Ann. N.Y. Acad. Sci.

ISSN 0077-8923

A N N A L S O F T H E N E W Y O R K A C A D E M Y O F SC I E N C E S
Issue: The Neurosciences and Music V

Efficacy of musical interventions in dementia:

methodological requirements of nonpharmacological trials
Séverine Samson,1,2 Sylvain Clément,1 Pauline Narme,3 Loris Schiaratura,4
and Nathalie Ehrlé1,5
1
Equipe Neuropsychologie: Audition, Cognition et Action (EA 4072), UFR de psychologie, Université Lille-Nord de France,
Villeneuve d’Ascq, France. 2 Unité d’épilepsie, Hôpital Pitié-Salpêtrière, Paris, France. 3 Equipe Neuropsychologie du
Vieillissement (EA 4468), Institut de Psychologie, Université Paris Descartes, Paris, France. 4 Laboratoire de Psychologie:
Interactions Temps Emotions Cognition (EA 4072), UFR de psychologie, Université Lille-Nord de France, Villeneuve d’Ascq,
France. 5 Service de Neurologie, CHU de Reims, Hôpital Maison-Blanche, CMRR Champagne-Ardenne, France

Address for correspondence: Séverine Samson, Department of Psychology, University of Lille, BP 60 149, 59653 Villeneuve
d’Ascq Cedex, France. severine.samson@univ-lille3.fr

The management of patients with Alzheimer’s disease is a significant public health problem given the limited effective-
ness of pharmacological therapies combined with iatrogenic effects of drug treatments in dementia. Consequently,
the development of nondrug care, such as musical interventions, has become a necessity. The experimental rigor of
studies in this area, however, is often lacking. It is therefore difficult to determine the impact of musical interventions
on patients with dementia. As part of a series of studies, we carried out randomized controlled trials to compare the
effectiveness of musical activities to other pleasant activities on various functions in patients with severe Alzheimer’s
disease. The data obtained in these trials are discussed in light of the methodological constraints and requirements
specific to these clinical studies. Although the results demonstrate the power of music on the emotional and behav-
ioral status of patients, they also suggest that other pleasant activities (e.g., cooking) are also effective, leaving open
the question about the specific benefits of music in patients with dementia. All these findings highlight the promising
potential for nonpharmacological treatments to improve the well-being of patients living in residential care and to
reduce caregiver burden.

Keywords: Alzheimer’s disease; music; nonpharmacological treatment; randomized controlled trial; emotion

Music-based therapeutic strategies in development of nonpharmacological complemen-

persons with dementia
The management of memory and behavioral disor-
ders in patients with dementia (PWD) is currently
unsatisfactory. Behavioral disorders are particularly
difficult to control and represent a main cause of
institutionalization1 and caregiver distress.2 In re-
cent years, significant advances have been made
in terms of understanding the pathophysiologi-
cal mechanisms of neurodegenerative diseases, but
current pharmacological treatments are essentially
symptomatic and do not have a satisfactory im-
pact on symptoms related to dementia progression.
The limited effectiveness of these treatments and se-
vere iatrogenesis associated with neuroleptics have
led several health institutions to recommend the
doi: 10.1111/nyas.12621
Ann. N.Y. Acad. Sci. 1337 (2015) 249–255 
C 2014 New York Academy of Sciences.
tary interventions as first-line treatment.3,4 As a re-
sult, music activities are seeing a growing success
with PWD as well as with caregivers.
PWD are reactive to music until very advanced
stages of the disease5–8 and can learn and recognize
musical tunes even in the severe stage. In contrast
with impaired verbal memory,6,9 music memory
seems to be partially preserved in PWD.5 In
addition, music easily elicits movements stimu-
lating interactions between perception and action
systems, as already underlined by Fraisse, Oléron,
and Paillard.10 These effects may be underpinned by
diminished control of inhibition in patients with se-
vere Alzheimer’s disease (AD). Indeed, it is common
to observe patients who spontaneously synchro-
nize their movements with music, and this can
249
Musical interventions in dementia
subsequently facilitate social cohesion in a group
setting. Finally, by inducing strong emotions,11,12
music can also help patients to relax by modulating
psychological and physiological functions, espe-
cially those related to stress.13 As a consequence,
the power of music and its nonverbal nature offer a
privileged communication medium when language
is diminished or abolished. Although the mech-
anisms underlying all these effects remain poorly
understood, the intriguing sensitivity of PWD to
music justifies its use for therapeutic purposes.
Assessing the efficacy of music-based
interventions in PWD
In the literature, numerous studies have claimed
that music-based interventions have positive effects
on the well-being of PWD, but there are few
controlled studies that provide strong evidence
supporting this statement. Even if the development
of better-controlled studies in recent years is
incontestable, deficiencies in reports of such clinical
trials are still frequent, as outlined in several
reviews.4,14–16 Limitations of these studies can be
due to various biases (i.e., unspecified selection cri-
teria, small sample size, lack of randomization and
of a blinded assessor, group dissimilarity at baseline,
no test-retest, no control group). The absence of a
nonmusic or another intervention group to control
for changes due to patients’ stimulation (and to
the social impact of group activities) also limits
the conclusion about the specific impact of a music
intervention. Moreover, there is virtually no ex-
perimental research about the potential long-term
effects of music-based activities in PWD and their
caregivers (except for three recent studies17–19 ).
Thus, there is an urgent need to go beyond intuitions
and investigate the efficiency of music-based inter-
vention in the treatment of PWD more rigorously
with adequate experimental methodology.
Well-designed and properly executed random-
ized controlled trials (RCTs) provide the best
evidence for the efficacy of nonpharmacological
treatments. As emphasized by a group of scien-
tists and editors who developed the CONSORT
(Consolidated Standards of Reporting Trials) state-
ment to improve the quality of RCT reporting,20
“trials with inadequate or poor methodological
approaches are associated with exaggerated treat-
ment effects” (p. 663). In other words, findings con-
taminated by numerous uncontrolled factors are
250 Ann. N.Y. Acad. Sci. 1337 (2015) 249–255 
Samson et al.
associated with biased estimates of treatment effects
and with systematic errors. In this paper, we dis-
cuss this issue by reporting two successive studies
to illustrate how methodological weaknesses might
bias results by amplifying the effect of a music inter-
vention and to warn clinicians and scientists about
the hasty conclusions that can result from a lack of
experimental rigor.
Insight from RCTs in patients with
advanced AD
In two previous studies,17,19 we performed RCTs to
examine the short- and long-term effects of a mu-
sic intervention (group-based musical activities) on
emotional state and behavioral functioning of PWD.
The main objective was to assess the efficacy of non-
pharmacological treatments on the well-being of
PWD. We were also interested in testing the possible
superiority of music over nonmusic interventions.
As a nonmusical activity, we selected cooking as it
provides an ideal control intervention for music.
Both activities are easily performed in a group set-
ting, are multisensory, pleasurable, and can trigger
old memories. The similarities and differences be-
tween these two studies are summarized in Table 1.
Study 1
In the first study,17 14 PWD were recruited within a
single center. All the participants met the diagnostic
criteria for dementia of Alzheimer’s type or mixed
dementia according to the DSM-IV.21 Only patients
with moderate to severe stages of dementia were
included. They were all native French speakers to
ensure familiarity with the songs selected for music
sessions. Patients were randomly assigned to each
intervention group, and a person not directly
involved in data collection performed the random-
ization. Patients engaged in either music or cooking
activities twice a week (2 h each session) for 1
month, with the total duration of the intervention
being 16 hours. Each intervention group included
seven patients supervised by a therapist with the
help of another person. During each intervention,
receptive (listening to music or tasting recipes) and
productive (clapping hands or singing with music
or preparing a recipe) phases were alternated. Two
different therapists were involved in this RCT, each
supervising the music or cooking intervention.
The one who supervised music intervention had
C 2014 New York Academy of Sciences.
Samson et al. Musical interventions in dementia

Table 1. List of items to control in RCTs investigating the efficiency of nonpharmacological treatments on PWD

Study 1: Clément et al. Study 2: Narme et al.

Items to control in RCTs (2012)17 (2014)19

Clinical population PWD PWD No change

Sample size N = 14 N = 48 Different
Attrition bias 21% 23% No change
Single- or multiple-center Single-center Single-center No change
Eligibility criteria (cf. text) Controlled Controlled No change
Study design (parallel or crossover) Parallel group Parallel group No change
Intervention group (music) Yes Yes No change
Control intervention group (cooking) Yes Yes No change
Control group (usual care) No No No change
Random group assignment Yes Yes No change
Test-retest (no differences in baseline Yes Yes No change
data)
Time period of intervention 4 weeks 4 weeks No change
Intensity (number of time per week) 2 2 No change
Dosage (duration of intervention) 16 hours 8 hours Different
Duration of follow-up (from the 8 weeks 8 weeks No change
beginning of intervention)
Number of therapists 2 1 (for both music and Different
cooking)
(1 for music and
1 for cooking)
Therapists’ personal preference Music (for music Cooking (for both Different
intervention) interventions)
No (for cooking
intervention)
Primary outcome measure Emotional state Emotional state No change
Blind assessment (interviewer) No Yes Different
Blind assessment (raters of video Yes Yes No change
recording)
Secondary outcome measures None Cognitive status Different
Functional status
Behavioral status
Caregivers’ distress
Similarities between interventions
(music vs. cooking)
• Active versus passive activities No Yes Different
• Attractiveness No Yes Different
• Novelty between sessions No No No change

a clear preference for music activities but no prior
education in music therapy.
Emotional state was determined by assessing
discourse content, emotional facial expressions,
and mood. These three outcome measures were
performed six times with each patient with two
evaluations before the intervention (BL–1 , BL0 ) to
obtain baseline measures and to control test–retest
effect, two evaluations to test short-term effects of
the intervention after the fourth (IMID ) and the
last sessions (IEND ), and two follow-up measures
to assess long-term effects after the end of the

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Musical interventions in dementia
intervention, 2 (POST+2 ) and 4 (POST+4 ) weeks
postintervention.
Discourse content and emotional facial expres-
sions were assessed using short semistructured
filmed interviews. During this interview a psychol-
ogist questioned each patient individually about his
or her feelings at the present time. However, this
person was not blind to the patient’s intervention
group. Emotional facial expressions and discourse
content were analyzed from the first two min of each
filmed interview. Two independent and blinded ob-
servers rated audio and video recordings to count
the number of positive and negative verbal and
facial expressions (according to the Facial Action
Coding System22 ). Mood was assessed with an
adaptation of the State–Trait Anxiety Inventory for
Adults (STAI-A).23 Unlike the standard procedure,
a caregiver completed the questionnaire. Instead of
using the global score, we separately summed the
ratings of the 10 positive and 10 negative statements,
consistent with how the facial expressions and dis-
course content were analyzed. From each measure
(facial expression, discourse, mood), an emotional
index was derived from the positive and the nega-
tive scores. A positive emotional index meant that
the patient displayed more positive than negative
emotions, and a negative emotional index meant
the reverse.
The change of emotional state was the primary
outcome of interest. This change was measured by
the difference in the emotional index for facial ex-
pressions, discourse content, and mood between
baseline and posttreatment assessments. As depicted
in Figure 1 (left panel), the mean emotional index
improved for discourse content, facial expressions,
and mood after the fourth (IMID ) and eighth (IEND )
music sessions, and this improvement persisted at 2
(POST+2 ) and 4 (POST+4 ) weeks after the end of the
intervention for discourse content and mood. Based
on this profile of results, we showed that music had
short-term positive effects on all three emotional
indices and long-term effects on two indices (dis-
course valence and mood). Conversely, there was
no significant benefit of cooking interventions on
emotional state, with the exception of a short-term
effect on mood. The findings of this study suggest
that music was more effective than cooking in im-
proving the emotional state of PWD.
As previously discussed,19,24 several methodolog-
ical weaknesses might have biased the reported
252 Ann. N.Y. Acad. Sci. 1337 (2015) 249–255 
Samson et al.
results. The person who interviewed the patients was
the therapist in charge of the music intervention.
Because she was not blind to the patient’s group,
the change in emotional state observed in the music
group might have been due to bias, not only by the
familiarity of the assessors but also by the implicit
memory of enjoyable social interactions during mu-
sic interventions. In addition, the small number of
participants might have compromised the general-
ization of the data. Therefore, it is difficult to con-
clude if the benefit of music in this study is domain
specific or if it is related to other confounding factors
such as familiarity, arousal, attractiveness, and/or
pleasantness. To overcome these pitfalls, we carried
out a second study.
Study 2
The general design of this second study19 was very
similar to that of the previous one, except for a few
differences that are outlined below and summarized
in Table 1. In this study we increased the sample size
and recruited 48 PWD in a single center (different
from study 1), with a similar attrition rate to our
previous study. We used the same three emotional
indices to examine patients’ emotional state, but we
also measured cognitive, functional, and behavioral
functioning as well as caregiver distress. Owing to
clinical constraints from the nursing home, we had
to reduce the duration of each intervention session
to 1 h, decreasing the total duration of interven-
tions from 16 to 8 hours. To control the potential
bias effect of specific therapist, a single person
supervised both music and cooking interventions.
We also improved the attractiveness of cooking
sessions by adapting the activities to patients and
balanced the proportion of active and passive ac-
tivities in both interventions. Finally, an important
difference concerned the psychologist in charge of
the interview. External to the residential care home,
this person was completely blind to the patient’s
intervention group, which had not been the case in
the previous study. Moreover, the psychologist who
assessed cognitive abilities and functional behaviors
and the caregivers who completed questionnaires
were all blinded as well. Therefore, all the assessors
(interviewer, psychologist, caregivers, and raters)
were blinded from the patient’s group affiliation.
The results of this “better-controlled” study,
displayed in Figure 1 (right panel), showed that
both music and cooking interventions resulted in
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Samson et al. Musical interventions in dementia

A B

Figure 1. Mean emotional indices (%) of the two intervention groups (music and cooking) for discourse content, facial expressions,
and mood across the six evaluations (bars represent the standard error of the mean, and lines with asterisks correspond to significant
differences (P < 0.05) between a value and the baseline (BL0 )). (A) Left panel, study 1;17 (B) right panel, study 2.19

improved emotional state as indicated by facial
expressions and mood indices. It is noteworthy that
the magnitude of the short- and long-term posi-
tive effects of music on emotional indices reported
in study 1 was reduced. Moreover, the music in-
tervention in study 1 was significantly better than
cooking in producing positive emotions in PWD,
illustrating the so-called exaggerated treatment ef-
fect. As depicted in Figure 1, the beneficial effect
of music in study 2 was no different from that of
cooking. Taken together, these findings suggest that
implicit associations between the pleasant activities
and the therapist (without any episodic memory of
music sessions) might have influenced the findings
of study 1. This effect seems to result, at least in part,
from interactions with a therapist rather than from
the musical intervention per se, emphasizing the
importance of using blind assessors (interviewers
and raters) in such studies.
Although we found that the effect of the music
intervention on patients’ emotional state was less
marked after strict control of different factors, there
were significant changes in several other measures
during and after both types of interventions rela-
tive to baseline. Specifically, we found that music
and cooking interventions also reduced the severity
of behavioral disorders and consequently dimin-
ished professional caregiver distress. These addi-
tional results seem even more reliable because many
methodological constraints have been taken into ac-
count in this second RCT. Overall, the novelty of
study 2 was in its finding that enjoyable or pleasant
activities other than music can also improve the
well-being of PWD and their caregivers. To further

Ann. N.Y. Acad. Sci. 1337 (2015) 249–255 

C 2014 New York Academy of Sciences. 253
Musical interventions in dementia
explore the impact of nonpharmacological ap-
proaches in dementia, it will be necessary to in-
clude another control group of participants who re-
ceive the usual care without any intervention. This
additional constraint will help to ensure that posi-
tive changes did not result from familiarity with the
assessor (interviewer) and cannot be attributed to
group activities in general, a placebo effect, or nat-
ural variations of disease. Such a study is presently
in progress in our laboratory.
Conclusions and future prospects
On the basis of the previously reported data, we can
conclude that nonpharmacological interventions,
such as music and cooking offered twice weekly
over 1 month to PWD with severe cognitive decline,
can improve emotional and behavioral functioning
in patients and reduce caregiver distress. We found
that music activities did not have greater therapeutic
effects than other pleasant activities. This absence of
difference between the benefits of music and cook-
ing argues against music specificity in improving
well-being in PWD.
As highlighted in this report, trials assessing
behavioral manipulations require additional con-
straints that are not always so crucial or rele-
vant in pharmacological therapy studies. The major
difficulty in such nonpharmacological trials is to
preserve blinding at every stage of behavioral eval-
uation. Even if the therapist cannot be blinded, the
healthcare professionals in charge of the participants
and the people assessing the patients (outcome as-
sessors) should be blinded. Contact among care-
givers, assessors, and therapists should be avoided,
thus limiting the risk for performance bias. In mul-
ticenter studies, other constraints requiring spe-
cific analysis are necessary to control care provider
and center. To help clinicians and scientists to im-
prove the quality of such studies, we proposed a
list of items to take into account in designing non-
phamacological RCTs (see Table 1). Such method-
ological rigor is in agreement with the CONSORT
statement20 and is necessary to document the pos-
sible impact of nonpharmacological therapy on be-
havioral responses in RCTs. This will be essential
to propose guidelines for the formulation of pub-
lic heath policies. Well-designed prospective trials
are therefore needed to establish the efficacy of
music interventions under clinical circumstances
and to generalize the recently published results.18,19
254 Ann. N.Y. Acad. Sci. 1337 (2015) 249–255 
Samson et al.
They will also be useful to clarify the precise mech-
anism by which nonpharmacological approaches,
and music intervention in particular, induce positive
emotional and behavioral changes in patients
with severe dementia and their family or medical
caregivers.
In view of the increasing number of PWD and
the limited resources of public health care, enjoyable
group activities provide a viable and promising al-
ternative to pharmacological treatments to improve
the emotional status of PWD and to reduce caregiver
distress. Nonpharmacological interventions such as
music or cooking involving one or two caregivers
with a group of six to eight patients are feasible
activities, especially for patients in residential care,
with a reasonable cost/benefit ratio.25
Acknowledgments
The authors are grateful to Amee Baird for her
helpful comments on previous versions of the
manuscript, to the psychologists (A. Tonini, L.
Sintes, A. Saenz, and S. Desdouits) who carried out
the evaluations and the interventions with the as-
sistance of L. Foulon and R. Goret. The authors are
also grateful to the caregivers of the Valenciennes
Hospital and Wilson Nursing Home who gave their
time ensuring the study feasibility. These studies
have received funding from the French Ministry
(ANR-09-BLAN-0310-02), the private Fondation
Plan Alzheimer, and the Institut Universitaire de
France to S.S.
Conflicts of interest
The authors declare no conflicts of interest.
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