The proper chord with music: Treatment of behavioral problems in dementia with individual music therapy.

Behavioral an psychological symptoms in dementia (BPSD) are core clinical
features that worsen functional decline and quality of life for patients in
health care settings and their caregivers. Concerns have been raise about the
efficacy and safety of pharmacological interventions. Moreover such
interventions pass over the unmet needs of patients who develop some behavioral
symptoms. Music therapy might be a suitable alternative, particularly also
because the patient is invited to participate en communicate possible needs in
a non-verbal way. Studies of music therapy interventions are often small,
loosely designed and poorly reported. We designed a single blind randomized
controlled study in which individual music therapy intervention is compared
with the possible effect of music only (by sound source) and the psychosocial
care as usual, where special attention is paid during activities.
in a parallel investigation the development of individual well-being and
engagement can be observed in a standardised longitudinal way, during the
interventions, because this might be a prerequisite for recovery of discomfort
that might be the cause of BPSD symptoms. Only tentative experience with such
an approach is available and a "time-series analysis" for the implementation of
person-centred care principles in the study outcome might be considered as a
proof of concept.

The hypothesis is that individual music therapy intervention, according to
professional standards, will lead to more symptom reduction of BPSD and a
better quality of life based on parameters observed by care givers, compared
with listening to music with a sound resource or the psychosocial interventions
as usual in a particular care setting.
It is further expected that well-being and engagement, according to
patient-centred care standards, wil show a positive development during the
music therapy interventions, which might be shown by longitudinal registration
of communication and participation scales (CODEM en PRS, respectively). To
demonstrate this a time-series analysis method is introduced, partly as a proof
of concept for further studies on this subject.

172 people with dementia and any kind of behavioral problem (BPSD) for which an
intervention is warranted, will be recruited from about 20 psychogeriatric
departments. Participants will be randomized after informed consent to get any
of the three following interventions: Individual music therapy, music listening
by sound resource or psychosocial intervention as usual.
Interventions will take place during 3 weeks, every week 3 interventions of 45
minutes. Before the start NPI and Qualidem are scored by a blinded test
assistent. During the 3 weeks of the intervention NPI and Qualidem will be
scored again. Three weeks after ending of the treatment period a further score
of NPI and Qualidem will be performed in order to show a carry-over effect
after the treatment period.

During the intervention period video registrations of 9 participants in each
treatment arm will be recorded 2 times during the intervention.
Based on standardized longitudinal observation methods scales for communication
(CODEM) and engagement (PRS) will be scored by a trained observator. The
evolution of well-being and engagement will be registered in a standardized
way, according to a Time-series analysis method.

The interventions (music therapy, passive listening to music and psychosocial
activities) are already in use in dementia care settings.

We don't expect any particular burden or risk for the participants, apart from
the burden they already have from their behavioral symptoms in the
institutionalized care setting.