NCT01744600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

November 30, 2012

Last Update Submit

December 19, 2014

Conditions

Keywords

DementiaMusic Therapy

Outcome Measures

Primary Outcomes (1)

  • Neuropsychiatric Inventory

    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.

    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 (3)

  • Dementia Care Mapping

    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.

  • Grounded theory-based interviews

    The two sets of interviews will be carried out during weeks 23 and 25.

  • Microanalysis of video recordings of sessions

    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.

Study Arms (2)

Music Therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in the control group will receive normal, standard daily care for the 22 week period.

Interventions

Music TherapyBEHAVIORAL

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.

Music Therapy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Homestead

Carterton, Oxfordshire, OX18 1NA, United Kingdom

Location

Fitzwarren House

Swindon, SN3 4TD, United Kingdom

Location

Related Publications (10)

  • 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.

    PMID: 16263837BACKGROUND
  • 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.

    PMID: 12404656BACKGROUND
  • 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.

    PMID: 20172811BACKGROUND
  • 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.

    PMID: 22432935BACKGROUND
  • 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.

    PMID: 22330325BACKGROUND
  • Glaser, B. G. and Strauss, A. L., 1967. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Trondalen, G., 2005. Significant moments" in music therapy with young persons suffering from anorexia nervosa. Music Therapy Today, 6, pp. 396-429.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Dementia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ming Hung Hsu, MA

    Methodist Homes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 6, 2012

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations