Lupine Publishers | Music Therapy Effects in People with Dementia
Abstract
Objective: Based on the
biopsychosocial model, we developed a paradigm to explore if music therapy (MT)
is effective in increasing the well-being of persons with dementia.
Method: A randomized
controlled trial, mixed method design was used. Twenty-seven persons with moderate/severe
dementia split into an experimental (n = 16; MT and standard care) and a
control (n = 11; standard care only) group were subjected to a cycle of MT
weekly sessions for five months. Quantitative levels of salivary cortisol,
health status (body functioning and structures and health-related states), and
outcome measures (psycho-behavioral disturbances and quality of life) were
associated with qualitative analysis of the participants’ behavior during MT
sessions.
Results: The study showed
that MT is effective in reducing psycho-behavioral disturbances and maintaining
a good quality of life. No apparent effects were found with respect to the
level of salivary cortisol. Qualitative analysis is very effective for
obtaining information on patient behavior during the MT.
Conclusions: The paradigm was
suitable to integrate quantitative and qualitative data on the effectiveness of
MT interventions.
Keywords: Dementia; Music Therapy; Quality of
Life; Geriatric Assessment; Biopsychosocial Model, Cortisol
Introduction
The effectiveness of music therapy (MT)
in the management of behavioral and psychological symptoms of dementia (BPSD)
is well documented in the literature [1-8]. However, evidence for the efficacy
of MT in dementia is still inconclusive [9]. The lack of evidence-based
practice in MT for dementia has been noted by several scholars [10-13], who
also found methodological limitations across the studies [5,14,15].and biases
due to unspecified criteria in participant selection to the studies, small
sample size, lack of randomization and blinded evaluation, group dissimilarity
at baseline, no test-retest studies, and lack of a control group [16].
Researchers must face a twofold challenge:
a. adopt a research method able to mix
quantitative and qualitative data that come from the interacting and complex
domains of human functioning and affect the progressive and unpredictable
course of dementia;
b. select a homogenous sample able to be
representative of the studied condition (dementia), so different from
individual to individual. With regard to the first point, according to the
geriatric medicine, the health status of older people with dementia and
therefore the effectiveness of the MT should be evaluated using the
Comprehensive Geriatric Assessment (CGA) [17]. This multidimensional,
multidisciplinary diagnostic instrument was designed to collect data on the
medical, psychosocial, and functional capabilities and limitations of older
patients. The geriatric assessment differs from a standard medical evaluation
because it takes into account also nonmedical domains emphasizing functional
ability and quality of life. So, the CGA is very compatible with the
International Classification of Functioning, Disability, and Health (ICF) based
on the biopsychosocial model [18].
In fact, both the CGA and the
biopsychosocial model are focused on human functioning as a
person–environmental interaction and integrating medical, psychological, and
social models of human functioning. As it was highlighted [19,20], the CGA and
ICF models include similar assessment domains: health condition, body functions
and structures, activities, participation, and contextual factors, and share a
common approach to the assessment of the person as a whole within the context
of both person’s capacities and expectations and supportive resources of the
environment. The second challenge posed to researchers is strongly correlated
to the first one. Because of the large number of variables affecting the health
status of people with dementia and the substantial individual differences in
the course of dementia, the scholar should remain cautious in generalizations,
provide clear patient anamnestic descriptions, and develop a longitudinal
design to control individual variability in the course of the disease to
control what characterizes individual history with respect to the effectiveness
of the MT intervention [3]. Innovative paradigms and research protocol have
been recently presented and mixed method [21]. have been used in order to
capture MT effects.
Study Paradigm
To overcome those challenges, the present
study developed a paradigm to assess the effectiveness of an MT treatment in
people with moderate/severe dementia, by adopting a biopsychosocial and CGA
perspective. A mixed method randomized controlled trial experiment was designed
to gather quantitative data on cognitive reserve, severity of dementia,
comorbidity, cognitive and physiological functions, and psychological
functioning and behavior, and qualitative data involving the phenomenological
observation of the MT interventions.
Expected Results
Go toTo
dispose of a paradigm able to study music therapy effects in participants with
dementia. To demonstrate the usefulness of our paradigm to explore if MT is
effective, we expect to observe the following results
a) Those who receive MT should have a
lower level of BPSD, as measured by the Neuropsychiatric Inventory (NPI),
Cohen- Mansfield Agitation Inventory (CMAI), and Cornell Scale for Depression
in Dementia (CDS) than the control group.
b) This result was expected from studies
founding that MT is useful for the management of BPSD in older people with
dementia [2,9,22].
c) Those receiving MT will have a higher
quality of life (QOL) than those in the control group.
d) QOL was identified as a central goal
in the treatment of dementia [11,23]. This result will replicate previous
studies that correlated MT with QOL of people with dementia [1,9,12,15].
e) Those receiving MT will have a lower
level of salivary cortisol, indicative of a lower level of stress, than those
in the control group.
f) This result will replicate a previous
study by Suzuki et al. [24]. who found a diminished secretion of cortisol
correlated with positive psychological well-being in people with dementia.
g) Those receiving MT will be able to
recognize nonverbal signs.
h) This result will replicate previous
studies finding that MT is effective for expanding group participation, archaic
expressive, and relational nonverbal abilities in those with moderate/severe
dementia [2,25].
Method
Participants
The study was a mixed method
single-blinded randomized controlled trial performed in two Italian nursing
homes. The protocol was approved by the Bioethics Committee of the University
of Perugia (MUSIC14). Inclusion and exclusion criteria were established by a
consensus of experts (geriatricians and psychologists). Inclusion criteria
were:
a. Diagnosis of Alzheimer or vascular
dementia or mixed dementia, defined according to the Diagnostic and Statistical
Manual of Mental Disorders: DSM-IV-TR criteria (DSM-IV [26];
b. Moderate or severe stage of dementia
according to the Clinical Dementia Rating [27]: score from 2 to 3;
c. Scores between 0 and 20 on the Mini
Mental State Examination [28].
Exclusion criteria were;
I. Wandering;
II. Diagnosis of frontotemporal dementia;
III. Diagnosis of Levy body dementia;
IV. Vegetative state;
V. Use of corticosteroids.
Informed consent was obtained from
proxies.
Experimental (EG) and control groups (CG)
were formed in the nursing homes. CG participants from each nursing home were
treated with usual activities (group games, arts, motor or sensorial
stimulation). EG participants were also involved in the usual activities when
not involved in music therapy. S.F., not involved in the assessment, randomly
assigned participants to CG or EG. A simple randomization was used.
Experimental Condition
The program consisted of 20 MT sessions:
once a week for 60 min. per session over 5 months. The model of the
intervention [29] belongs to the humanistic MT [30-32] The MT intervention can
be ascribed among the active techniques, characterized by direct interactions
with participants using musical improvisation with the aim of stimulating
communication skills, improving relational abilities, and reducing BPSD [33].
The intervention was conducted in a structured therapeutic setting, in a large
and quiet room of the nursing home where participants dwelled. Music therapy
was conducted by a professional music therapist together with a formal
caregiver of the nursing home. Number of participants was 10 in a nursing home
and 6 in the other.
Measures
Quantitative and qualitative data were
collected in the manner summarized in Table 1. These measures consisted of the
following:
Table 1: Timetable of experimental procedure and timing
of measures collection.
ADCS–ADL = Alzheimer Disease Cooperative Study-Activities of
Daily Living; CDR = Clinical Dementia Rating Scale; CDS = Cornell Depression
Rating Scale; CIRS-s/c = Cumulative Illness Rating Scale severity/comorbidity;
CMAI = Cohen–Mansfield Agitation Inventory; CO = salivary cortisol level; grey
= MT sessions; Microanalysis = sessions video analyzed; MMSE = Mini Mental
State Examination (row score); NPI = Neuropsychiatric Inventory; QOL–C =
Quality of Life Alzheimer Disease caregiver version; QOL–P = Quality of Life
Alzheimer Disease patient version; S = music therapy session; T = month of the
experimental phase; WHODAS 2.0 = World Health Organization Disability
Assessment Schedule 2.0.
I. Clinical Interview on
Socio-Demographic and Clinical Data (C–Int): An interviewer asked participants
questions about cultural person capital (cognitive reserve index), medical
history, and pharmacological treatment.
II. Cortisol Biological Marker
(CO): The
measure of salivary cortisol level (CO) was performed on unstimulated whole
saliva collected from passive drooling. Unstimulated whole saliva is the
baseline saliva present in the oral cavity for the majority of a 24– hour
period. To avoid variations due to circadian rhythm, saliva specimens were
taken at a fixed time, immediately before the MT session (10 a.m.) and
immediately after the session (11 a.m.) in both groups.
III. Cumulative Illness Rating
Scale (CIRS) [34]: It
is a summary measure of illness severity (CIRS-s) and comorbidity (CIRS-c).
IV. Clinical Dementia Rating
(CDR) [27]: is
a global staging measure of dementia.
V. Mini Mental State
Examination (MMSE) [28]: This is the most commonly used screening test
of cognitive functions.
VI. Alzheimer Disease
Cooperative Study-Activities of Daily Living (ADCS-ADL) [35]: This is an
inventory to assess activities of daily living for clinical trials in dementia.
VII. World Health Organization
Disability Assessment Schedule 2.0 (WHODAS 2.0) [36,37]: Generic
assessment instrument to provide a standardized cross-cultural method for
measuring activity limitations and participation restrictions, largely employed
in geriatric settings [38]. The Italian 12-item version of the WHODAS 2.0
interviewer-administered proxy form was used [37]. The simple scoring option
was adopted [36].
VIII. Neuropsychiatric
Inventory (NPI) [39]: assesses
neuropsychiatric disturbances common in dementia together with the amount of
caregiver distress engendered by each of the neuropsychiatric disorders.
IX. Cornell Scale for
Depression in Dementia (CDS) [40]: Clinician-administered instrument
that uses information from interviews with both the patient and an informant to
evaluate depression in dementia. It was also validated in patients with
moderate to severe dementia [41].
X. Cohen-Mansfield Agitation
Inventory (CMAI) [42]: In this questionnaire, caregivers rate the
frequency of manifestations of agitated behaviors in elderly persons. The
Italian 30-item proxy version [43,44]. was administered.
XI. The Quality of Life –
Alzheimer’s Disease scale (QOL– AD) [45]: Developed for individuals with
dementia, it comprises both a version for the person with dementia (QOL–P) and
a version for the caregiver (QOL–C).
XII. Microanalysis on MT
sessions’ Video Clips (Microanalysis) [46,47]: This is a
five-step procedure for video analysis to investigate the communicative
response of a specific client in a music therapy treatment. A consensus of
experts (music therapist and psychologist) developed criteria to identify the
patient’s and music therapist’s salient behaviors (e.g., when the patient joins
in singing, plays, smiles, shows a gaze orientation, spontaneously moves their
body, etc.) during MT intervention (videotaped). A trained group of psychology
students analyzed the video of the MT sessions. Starting from the results of
this analysis, the music therapist composed a video clip consisting of the most
salient moments of the therapy of each participant. The microanalysis provides
a clear distinction between description, observation, personal reflections, and
interpretations of the clip content. The assessment measures (CDR, MMSE,
ADCS–ADL, NPI, CDS, CMAI) were adopted to comprehensively cover the geriatric
assessment domains of the CGA [17], in fact these are extensively employed in
geriatric medicine.
Procedure
The study covers a period of twelve
months (T0–T11). Twenty music therapy sessions (S1–S20) were administered to
two experimental groups, once a week in the morning, for 60 min. per session
over 5 months (T3–T8), starting three months after the patient eligibility
assessment (T0). The MT treatment was evaluated longitudinally four times: (i)
at the beginning of the MT treatment (T3), (ii) at the beginning of the fourth
month of treatment (T6), at the end of the MT treatment (T8), and three months
after the MT treatment (T11). Salivary cortisol fluid was sampled at the time
of the second MT session (S2), midway through the sessions (S11), and at the
time of the last session (S20). Samples were taken at fixed times, to avoid
variations due to circadian rhythms: immediately before the beginning of the MT
session (10:00 a.m.) and immediately after (11:00 a.m.). Those in the control
group had salivary fluid sampled on the same days and at the same times. Ten
out of 20 MT sessions (S1; S2; S5; S7; S10; S11; S14; S16; S19; S20) were also
videotaped for the microanalysis. As Microanalysis is a very long procedure, it
was conducted limited to three clinical case casually chosen from the EG.
Geriatricians provided information on the personal and clinical history (C–Int)
severity of dementia (CDR) and comorbidity (CIRS). Caregivers were interviewed
to obtain their assessments of the patients/participants neuropsychiatric
symptoms (NPI, CDS, CMAI), functional status (ADCS–ADL), quality of life
(QOL–C), and activity limitations and participation restrictions (WHODAS 2.0).
Patients were assessed on the cognitive status (MMSE) and quality of life
(QOL–P). Three biologists were involved in the salivary cortisol level
analysis. Table 1 summarizes the timing of measures collection. The
professional administering interviews and measures and respondents involved in
the study were blind to patients’ membership in the EG or CG. The music
therapist was unaware of the changes in cognitive, functioning, and behavioral
status measured during the study (Table 1).
Analysis
Mann–Whitney and Wilcoxon tests were
performed on health status and outcome measures. Statistical significance was
defined as p ≤ 0.05 [48]. On biological measures, a t-test was also conducted,
using the bootstrap method. Analyses were performed through IBM – Statistical
Package for the Social Sciences, version 24 for Windows, Armonk, NY.
Qualitative data were inserted into an Excel file according to the
Microanalysis guidelines developed by Ridder [46].
Results
Demographic
A total of 27 people with dementia were
enrolled and blinded randomized into the CG (n = 11; male = 3; mean age = 83.36
± 9.19; mean education in years = 6.91 ± 4.50) and EG (n = 16; male = 3; mean
age = 85.94 ± 8.54; mean education in years = 4.75 ± 3.00). No differences in
health status measures and outcome measures were found between the CG and EG at
baseline. Four patients died during the study and two were hospitalized. So for
these cases, some data are missing.
Health Status
The analysis reveals a worsening of
dementia severity (CDR) together with an improvement on activities of daily
living (ADCS– ADL) in the EG: the CDR score in the T0 vs. T8 comparison (p =
0.046) significantly increased. The ADCS–ADL score significantly decreased from
T0 to T3 (p=0.020) and T6 to T8 (p=0.003) and significantly increased from T0
to T6 (p=0.049) and T3 to T6 (p=0.003). No differences were found on the health
status measures in the CG.
Outcome
Figure 1: Significant differences between EG and CG on
outcome measures detected with Wilcoxon non-parametric statistic. The
horizontal axis indicates month of the experimental phase (T); the vertical
axis indicates QOL scores (range 0–48, the higher scores, the better QOL–AD).
ADCS–ADL = Alzheimer Disease Cooperative Study-Activities of
Daily Living; CDR = Clinical Dementia Rating Scale; CDS = Cornell Depression
Rating Scale; CIRS-s/c = Cumulative Illness Rating Scale severity/comorbidity;
CMAI = Cohen–Mansfield Agitation Inventory; MMSE = Mini Mental State
Examination (row score); NPI = Neuropsychiatric Inventory; QOL–C = Quality of
Life Alzheimer Disease caregiver version; QOL–P = Quality of Life Alzheimer
Disease patient version; WHODAS 2.0 = World Health Organization Disability
Assessment Schedule 2.0.
Differences in outcome measures were
observed within and between the CG and EG from T0 to T11, as follows. A
significant difference on QOL–AD between samples emerged at T8. In particular,
QOL–P (p < 0.05) had a higher score in the EG (32.86 ± 9.87) than in the CG
(20.71 ± 9.03) (Figure 1). No differences between groups on the other outcome
measures (NPI, CDS, CMAI, and QOL–C) were found from T0 to T11. No differences
between QOL–C and QOL–P were observed from T0 to T11. Table 2 displays
differences within samples in dementia-related neuropsychiatric disturbance
detected using the Wilcoxon non-parametric statistic. From T3 to T11 (p =
0.027) and from T6 to T11 (p = 0.007), the NPI score in the EG significantly
increased. In the CG, the NPI score significantly increased from T0 to T8 (p =
0.050). Significant declines in depression (CDS) scores were found in the EG
from T0 to T3 (p =
0.054),
and scores remained lower at T6 (p = 0.001), T8 (p = 0.001), and T11 (p =
0.002). CDS scores also significantly decreased from T3 to T6 (p = 0.006), and
the significant difference remained at T11 (p = 0.022). There was also a
significant decrease between T8 and T11 (p = 0.046). For the CG, there was a
significant decrease in CDS scores between T0 and T11 (p = 0.011). Agitation
(CMAI) scores fluctuated over the course of the study. A significant decrease
was observed in the EG between T0 and T6 (p = 0.005), and the T3 vs. T6
difference was also significant (p = 0.017), whereas a significant increase
occurred from T6 to T8 (p = 0.010), which remained at T11 (p = 0.012 for T6 vs.
T11). A significant decrease was observed in the CG for T0 vs. T8 (p = 0.015),
part of which took place between T6 and T8 (p = 0.018). With respect to the
QOL–AD, there are no differences in EG and CG on QOL–C, whereas a significant
decrease was observed in the CG on QOL–P at T0 vs. T3 (p = 0.043) and T3 vs. T8
(p = 0.043). Figure 2 displays the graphs related to the results on the outcome
measures. For CO, Figure 3 shows increases from pre to post MT in S2, S11, and
S20, as well as for the measures taken at the corresponding times for the CG.
(Figure 2) Both in the EG and in the CG the CO collection procedure appeared to
be stressful. Some patients did not secrete enough saliva to measure CO. In the
CG, results were obtained from five patients for S2, S11, and S20. The mean
value in S2 increased from 6.678 (± 0.434) to 7.318 (± 0.238) μg/l (p = 0.077).
In S11 there was a significant increase from 6.458 (± 0.395) to 7.526 (± 0.327)
μg/l (p = 0.041). There was also an increase from 7.420 (± 1.076) to 7.956 (±
0.571) μg/l (p = 0.340) in S20. In the EG, results were obtained from nine
patients for S2, S11, and S20. The mean value in S2 significantly increased
from 6.359 (± 1.045) to 6.990 (± 1.021) μg/l (p = 0.026). In S11 it slightly
increased from 7.073 (± 1.024) to 7.266 (± 1.053) μg/l (p = 0.086). There was
also an increase from 7.111 (± 0.700) to 7.406 (± 0.703) μg/l (p = 0.672) in
S20. (Figure 3) Identical results were obtained from the bootstrap analysis.
Microanalysis of Mrs. R. a Patient of the Experimental Group
Mrs. R. microanalysis is reported
because she represents an emblematic clinical case for the age, the severity of
the clinical condition and the sensorial impairment. This patient was a 91 year–
old woman with moderate/severe vascular dementia (CDR = 2 at T0, T8 and T11;
MMSE = 14 at T0; MMSE = 17 at T3; MMSE = 17 at T8; MMSE = 12 at T11). She had a
first-grade education and worked as a housekeeper. She had a severe visual
deficit, hypertensive heart disease, chronic obstructive bronchopneumopathy,
controlled hypothyroidism, polyarthritis, and suffered from a hip fracture
(CIRS-c = 5 at T0, T8, and T11; CIRS-s = 1.86 at T0, T8, and T11). All
self-administered measures were provided by a formal caregiver (healthcare
provider employed in the nursing home). At T0 and T3, she needed help in all
basic and instrumental activities of daily living (ADCS–ADL = 5 at T0; ADCS–ADL
= 3 at T3) except for the use of a fork or a spoon. At T6 and T8, she combed
her hair, asking to listen to the radio, and commented on the news (ADCS–ADL =
11 at T6). At T8 and T11, she reduced her activities (ADCS–ADL = 7 at T8;
ADCS–ADL = 4 at T11). The WHODAS 2.0 score remained the same throughout the
study. Pharmacological treatment remained stable during the study. The CO
before S2 was 8.28 μg/l and increased to 9.03 μg/l after the MT. At S11 CO was
6.85 μg/l before and 7.33 μg/l after while at S20 they were 7.84 μg/l before
and 8.02 μg/l after. On the NPI at baseline, Ms. R presented severe delusions,
hallucinations, sleep disturbances, and sometimes depressive symptoms (NPI = 46
at T0; NPI = 36 at T3; NPI = 11 at T6; NPI = 52 at T8; NPI = 43 at T11).
She was verbally aggressive and engaged
in repetitive actions (CMAI = 50 at T0; CMAI = 38 at T3; CMAI = 38 at T6; CMAI
= 59 at T8; CMAI = 58 at T11). She expressed depressive symptoms during the
study (CDS = 17 at T0; CDS = 5 at T3; CDS= 0 at T6; CDS = 3 at T8; CDS = 0 at
T11). She gave unreliable answers for the QOL items at T0 and T8, (QOL–P at T0
and T8 was inapplicable) and answers (QOL–P = 28 at T3; ADCS–ADL = 31 at T11)
comparable to those given by the caregiver (QOL–C = 30 at T0; QOL–C = 32 at T3;
QOL–C = 33 at T8; QOL–C = 28 at T11) at T3 and T11. Sessions graphs evidenced a
progressive increase in involvement in the MT (eye contact, language, and
spontaneous movement). (Figure 4) The music therapist reported that Mrs. R
reveals receptive participation in the MT by listening, marking the beat, and
playing the maracas. Her behavioral response in the sessions was very positive,
and she had her identity and self-worth confirmed by the experience. She was
also emotionally affected by the songs, showing interest in the therapist
(e.g., by searching for a touch). Based on the video analysis (Supplemental
Material), it was concluded that Mrs. R. benefited from the MT as showed in.In the column on the right, clips and
sequences refer to the video consisting of the most salient moments of the
therapy of Mrs. R. created by the therapist (Supplemental Material).
Discussion
Several studies have suggested the
possibility of innovative paradigms able to capture MT effects in dementia
[5,9,15]. The present study aimed to demonstrate the usefulness of our
biopsychosocial paradigm to explore if MT is useful. To reach this aim, we used
outcome measures such as the NPI, CMAI, CDS, and QOL–AD to assess the impact of
music therapy on behavioral disturbances and quality of life in persons with
moderate/ severe dementia living in a nursing home. Biological markers and
relational aspects of behavior were also assessed using salivary cortisol
analysis and Microanalysis, respectively. At the same time, health status was
monitored throughout the study with the C–Int, CDR, CIRS, MMSE, WHODAS 2.0, and
ADCS–ADL. The biopsychosocial paradigm seems capable of capturing MT effects on
the degenerative and progressive process of ingravescent health conditions that
characterize dementia. In fact, as expected (second prediction), a significant
decrease in quality of life (QOL–P score) was observed for the CG but not for
the EG [15], even though health status worsened in the EG. Moreover, the EG
manifested improvement in functional capacity, showing significant increases in
average ADCS–ADL scores. However, the prediction that the EG would obtain NPI,
CMAI, and CDS scores lower than the CG (i.e., manifest a lower level of
behavioral and psychological symptoms of dementia) was disconfirmed, although
within the EG there was a nonsignificant trend toward decreased behavioral
disturbances from T0 to T11, partially confirming previous studies [2,9,22].
The third prediction—that EG participants would show decreased signs of stress,
as indicated by salivary cortisol (CO) levels—was not confirmed. Our results
showed no significant difference between EG and CG on CO; in addition, a
significant CO increase was present in S2 on EG and in S11 on CG. However,
patients e2, e6, and e8, belonging to the EG, showed a reduced CO at S11.
Literature is controversial about the
effect of MT. Although Evans et al. [49] and Suzuki et al. [24] found a
diminished secretion of cortisol correlated with positive psychological
well-being, respectively in aging people the first and people with dementia the
last; conversely, Takahashi and Matsushita [50] found no significant effect
among person with moderate and severe dementia after MT. The fourth
prediction—that social skills and participation would be enhanced by MT—was
supported. Through the Microanalysis, it was possible to demonstrate that
salient behaviors (e.g., when the patient joins in singing, plays, smiles,
makes appropriate eye contact during interaction, spontaneously moves their
body, etc.) were enhanced, providing evidence that MT is effective for
enriching relational and communicative abilities in those with moderate/severe
dementia, as Raglio et al. [2] found. Despite her CO increasing (Figure 3), Ms.
R (e6) was engaged with positive emotions with the music therapist and
participated actively in the group activities. The fact that CO collection was
perceived by the patients as a stressful procedure might explain the fact that
CO increased in both the EG and the CG. Furthermore, the increase in CO after
MT may be indicative of beneficial stress (eustress) and not negative stress
(distress) [51], that is a consequence of patient’s activation following the
biopsychosocial intervention. In fact, as Chanda and Levitin argue [14], active
MT intervention (direct interactions to stimulate participants) could increase
cortisol.
Limitations of the Study
The small sample size, the heterogeneity
of the subjects, and the presence of formal caregivers reduced the possibility
of generalizing the results. Futures studies are required to confirm the
utility of our paradigm. The majority of the quantitative outcomes (Table 2)
are not statistically significant. We know that statistical significance in
psychosocial studies is a highly controversial issue. In dementia studies,
statistical comparison between groups (experimental and control) could be
compromised by a twofold difficulty [52]: the short-term and non-permanent
changes in the expression of signs and symptoms of a single individual in the
same day; 2) the variability of the expression of signs and symptoms among
person with the same diagnosis. Nevertheless, in our study, notable changes in
individual measures was observed (although not statistically significant) that
might be considered significant from a clinical point of view. Although a
clinical analysis of our findings is indubitably interesting, it is beyond the
aim of the present study. In summary, the results suggested that the paradigm
is effective in demonstrating MT effects in patients with moderate/severe
dementia. Active MT is effective in preserving a higher quality of life in
institutionalized older adults with moderate/severe dementia. According to
demographic projections, the oldest old with dementia will increase in the
coming years, and it will be important to have means available to reliably
detect the effects of bio(eco) psychological (usually called non-pharmacological)
interventions designed to increase the quality of life in those with dementia.
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