementia caregivers. Specifically, the study will explore whether a TM program can improve psychological stress, quality of life, affect and cognitive performance of dementia caregivers when compared to wait-list control.
Trial website
Trial related presentations / publications
Leach MJ. Francis A. Ziaian T. (2015) Transcendental Meditation for the improvement of health and wellbeing in community-dwelling dementia caregivers [TRANSCENDENT]: a randomised wait-list controlled trial. BMC Complementary & Alternative Medicine. 15: 145.

Leach MJ. Francis A. Ziaian T. (2016) Recruiting dementia caregivers into clinical trials: lessons learnt from the Australian TRANSCENDENT trial. Alzheimer Disease & Associated Disorders. 30(4): 338-344.
Public notes

Contacts
Principal investigator
Name 37854 0
Dr Matthew Leach
Address 37854 0
School of Nursing & Midwifery, Centenary Building, University of South Australia, North Terrace, Adelaide, SA, 5000
Country 37854 0
Australia
Phone 37854 0
+61 8 8302 2846
Fax 37854 0
Email 37854 0
matthew.leach@unisa.edu.au
Contact person for public queries
Name 37855 0
Dr Matthew Leach
Address 37855 0
School of Nursing & Midwifery, Centenary Building, University of South Australia, North Terrace, Adelaide, SA, 5000
Country 37855 0
Australia
Phone 37855 0
+61 8 8302 2846
Fax 37855 0
Email 37855 0
matthew.leach@unisa.edu.au
Contact person for scientific queries
Name 37856 0
Dr Matthew Leach
Address 37856 0
School of Nursing & Midwifery, Centenary Building, University of South Australia, North Terrace, Adelaide, SA, 5000
Country 37856 0
Australia
Phone 37856 0
+61 8 8302 2846
Fax 37856 0
Email 37856 0
matthew.leach@unisa.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
Study participants have not consented to their data being used by third parties or for purposes other than that described in the approved study protocol.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3169Study protocolLeach MJ. Francis A. Ziaian T. (2014) Improving the health and wellbeing of community-dwelling carers of dementia sufferers – study protocol of a randomised controlled trial of structured meditation training. Journal of Alternative & Complementary Medicine. 20(2): 136-141.  


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Leach MJ. Francis A. Ziaian T. (2015) Transcendent... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTranscendental Meditation for the improvement of health and wellbeing in community-dwelling dementia caregivers [TRANSCENDENT]: A randomised wait-list controlled trial.2015https://dx.doi.org/10.1186/s12906-015-0666-8
N.B. These documents automatically identified may not have been verified by the study sponsor.