History of Changes for Study: NCT01744600
Music Therapy in Methodist Homes: a Study Investigating the Impact of a Music Therapy Programme
Latest version (submitted December 19, 2014) on
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Study Record Versions
Version A B Submitted Date Changes
1 December 5, 2012 None (earliest Version on record)
2 January 29, 2013 Outcome Measures, Study Status, Study Description and Oversight
3 February 1, 2013 Recruitment Status, Contacts/Locations, Study Status, Eligibility and Study Description
4 May 15, 2013 Recruitment Status, Study Status and Contacts/Locations
5 December 19, 2014 Recruitment Status, Study Status and Study Design
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Study NCT01744600
Submitted Date:  December 5, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: MTRP-301013
Brief Title: 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.
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2012
Overall Status: Not yet recruiting
Study Start: January 2013
Primary Completion: September 2013 [Anticipated]
Study Completion: October 2013 [Anticipated]
First Submitted: November 30, 2012
First Submitted that
Met QC Criteria:
December 5, 2012
First Posted: December 6, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 5, 2012
Last Update Posted: December 6, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Methodist Homes for the Aged
Responsible Party: Sponsor
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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 three 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 baseline during week 1, then at week 13, week 21 and as a follow-up at week 29. 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 over weeks 2-3; then at weeks 14-15; weeks 22-23; and as a follow-up at weeks 30-31.
  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 at weeks 27-28 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.

Open or close this module Conditions
Conditions: Dementia
Keywords: Dementia
Music Therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 31 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Music Therapy
Participants in the experimental group will receive one active individual music therapy session each week for 22 weeks. Each session will last thirty minutes.
Behavioral: Music Therapy
The music therapy intervention will consist of individual active music therapy session each week for a period of 22 weeks. Each session will last 30 minutes.
No Intervention: Control
Participants in the control group will receive normal, standard daily care for the 22 week period.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Neuropsychiatric Inventory
[ Time Frame: At baseline during week 1, then at week 13, week 21 and as a follow-up at week 29. ]

The NPI assesses the neuropsychiatric symptoms and pathology of patients with Alzheimer's disease and other neurodegenerative disorders.

Ten behavioural areas (delusions, hallucinations, agitation/aggressions, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability and aberrant motor behaviour) and two neuro-vegetative areas (sleep and night-time behaviour disorders, and appetite and eating disorders) are assessed.

Changes in these areas of behaviour over the two weeks prior to interview will be investigated. This project will employ the version of the NPI which has been developed for use within institutional settings (NPI-NH). The interviews will be conducted with an informed professional caregiver.

Secondary Outcome Measures:
1. Dementia Care Mapping
[ Time Frame: At baseline over weeks 2-3, then at weeks 14-15, weeks 22-23 and as a follow-up at weeks 30-31. ]

Dementia Care Mapping (DCM) is an observational tool used within institutional settings that aims to provide information on residents' well-being and the quality of care delivered by staff. During a mapping session, the mapper(s) record resident's behaviours, mood, engagement and interactions with staff over a defined time period, within a communal area. For the purposes of this study, participants will be observed for two consecutive hours beginning from one hour prior to lunch.

Each construct of behaviour, mood and engagement is systematically coded within 5-minute time frames, and the resulting data set is then analysed to give an overall 'wellbeing' level. Staff-resident interactions are recorded as and when they occur, according to type and potential for well-being, and are named as 'personal detractors' or 'personal enhancers'. These aim to give an overall picture of the level and quality of person-centred-care being delivered.

2. Grounded theory-based interviews
[ Time Frame: The two sets of interviews will be carried out during weeks 27-28. ]

Two sets of Grounded Theory-based interviews will be carried out with care staff to explore their perceptions of music therapy. Grounded theory, developed by Glaser and Strauss (1967), is an inductive methodology by which theories are systematically generated from data without the use of pre-determined hypotheses. The process consists of a period of data collection; 'coding', in which themes and categories within the data are identified; 'memo-ing', the writing up of theoretical ideas on the codes and their relationships; and 'sorting' the memo's into an outline of the emerging theory. The phases of data collection, coding and memo-ing are ongoing and overlap, enabling an organic, flexible approach for themes to emerge within.
3. Microanalysis of video recordings of sessions
[ Time Frame: 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. ]

The method of microanalysis employed in this project will follow a similar procedure to those outlined by Ridder (2003), De Backer, (2005) and Trondalen (2005).

After each music therapy session, the research assistant and music therapist will play back the video recording and transcribe the interactions and expressions of the therapist and client. An Excel file developed by the Lead Researcher for this purpose will be used during this process.

The session will be divided into one-second timeframes and data will be recorded separately for both the therapist and client. For each timeframe that an expression is observed, a code will be chosen and inputted according to the nature of the client or therapist's expressions: musical, verbal, non-verbal or mixed. 'Special events' will also be recorded as and when they happen; these are sudden behaviours or changes in behaviours that raise questions and reflect something significant about the experience of the client in that moment.

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No

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 three 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 three 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.
Open or close this module Contacts/Locations
Central Contact Person: Ming Hung Hsu, MA
Telephone: 01785 228324
Study Officials: Ming Hung Hsu, MA
Principal Investigator
Methodist Homes
Locations: United Kingdom
Horfield Lodge
Bristol, United Kingdom, BS7 8SU
Contact:Principal Investigator: Ming Hung Hsu, MA
United Kingdom, Oxfordshire
The Homestead
Carterton, Oxfordshire, United Kingdom, OX18 1NA
Contact:Principal Investigator: Ming Hung Hsu, MA
United Kingdom, Wiltshire
Fitzwarren House
Swindon, Wiltshire, United Kingdom, SN3 4TD
Contact:Principal Investigator: Ming Hung Hsu, MA
Open or close this module IPDSharing
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Open or close this module References
Citations: 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. PubMed 16263837
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. PubMed 12404656
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. PubMed 20172811
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. PubMed 22432935
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. PubMed 22330325
Glaser, B. G. and Strauss, A. L., 1967. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine.
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.
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.
Trondalen, G., 2005. Significant moments" in music therapy with young persons suffering from anorexia nervosa. Music Therapy Today, 6, pp. 396-429.
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