Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT00448318 |
| Other study ID # |
WKG_07_BB |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2/Phase 3
|
| First received |
March 14, 2007 |
| Last updated |
March 14, 2007 |
| Start date |
March 2007 |
| Est. completion date |
October 2008 |
Study information
| Verified date |
February 2007 |
| Source |
National Ageing Research Institute, Australia |
| Contact |
Jonathan B Barber, PhD |
| Phone |
+61 3 8387 2638 |
| Email |
b.barber[@]nari.unimelb.edu.au |
| Is FDA regulated |
No |
| Health authority |
Australia: Department of Health and Ageing Therapeutic Goods Administration |
| Study type |
Interventional
|
Clinical Trial Summary
Dementing syndromes are, for the most part, incurable. People with dementia become highly
dependent and frequently have to move from their homes into residential aged care
facilities.
Medications aimed at reducing the severity of a number of symptoms associated with the
different types of dementia have had only modest success.
Increasingly, people with dementia, their families and carers are turning to supplementary
or alternative approaches to the management of their symptoms. There are many published
reports describing the successful use of music therapy in reducing the severity of many
symptoms of dementia. These include reports of improved memory, improved language skills,
reduced anxiety and depression, reductions in agitation and disruptive behaviours and better
social relationships with family, peers and carers. However, the quality of evidence they
provide for the most part fails meet the standards of evidence required by health care
providers. This clinical trial will examine the effects of a music therapy intervention.
The study will recruit 180 patients in sub-acute hospital wards. Participants will be
randomly placed in groups that receive either occupational therapy or music therapy. Before
the therapy programs begin, we will use questionnaires to measure memory function, language
ability, orientation and mood. We will also record brain activity from the surface of the
scalp, blood pressure and pulse to examine physiological responses. The same measures will
be repeated after the 3 weeks of therapy to determine whether there has been any improvement
in the symptoms of the participants and whether the group that had music therapy showed
greater improvement than the group that had occupational therapy. We will make a video
recording during one therapy session to allow us to observe levels of engagement and to
assess changes in facial expressions. This will provide information about the immediate
effects of music on mood and social interaction. The information we collect about brain
activity and blood pressure will help us to understand how music therapy might bring about
changes in the symptoms of dementia. This understanding will be useful in developing better
applications of music therapy. It will also add to our current knowledge about how the
various diseases cause the problems they do.
In summary, the primary aim of the project is to determine whether the reported effects of
music therapy are supported by objective evidence.
Description:
RATIONALE: Dementia presents a significant health problem throughout the world. We will
compare the effects of a music therapy intervention and an occupational therapy intervention
in a randomised controlled trial conducted with hospitalised older people with dementia.
The study will employ physiological, psychometric and observer-rated measures to monitor
change over time in a range of parameters including cognitive and behavioural responses,
mood and agitation, CNS function, facial expression and blood pressure. The battery of
psychometric instruments consists of well-validated and reliable measures. Cognitive status
will be measured using The Mini-Mental State Exam (Folstein et al, 1975) and the Hierarchic
Dementia Scale (Cole and Dastoor, 1996) Mood will be assessed using the Geriatric Depression
Scale (Yesavage et al., 1983). A wide range of behaviours will be assessed with the
Cohen-Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield, J., 1986). To monitor changes
related to the music and non-music interventions, we will employ the EEG methods that will
detect changes in dementia-related generalised, global slowing of the EEG as well as more
localised changes at sites in anterior and posterior regions of both cerebral hemispheres.
EEG-coherence methods will be used to assess intrahemispheric and interhemispheric
functional interactions. We will also record auditory evoked potentials to evaluate changes
in the attentional status of participants. This will provide data that will detect change
over time in response to the interventions. The Facial Activation Coding System (Ekman &
Friesen, 1978) allows systematic analysis of facial expressions from video-taped recordings.
It has been used with people with dementia to provide valid and reliable quantitative
estimates of pain states (Hadjistavropoulos et al., 2000). It will be employed here to
quantitatively evaluate changes in facial expression that occur during the intervention
sessions. This will allow us to observe within group changes and between group differences
in the range of expressive responses. Changes in blood pressure will provide a means of
evaluating physiological responses to the interventions.
AIMS: The primary aim of the present study is to determine whether the symptomatic
improvements attributed to music therapy are supported by empirical evidence derived from a
battery of psychometric and observational measures. A second aim is to determine whether
neurophysiological measures (EEG frequency, EEG-coherence, EP) and vascular activity (blood
pressure) reflect central nervous system and autonomic changes that directly correlate with
reductions in dementia-related symptoms.
Specifically, the study will investigate the following hypotheses –
1. Music employed as a therapeutic medium will reduce symptomatic cognitive, behavioural,
emotional and functional deficits associated with dementia.
2. Symptomatic changes will correlate with physiological changes. METHODOLOGY: This study
will take advantage of an established collaborative network between the Department of
Psychiatry, The University of Melbourne, The National Ageing Research Institute, The
Cognitive, Dementia and Memory Service (CDAMS) at The Royal Melbourne Hospital and the
CDAMS at the St George’s Hospital campus of St Vincent’s Health. The research team
covers several disciplines including aged psychiatry, neuropsychiatry, geriatric
medicine, neuropsychology, behavioural neuroscience, electrophysiology, music and music
therapy.
SUBJECTS: One hundred and eighty sub-acute patients with mild, moderate and severe dementia
will be recruited from RMH (Royal Park Campus) and St Georges Hospital over a period of 18
months. There will be a potential pool of approximately 800 patients over the planned 18
month data collection period. We anticipate that with ineligibility of 30%, an attrition
rate of up to 20-25% and time lost to holidays and a participation rate of 70%, our total
cohort will be approximately 260, leaving substantial redundancy over the numbers required
to power the study.
Testing will commence when each patient has settled for one week when the majority of
illnesses are stabilised and medications adjusted. A full medical assessment will be
available for all participants in order to evaluate medical comorbidity, cognitive status
and dementia diagnosis. This information will include results of physical examination, blood
tests, Ct scan, informant history and neuropsychological assessment which includes the
administration of the MMSE (Folstein et al. 1975) and classification according to DSM-IV,
ICD-10 and NINCDS-ARDRA criteria, the current research gold standard for dementia diagnosis
(American Psychiatric Association, 1994). Consensus diagnosis with information available
will be made by the clinicians involved in the study. Primary diagnoses, comorbidities and
medications will be monitored. Recruitment will be undertaken in accordance with procedures
approved by The Mental Health Research and Ethics Committee, Melbourne Health Network, the
St Vincent’s Health Research Ethics Committee. Given the nature of our participants’
diagnoses, it is recognised that they cannot give informed consent.
PROCEDURE: Participants will be randomly assigned to either the music intervention group or
the control (occupational therapy) group. Both groups will undertake three 50 minute
intervention sessions per week for three weeks giving a total of nine interventions. Each
session will be conducted with groups of 4 - 6 participants.
Pre and post measures will be made on the day prior to the therapy session and the day after
the last therapy session. These measures are as follows:
- EEG recording made that will yield slow/fast ratio data and resting state and
music-listening EEG-coherence data and auditory evoked potential data.
- Four blood pressure and pulse readings taken at hourly intervals to establish a mean
baseline.
- Questionnaires - Mini Mental State Examination, Hierarchic Dementia Scale, Geriatric
Depression Scale will be administered prior to the first intervention session and after
the ninth intervention session.
Pre and post testing involving will take approximately 90 minutes in total. Video recordings
will be made using two cameras during the fifth therapy session. The first camera will be
located on a tripod such that the whole group, including the therapist, will be continuously
in frame to facilitate subsequent observations about participation and social interactions.
The second camera will be hand held and will take film of the faces of each participant
during the session for subsequent coding of changes in facial expressions using the Facial
Activation Coding System.
Further information will be compiled by members of the research team. This information, used
to monitor comorbid conditions and pre and post changes, will be derived from patient
records. It will be collected the following instruments
- The Clinical Dementia rating Scale (Hughes et al, 1982)
- The Barthel Index (Mahoney and Barthel, 1965)
- The Cumulative Illness Rating Scale (Linn et al 1968).
- The Neuropsychiatric Inventory (Cummings, 1997) Finally, The Cohen-Mansfield Agitation
Inventory (Weiner et al, 1998) will administered pre and post intervention by a
researcher in consultation with nursing staff.
In addition to the above measures, the full range of treatments outside the music therapy
interventions received by participants in both groups will be documented. This will enable
the researchers to monitor the levels of therapist contact experienced by participants in
both the music therapy and control groups. It will also provide data that may be used as
covariates in a number of statistical analyses.
INCLUSION CRITERIA:People with a clinical diagnosis of dementia who are currently in
sub-acute aged care hospital wards; EXCLUSION CRITERIA: delirium; acute medical conditions
(eg pneumonia and cardiac failure) where it is likely that participation is
contra-indicated; primary psychiatric conditions; severe hearing impairment; RANDOMISATION
PROCEDURES: A stratified randomization procedure will be used to ensure that both the
experimental and control groups are at least broadly homogeneous with respect to cognitive
status. The procedure will be applied separately within each of the two hospital facilities
with allocation made progressively as people enter the study. After consent has been
acquired and the pre-intervention measures taken, participants will be coded, stratified
into two levels according to MMSE scores then allocated to treatment groups according to the
computer generated random sequences. The sequences will be generated using research
randomiser, an online web-based program (http://www.randomizer.org/form.htm). The person
responsible for implementing the allocation sequence will be either a member of the hospital
staff or a NARI staff member who has no involvement in any other aspect of the study. That
person will be responsible for de-identifying participants using a conventional coding
system. Baseline and post-intervention data collection procedures will be administered by
persons who have no other role in the project procedures and will remain blind to treatment
allocation. Baseline testing will take place before allocation. As they will have no contact
with participants during the intervention procedures and because patient identification is
coded by an independent person, the blind can be maintained. As added protection,
psychometric instruments (MMSE, HDS and GDS) will be assessed only once by an assessor for
each participant. That is, if Assessor A administers the instruments with Participant A for
baseline testing, Assessor B will administer the instruments post-intervention for
Participant A. This will avoid any unintended prior knowledge of individual participant
performance and so help to ensure post-treatment blinding with respect to active versus
control group assignment. The instruments to be used have clear and established
implementation procedures with high inter-rater reliability. After the post-intervention
assessments have been taken for each participant, the assessors will be asked to nominate
which group they thought the participant was in. A simple statistical analysis will be able
to detect whether there is a significant bias in group assignment or whether assignment is
no better than chance. Bias may arise, for example, if one treatment group has an outcome
that strongly differentiates it from the other.. It is noted that, while there are other
potential stratification factors (eg age, gender, diagnoses), the use of more factors
rapidly becomes unfeasible. Because current cognitive status has some prognostic relevance,
particularly with regard to music therapy, it has been decided to use that measure as the
sole stratification factor.
STATISTICAL ANALYSES: Given the multiple dependent variables being monitored in this study,
a MANOVA will be used to test for between-group differences with post-hoc univariate
comparisons as required. Based on previous studies at NARI referred to above using similar
measures we expect that 90 subjects per group will detect a 25% change in mean values with
at least 80% power (alpha .05). For test-retest data, a two way repeated measures MANOVA
(group, time) will be used to examine changes over the duration of the intervention, group
effects and the interaction between these factors. Bivariate correlations and multiple
regression analyses will be used to explore the relationships between the various measures
(EEG, FACS, MMSE, HDS, self-report and observational measures). Similar comparisons can also
be made for change scores within each domain of parameters (objective, psychometric,
self-report) and the way they co-vary over time.
