Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000896976
Ethics application status
Approved
Date submitted
24/05/2011
Date registered
23/08/2011
Date last updated
23/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Multiple Sessions of Group Music Therapy on Anxiety, Depression and Quality of Life in Older Adults With Psychiatric Disorders - A Pilot Study
Scientific title
The Effect of Multiple Sessions of Group Music Therapy on Anxiety, Depression and Quality of Life in Older Adults With Psychiatric Disorders - A Pilot Study
Secondary ID [1] 262247 0
Nil
Universal Trial Number (UTN)
U1111-1121-6958
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 267938 0
Depression 267939 0
Quality of Life 267940 0
Condition category
Condition code
Mental Health 268084 268084 0 0
Anxiety
Mental Health 270733 270733 0 0
Depression
Mental Health 270734 270734 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Music Therapy: 10 group sessions. 1 session each week for 10 consecutive week. Each session of 60 minutes length. The sessions will be facilitated by a trained music therapist.

Music therapy is a client centred therapy. The exact structure of sessions depends on the presentation of participants. Sessions are likely to include improvised music making and/or the singing of familiar songs as the therapist encourages, supports and accompanies clients’ active music making. Clients may contribute during sessions by speaking, singing and/or playing instruments that are accessible to them.
Intervention code [1] 266636 0
Treatment: Other
Intervention code [2] 267001 0
Rehabilitation
Comparator / control treatment
There is only one treatment group in this study. The participants act as their own control. Each participant initially has 4 weeks of standard care only (control) followed by 4 weeks of music therapy (intervention) and standard care. Standard care is the delivery of regular services by the Mental Health Services for Older People team to assist the client as decided by the weekly Multi-Disciplinary Team (MDT) meetings. This includes interventions from professionals within the team such as psychiatrists, psychologists, community nurses, social workers and occupational therapists.
Control group
Active

Outcomes
Primary outcome [1] 266822 0
Statistically significant reduction in (p<0.05) Trait Domain of the State Trait Anxiety Inventory for music therapy as compared to the control intervention.
Timepoint [1] 266822 0
4 weeks before the start of music therapy
Before the 1st music therapy session
After the last music therapy session
week 4 after the last music therapy session
week 10 after the last music therapy session
Primary outcome [2] 266823 0
Statistically significant reduction in (p<0.05) 17 item Hamilton Depression Scale for music therapy as compared to the control intervention.
Timepoint [2] 266823 0
4 weeks before the start of music therapy
Before the 1st music therapy session
After the last music therapy session
week 4 after the last music therapy session
week 10 after the last music therapy session
Secondary outcome [1] 276451 0
Improved SF12v2 Quality of Life Survey outcomes for music therapy as compared to the control intervention.
Timepoint [1] 276451 0
4 weeks before the start of music therapy
Before the 1st music therapy session
After the last music therapy session
week 4 after the last music therapy session
week 10 after the last music therapy session

Eligibility
Key inclusion criteria
-Client of the Mental Health Services for Older People community team.
-Clients with prominent symptoms of anxiety and depression as part of their presentation.
-Clients aged 65 years and above.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Clients that are predicted by their key worker to be unable to attend the group and/or complete the outcome measures due to mental or physical ill-health.
-Clients less than 65 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects will be enrolled from the clients of the Mental Health Services for Older People Team. All clients recieve the music therapy treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 3602 0
New Zealand
State/province [1] 3602 0
Auckland

Funding & Sponsors
Funding source category [1] 267132 0
Hospital
Name [1] 267132 0
Counties Manukau District Health Board
Country [1] 267132 0
New Zealand
Primary sponsor type
Individual
Name
Ajay Castelino
Address
Mental Health Services for Older People
Middlemore Hospital
Private Bag 93311, Otahuhu 1640,
Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 264207 0
Hospital
Name [1] 264207 0
Middlemore Hospital
Address [1] 264207 0
Mental Health Services for Older People
Middlemore Hospital
Private Bag 93311, Otahuhu 1640,
Auckland, New Zealand
Country [1] 264207 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271684 0
New Zealand Health and Disabilities Committee
Ethics committee address [1] 271684 0
Ethics committee country [1] 271684 0
New Zealand
Date submitted for ethics approval [1] 271684 0
01/06/2011
Approval date [1] 271684 0
12/07/2011
Ethics approval number [1] 271684 0
NTX/11/07/068

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32653 0
Address 32653 0
Country 32653 0
Phone 32653 0
Fax 32653 0
Email 32653 0
Contact person for public queries
Name 15900 0
Ajay Castelino
Address 15900 0
Mental Health Services for Older People
Middlemore Hospital
Private Bag 93311, Otahuhu 1640,
Auckland, New Zealand
Country 15900 0
New Zealand
Phone 15900 0
0064-9-2709797
Fax 15900 0
Email 15900 0
[email protected]
Contact person for scientific queries
Name 6828 0
Ajay Castelino
Address 6828 0
Mental Health Services for Older People
Middlemore Hospital
Private Bag 93311, Otahuhu 1640,
Auckland, New Zealand
Country 6828 0
New Zealand
Phone 6828 0
0064-9-2709797
Fax 6828 0
Email 6828 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.