NCT00448318

Brief Summary

Dementing syndromes are, for the most part, incurable. People with dementia become highly dependent and frequently have to move from their homes into residential aged care facilities. Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success. Increasingly, people with dementia, their families and carers are turning to supplementary or alternative approaches to the management of their symptoms. There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia. These include reports of improved memory, improved language skills, reduced anxiety and depression, reductions in agitation and disruptive behaviours and better social relationships with family, peers and carers. However, the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers. This clinical trial will examine the effects of a music therapy intervention. The study will recruit 180 patients in sub-acute hospital wards. Participants will be randomly placed in groups that receive either occupational therapy or music therapy. Before the therapy programs begin, we will use questionnaires to measure memory function, language ability, orientation and mood. We will also record brain activity from the surface of the scalp, blood pressure and pulse to examine physiological responses. The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy. We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions. This will provide information about the immediate effects of music on mood and social interaction. The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia. This understanding will be useful in developing better applications of music therapy. It will also add to our current knowledge about how the various diseases cause the problems they do. In summary, the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 16, 2007

Status Verified

February 1, 2007

First QC Date

March 14, 2007

Last Update Submit

March 14, 2007

Conditions

Keywords

Controlled clinical trial

Outcome Measures

Primary Outcomes (4)

  • Mini Mental State Examination: baseline cf. post intervention scores.

  • Hierarchic Dementia Scale: baseline cf. post intervention scores.

  • Geriatric Depression Scale: baseline cf. post intervention scores.

  • Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Secondary Outcomes (4)

  • EEG fast/slow ratio: baseline cf. post intervention scores.

  • EEG Coherence: baseline cf. post intervention scores.

  • EEG evoked potentials:baseline cf. post intervention scores.

  • Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Interventions

Music TherapyPROCEDURE

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of dementia

You may not qualify if:

  • delirium
  • acute medical conditions (eg pneumonia, cardiac failure)
  • primary psychiatric conditions (eg schizophrenia)
  • severe hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Ageing Research Institute

Parkville, Victoria, 3052, Australia

Location

Related Publications (1)

  • van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.

MeSH Terms

Conditions

DementiaAlzheimer DiseaseDementia, VascularLewy Body Disease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jonathan B Barber, PhD

    National Ageing Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 16, 2007

Study Start

March 1, 2007

Study Completion

October 1, 2008

Last Updated

March 16, 2007

Record last verified: 2007-02

Locations