Background and rationale
Dementia is a common disease and in 2021, the World Health Organization estimated that around 55 million people have dementia worldwide [
1]. Dementia is a neurodegenerative syndrome characterized by a progressive deterioration of cognitive function, in particular memory but other cognitive domains such as language, praxis, visual perception and most notably executive functions are also often affected [
2]. Personality and behavior changes, together with a decline in the ability to perform activities of daily living, may result in a loss of independence. The personality and behavioral changes are often reflected in Neuropsychiatric Symptoms (NPS). More specifically, NPS may express itself in, for example, agitation, disinhibition, irritability, delusions, hallucinations, depression, anxiety and apathy. These symptoms are ubiquitous in nursing home patients with dementia, with overall rates of more than 80% [
3].
As there are no curative treatments for dementia yet, it is important to focus on interventions that may have beneficial effects on well-being and maintain an optimal quality of life. Quality of life is defined by the WHO as “individuals’ perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns” [
4]. Well-being is defined in terms of a state of equilibrium existing between personal resources and life challenges that, when achieved, gives rise to positive emotions and psychological health [
5]. The constructs of QoL and well-being have often been used inter-changeably in dementia research [
6].
There is a growing consensus that quality of life is an important outcome for assessing the effectiveness of interventions for dementia in clinical trials even though it concerns a multidimensional construct influenced by a variety of factors [
7,
8]. An observational study in 288 nursing home residents with dementia, showed that NPS such as agitation and depression were particularly strong predictors of poor QoL [
9]. These results underline the growing awareness that NPS independently decreases QoL in moderate and severe stages of dementia [
9]. Pain is highly prevalent in nursing home residents [
10,
11] and can also cause NPS and influences their quality of life directly [
12]. Nursing home residents with severe cognitive impairment who have difficulty expressing pain may manifest it through agitation, aggression, or withdrawal [
10]. Pain in dementia may express itself also through vocalizations (e.g., crying, screaming, noisy breathing), specific facial expressions (e.g. grimacing) and body language such as restless behaviour [
13,
14].
Another factor that may reduce QoL of people with dementia is a deterioration of sleep quality. Sleep disturbances include poor sleep efficiency and increased night awakenings. Petrovsky [
15] used domains of Lawton’s framework for quality of life in persons with dementia to synthesize current knowledge on the association between sleep disruption and quality of life in persons with dementia. Sleep disruption was negatively associated with all of four QoL domains (physical functioning, social/behavioral functioning, emotional well-being and cognitive function). In sum, neuropsychiatric symptoms, in relation to or provoked by pain and sleep disturbances, reduces QoL in people with dementia.
Consequently, the question arises if adequate strategies are available for treating this triad of symptoms, i.e. NPS, pain, and sleep disturbances, and hence, improving QoL, in people with dementia. NPS are often treated pharmacologically with psychotropic drugs, which frequently cause unwanted side effects, such as somnolence and extrapyramidal symptoms [
16]. Psychosocial interventions, however, may obviate the indication for antipsychotic drug prescriptions [
17]. Moreover, therapies such as validation, reminiscence, psychomotor therapy, multisensory stimulation and music therapy can increase QoL of people with dementia and their caregivers [
18]. Sikkes et al. reviewed the evidence and found that various non-pharmacologic treatments such as music therapy effectively improve behavior [
19].
Music therapy is a non-pharmacological intervention which is used as a treatment for NPS in patients with dementia [
20‐
22]. In the USA, music therapy is defined by the American Music Therapy Association (AMTA) as “the clinical and evidence-based use of music interventions within a therapeutic relationship to accomplish individualized goals by a credentialed professional who has completed an approved music therapy program” [
23]. This definition of music therapy and the accompanying AMTA Standards of Practice recommend an individualized treatment process, including referral, building a therapeutic relationship, assessment, observation, targeting individualized goals and objectives, treatment planning, protocol selection and implementation, termination and evaluation [
24]. The number of studies examining the effects of music therapy for people with dementia has increased over time [
25]. A Cochrane review in 2011 [
26] included 10 studies mostly of poor quality and could not draw firm conclusions about the effects of music therapy in the treatment of behavioral, social, cognitive and emotional problems of older people with dementia. In an update of the Cochrane review [
27] twenty-two studies were included. The results from the review suggest that music therapy may also improve emotional well-being including quality of life. However, outcomes could be based on recall or direct observation, and not all outcomes are assessed blinded. The results of the review further suggest that providing institutionalized people with dementia with at least five sessions of a music-based therapeutic intervention might reduce NPS. Moreover, individual therapy, compared with group therapy, had larger effects on behavioral outcomes (agitation, aggression and overall behavioral problems).
Indeed, music therapy can be offered via individual treatment, as well as through a group approach [
28]. The group approach benefits engagement and social interaction but in advanced stages of dementia, individual music therapy can better reach the residents with communicative limitations. Personalized interventions with music or music therapy may be a predictor of success [
20].
In 2010, we conducted a randomized pilot study on individual music therapy in a nursing home in the Netherlands. The intervention group received individual music therapy from a qualified music therapist who used a person-centered approach. The results pointed to possible reduction of NPS in patients who received individual music therapy compared to patients in the control condition who received usual care [
29]. The sample size of the pilot study was very small and the outcome assessments were not blinded. Sakamoto [
30] conducted an RCT in 2013 with blinded outcome assessment and individual intervention sessions carried out by music facilitators. The study indicated that interactive individualized interventions reduce stress and increase relaxation in individuals with severe dementia immediately after the intervention.
Trial design
The design involves an individual randomized controlled trial (RCT) employing longitudinal repeated measurements in nursing home residents with dementia and NPS. The study is single blinded. The research assistant who assesses the primary outcome well-being and the secondary outcome pain through observation does not know whether residents participate in the experimental group or the control group. The music therapist and the patients themselves cannot be blinded to the condition they are assigned to. Nursing staff that performs the measurements as part of the secondary outcomes is not blinded either. The research takes place at eight nursing homes facilities of a health care organization in the Netherlands. Music therapy is provided in 30-minutes sessions, twice a week for 12 weeks, in their own room. The control group receives a ‘social’ visit with individual attention with the same frequency and of the same duration.
A process evaluation is performed according to an approach developed by Saunders [
31], using components from Linnan and Steckler’s [
32]. The process evaluation is based on mixed methods, collecting quantitative and qualitative data. Qualitative data collection comprises a focus group discussion with participants of health care professionals to evaluate barriers and facilitators influencing the implementation of research protocol. Quantitative data is gathered with questionnaires about reach, dose delivered, dose received, fidelity, recruitment and participant engagement. Quantitative data is gathered with questionnaires at 1, 2, 6 and 12 weeks after the baseline assessment completed by music therapists (intervention) or attendants (control). The questionnaires include items about participation in the sessions, fidelity, dose, engagement and about levels of implementation. Nurses and a research assistant will fill a questionnaire at the end of treatment to evaluate the process of implementation. Quantitative data will be analyzed with descriptive statistics.