Clinical trial NCT01744600: Music Therapy in Methodist Homes: a Study Investigating the Impact of a Music Therapy Programme
Official title: Music Therapy in Methodist Homes: a Cluster Randomised Controlled Trial Including Mixed Methods Analysis Investigating the Efficacy of the Impact of a Music Therapy Programme on Caring for People With Dementia Who Have Behavioural Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Music Therapy
Lead sponsor: Methodist Homes for the Aged
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a cluster randomised control trial, which aims to investigate the effectiveness of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in older adults with dementia. In particular, the study aims to identify the main components of music therapy that are key in achieving this. The study will also explore carers' perceptions of music therapy, and investigate whether carers become more attentive to patients' needs and more able to manage patients' BPSD as a result of the music therapy programme.

Detailed description: While music therapy has been noted to be an effective intervention in decreasing agitation and disruptive behaviour in adults with dementia (Livingston et al, 2005), these effects have only been demonstrated during and immediately after sessions, arguably due to the progressive nature of dementia. To achieve long-lasting therapeutic change, it seems necessary to consider the specific elements that work in music therapy, and extract them for use within other activities. It is hypothesised that the use of such elements within additional activities and care provision, alongside regular music therapy sessions, may result in decreasing residents' BPSD for a longer duration of time.

Little research has been carried out that specifically identifies the key elements of music therapy which contribute to its efficacy within the field of dementia. This study aims to support existing evidence highlighting the significance of using music therapy within dementia care, and, importantly, identify what elements are principally involved in producing changes in behaviour and levels of well-being. The study will also incorporate the collection of dementia residents' physiological data, specifically their Electrodermal Activity (EDA), during therapy sessions. This will be measured by recording participants' levels of skin conductance (microSiemens/cm); this is controlled by the Sympathetic Nervous System and roughly thought of as the Fight or Flight system. Many efforts have been made to explore how skin conductance indicates the levels of emotional arousal, for example, high skin conductance indicates excitement or stress; low skin conductance indicates sadness or calmness. (Poh et. al., 2010; 2012; Van Dooren et. al., 2012). The skin conductance data is proposed to help identify the key elements and observable phenomena of the videoed music therapy sessions showing reduced presentation of BPSD.

If the current study is able to identify such elements, these findings will enable future research to investigate more comprehensively how these can be transplanted into other activities to optimise their effects.

Participants will be recruited from two residential Methodist Homes, and using a cluster randomized control design, will be allocated to either the control group on intervention group. Participants in the control group will receive standard daily care for 22 weeks. Participants in the intervention group will, in addition to daily standard care, receive one session of individualised active music therapy once a week for a period of 22 weeks.

Music therapy sessions will last 30 minutes. During the session the participant will wear a 'Q-sensor' device around their wrist, which will record their skin conductance levels. Each session will be video-recorded.

A communication system will be employed after each therapy session, in which video clips of the session demonstrating the participant engaging in an interaction or expression will be presented to care staff. This process will aim to demonstrate to staff how Behavioural and Psychological Symptoms of Dementia (BPSD) are minimised by music therapy techniques, the possible causes of BPSD, and how the therapist has made use of the participants' remaining abilities to enhance and facilitate their involvement and interpersonal communication within sessions.

The primary outcome measure will be the Neuropsychiatric Inventory, a standardised questionnaire used to assess the psychopathology of dementia patients. This will be carried out with residents' keyworkers at the following time points: as a baseline measure in the 2 weeks prior to the commencement of the music therapy intervention period, then at weeks 11-12, weeks 21-22 and as a follow-up at weeks 27-28. There will be three secondary outcome measures:

1. dementia care mapping, an observational tool used to assess the quality of care delivered by staff. This will be carried out at baseline in the 2 weeks prior to the commencement of the music therapy intervention; then at weeks 11-12; weeks 21-22; and as a follow-up at weeks 27-28.
2. microanalysis of video recordings of music therapy sessions, in conjunction with data on participants' arousal levels during sessions, measured by a skin conductance device worn on the wrist. This will take place each week after each music therapy session for the duration of the 22 week intervention period.
3. grounded-theory based interviews. These will be carried out with care staff during weeks 23 and 25 to explore carers' perceptions of music therapy.

Further analysis of video recordings of sessions will be conducted following the completion of the 22-week period of music therapy treatment to further investigate key moments within sessions.

Eligibility criteria: 31 participants are proposed to be recruited in total. This number comprises 16 resident participants, 14 staff participants and 1 music therapist.

The music therapist has already been recruited for the study and works within for the organisation's music therapy service in the two homes to be used as the research sites. The inclusion and exclusion criteria for staff and residents are outlined below.

Inclusion Criteria:

The proposed inclusion criteria for care home residents are as follows:

* Participants will be a resident at one of the two residential homes identified as the research sites, in one of the two house units that will be used in the project in each home.
* Participants will have a diagnosis of dementia
* Participants will display at least one symptom of BPSD
* Participants will be at least 40 years of age

The proposed inclusion criteria for staff participants are as follows:

* Staff participants will have at least three months' experience of working with the resident participant(s)
* Staff participants will have an in-depth knowledge of the resident participant(s) in a 'keyworker' role

Exclusion Criteria:

The proposed exclusion criterion for care home residents is as follows:

• Residents will be excluded if their health appears to be at a risk which raises concerns regarding their sustained involvement within the study, apparent from a general health examination with their General Practitioner

The proposed exclusion criteria for care staff participants is as follows:

* Staff who have not worked with the resident participant(s) in a 'keyworker' role for at least three months.
* Staff who would be unable to regularly work on the specific days they would be required within the home.

Primary outcomes:
measure: Neuropsychiatric Inventory
timeFrame: At baseline in the 2 weeks prior to the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at week 27-28.
Secondary outcomes:
measure: Dementia Care Mapping
timeFrame: At baseline in the 2 weeks prior to the start of the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at weeks 27-28.
measure: Grounded theory-based interviews
timeFrame: The two sets of interviews will be carried out during weeks 23 and 25.
measure: Microanalysis of video recordings of sessions
timeFrame: Video recordings of music therapy sessions will be analysed for the duration of the 22 week intervention period, immediately after each weekly music therapy session.
Other outcomes:
Locations:
city: Carterton
country: United Kingdom
facility: The Homestead
state: Oxfordshire
city: Swindon
country: United Kingdom
facility: Fitzwarren House
Study officials:
affiliation: Methodist Homes
name: Ming Hung Hsu, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Livingston G, Johnston K, Katona C, Paton J, Lyketsos CG; Old Age Task Force of the World Federation of Biological Psychiatry. Systematic review of psychological approaches to the management of neuropsychiatric symptoms of dementia. Am J Psychiatry. 2005 Nov;162(11):1996-2021. doi: 10.1176/appi.ajp.162.11.1996.
citation: Fossey J, Lee L, Ballard C. Dementia Care Mapping as a research tool for measuring quality of life in care settings: psychometric properties. Int J Geriatr Psychiatry. 2002 Nov;17(11):1064-70. doi: 10.1002/gps.708.
citation: Poh MZ, Swenson NC, Picard RW. A wearable sensor for unobtrusive, long-term assessment of electrodermal activity. IEEE Trans Biomed Eng. 2010 May;57(5):1243-52. doi: 10.1109/TBME.2009.2038487. Epub 2010 Feb 17.
citation: Poh MZ, Loddenkemper T, Reinsberger C, Swenson NC, Goyal S, Sabtala MC, Madsen JR, Picard RW. Convulsive seizure detection using a wrist-worn electrodermal activity and accelerometry biosensor. Epilepsia. 2012 May;53(5):e93-7. doi: 10.1111/j.1528-1167.2012.03444.x. Epub 2012 Mar 20.
citation: van Dooren M, de Vries JJ, Janssen JH. Emotional sweating across the body: comparing 16 different skin conductance measurement locations. Physiol Behav. 2012 May 15;106(2):298-304. doi: 10.1016/j.physbeh.2012.01.020. Epub 2012 Feb 4.
citation: Glaser, B. G. and Strauss, A. L., 1967. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine.
citation: De Backer, J., 2005. The transition from sensorial impression to a musical form ( proto-symbolism) in psychotic patients in a music therapeutic process. Ph. D. Aalborg University.
citation: Ridder, H.M.O., 2003. Singing dialogue: Music therapy with persons in advanced stages of dementia. A case study research design. Ph. D. Aalborg University.
citation: Trondalen, G., 2005. Significant moments" in music therapy with young persons suffering from anorexia nervosa. Music Therapy Today, 6, pp. 396-429.
citation: Hsu MH, Flowerdew R, Parker M, Fachner J, Odell-Miller H. Individual music therapy for managing neuropsychiatric symptoms for people with dementia and their carers: a cluster randomised controlled feasibility study. BMC Geriatr. 2015 Jul 18;15:84. doi: 10.1186/s12877-015-0082-4.