Improving the Health and Well-Being
of Community-Dwelling Caregivers of Dementia Sufferers:
Study Protocol of a Randomized Controlled
Trial of Structured Meditation Training
Matthew J. Leach, PhD,1 Andrew Francis, PhD,2 and Tahereh Ziaian, PhD1
Background: Caring for a person with dementia can be an unrelenting and burdensome task, one that is often
detrimental to the caregiverâ€™s health, well-being, and functionality. The enduring stress and frustration of the
caregiver role can also contribute to poorer outcomes for dementia sufferers. Building on growing clinical
interest in the capacity for Transcendental Meditation (TM; a relaxation technique) to reduce stress and anxiety
in healthy workers, this study examines whether similar improvements could be experienced by dementia
Objective: The study objective was to ascertain whether a TM program can improve psychological stress, quality
of life, affect, and cognitive performance of dementia caregivers.
Design: The study was a pilot prospective, single-center, randomized wait-list controlled trial with two parallel
Setting/subjects: Community-dwelling carers of persons with diagnosed dementia, residing in metropolitan
Adelaide, South Australia, were included in this study.
Interventions: Participants will be randomly assigned to a 13-hour TM training program or wait-list control over
Outcomes: Primary outcomes include quality of life and stress. Secondary outcomes include affect, cognitive
performance, cost-effectiveness, and study feasibility. Outcomes will be assessed at baseline, week 12 (postintervention), and week 24 (follow-up).
Results: Results are expected to be available early in 2014.
Conclusions: This project responds to a need for robust evidence of the clinical and economic effectiveness of TM
for the management of caregiver stress. If Transcendental Meditation is shown to be effective, it could indicate a
simple, cost-effective, and easily implemented strategy to assist many of the growing numbers of caregivers to
cope with the demanding and often difficult caregiver role.
Dementia is a syndrome characterized by progressive
decline in global cognitive ability, paralleled by increasing dependence on others (such as family) for activities
of daily living. It is estimated that more than 24.3 million
people across the globe suffer from dementia; this is predicted
to rise to over 81.1 million in 2040.1 The combination of
chronicity and prevalence contributes to a substantial disease
burden. In Australia, 266,000 people have dementia,2 which
accounts for 5.3% of all disability-adjusted life years lost due
to disease in older Australians.3
The burden on the health system in terms of financial and
human resources is also considerable, with direct and indirect health care expenditure on dementia in Australia in 2002
estimated at AU$6.6 billion.3 Assuming the same cost of
AU$40,519 per person with dementia, and the estimated
prevalence of dementia reported in 2011 (i.e., 266,000
School of Nursing & Midwifery, University of South Australia, Adelaide, South Australia.
School of Health Sciences, RMIT University, Bundoora, Victoria.
THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 20, Number 2, 2014, pp. 136â€“141
Âª Mary Ann Liebert, Inc.
Australians),2 the total cost of dementia care in Australia in
2011 is predicted to be closer to AU$10.8 billion. The cost of
care provided by family carers, who deliver a large proportion of dementia care in Australia, accounts for a third
($3.4 billion) of this estimate.
The impact of dementia on family caregivers is substantial.
In financial terms, carers may experience loss of earnings, either from reduced working hours or relinquished employment.4 Carers of people with dementia also report high levels
of stress, sleep disturbance, depression, anxiety, social isolation, comorbid illness and impaired cognitive performance, as
well as reduced quality of life.5â€“8 Studies also indicate a sixfold
increased risk of dementia in community-dwelling carers of
dementia sufferers when compared to noncaregivers.9 The
enduring stress and frustration of caring for a person with
dementia, or caregiver burden, is also associated with poor
outcomes for dementia sufferers, including decreased quality
of life, reduced functional and psychological status, and early
nursing home placement7,10,11; all of this contributes to further
distress in the carer.7 The need to improve the emotional,
psychological, and physical well-being of carers thus has important health, social, and economic implications.
Some complementary therapies, specifically relaxation
therapies, have demonstrated promising effects in the management of conditions either induced or exacerbated by
stress, including anxiety,12 migraine,13 and irritable bowel
syndrome.14 This suggests that these therapies may help to
reduce caregiver burden. Many of these therapies may work
by inducing the relaxation response. Smithâ€™s Attentional
Behavioural Cognitive relaxation theory proposes that all
approaches to relaxation have the potential to evoke one or
more of 15 factor-analytically derived relaxation states, or
â€˜â€˜R-States,â€™â€™ such as physical relaxation, awareness, and feeling energized.15
One form of relaxation therapy that demonstrates promise
as a treatment for stress is Transcendental Meditation (TM).
This therapy, which originated in India in the 1950s, is a form
of concentrative meditation that allows an individualâ€™s attention to travel naturally to a less active, quieter style of
mental functioning, to produce a unique psychophysiological state of restful alertness.16 Unlike many other forms of
relaxation, TM is highly standardized, relatively effortless,
easily learned, convenient (i.e., can be practiced anywhere
and anytime), and without ongoing cost to the user16; TM
has also been shown to produce larger effects in patients
with anxiety when compared to other relaxation techniques.16 These features make TM a suitable and accessible
relaxation technique for busy caregivers.
Although there have been no studies to date examining the
effects of TM on any outcome in carers, evidence from a small
US pilot study of 31 dementia caregivers suggests that another
form of relaxation therapy, mindfulness meditation, may be
more effective than respite in reducing carer stress.17 In view
of these findings, and the results of an earlier randomized
controlled trial showing TM to be comparable with other
kinds of relaxation therapies in reducing anxiety in patients
diagnosed with anxiety neurosis,18 it is plausible that TM also
may be beneficial in attenuating stress and anxiety in dementia caregivers. This is, in part, supported by evidence from
controlled trials examining the effects of TM in workers.19,20
Given the implications of stress on carers, their family, and
the wider community, and the favorable effects of TM on
stressful symptoms, while bearing in mind the paucity of
trials on TM and stress, the high risk of bias of these studies,
and the absence of data on the effects of TM in caregivers,
further research in this area is well justified.
This project responds to a need for robust evidence of the
clinical and economic effectiveness of TM for the management
of caregiver stress. In doing so, the proposed study will address the criticisms of previous TM trials, including (1) using
outcome measures with established validity and reliability, (2)
ensuring the study design and the reporting of study methods
and findings meet the minimum requirements set out in
the Consolidated Standards of Reporting Trials (CONSORT)
statement, (3) avoiding comparing the effectiveness of TM
with other forms of relaxation therapy, and (4) ensuring the
study is registered on a clinical trial register, and the study
protocol is published in the public domain.
The Transcendental Meditation for carers of dementia sufferers trial (TRANSCENDENT) is a pilot prospective, singlecenter, randomized wait-list controlled trial (RCT) with two
parallel arms. This design will control against major sources of
bias and attempt to discredit any alternative causal explanation; this will provide a sound basis for evaluating the effectiveness of Transcendental Meditation, and for determining
the feasibility of conducting a larger trial in this area. While
participant blinding is not possible in this trial due to the nature
of the intervention, staff involved in data collection, data entry,
and data analysis will be blinded to treatment assignment.
TRANSCENDENT is designed to address the following
1. Establish whether TM improves health-related quality
of life in community-dwelling carers of dementia sufferers when compared to wait-list control (WLC).
2. Ascertain whether TM reduces psychological stress in
community-dwelling carers of dementia sufferers when
compared to WLC.
1. Determine whether TM improves affect in communitydwelling carers of dementia sufferers relative to WLC.
2. Ascertain whether TM improves cognitive performance
in community-dwelling carers of dementia sufferers
when compared to WLC.
3. Determine whether TM is cost-effective in improving
health-related quality of life in community-dwelling
carers of dementia sufferers relative to WLC.
4. Determine the feasibility of implementing the project as
a larger RCT.
Individuals meeting the following selection criteria will be
eligible to participate in TRANSCENDENT.
TRANSCENDENT STUDY PROTOCOL 137
The inclusion criteria were as follows: (1) Nonprofessional,
community-dwelling carer of a person with diagnosed dementia; (2) Not received previous instruction on the TM
technique; (3) Able to provide written consent; (4) Able to
speak, read, and understand English; and (5) Available and
willing to complete all intervention sessions and assessments.
The exclusion criteria were as follows: (1) History of any
condition causing moderate-to-severe cognitive impairment;
(2) Commenced or ceased psychotropic medication within the
past 6 weeks; (3) Participated in a clinical trial within the past
30 days, where psychological outcomes and quality of life
were outcomes of interest; (4) Practices some form of mindâ€“
body therapy on a regular basis (i.e., at least once a month); (5)
Consults a psychologist/psychiatrist at least once a week; and
(6) Taken a recreational drug in the past 15 days.
The sample size was based on an expected mean difference in quality of life (AQoL) of 0.1 utility points between the
TM and WLC groups. Assuming a standard deviation of
12.5% and 10% attrition, a sample size of 18 patients will be
required in each arm. A total of 36 participants will have 80%
power for a two-way repeated-measures analysis of variance
(RM-ANOVA) to detect a statistically significant difference
in quality of life with a two-tailed alevel set at 0.05. This
sample will be sufficient to test the feasibility of the study,
and to generate the necessary data to estimate the sample
size for a larger clinical trial.
TRANSCENDENT will be administered by the University
of South Australia, and implemented through the positive
aging center (Woodside, South Australia), and the Maharishi
Invincibility Centre (Parkside, South Australia).
Nonprofessional, community-dwelling carers will be informed of the study through notices mailed to them by the
Adelaide Hills Council and multiple carer respite agencies
throughout Central Adelaide. In addition, study flyers will
be posted on the noticeboards of community health centers,
Adelaide Hills Council offices, and general practices within
the Adelaide Hills Council and Central Adelaide area. A
media release will also be disseminated to local newspapers,
radio stations, and television networks. Carers expressing
interest in participating in the project will be asked to contact
the research assistant (by phone) for further information and
screening. Carers eligible to participate in the study will be
posted/e-mailed a copy of the participant information sheet
and consent form to read and discuss with family/friends in
order to make an informed decision. One week after dispatching the study information, participants will be contacted by phone to gauge their â€˜â€˜capacity to give consentâ€™â€™
(i.e., the ability to provide a brief description of the study
purpose, and outline what their involvement in the study
might entail). Participants able to provide a satisfactory response to these questions will be invited to sign the written
consent form and return it to the research assistant using the
attached reply-paid envelope. Participant recruitment is expected to commence in April 2013 and be completed by May
2013. The planned end date for the trial is December 2013.
Enrolled participants will be randomly assigned to TM or
WLC at a ratio of 1:1 (Fig. 1). To approximate equality of
sample sizes in each study group, block randomization will
be used with computer-generated randomly permuted
blocks of four; this will be performed prior to participant
recruitment, and by a researcher not involved in the implementation of treatment assignment. Randomization codes
will be held in sequentially numbered opaque sealed envelopes. Each envelope will be selected by the research assistant (who will be unaware of the allocation sequence) in
consecutive order at the time of participant enrolment.
The primary and secondary endpoints of TRANSCENDENT
are conceptualized and operationally defined as follows:
Health-related quality of life (HR-QoL) refers to an individualâ€™s sense of well-being and an ability to enjoy normal life
activities. Given that carers of persons with dementia demonstrate a significant decline in quality of life,5,6 it is important to recognize the participantâ€™s perception of change in
response to each treatment in order to capture any patientcentered benefits resulting from each intervention. HR-QoL
index scores will be measured using the Assessment of
Quality of Life 8-dimension (AQoL-8D) instrument. This
instrument, which takes less than 10 minutes to complete,
will be self-administered by participants at baseline (week 0),
postintervention (week 12), and follow-up (week 24).
Stress is a physiological and psychological response to an
intrinsic or extrinsic event or situation. Carers of people with
dementia report high levels of stress,5,6 which can contribute
toward impairments in cognitive performance, sleep disturbance, depression, and other comorbidities.4â€“6 Caregiver
stress can also contribute to poor outcomes in dementia
sufferers.10,11,21 Stress is a particularly important outcome as
it has notable consequences for the health and well-being of
the carer, as well as those under their care. Mean stress score
will be measured using the WebNeuro test battery (a selfadministered, validated, neurocognitive assessment measure). The test battery will take participants between 50 and
60 minutes to complete, and will be performed at baseline,
postintervention, and follow-up.
Affect is the expression of feelings or emotions. A number
of systematic reviews report a higher prevalence of affective
disorders (such as depression and anxiety) in dementia
caregivers when compared with noncaregivers.7 This is
likely to impact on the caregiversâ€™ capacity to self-care and to
care for the person with dementia. Affect, specifically (1)
emotional resilience, (2) feelings of depression, and (3) feelings
of anxiety, will be measured using the WebNeuro test battery.
138 LEACH ET AL.
Cognitive performance is the ability to process information,
apply previously acquired knowledge, build understanding,
and initiate responses. Carers of people with dementia report
high levels of stress,5,6 and stress has been shown to impair
cognitive performance.4 Importantly, reduced cognitive
performance in caregivers predicts poor physical function
and ability to care.8 Cognitive performance, specifically (1)
psychomotor response speed, (2) impulsivity, (3) attention
and concentration, (4) information processing efficiency, (5)
working memory, and (6) executive function, will be measured using the WebNeuro test battery.
Cost-effectiveness will be determined using cost-utility
analysis; this will examine the cost and effectiveness of each
intervention using the quality-adjusted life year (QALY) as
its unit of effectiveness. The AQoL-8D will be used to derive
quality-of-life utility scores and to measure any change over
the trial period. Results for each group will be compared to
identify any differential change in quality of life that can be
multiplied by time to generate quality-adjusted life year
(QALY) gain or loss for each intervention group. The cost of
each intervention will be derived from trial cost data. This
will be combined with QALYs to estimate cost per QALY
gain, with the assumption that TM is more expensive than
WLC but delivers greater quality of life. This outcome will be
assessed on completion of the study.
Feasibility, in the context of this study, refers to the ease and
practicality of reproducing the study on a larger scale, that is,
as a larger randomized controlled trial. Feasibility will be
determined by (1) measuring rates of participant recruitment,
retention, and response, (2) reporting the efficiency of each
FIG. 1. Flowchart of Transcendental Meditation for carers of dementia sufferers trial
TRANSCENDENT STUDY PROTOCOL 139
recruitment strategy, (3) recording participant experiences of
the study (via the trial exit survey) and semi-structured participant interviews, and (4) evaluating the logistics of the trial
methodology and procedures. This outcome will be assessed
on completion of the study.
Participants will be randomly assigned to one of two groups:
TM or WLC. The 12-week (13-hour) TM training program
comprises a 1-hour introductory session, 30-minute personal
instruction, three 1.5-hour training sessions (over the first
week), followed by three weekly 1-hour classes and four 2-
weekly 1-hour classes, 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 2-weekly sessions will focus on assessing, refining,
and mastering the TM technique.
Participants assigned to wait-list control will receive 24
weeks of no intervention, followed by a 4-week healthy lifestyle education (HLE) program. (Due to resource constraints,
it is not feasible to offer TM to the WLC group; hence, participant information will clearly identify HLE as the comparative intervention). The wait-list arm is a critical component of
the study design as it will control for nonspecific effects and
bias. The HLE program comprises 4 weekly 90-minute sessions. These sessions will be facilitated by an experienced TM
instructor. Sessions will focus on developing skills and
knowledge that foster a healthy diet and lifestyle, including
yoga, preparation of healthy meals, and stress management.
All treatment and control sessions will be delivered face-toface, in groups, during business hours at the positive aging
center (Woodside, South Australia) and the Maharishi Invincibility Centre (Parkside, South Australia). Subjects in both
groups also will be contacted by telephone every 6 weeks to
monitor retention and participant experience.
Data from all completed outcome measures will be entered
onto SPSS (v. 20), and analyzed by intention-to-treat. Measures
of central tendency and variability will be used for descriptive
data where values are normally distributed. Medians and the
interquartile range will be used to describe data that are not
normally distributed. For categorical variables, frequency distributions and percentages will be used to describe categorical
data. Differences between the two 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 RM-ANOVA. RM-ANOVA was specifically
chosen because outcomes will be assessed at three different
points in time. The cost-effectiveness of each treatment will be
determined using cost-utility analysis (as previously described). The primary outcome of the cost-utility analysis will
be the incremental cost-effectiveness ratio; this is the difference
in the expected costs of each intervention, divided by the difference in expected QALYs between each intervention.
Data collection is expected to commence in April 2013.
Results are anticipated for early 2014.
Caregivers are often referred to as the silent victims of
dementia. Not only can the enduring stress and burden of
the caregiver role take its toll on the carer financially, but
also socially, physically, and mentally. Each of these corollaries, which are potentially preventable, can further distress the caregiver and person with dementia, and further
encumber the community and health care system. This
suggests that there are potentially considerable health, social, and economic implications for reducing caregiver
stress and burden.
We hypothesize that TM will safely and effectively reduce
caregiver stress and burden, and in so doing, bring about
immediate improvements in the quality of life, cognitive
performance, and affect of dementia caregivers. The potential downstream effects of this are numerous, including an
increased capacity for caregivers to care for the person with
dementia and engage in paid employment; delays in the
placement of dementia sufferers into nursing homes; and
reduced caregiver demand for health services.
While there is an initial cost of TM training, there are no
ongoing costs to the user in maintaining this therapy. This,
together with the potential benefits of TM alluded to previously, suggest that considerable health care costs attributed
to caregiver stress could be averted through effective caregiver training in TM.
Caring for a person with dementia can be a relentless
and onerous task, one that is often detrimental to the
caregiverâ€™s health and well-being. With more than 24.3
million people across the globe suffering from dementia,
and numbers forecast to increase as the population ages,
any initiatives that contribute to caregiver health and wellbeing are important and valuable. If this research demonstrates that TM is effective, it could indicate a simple,
cost-effective, and easily implemented strategy (that could
complement and perhaps reduce the need for other forms
of intervention) to assist many of the growing numbers of
caregivers to cope with the demanding and often difficult
The conduct of this trial would not be possible without the
tremendous support provided by Vladimir Lorenzon and
Heather Lorenzon (Maharishi Invincibility Centre, Parkside),
Dr. Richard Clarke (Brain Health Clinics, Adelaide) and the
Adelaide Hills Council (particularly Ann Jackson, Anne Ellis,
and Rebecca Shepherd). TRANSCENDENT is primarily
funded by an Alzheimerâ€™s Australia Dementia Research
Foundation grant, with additional funding provided by the
West Torrens City Council and the School of Nursing &
Midwifery, University of South Australia.
Ethics approval for the conduct of this trial was granted by
the Human Research Ethics Committee of the University of
No competing financial interests exist.
140 LEACH ET AL.
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2. Deloitte Access Economics. Dementia across Australia:
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4. Van Vliet D, de Vugt ME, Bakker C, et al. Impact of early
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5. Mioshi E, Bristow M, Cook R, Hodges JR. Factors underlying
caregiver stress in frontotemporal dementia and Alzheimerâ€™s
disease. Dement Geriatr Cogn Disord 2009;27:76â€“81.
6. Etters L, Goodall D, Harrison BE. Caregiver burden among
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12. Manzoni GM, Pagnini F, Castelnuovo G, Molinari E. Relaxation training for anxiety: A ten-year systematic review
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Address correspondence to:
Matthew J. Leach, PhD
School of Nursing & Midwifery
University of South Australia
Adelaide SA 5000
E-mail: [email protected]
TRANSCENDENT STUDY PROTOCOL 141
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