Original Research Article Accepted: June 2, 2009 Published online: July 23, 2009
Dement Geriatr Cogn Disord 2009;28:36–46 DOI: 10.1159/000229024
Effect of Music Therapy on Anxiety and Depression in Patients with Alzheimer’s Type Dementia: Randomised, Controlled Study S. Guétin a, c, d F. Portet a M.C. Picot b C. Pommié a, c M. Messaoudi a L. Djabelkir a A.L. Olsen c M.M. Cano c E. Lecourt d J. Touchon a, c a
Service de Neurologie, Centre Mémoire de Ressources et de Recherches (CMRR), Inserm U888, CHRU Montpellier, and b Département d’Information Médicale, CHRU Arnaud de Villeneuve, Montpellier, c Association de Musicothérapie Applications et Recherches Cliniques (AMARC) and d Laboratoire de Psychologie Clinique et Psychopathologie (LCPL) EA 4056, Université Paris 5 – Renée Descartes, Paris, France
Key Words Music therapy ⴢ Alzheimer’s disease ⴢ Depression ⴢ Anxiety
Abstract Background/Aims: Numerous studies have indicated the value of music therapy in the management of patients with Alzheimer’s disease. A recent pilot study demonstrated the feasibility and usefulness of a new music therapy technique. The aim of this controlled, randomised study was to assess the effects of this new music therapy technique on anxiety and depression in patients with mild to moderate Alzheimer-type dementia. Methods: This was a single-centre, comparative, controlled, randomised study, with blinded assessment of its results. The duration of follow-up was 24 weeks. The treated group (n = 15) participated in weekly sessions of individual, receptive music therapy. The musical style of the session was chosen by the patient. The validated ‘U’ technique was employed. The control group (n = 15) participated under the same conditions in reading sessions. The principal endpoint, measured at weeks 1, 4, 8, 16 and 24, was the level of anxiety (Hamilton Scale). Changes in the depression score (Geriatric Depression Scale) were also analyzed as a secondary endpoint. Results: Significant improvements in anxiety (p ! 0.01) and depression (p ! 0.01) were observed in the music therapy group as from week 4 and until week 16.
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The effect of music therapy was sustained for up to 8 weeks after the discontinuation of sessions between weeks 16 and 24 (p ! 0.01). Conclusion: These results confirm the valuable effect of music therapy on anxiety and depression in patients with mild to moderate Alzheimer’s disease. This new music therapy technique is simple to implement and can easily be integrated in a multidisciplinary programme for the management of Alzheimer’s disease. Copyright © 2009 S. Karger AG, Basel
Introduction
According to a recent study, 24.3 million people currently suffer from Alzheimer’s disease or related disorders, and 4.6 million new cases are reported worldwide each year. The number of patients is expected to double every 20 years, to reach 43.2 million by 2020 and 81.1 million by 2040 [1]. Alzheimer’s type dementia (AD) is the most common degenerative disease, with only half of the cases being diagnosed and one third treated. With the 2-fold increase in the number of cases anticipated over the next few decades, this progressive disease has become a major public health problem. Alzheimer’s disease is characterised by acquired impairment in cognitive function, with a gradual impact on the patient’s professional Stéphane Guetin 9 rue Léon Cogniet FR–75017 Paris (France) Tel. +33 6 20 47 67 57, E-Mail
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and social/family activities. Changes in emotions and behavioural disorders are generally already present. Various types of depressive and anxiety disorder may develop and are said to be among the earliest noncognitive expressions of the disease [2]. Psychological/behavioural disorders become apparent from the start of progression: a tendency towards isolation, apathy, lack of interest and gradual withdrawal from activities. These disorders are often associated with irritability, aggression and uncharacteristic emotional reactions [3]. Recent clinical studies, namely in functional neuroimaging, have been able to evidence the favourable role of music therapy in the management of Alzheimer’s disease [4, 5]. Music-based therapy corresponds to 2 fundamental methods, a ‘receptive’ listening-based method, and an ‘active’ method, based on playing musical instruments. Music therapy was defined by Munro and Mount [6] as: ‘the intentional use of the properties and the potential of music and its impact on the human being’. Receptive music therapy is perceived by Biley [7] as a ‘controlled method for listening to music, making use of its physiological, psychological and emotional impact on the individual during treatment for an illness or trauma’. A distinction is generally made between 2 types of receptive method: (1) receptive ‘relaxation’ music therapy [8, 9]: this method is similar to other approaches, such as hypnosis, sophrology and relaxation in general, and is often used in the treatment of anxiety, depression and cognitive disorders; (2) receptive ‘analytical’ music therapy: in this instance, music is used as a medium for ‘analytical’ psychotherapy [10]. The aim is to encourage the expression and development of thought. It may thus allow patients with cognitive disorders to stimulate, use and discover their remaining abilities. This psychotherapeutic approach encourages emotional and self-enhancing support. It may be perceived as a type of psychotherapy practised in line with the major current trends in psychotherapy. The most widely used method in the context of dementia is receptive ‘relaxation’ music therapy. The use of this method is able to reduce the frequency and extent of affective and psychological/behavioural disorders. Music is a major means of triggering emotions and helping patients express themselves verbally. Music therapy stimulates intellectual function, acts on anxiety and depression and thus significantly improves autonomy in patients suffering from Alzheimer’s disease [11– 15]. This is because the music is chosen on the basis of personal experience, which will stimulate memory by evoking autobiographical events. Listening to music, together with the resulting relaxation factor, is also effec-
tive in numerous areas. Choosing music connected to the individual’s personal experience is thus of paramount importance. These studies confirm that music therapy has a relaxing effect on patients suffering from Alzheimer’s disease. A pilot study demonstrated the feasibility and benefit of individual receptive music therapy sessions. Significant improvements in anxiety and depression (p ! 0.001) were observed from the first session and were maintained significantly during the subsequent sessions. The physical and mental burden felt by the main caregiver was reduced significantly (p ! 0.01). The sessions helped stimulate cognitive function by encouraging memory encoding and recall [16]. The results obtained made it possible to estimate the number of subjects required to set up a randomised controlled study. The primary objective of this randomised controlled study is to evaluate the impact of short- and mediumterm music therapy on anxiety disorders in patients suffering from mild to moderate stages of AD. The secondary objectives concern depression and the persisting effect of music therapy up to 2 months after discontinuation of the sessions.
Effect of Music Therapy in Alzheimer’s Disease
Dement Geriatr Cogn Disord 2009;28:36–46
Materials and Methods Consent This study received a favourable opinion from the ethics committee, as required by French legislation on bioethics, even though the study does not entail any additional risks (music therapy session, no impairment of physical or psychological integrity). During the inclusion visit, and before any subjects were included in the study, potentially eligible subjects (or their family or legal representative) signed the informed consent form (stating that they did not object) to take part in the project. Type of Study The study design corresponded to a randomised, controlled, comparative, single-centre study, with the results evaluated under blind conditions. The study was conducted over a total duration of 18 months, with a follow-up period of 6 months. Study Population The included patients were residents at the Les Violettes nursing home in Montpellier over the period from September 2007 to April 2008. They all suffered from mild to moderate stages of AD. Each patient was required to have a baseline Mini Mental State Evaluation (MMSE) [17, 18] score of between 12 and 25 and a baseline Hamilton Anxiety Scale score of at least 12. The included patients were men or women aged 70–95 years, with adequate verbal or written expression, visual and hearing abilities (hearing aids not permitted) in order to carry out the tests. All of the patients had been receiving stable anticholinergic treatment for 6 months. Psychotropic and anxiolytic treatment was authorised at
37
W16
W24
With music therapy (n = 15)
Patient recruitment 12 weeks Without music therapy (n = 15) Clinical evaluations D0
W4
W8
W16
W24
Fig. 1. Study flow chart.
stable reduced doses. Patients considered highly likely not to comply with the protocol or to drop out of the study as well as those suffering from a life-threatening illness during the envisaged study period were not included in the study. Likewise, patients with other neurological disorders, stroke, Parkinson’s disease, epilepsy, Lewy body dementia defined by the presence of extrapyramidal symptoms, hallucinations, unexplained episodes of confusion, dementia possibly of vascular origin (modified Hachinski ischaemia score 1 4), frontal dementia (frontal score 1 3) and psychiatric disorders (schizophrenia, bipolar disorders or depression as per the major depressive disorder criteria of DSM-IV) were not included in the study. Sample Size The number of subject required was estimated at 11 per group for a type I risk of 5% and a power of 90% with a 2-sided hypothesis. This sample size was based on the results of the preliminary study [16], taking an improvement corresponding to 7 units (on the Hamilton Scale) with a standard deviation of 2.6 in the music therapy group versus an improvement corresponding to 3 in the control group (improvement close to the standard deviation). Considering the anticipated number of patients lost to follow-up, the sample size for the group was increased to 15 subjects per group. Thirty subjects in total were included in the context of the study. Authorised Medication/Concomitant Medication All medicinal products and preparations, including over-thecounter products, taken by the patient during the study were recorded in the case report form stating the name, dosage, indication and treatment duration. The intake of medicinal products was recorded at each followup visit. No modifications in medication or significant changes in medicinal product intake were observed during the study, irrespective of therapeutic class and patient group. Method All of the included patients underwent a clinical evaluation and neuropsychological assessment at day 0 (D0), week 4 (W4), W8, W16 and W24. This follow-up was carried out in a visit context. Each subject underwent a clinical examination by a neurologist experienced in the diagnosis of AD, together with a neuropsychologist, and carried out all of the envisaged tests and examinations.
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Dement Geriatr Cogn Disord 2009;28:36–46
Thirty patients in total were randomised to one of the 2 groups, i.e. 15 patients per group. The subjects were followed up at W4, W8, W16 and W24 (fig. 1). In the group of patients undergoing music therapy, the sessions took place once a week between D0 and W16. The patients in the control group, without music therapy, took part in a different type of session (rest and reading), under the same conditions and at the same intervals. The results obtained at D0, W4, W8, W16 and W24 were collected by an independent neuropsychologist assessor (D.L.), not belonging to the care team and unaware of the type of intervention. The assessment at W24 made it possible to observe the potential persisting effect of music therapy. Intervention Method The individual receptive music therapy method was used. This may help reduce anxiety, depression and agitation in patients suffering from Alzheimer’s disease [19, 20]. The music was chosen based on the patients’ personal tastes following an interview/ questionnaire. Choosing music connected to the individual’s personal experience is of paramount importance. The style of music chosen varies from one patient to another, but also from one session to another for a given patient. The Centre Hospitalier Régional de Montpellier (CHRU) and Association de Musicothérapie Applications et Recherches Cliniques (AMARC) thus designed a computer program for this purpose. This makes it possible to select a musical sequence suited to the patient’s request from the different musical styles suggested (classical music, jazz, world music, various). The standard musical sequence, lasting 20 min, is broken down into several phases which gradually bring the patient into a state of relaxation according to the new ‘U sequence’ method [8, 9, 16]. This works by reducing the musical rhythm, orchestral formation, frequency and volume (descending ‘U’ phase). After a phase of maximum relaxation (bottom ‘U’ segment), a re-enlivening phase follows (ascending ‘U’ segment) (fig. 2). All of the music sequences, constructed using the ‘U sequence’ method, were specially created by the record publishing company, Music Care (table 1). The music was streamed via headphones in the patients’ rooms. The patients were either in a supine position or seated in a comfortable armchair. They were also offered a mask so as to avoid visual stimuli, thus encouraging them to concentrate on the music.
Guétin et al.
Stimulating rhythm
95 >T > 80 OF: 10–20
80 >T > 60 OF: 5–10
80 >T > 60 OF: 8–10
60 >T > 40 OF: 2–5
Moderate rhythm
60 >T > 40 OF: 3–8 40 >T > 30 OF: 1–3
Fig. 2. New music therapy technique: the ‘U’ sequence. Arrows indicate volume level. T = Tempo (beats per minute); OF = orchestral formation (number of instruments).
Table 1. Choice of suggested music styles
Classical
Jazz
World
Various
Piano Violin Flute Harp Oboe
Piano Guitar Saxophone Trumpet Trombone
Cuba Andes India Ireland Spain
Popular accordion music World accordion music Classic vocals Popular vocals New age music
Randomisation The patients were allocated to the different groups by randomisation at the end of the inclusion visit (V0), after patient information, verification of inclusion and exclusion criteria, and signing the consent form. Randomisation was generated in blocks of 4 by the methodological team (Clinical Research Unit, Montpellier CHRU). Study Endpoints • The primary study endpoint corresponded to anxiety between D0 and W16, measured using the Hamilton Scale, with the total score ranging from 0 to 56 [21, 22]. This scale consists of 14 items covering all of the sectors of psychosomatic anxiety. • The secondary endpoints corresponded to depression measured by means of a score obtained from the Geriatric Depression Scale (GDS) questionnaire. This is a self-assessment questionnaire consisting of 30 dichotomous questions, perceived as the reference diagnostic tool for evaluating depression in the elderly. The maximum score is 30 [23]. Statistical Analysis All of the randomised patients were included in the intent-totreat population. An overall description of each variable consid-
Effect of Music Therapy in Alzheimer’s Disease
Slow rhythm (relaxation) 20 min
ered was drawn up for each group. The quantitative data were described in terms of sample size, mean, standard deviation and range (minimum and maximum). The qualitative data were described by their distribution in terms of sample size and percentage by class. The normality of data was verified using the Kolmogorov-Smirnov test. The comparability of the 2 groups was verified on the baseline data (D0). The means were compared using Student’s t test or the Mann-Whitney nonparametric test. Qualitative variables were compared with the 2 test or Fisher’s exact test. A multivariate analysis was performed by means of ANOVA with repeated measures, in order to study the overall changes in the endpoints measured during follow-up. The differences between 2 consecutive time points and between each time point and D0 were tested. The tests were 2-sided, with a significance limit of 5%. The statistical analysis was performed using SAS쏐 software V9.1.
Results
Figure 3 illustrates the patient distribution within the groups. Two patients were prematurely withdrawn from the study in the intervention group: 1 between W8 and W16 owing to an intercurrent event not related to the study (life-threatening situation, hospitalisation), and the second died between W16 and W24. Four patients were withdrawn from the study in the control group: 1 between W4 and W8 due to dropping out, 1 between W4 and W8 owing to an intercurrent event not related to the study (hospitalisation), 1 patient died between W4 and W8, and the last patient dropped out between W16 and W24. Dement Geriatr Cogn Disord 2009;28:36–46
39
Institutionalised Alzheimer’s patients n = 38
Excluded patients n=8
Patients meeting the criteria n = 30
Randomisation D0
Patient withdrawn from study (hospitalisation)
Intervention group n = 15
Control group n = 15
W4 (n = 15)
W4 (n = 15)
W8 (n = 15) W8 (n = 12)
W16 (n = 14) Patient withdrawn from study (death)
Patients withdrawn from study (drop-out, hospitalisation, death)
W16 (n = 12) Patient withdrawn from study (drop-out)
W24 (n = 13)
W24 (n = 11)
Intent-to-treat analysis group (D0) n = 15
Intent-to-treat analysis group (D0) n = 15
Fig. 3. Distribution of the included patients into 2 groups.
Randomised Comparative Study The comparability of the 2 groups was verified at inclusion (table 2) for the main demographic, sociocultural and medical characteristics. The 2 groups were comparable at inclusion in terms of demographic and sociocultural data and history of the disease, apart from there being a higher number of women in the music therapy group. 40
Dement Geriatr Cogn Disord 2009;28:36–46
The data relating to patient clinical examination are described and compared between the 2 groups in table 2. The score for the Hamilton Anxiety Scale, the MMSE score and the GDS score, obtained during the baseline visit, are shown. No statistically significant differences are observed between the 2 groups as regards the scores obtained for the Hamilton Scale, GDS and MMSE at inclusion. Guétin et al.
Table 2. Randomised comparative study
Variable Gender1 male female total Marital status1 single lives with partner widowed or divorced total Place of residence1 large town medium-sized town rural setting total Education level1
