Running head: RESEARCH PROPOSAL: EFFECT OF MUSIC THERAPY IN DEMENTIA1

Research Proposal: Effect of Music Therapy in Dementia

Kyle Cahill, Kelsey Madea, Ashley Vigorita

University of New Hampshire

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Abstract

The purpose of this study is to explore the effect a music therapy program has on

decreasing the symptom of agitation in older adults living with moderate to severe dementia

when compared with standard dementia interventions. This study will include older adults living

in a skilled nursing facility with a DSM-5 diagnosis of moderate to severe dementia. The eligible

participants in the treatment group will be randomly chosen from a list of older adults who have

been recommended for a music therapy program at their facility. Researchers will use the Cohen-

Mansfield Agitation Inventory (CMAI) and the Agitated Behavior Scale (ABS) as outcome

measurement tools to assess agitation symptom levels. It is expected that this study will produce

knowledge about the efficacy of music therapy as a treatment in decreasing agitation symptoms.

This knowledge will help clinicians form more effective treatment plans for individuals living

with moderate to severe dementia.

Introduction

Dementia is a progressive and deteriorating condition of the brain. While most

individuals with dementia are of advanced age, the condition can be experienced by anyone

within a wide range of ages (Ridder, Stige, Qvale, & Gold, 2013). In 2012, it was estimated that

36 million individuals worldwide lived with dementia. This figure is expected to increase to over

65 million individuals worldwide by the year 2030 (Lin et al., 2010; Ridder et al.). While it is

true that dementia is pervasive throughout many populations, its effect is most concentrated

within elderly populations living in skilled nursing facilities and other long term care facilities.

Some studies have shown that as high as 80% of the individuals within these populations live

with dementia (Ridder et al.). In order to continue providing quality care and to continue

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facilitating a high quality of life for individuals in older age groups, it has become incumbent

upon allied health professionals to reconsider the current model of dementia treatment.

The effects of dementia manifest physically, cognitively, and behaviorally. In the past,

primary methods of treatment have included psychotropic medications. However, what health

professionals in the past have failed to realize is that this form of treatment merely addresses the

symptoms of the condition, rather than the underlying causes of symptom expression (Ridder et

al., 2013). The combination of ineffective results and negative side effects has led towards a need

for alternate forms of treatment. In keeping with the occupational therapy ideal of client-

centeredness, many health care professionals have begun turning to alternate treatments that

focus on treating the patient rather than treating the symptoms (Vink et al., 2012). In some cases,

client-centered treatments have already shown to provide the same level of, if not better,

outcomes than traditional pharmacological treatments. One such approach that has begun to

influence the intervention of dementia in older adults is music therapy

Among the various symptoms experienced by individuals with dementia, agitation is one

of the most prevalent. Agitation is a symptom characterized by inappropriate verbal, vocal, or

motor activity and is the most significant cause of distress for patients and caregivers alike in the

later stages of dementia (Ridder et al., 2013). Studies within the last couple of years have

observed the relationship between alternate therapies, such as music therapy, and the

psychological symptoms of dementia, such as agitation. According to Lum (2011), music

therapy, when combined with reminiscence therapy, provided the sense of warmth and an

increased likelihood to partake in meaningful occupation. A strong correlation between music

and meaningfulness in life was also supported by (Craig, 2007). Two other studies showed

similar results of an observed positive change in short term quality of life when implementing

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music therapy into the lives of older individuals with dementia (Ridder et al.; Solé, Mercadal-

Brotons, Galati, & De Castro, 2014). Overall, studies on this topic concur that music therapy is

an effective way to promote social and emotional well-being by activating or relaxing the client

with music that they find to be meaningful in some way (Vink et al., 2012). Nonetheless, there

are gaps in the methodology of the current studies. No study has yet isolated music therapy as a

unique and effective treatment that is capable of treating the cognitive symptoms of dementia,

such as agitation. Moreover, the efficacy of music therapy has not been compared on its own to

the efficacy of more standardized treatments, such as psychotropic medications. Thus, the

purpose of this study is to examine the efficacy of music therapy in treating the symptom of

agitation in older adults living with dementia as compared to more typical treatment strategies.

In this study, music therapy, the independent variable, can be defined as an alternate form

of therapy that will be applied three times a week for six months to older individuals living with

dementia. Agitation, which is the dependent variable, can be defined as a symptom of dementia

whose level of expression will be affected by musical therapy. It is hypothesized that music

therapy will provide a more significant reduction in agitation experienced by older adults with

dementia than the typical treatment interventions will.

Methods

For this study, an exploratory design will be used to compare two groups looking at the

effects of music therapy on levels of agitation in older adults living with moderate to severe

dementia. We will compare those receiving music therapy against those receiving standard

dementia treatment. Under consideration of ethical issues, due to the knowledge the researchers

have on symptomatology of dementia, a caregiver or a proxy caregiver will sign the consent

form giving researchers permission to include participant information in the study.

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This study will target individuals living in a nursing home who have moderate to severe

dementia. The inclusion criteria for the treatment group includes being diagnosed based on the

DSM-5 criteria, and referred to a music therapy treatment program. Both the participants in the

treatment group and the control group have to be experiencing symptoms of agitation and have a

steady medication regimen for at least six months. The exclusion criteria will include individuals

who have had a medication change within the past six months or are involved in other

interventions in order to control for contamination and/or co-intervention bias. We will use

convenience sampling by choosing skilled nursing facilities that are starting a music therapy

treatment group and by selecting participants from the music therapy referral list. Consent forms

will be given to all eligible members on the music therapy referral list and based on an effect size

of 0.5 according to a similar study done by Hsin et al. (2014), a sample size of at least 62

participants was needed for this study. The method of observation that we will use is naturalistic

observation, so we will collect information about the participants with no manipulation during

their interventions. The outcome we will focus on assessing is the symptom of agitation and how

music therapy affects the levels of agitation experienced by the participants. We will measure

this using Cohen-Mansfield Agitation Inventory (CMAI) and the Agitated Behavior Scale

(ABS). Our statistical analysis will be the non-parametric Wilcoxon signed ranks test to compare

the pre and post agitation scores and the follow up scores to determine the effectiveness of music

therapy compared to standard treatment.

One assessment tool that will be used to measure changes in agitation is the CMAI. The

CMAI is a caregiver’s questionnaire that utilizes a 7 point scale to assess 29 behaviors associated

with agitation. It is a tool that has been designed specifically for the nursing home setting. In a

recent study, the internal reliability for the CMAI was reported as being good (Cronbach’s alpha

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= .86). Additionally, to test for validity, CMAI scores for one sample were compared against

Behavioral Syndromes Scale for Dementia (BSSD) and the Behavioral Pathology in Alzheimer's

Disease (Behave—AD) scores in the same sample. The CMAI outcomes correlated favorably to

these recognized and well-accepted assessments, indicating that the validity of the CMAI in

assessing agitation in dementia patients is also good (Sung, Lee, Li, & Watson, 2012).

A second assessment that will be used to measure changes in agitation is the ABS. The

ABS is a fourteen question instrument with questions graded on a scale of 1-4. The assessment

was originally created to assess agitation in people with traumatic brain injuries, but has

displayed value in assessing those with dementia. In one study, the internal reliability of the ABS

was reported as being adequate to excellent (Cronbach’s alpha = .808). Additionally, in the same

study, ABS scores were associated with 36% to 62% of the variance in 15 of 16 correlations

with simultaneous, independent observations of agitation by experts. Essentially, the study

confirmed the validity of the ABS by demonstrating that clinical reasoning of professionals

experienced in treating individuals with cognitive disorders was aligned with the observed ABS

scores (Bogner and Corrigan, 2001).

Conclusion

The primary limitation of the proposed study is its subjectivity. Given the nature of

exploratory studies and of naturalistic observation, the information that is collected will be left

up to the interpretation of researchers and is susceptible to interpreter bias. Specifically, the

researchers have hypothesized that music therapy will reduce agitation in individuals with

dementia, meaning that this preconceived notion could easily influence observations and the

interpretation of results done. The idea of researchers falsely confirming a result based on

previous ideas is known as confirmation bias and poses a significant threat to this study.

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Additionally, a potential confounding variable could be the length of stay in a nursing home for

each participant and the different levels of dementia experienced. Variations in lengths of stay

could presumably affect participant’s openness and motivation to participate fully in alternate

treatments given their experiences with other standard treatments. In the future, to overcome the

bias that has been previously mentioned and to make more definitive conclusions, it would be

beneficial to use an experimental study design that gathers quantitative data.

In conclusion, it is expected that music therapy will significantly reduce the expression of

agitation in older adults with moderate to severe dementia, when compared to more typical

intervention techniques. This is significant in regards to occupational therapy given the

profession’s goal of being evidence-based and outcomes-based. With substantial evidence

supporting an alternate form of treatment in a growing area of concern, occupational therapists

will be able to more efficiently and more effectively treat clients. Additionally, therapists and

facilities will then be able to devote less time and monetary resources towards ineffective

treatment strategies, and these resources could be reallocated to promote future research and

other advances within the profession. Overall, this study represents an opportunity to help

continue the development of occupational therapy into a powerful and respected field of practice.

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References

Cohen-Mansfield, J. (1991). Instruction manual for the Cohen-Mansfield Agitation Inventory

(CMAI). The research Institute of the Hebrew Home of Greater Washington.

www.dementia-assessment.com.au/symptoms/cmai_manual.pdf (accessed April 20,

2016)

Craig, D. G. (2007). Exploratory study of the concept of meaningfulness in music. Nordic

Journal of Music Therapy, 16(1), 3-13. doi: 10.1080/08098130709478169

Bogner, J. (2000). The Agitated Behavior Scale. The Center for Outcome Measurement in Brain

Injury. http://www.tbims.org/combi/coglog ( accessed April 20, 2016 ).

Bogner, J., Corrigan, J., et al. (2001). "Role of agitation in prediction of outcomes after

traumatic brain injury." American Journal of Physical Medicine and Rehabilitation.

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http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=1071 (accessed

April 25, 2016).

Hsin, C., Chyn-Yng, Y., Yu, L., Keng-Liang, O., Tso-Ying, L., O’Brien, A. P., & Kuei-Ru, C.

(2014). The impact of group music therapy on depression and cognition in elderly

persons with dementia: A randomized control trial. Biological Research for Nursing,

16(2), 209-217. doi: 10.1177/1099800413485410

Lin, Y., Chu, H., Yang, C., Chen, C., Chen, S., Chang, H., & ... Chou, K. (2011). Effectiveness

of group music intervention against agitated behavior in elderly persons with

dementia. International Journal Of Geriatric Psychiatry, 26(7), 670-678.

doi:10.1002/gps.2580

Lum, C., (2011). Reflective dialogues in community engagement: an exploratory experience in

a singapore nursing home and day-care centre for senior citizens. International

Journal of Community Music, 4(2), 185-197. doi: 10.1386/ijcm.4.2.185_1

Ridder, H. O., Stige, B., Qvale, L. G., & Gold, C. (2013). Individual music therapy for agitation

in dementia: an exploratory randomized controlled trial. Aging & Mental Health, 17(6),

667-678. doi:10.1080/13607863.2013.790926

Solé, C., Mercadal-Brotons, M., Galati, A., & De Castro, M. (2014). Effects of group music

therapy on quality of life, affect, and participation in people with varying levels of

dementia. Journal of Music Therapy, 51(1), 103-125. doi: 10.1093/jmt/thu003

Sung, H., Lee, W., Li, T., & Watson, R. (2012). A group music intervention using percussion

instruments with familiar music to reduce anxiety and agitation of

institutionalized older adults with dementia. International Journal of Geriatric

Psychiatry, 27(6):621-7. doi: 10.1002/gps.2761

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Vink, A. C., Zuidersma, M., Boersma, F., Jonge, P., Zuidema, S. U., & Slaets, J. J. (2013). The

effect of music therapy compared with general recreational activities in reducing

agitation in people with dementia: a randomised controlled trial.

International Journal of Geriatric Psychiatry, 28(10), 1031-1038. doi:10.1002/gps.3924

Appendix 1

1. This research grant is through the Alzheimer’s Association focusing on specific studies

like developing treatments/therapies, including behavioral studies which is what our

study is looking at, the effectiveness of music therapy on the specific behavior of

agitation in people with dementia. This grant is for $175,000 over three years, a

minimum of two years. http://www.alz.org/research/downloads/AACF-D.pdf

2. This grant from AOTF is for smaller studies that will help lay more foundation for larger

studies to be done. This grant is for up to $50,000 in direct/indirect costs.

http://www.aotf.org/scholarshipsgrants/aotfinterventionresearchgrantprogram

3. This research award is from the American Music Therapy Association and fits our

research because we will be looking at the effectiveness of music therapy along with

seeing the outcomes in the area of wellness in the participants. This award is from $2,500

to $15,000. http://www.musictherapy.org/research/fultz/

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Appendix 2

Craig, D. G. (2007). Exploratory study of the concept of meaningfulness in music. Nordic

Journal of Music Therapy, 16(1), 3-13. doi: 10.1080/08098130709478169

Level III Research

AbstractAn essential part of music education/therapy is selecting music that will be meaningful to clients and students in order to motivate engagement and success in music activities. This study explores the concept of meaningfulness of music by drawing from theoretical interpretations and investigating possible factors associated with the term. Based on the constructs of purpose, security/efficacy, worthiness/self–worth, and value/importance, 10 statements were developed to identify factors associated with the perception of meaningfulness in a music listening task. Thirty–three college students utilized music identified as meaningful and not particularly meaningful, rating agreement with the ten statements. Results indicated that certain factors appeared to be more associated with the perception of meaningfulness in music than others. Specifically, being moved by music, the occurrence of memories or associations to music, and considering music as valuable, important, or a reflection of personal identity were important factors associated with meaningfulness. Suggestions for further research are proposed.

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Lin, Y., Chu, H., Yang, C., Chen, C., Chen, S., Chang, H., & ... Chou, K. (2011). Effectiveness

of group music intervention against agitated behavior in elderly persons with

dementia. International Journal Of Geriatric Psychiatry, 26(7), 670-678.

doi:10.1002/gps.2580

Level IV research

AbstractOBJECTIVES:This study explored the effectiveness of group music intervention against agitated behavior in elderly persons with dementia.

METHODS:This was an experimental study using repeated measurements. Subjects were elderly persons who suffered from dementia and resided in nursing facilities. In total, 104 participants were recruited by permuted block randomization and of the 100 subjects who completed this study, 49 were in the experimental group and 51 were in the control group. The experimental group received a total of twelve 30-min group music intervention sessions, conducted twice a week for six consecutive weeks, while the control group participated in normal daily activities. In order to measure the effectiveness of the therapeutic sessions, assessments were conducted before the intervention, at the 6th and 12th group sessions, and at 1 month after cessation of the intervention. Longitudinal effects were analyzed by means of generalized estimating equations (GEEs).

RESULTS:After the group music therapy intervention, the experimental group showed better performance at the 6th and 12th sessions, and at 1 month after cessation of the intervention based on

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reductions in agitated behavior in general, physically non-aggressive behavior, verbally non-aggressive behavior, and physically aggressive behavior, while a reduction in verbally aggressive behavior was shown only at the 6th session.

CONCLUSIONS:Group music intervention alleviated agitated behavior in elderly persons with dementia. We suggest that nursing facilities for demented elderly persons incorporate group music intervention in routine activities in order to enhance emotional relaxation, create inter-personal interactions, and reduce future agitated behaviors.

Lum, C., (2011). Reflective dialogues in community engagement: an exploratory experience in

a singapore nursing home and day-care centre for senior citizens. International

Journal of Community Music, 4(2), 185-197. doi: 10.1386/ijcm.4.2.185_1

Level III Research

Abstract:

This study documents a reflective journey of a community music programme initiated by a

university music education faculty member and an occupational therapist within the setting of a

nursing home and day-care centre in Singapore. Weekly music interaction sessions in

conjunction with reminiscence therapy were conducted over a period of five months. The

purpose of the study was to explore and examine the group music engagement process between

the music educators and senior citizen participants. It was noted that the subsequent planning and

execution of the programme catering to the social, cultural and historical contexts of the senior

citizens created a mutual learning environment that brought enjoyment, social and physical

engagement, social bonding, collective and personal expression, and empowerment to the senior

citizens and the music educators.

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Ridder, H. O., Stige, B., Qvale, L. G., & Gold, C. (2013). Individual music therapy for agitation

in dementia: an exploratory randomized controlled trial. Aging & Mental Health, 17(6),

667-678. doi:10.1080/13607863.2013.790926

Level I Research

AbstractOBJECTIVES:Agitation in nursing home residents with dementia leads to increase in psychotropic medication, decrease in quality of life, and to patient distress and caregiver burden. Music therapy has previously been found effective in treatment of agitation in dementia care but studies have been methodologically insufficient. The aim of this study was to examine the effect of individual music therapy on agitation in persons with moderate/severe dementia living in nursing homes, and to explore its effect on psychotropic medication and quality of life.

METHOD:In a crossover trial, 42 participants with dementia were randomized to a sequence of six weeks of individual music therapy and six weeks of standard care. Outcome measures included agitation, quality of life and medication.

RESULTS:Agitation disruptiveness increased during standard care and decreased during music therapy. The difference at -6.77 (95% CI (confidence interval): -12.71, -0.83) was significant (p = 0.027), with a medium effect size (0.50). The prescription of psychotropic medication increased significantly more often during standard care than during music therapy (p = 0.02).

CONCLUSION:This study shows that six weeks of music therapy reduces agitation disruptiveness and prevents medication increases in people with dementia. The positive trends in relation to agitation frequency and quality of life call for further research with a larger sample.

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Solé, C., Mercadal-Brotons, M., Galati, A., De Castro, M. (2014). Effects of group music therapy

on quality of life, affect, and participation in people with varying levels of dementia.

Journal of Music Therapy, 51(1), 103-125. doi: 10.1093/jmt/thu003

Level III Research

AbstractBACKGROUND:There is substantive literature reporting the importance and benefits of music and music therapy programs for older adults, and more specifically for those with dementia. However, few studies have focused on how these programs may contribute to quality of life.

OBJECTIVES:Objectives for this exploratory study were: (a) to evaluate the potential effect of group music therapy program participation on the quality of life of older people with mild, moderate, and severe dementia living in a nursing home; (b) to identify and analyze changes in affect and participation that take place during music therapy sessions; and (c) to suggest recommendations and strategies for the design of future music therapy studies with people in various stages of dementias.

METHODS:Sixteen participants (15 women; 1 man), with varying level of dementia participated in 12 weekly music therapy sessions. Based on Global Deterioration Scale (GDS) scores, phases of cognitive function were as follows: mild (n = 9; GDS 3-4), moderate (n = 5; GDS 5), and severe (n = 2; GDS 6-7). Data were collected using the GENCAT scale on Quality of Life. Sessions 1, 6, and 12 were also video recorded for post-hoc analysis of facial affect and participation behaviors.

RESULTS:There was no significant difference in quality of life scores from pre to posttest (z = -0.824; p =0.410). However, there was a significant improvement in median subscale scores for Emotional Well-being (z = -2.176, p = 0.030), and significant worsening in median subscale scores for Interpersonal Relations (z =-2.074; p = 0.038) from pre to posttest. With regard to affect and participation, a sustained high level of participation was observed throughout the intervention program. Expressions of emotion remained low.

CONCLUSIONS:Authors discuss implications of study findings to inform and improve future research in the areas of music therapy, quality of life, and individuals with dementia.

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Vink, A. C., Zuidersma, M., Boersma, F., Jonge, P., Zuidema, S. U., & Slaets, J. J. (2013). The

effect of music therapy compared with general recreational activities in reducing

agitation in people with dementia: a randomised controlled trial.

International Journal

of Geriatric Psychiatry, 28(10), 1031-1038. doi:10.1002/gps.3924

Level I Research

AbstractOBJECTIVE:This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities.

METHODS:In a randomised controlled design, residents with dementia (n = 94) were allocated to either music therapy or recreational activities. Both music therapy and general activities were offered twice weekly for 4 months. Changes in agitation were measured with a modified Cohen-Mansfield Agitation Inventory (CMAI) at four intervals on each intervention day. A mixed model analysis was used to evaluate the effectiveness of music therapy, compared with general activities, on CMAI scores at 4 h after the intervention, controlled for CMAI scores at 1 h before the session and session number.

RESULTS:Data were analysed for 77 residents (43 randomised to music therapy and 34 to general activities). In both groups, the intervention resulted in a decrease in agitated behaviours from 1 h before to 4 h after each session. This decrease was somewhat greater in the music therapy group than in the general activities group, but this difference was statistically not significant (F = 2.885, p = 0.090) and disappeared completely after adjustment for Global Deterioration Scale stage (F = 1.500; p = 0.222).

CONCLUSIONS:Both music therapy and recreational activities lead to a short-term decrease in agitation, but there was no additional beneficial effect of music therapy over general activities. More research is required to provide insight in the effects of music therapy in reducing agitation in demented older people.

Appendix 3

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The first assessment we chose was the Agitated Behavior Scale (ABS). The ABS was

created to assess the extent and nature of agitation in traumatic brain injury recovery. This

assessment helps treatment professionals gain objective information about a patient’s agitation.

ABS has also been proven to be extremely helpful in gaining information about the nature of

agitation for those with progressive dementias. The ABS is a 14 item instrument with a minimum

score of 14 and a maximum score of 56. The person being observed is rated on a 1-4 scale with 1

being that the behavior in that item is not present, and 2,3, or 4 indicate that the behavior is

present, and the number ascribed indicated the severity and extent to which the occurrence of the

behavior interferes with functional behavior. Below is a copy of an ABS score sheet with a

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description of the scoring.

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The second tool we chose for this study was the Cohen-Mansfield Agitation Inventory

(CMAI). The CMAI consists of 29-items, each rated on a 7-point scale of frequency, to assess

agitation and is rated by a primary caregiver in regards to the frequency the participant shows

physically aggressive, physically non-aggressive, and verbally agitated behaviors. The CMAI

takes around 20 minutes to administer and is a face-to-face interview where the research assistant

reads each category aloud to the caregiver. The caregivers are given a copy, or shown a copy, of

the instrument before the interview which allows them to think about the questions in advance.

The rating scale for the CMAI is as follows: 1-Never, 2-Less than once a week but still

occurring, 3-once or twice a week, 4-several times a week, 5-once or twice a day, 6-several times

a day, 7-several times an hour. There are five different versions of the CMAI the long form, long

form with expanded definitions, short form, community form (CMAI-C), and the disruptiveness

form. For the purpose of this study we used the Long form version of the CMAI which is the

original form of the assessment. Below is a picture that shows questions 1-6 on the long form.

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