Musicoterapia in ambito neurologico Alfredo Raglio Dipartimento di Scienze Biomediche e Chirurgico-Specialistiche Sezione di Clinica Neurologica – Università di Ferrara
[email protected] Dr. Alfredo Raglio
A.A. 2012-2103
NECESSITA DI DEFINIRE LA MUSICOTERAPIA…
Dr. Alfredo Raglio
A.A. 2012-2103
9 th WORLD CONGRESS OF MUSIC THERAPY: Music Therapy: a global mosaic many voices, one song WASHINGTON, D.C., 1999 Dr. Alfredo Raglio
A.A. 2012-2103
La Musicoterapia è ...l'uso della musica e/o dei suoi elementi (suono, ritmo, melodia e armonia) per opera di un musicoterapeuta qualificato, in un rapporto individuale o di gruppo, all interno di un processo definito, per facilitare e promuovere la comunicazione, le relazioni, l'apprendimento, la mobilizzazione , l'espressione l organizzazione ed altri obiettivi terapeutici degni di rilievo, nella prospettiva di assolvere i bisogni fisici, emotivi, mentali, sociali e cognitivi. La Musicoterapia si pone come scopi di sviluppare potenziali e/o riabilitare funzioni dell'individuo in modo che egli possa ottenere una migliore integrazione sul piano intrapersonale e/o interpersonale e, conseguentemente, una migliore qualità della vita attraverso la prevenzione, la riabilitazione o la terapia .
(8 th WORLD CONGRESS OF MUSIC THERAPY, AMBURGO, 1996) Dr. Alfredo Raglio
A.A. 2012-2103
Dr. Alfredo Raglio
A.A. 2012-2103
Clinical Psychology Review 29 (2009) 193–207
Contents lists available at ScienceDirect
Clinical Psychology Review
Dose–response relationship in music therapy for people with serious mental disorders: Systematic review and meta-analysis Christian Gold a,⁎, Hans Petter Solli b,c, Viggo Krüger b, Stein Atle Lie a a
Unifob Health, Bergen, Norway
“…Music therapy is University a special type of psychotherapy where forms of musical interaction and communication are used alongside verbal of Bergen, Norway Diakonale Hospital, Oslo, Norway communication. It Lovisenberg has been defined as “a systematic process of intervention wherein the therapist helps the client to promote health, using music experiences and the relationships developing through them as dynamic forces of change” (Bruscia, 1998). The types of ‘music experiences’ can include a rused t i cin l emusic i n ftherapy o a b s tfree r a acnd t structured improvisation, other types of active music-‐making by patients, and listening to music. Improvisation is perhaps the most prominent form of musical interaction in music therapy. It has been Article history: Serious mental disorders have considerable individual and societal impact, and traditional treatments may Received 30 any June 2008 described as central in m music therapy models. lient(s) and therapist n musical instruments hey have chosen, showClimited effects. Music therapy mayimprovise be beneficial inopsychosis and depression, includingttreatmentReceived in revised form 6 January 2009 resistant cases. Theoaim of this review was t toheme. examine the benefits of music therapy for speople with serious playing together freely o r w ith a g iven s tructure o r a m usical r n on-‐musical M usic t herapists a re pecifically trained to Accepted 12 January 2009 mental disorders. All existing prospective studies were combined using mixed-effects meta-analysis models, intervene therapeutically within the medium, for eallowing xample to support by pofroviding rhythmical or pre-post tonal study), grounding, to clarify, to confront to examine the influence study design (RCT vs. CCT vs. type of disorder Keywords: (psychotic vs. non-psychotic), and number of sessions. Resultsm showed therapy, when added toin music therapy Psychosis or to challenge the client's expression in the music (Bruscia, 1987; Wigram, 2004). Other odes that of music music experiences standard care, has strong and significant effects on global state, general symptoms, negative symptoms, Depression include playing composed singing aanxiety, nd wfunctioning, riting or and improvising songs (Baker dose–effect & Wigram, 2005), and listening to musical engagement. Significant relationships were Psychotherapy music on instruments, depression, identified for general, negative, and depressive symptoms, as well as functioning, with explained variance Dose–effect relationship music (Grocke & W igram, 2006). Songs may be used by clients as a Mixed-effects meta-analysis ranging from 73% to 78%. Small effect sizes for these outcomes are achieved after 3 to 10, large effects after 16 safe, structuring and socially acceptable form in wtohich they The can express hich might be helps too people overwhelming to 51 sessions. findings suggestfeelings that music w therapy is o antherwise effective treatment which with psychotic and non-psychotic severe mental disorders to improve global state, symptoms, and functioning. express. Music listening may be helpful to bring up and make available therapeutically relevant issues (emotions, associations, Slight improvements can be seen with a few therapy sessions, but longer courses or more frequent sessions memories, identity issues). are needed to achieve more substantial benefits. © 2009 o Elsevier Ltd. All rights reserved. All these different modes of ‘music experiences’ become therapeutic by being used in the context f a therapeutic relationship. Verbal discussions, reflections, or interpretations connected to the music are important to help clients explore the potential meaning of an experience, and to Contents relate a new experience within therapy to situations in the client's life. The degree to which the music experience itself, versus the verbal reflection 1. Introduction . . c . onnected . . . . . . . .to . i. t, . i. s . s.een . . . a.s . the . . .active . . . . a . gent . . . . o. f . c.hange . . . . .m . ay . . v . ary . . . b.etween . . . . . .m. odels . . . . o . f m 194usic therapy Music therapy in mentalH health. . . . t . reatments . . . . . . . . t.hat . . .rely . . .solely . . . . o . n . .the . . .d.irect . . . e . ffects . . . . .o.f .m. usic . . . a . lone, . . . 194 (Garred, 2004), as well 1.1. as between clients. owever, which do not 1.2. Music therapy—the evidence to date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195 “involve or depend upon rocess of intervention nd change 1.3. a p Research questions addressed in thisareview . . . . .w . ithin . . . . a. c . lient–therapist . . . . . . . . . . . .relationship” . . . . . . . . . .(“auxiliary . . . . . . . .level”, . 195 Bruscia, 1998, p. Method T . he . . .term . . . .‘music . . . . .m . edicine’ . . . . . . i. s . s. ometimes . . . . . . . .u.sed . . t . o . d . istinguish . . . . . . . . s. uch . . . t.reatments . . . . . . . .from . . . .m . usic . 196therapy.”… 195), are not music t2.herapy. Dr. Alfredo Raglio A.A. 2012-2103 b c
2.1.
Criteria 2.1.1. 2.1.2. 2.1.3. 2.1.4. 2.1.5.
for selecting studies Study design . . . Study quality . . . Participants . . . . Interventions . . . Outcomes. . . . .
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196 196 196 196 196 196
after initiation of trazodone, and the headache disaped when the the agent agent was was discontinued. discontinued. The The temporal temporal d when onship suggested suggested that that the the headache headache could could be be the the adverse adverse onship t of of trazodone trazodone use. use. The The possibility possibility of of the the headache headache caused caused rotonin syndrome syndrome is is not not likely likely due due to to the the lack lack of of clinically clinically rotonin ciated findings of of mental mental status status change, change, autonomic autonomic hyperhyperiated findings ity or neuromuscular neuromuscular abnormalities. abnormalities. ty or he most common common side-effects side-effects that that lead lead to to discontinuation discontinuation e most azodone for for treatment treatment of of insomnia insomnia are are sedation, sedation, dizzidizziazodone 2 and psychomotor impairment. 2 To our knowledge, and psychomotor impairment. To our knowledge, are few reports of severe headache as an adverse effect are few reports of severe headache as an adverse effect d to trazodone use. In 1992, Workman et al. reported d to trazodone use. In 1992, Workman et al. reported a 35-year-old patient who possessed a genetic predisa 35-year-old patient who possessed a genetic predision toward migraine suffered from severe migraine ion toward migraine suffered from severe migraine ache after trazodone treatment.3 The mechanism of ache after trazodone treatment.3 The mechanism of done-induced headache is not clear. Serotonin-releasing done-induced headache is not clear. Serotonin-releasing r and serum serotonin increase during headache attacks r and serum serotonin increase during headache attacks cerebral vessels are highly innervated by serotonin fibers cerebral vessels4,5are highly innervated by serotonin fibers raphe nuclei. Workman et al. indicated that migraine raphe nuclei.4,5 Workman et al. indicated that migraine ache may be evoked by trazodone through its active ache may be evoked by trazodone through its active bolite, m-chlorophenylpiperazine, which is a potent bolite, is a potent elective m-chlorophenylpiperazine, serotonin receptor agonist.which In addition, this elective serotonin receptor agonist. In addition, this
Received 14 June 2011; revised 8 August 2011; accepted 23 23 September September 2011. 2011. accepted
Neurology Issue
When music music becomes becomes music music therapy therapy When doi:10.1111/j.1440-1819.2011.02273.x doi:10.1111/j.1440-1819.2011.02273.x Psychiatry and Clinical Neurosciences 2011; 65: 679–683
S
CIENTIFIC LITERATURE PROVIDES evidence of the CIENTIFIC LITERATURE PROVIDES evidence of the unquestionable effects of music both in pathological coneffects of music boththerapeutic in pathological conIunquestionable personally that music embodies potentialion the texts and uponsee individuals generally speaking.11 Also Also on the texts and upon individuals generally speaking. ties as suggestive – but not scientifically proven. physiological, neurophysiological, biological and neurochemiphysiological, neurophysiological, biological and neurochemiexample, ‘Mozart’s music’ is an concept:22 calFor levels, confirmation of such effects hasinsufficient been forthcoming. cal levels, confirmation of suchoreffects hasfrom beenDon forthcoming. which Mozart? The Requiem an aria Giovanni? Empirically, all individuals can experience well-being and Empirically, all individuals can experience well-being and positive emotions when that has parWhy Mozart and not thelistening Beatles ortoB.music McFerrin? Andsome addresspositive emotions when listening to music that has some particular significance forwhat? them,How? or can derive pleasure from ing whom? Producing ticular significance for them, or can derive pleasure from socializing a musical experience (making or listening tomusicmusic With these queries in mind, the international socializing a musical experience (making or listening to music Psychiatry and Clinical 2011; 65: 679–683 together with others), Neurosciences buthas allintroduced the above, while emphasizing the therapeutic community – as an essential comtogether with others), but all therefers above, while emphasizing the potentialities of music, usually to momentary effects that 3,4 ponent of therapy by music – the concept of ‘relationship’. potentialities of music, elude therapeutic logic.usually refers to momentary effects that Thetherapeutic above thoughts elude logic. can help re-model music-therapeutic I personally see that music potentialipractices by introducing theembodies followingtherapeutic aspects (Evidence Based tiesMusic as suggestive but not scientifically proven. 5,6 musical and Therapy–and Evidence Based Practice): For example, ‘Mozart’s music’ is an insufficient relational training of music therapists, presence of concept: a therapeu011 The Authors which Mozart? The Requiem or an aria from Giovanni? 011 The Authors tic setting, a theoretical/methodological Don background, aims hiatry and Clinical Neurosciences © 2011 Japanese Society of Psychiatry andBeatles Neurology Why Mozart and not the or B. McFerrin? And addressoriented to the achievement of stable and longlasting hiatry and Clinical Neurosciences © 2011 Japanese Society of Psychiatry and Neurology ing whom? Producing what? How? improvements (according to type gravity of pathologies With these queries in mind, theand international musicconsidered), content (active and/or receptive techniques) therapeutic community has introduced – as an essential com3,4 the facilitating intra-by and inter-personal with ponent of therapy music – the conceptrelationships of ‘relationship’. patient/client and rigorous assessment The above thoughts can help re-modelcriteria. music-therapeutic practices by introducing the following aspects Based I believe that neither music nor the(Evidence sonorous-musical 5,6 musical and if Music Therapy andtoEvidence Based Practice): element can fail keep these concepts in due consideration relational of music therapists, presence of aIn therapeuthey aretraining to assume a potential therapeutic value. therapeutic tic applications setting, a theoretical/methodological aims it is of essential importancebackground, that the individual’s oriented to the achievement of stable longmusicality and musical potential shouldand emerge: thislasting can only improvements (according to type and gravity of pathologies happen through the relationship between the music therapist considered), content (active and/or receptive techniques) and the patient/client mediated by the power of music. This is facilitating intra- and inter-personal relationships with the what definesand therigorous therapeutic specificity of music and contextupatient/client assessment criteria. I believe that neither music nor the sonorous-musical element can fail to keep these concepts in due consideration if they are to assume a potential therapeutic value. In therapeutic applications it is of essential importance that the individual’s musicality and musical potential should emerge: this can only happen through the relationship between the music therapist and the patient/client mediated by the power of music. This is what defines the therapeutic specificity of music and contextu-
Letters to the Editor 683
alizes the various possible interventions through music. Music can be the source of deep pleasure, it can stimulate relationships and attentive and cognitive functions, but it becomes therapeutic practice only in the presence of the essential components mentioned above.
REFERENCES
Letters to the Editor 683 Psychiatry and Clinical Neuroscience 1. Sacks O. The power of muisc. Brain 2006; 129: 2528–2532.
2. Koelsch S. Towards a neural basis of music-evoked emotions. Trends Cogn.possible Sci. 2010; 14: 131–137. alizes the various interventions through Music Volume 65,itIssue 7, music. (/doi/10.1111/pcn.2011.65.issue-7/issu C. All those things with music J. Music can 3.beGold the source of deep pleasure, can(Editorial). stimulate Nord. relationTher.attentive 2009; 18:and 1–2.cognitive functions, but it becomes ships and , Kruger et alInformation . Dose-response relationship 4. Gold practice C, Solli HP therapeutic only in theVpresence of the essential com- in Additional muisc therapy above. for people with serious mental disorders: systemponents mentioned atic review and meta-analysis. Clin. Psychol. Rev. 2009; 29: 193– 207. How to Cite REFERENCES 5. Vink A, Bruinsma M. Evidence based music therapy. Music 1. Sacks O. The power of 4: muisc. Brain 2006; 129: Ther. Today 2003; 1–26. Available from2528–2532. URL: http://www. 2. Koelsch S. Towards a neural basis of music-evoked emotions. musictherapyworld.de (last accessed 4 JulyWhen 2004). music becomes music therapy. Psy Raglio, A. (2011), Trends Cogn. Sci. 2010; 14: 131–137. 6. Edwards J. Possibilities and problems for evidence-based prac3. Gold C. All those 683. things with music (Editorial). Nord. J. Music doi: 10.1111/j.1440-1819.2011.02273.x in music therapy. Arts Psychother. 2005; 32: 293–301. Ther.tice 2009; 18: 1–2. 4. Gold C, Solli HP, Kruger V et al. Dose-response relationship in
Alfredo Raglio, MA (Music Therapy) muisc therapy for people with serious mental disorders: systemSospiro Foundation, atic review and meta-analysis. Clin. Psychol. Rev. 2009;Cremona, 29: 193– Italy 207. Email:
[email protected] M. Evidence based therapy. Music2011; 5. Vink A, BruinsmaReceived 25 July 2011;music revised 22 August Ther. Today 2003; 4: 1–26. Available from URL: http://www. accepted 23 September 2011. musictherapyworld.de (last accessed 4 July 2004). 6. Edwards J. Possibilities and problems for evidence-based practice in music therapy. Arts Psychother. 2005; 32: 293–301.
Author Information
Sospiro Foundation, Cremona, Italy, Email: raglioa@
Publication History
Alfredo Raglio, MA (Music Therapy) Cremona, Italy 19 DEC 2011 1. Sospiro IssueFoundation, published online: Email:
[email protected] Article first 22 published online: 19 DEC 2011 Received 2. 25 July 2011; revised August 2011; accepted 23 September 2011.
http://onlinelibrary.wiley.com.bibliosan.cilea.it/doi/10.1111/j.1440-1819.2011.02273.x/fu
Dr. Alfredo Raglio
A.A. 2012-2103
Differences between “music” and “music therapy” interventions in dementia.
(Raglio & Gianelli, Current Alzheimer Research, 2009, 6, 293-301). MUSIC
MUSIC THERAPY
Presence of a professional of the music area
Presence of a professional of the musictherapeutic area with specific relational and musical competences
Absence of a specific therapeutic setting
Presence of a structured therapeutic setting
Absence of a specific intervenion model
Presence of a music-therapeutic referential model grounded on theoretical and methodological criteria
Aims: temporary well-being, improving mood, promoting socialization, memories and stimulation of frames of mind, relaxation, etc.
Aims (aspiring to become stable and longlasting over time): attenuation of behavioral and psychiatric symptoms and prevention/ stabilization of complications; increase in communication and relationship skills
Contents: structured musical initiatives (rhythmic use of instruments, singing, movement associated to music, etc.) and listening to music (classical music, favourite music, etc.)
Contents: sonorous-musical improvisation; listening activities that involve verbal and elaborative competences (preferably at initial stages of dementia) Dr. Alfredo Raglio
A.A. 2012-2103
Altri interventi con la musica in ambito clinico… ! ATTIVITA’ DI PRODUZIONE MUSICALE ! ASCOLTO MUSICALE INDIVIDUALIZZATO ! BACKGROUND MUSIC ! MUSICA E MOVIMENTO ! …
QUALI OBIETTIVI? IN QUALE AMBITO CLINICO? QUALI CONTENUTI? QUALI PROFESSIONISTI? Dr. Alfredo Raglio QUALI MODALITA’ DI VERIFICA?...
A.A. 2012-2103
MUSIC THERAPY MODELS (WORLD FEDERATION OF MUSIC THERAPY, 1999)
! CREATIVE MUSIC THERAPY (NORDOFF-
ROBBINS)
! ANALITICAL MUSIC THERAPY (PRIESTLEY) ! BEHAVIORAL APPROACH (MADSEN) ! GUIDED IMAGERY AND MUSIC (BONNY) ! BENENZON MUSIC THERAPY (BENENZON)
Dr. Alfredo Raglio
A.A. 2012-2103
IN SINTESI… ORIENTAMENTO
ORIENTAMENTO
UMANISTICO
PSICODINAMICO
↓
↓
VALENZA ESPRESSIVA
VALENZA INTROSPETTIVA
(enfasi sulla componente estetica)
(enfasi sulla componente relazionale)
↓
↓
LA LIBERTA ESPRESSIVA FACILITA IL FLUSSO EMOTIVO EVITANDO IL BLOCCO DEL PENSIERO E DELLA CREATIVITA
L ASTENSIONE DALL AZIONE CONTATTA LE VERE EMOZIONI E SVILUPPA IL PENSIERO
Dr. Alfredo Raglio
A.A. 2012-2103
Quale musicoterapia? ! Musicoterapia ! musicoTerapia ! MusicoTerapia
Dr. Alfredo Raglio
A.A. 2012-2103
Altri modelli…
! L’approccio neuroscientifico (ambito neurologico)
Dr. Alfredo Raglio
A.A. 2012-2103
Le principali tecniche…
! TECNICHE IMPROVVISATIVE
! TECNICHE RECETTIVE
Dr. Alfredo Raglio
A.A. 2012-2103
Gli ambiti applicativi… ! PSICHIATRICO ! NEUROPSICHIATRICO INFANTILE ! NEUROLOGICO ! GERIATRICO ! ONCOLOGICO/CURE PALLIATIVE ! …
Dr. Alfredo Raglio
A.A. 2012-2103
LA LETTERATURA SCIENTIFICA…
Dr. Alfredo Raglio
A.A. 2012-2103
LA RICERCA PUO’ ESSERE INTESA COME SISTEMATIZZAZIONE E VALUTAZIONE DELL’INTERVENTO TERAPEUTICO Dr. Alfredo Raglio
A.A. 2012-2103
Necessità di definire i contenuti degli interventi (M o MT)e di utilizzare metodologie di ricerca adeguate
Dr. Alfredo Raglio
A.A. 2012-2103
EVIDENCE BASED MEDICINE ê EVIDENCE BASED MUSIC THERAPY
(Edwards, 2002; 2004; Vink & Bruinsma, 2003; Rolvsjord et al., 2005; Abrams, 2010) Dr. Alfredo Raglio
A.A. 2012-2103
“Evidence Based Music Therapy is a method in which the music therapist, in each decision he or she makes, tries to integrate best available scientific evidence with his or her own experience, combined with the values, expectations and wishes of his or her patient. Evidence Based Music Therapy is based on the principles of Evidence Based Medicine”. (Vink & Bruinsma, 2003) Dr. Alfredo Raglio
A.A. 2012-2103
LEVEL OF EVIDENCE !
Systematic review that is based on RCT's
! RCT or CCT studies
!
Patient-‐series with or without controls
! Case studies ! Expert opinions
! Qualitative research
Dr. Alfredo Raglio
A.A. 2012-2103
LA RICERCA IN MUSICOTERAPIA …
Dr. Alfredo Raglio
A.A. 2012-2103
LETTERATURA SCIENTIFICA …
Dr. Alfredo Raglio
A.A. 2012-2103
igram T W , T e l h TO, Da l a d l e H Gold C,
Musicoterapia e… Depressione (Maratos et al., 2009) • Cure di fine vita (Bradt & Dileo, 2010) • Danno cerebrale acquisito (Bradt et al., 2010) • Autismo (Gold et al., 2010) •
Demenza (Vink et al., 2011) • Schizofrenia (Mössler et al., 2011) •
ibrary Raglio … hed in The CochranDr.e LAlfredo
blis n and pu io t a r o b a e Coll Cochran e h T y b ed maintain ared and
A.A. 2012-2103
Esempi di RCTs in musicoterapia
Dr. Alfredo Raglio
A.A. 2012-2103
Efficacy Of Music Therapy In The Treatment Of Behavioral And Psychiatric Symptoms Of Dementia Raglio A, Bellelli G, Traficante D, Ubezio MC, Gianotti M, Villani D, Trabucchi M,
Alzheimer Dis Assoc Disor, 2008; 22:158-162 Fondazione Sospiro (CR) Gruppo Ricerca Geriatrica (BS) Unità Valutazione Alzheimer, Ancelle della Carità (CR) RSA Salò (BS) Fondazione Piccinelli (BG) Dr. Alfredo Raglio
A.A. 2012-2103
Efficacy of music therapy treatment based on cycles of sessions: a randomized controlled trial. Raglio A, Bellelli G, Traficante D, Gianotti M, Ubezio MC, Gentile S, Villani D, Trabucchi M Aging and Mental Health, 2010, 14, 900-904 Fondazione Sospiro (CR) Gruppo Ricerca Geriatrica (BS) Unità Valutazione Alzheimer, Ancelle della Carità (CR) RSA Salò (BS) Fondazione Piccinelli (BG) Fondazione S. Chiara (BG) IRCCS Don Gnocchi (MI) Dr. Alfredo Raglio
A.A. 2012-2103
Background: Music therapy has been proposed as a valid approach for behavioral and psychological symptoms (BPSD) of dementia.
Dr. Alfredo Raglio
A.A. 2012-2103
Objective: to assess MT effectiveness in reducing BPSD in persons with dementia.
Dr. Alfredo Raglio
A.A. 2012-2103
Methods:
-‐ Sixty persons with moderate-‐severe dementia (CDR 2-‐4)
-‐ Experimental group (n=30): 30-‐36 MT sessions (30 min/ session) -‐ Control group (n=30): educational support or entertainment activities. -‐ Subjects were randomly assigned to experimental or control group -‐ multidimensional assessment (MMSE, Barthel Index and NPI) -‐ Improvisational/intersubjective MT approach -‐ Music therapists: 5-‐year training focused on the relational MT approach applied in particular on persons with dementia -‐ MT evaluation: items taken from MTCS (Raglio et al., 2006) Dr. Alfredo Raglio
A.A. 2012-2103
Main difference between the two studies: -‐ The first study was based on a continuous treatment: 30
biweekly sessions (16 weeks)
-‐ The second study was based on 3 cycles of 12 sessions each, 3 times a week (36 sessions) and each cycle of treatment was followed by 1 month of wash-‐out
Dr. Alfredo Raglio
A.A. 2012-2103
MAIN RESULTS (first study)
Dr. Alfredo Raglio
A.A. 2012-2103
RaglioDisord et al Alzheimer Dis Assoc
Windows. The cognitive, functional, and behavioral 35 scores were submitted to a mixed analysis of variance, 30 25 with 1 repeated (time: before, after 8wk, after 16wk 20 25 ** 15 and4wkafterendoftreatment)and1independentfactor *** *** 10 (group: experimental and control). Dementia severity 20 ** 5 15 was considered as covariate. *** *** 0 Each NPI item score was submitted to Friedmann’s 10 4 weeks after Before Treatment After 8 weeks After 16 weeks end of analysis of variance for nonparametric data,25 comparing treatment 5 the variations occurred Experimental in the 4 differentGroup surveys (beforeControl Group the treatment, 8wk and 16wk after beginning of 0 Before Treatment After 8 weeks After 16 weeks 4 weeks after FIGURE 1. Average NPI global scores in the experimental and treatment and**P