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Trial registered on ANZCTR


Registration number
ACTRN12618000919213
Ethics application status
Approved
Date submitted
29/05/2018
Date registered
31/05/2018
Date last updated
10/12/2021
Date data sharing statement initially provided
3/05/2019
Date results provided
10/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Group music therapy to support community-dwelling people living with dementia and their family carers.
Scientific title
Therapeutic songwriting to support relationship quality among community-dwelling people living with dementia and their family caregivers: A single group design.
Secondary ID [1] 295035 0
Nil known
Universal Trial Number (UTN)
U1111-1214-8600
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 308068 0
Depression 308070 0
Condition category
Condition code
Neurological 307119 307119 0 0
Dementias
Neurological 307120 307120 0 0
Alzheimer's disease
Mental Health 307121 307121 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial investigates the effects and experience of a therapeutic group songwriting intervention for people with dementia and their family caregivers living in the community. The therapeutic group songwriting process involves the shared creation of lyrics and music to address psychosocial, emotional, cognitive and communication needs within a supportive therapeutic relationship. The intervention may include other support activities and music therapy processes, such as warm-up activities, familiar song-singing, music listening, reminiscence, discussion, and recording the song. Materials will include musical instruments and recording equipment (e.g. microphone, laptop).

This intervention includes 6 x 1hr songwriting sessions, once/week for 6 weeks. Sessions will be delivered face to face in a small group setting (3-4 dyads/6-8 people in each group) and will take place at community centres made available through associated Aged and Community Care providers. Sessions will be delivered by a Registered Music Therapist (RMT) with experience facilitating and researching therapeutic group songwriting with people with dementia and family caregivers of people with dementia in community settings.

While a protocol has been developed to guide the six sessions of group therapeutic songwriting, a person-centred, experience-based model of songwriting facilitated by a registered music therapist will allow for the intervention to be personalised to the needs of individuals and the groups of individuals. The music therapist will follow a pre-developed protocol and session guidelines. Each session will be video recorded. These recordings will be used to check that procedures have been followed for the purposes of fidelity.
Intervention code [1] 301373 0
Treatment: Other
Comparator / control treatment
The study has been updated to a single group pre-post design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306075 0
Caregiver-reported quality of relationship with their family member living with dementia as assessed by the Quality of the Caregiver Patient Relationship (QCPR) questionnaire.
Timepoint [1] 306075 0
At baseline, week 7 (1-week post-intervention - primary endpoint), and week 13 (7-weeks post-intervention)
Secondary outcome [1] 347480 0
Presence of symptoms of depression as assessed by the Patient Health Questionnaire (PHQ-9) for family caregivers.
Timepoint [1] 347480 0
Baseline, week 7 (1-week post-intervention), and week 13 (7-weeks post-intervention)
Secondary outcome [2] 347481 0
Quality of life as assessed by the Assessment of Quality of Life (AQoL-8D) for family caregivers
Timepoint [2] 347481 0
Baseline, week 7 (1-week post-intervention), and week 13 (7-weeks post-intervention)
Secondary outcome [3] 347482 0
Family caregivers' level of social engagement and connectedness as assessed by the Social Connectedness Scale (SCS)
Timepoint [3] 347482 0
Baseline, week 7 (1-week post-intervention), and week 13 (7-weeks post-intervention)
Secondary outcome [4] 347483 0
Family caregivers perceived level of caregiver burden as assessed by the Zarit Burden Scale (ZBS)
Timepoint [4] 347483 0
Baseline, week 7 (1-week post-intervention), and week 13 (7-weeks post-intervention)
Secondary outcome [5] 347515 0
Presence of symptoms of depression as assessed by the Cornell Scale for Depression in Dementia (CSDD) for people living with dementia
Timepoint [5] 347515 0
Baseline, week 7 (1-week post-intervention), and week 13 (7-weeks post-intervention)
Secondary outcome [6] 347516 0
Quality of life as assessed by the Quality of Life-AD (QoL-AD) for people with dementia
Timepoint [6] 347516 0
At baseline, week 7 (1-week post-intervention), and week 13 (7-weeks post-intervention)

Eligibility
Key inclusion criteria
All participants are required to have functional hearing and speak English in order to be eligible to participate in the study. Inclusion criteria for participants with dementia includes: 1) aged 60 years or older; and 2) a diagnosis of probable/possible dementia consistent with the DSM-V, or the National Institute on Ageing/Alzheimer’s Association (NIA/AA) diagnostic guidelines for Alzheimer’s disease12 as assessed by a geriatrician, neuropsychologist or other health professionals. Inclusion criteria for family caregivers includes: 1) aged 18 years and older; and 2) the primary non-professional caregiver responsible for the day to day needs of their loved one living with dementia (e.g. spouse, child, relative, friend).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria includes participants who are: 1) non-English speaking; 2) have non-functional hearing; and 3) are <18 years old if the family caregiver or <60 years old if the person with dementia. Additionally, people with dementia will be excluded if they do not have a diagnosis of probable/possible dementia consistent with DSM-V or NIA/AA guidelines. Caregivers will be excluded if they are not the primary caregiver for the person with dementia, or if they are paid in their caregiving role.

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)
Participants will not be randomised to groups in this single group design.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This project is not a randomised controlled trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analysis of pre-post single group outcome measures will utilise repeated analysis of variance and paired sample t-tests using a significance level of 0.5. All analyses will be conducted according to intention-to-treat principles. Effect size calculations will also be conducted, in addition to the probability analyses to determine the size of any clinically significant changes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2018
Actual
3/09/2018
Date of last participant enrolment
Anticipated
3/06/2019
Actual
30/11/2018
Date of last data collection
Anticipated
30/09/2019
Actual
1/03/2019
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22827 0
3083 - Bundoora
Recruitment postcode(s) [2] 22828 0
3020 - Sunshine
Recruitment postcode(s) [3] 26367 0
3030 - Werribee

Funding & Sponsors
Funding source category [1] 299615 0
Charities/Societies/Foundations
Name [1] 299615 0
Dementia Australia Research Foundation
Country [1] 299615 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
234 St Kilda Road
Southbank, Victoria 3006 Australia
Country
Australia
Secondary sponsor category [1] 298943 0
None
Name [1] 298943 0
Address [1] 298943 0
Country [1] 298943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300518 0
Human Research Ethics Committee (University of Melbourne)
Ethics committee address [1] 300518 0
Ethics committee country [1] 300518 0
Australia
Date submitted for ethics approval [1] 300518 0
Approval date [1] 300518 0
20/04/2018
Ethics approval number [1] 300518 0
1851252.1

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

Contacts
Principal investigator
Name 83918 0
Dr Imogen Clark
Address 83918 0
Room 228, Building 862, 234 St Kilda Road
Southbank, Victoria 3006 Australia
Country 83918 0
Australia
Phone 83918 0
+61 3 8344 4449
Fax 83918 0
Email 83918 0
imogen.clark@unimelb.edu.au
Contact person for public queries
Name 83919 0
Phoebe Stretton-Smith
Address 83919 0
Room 227, Building 862, 234 St Kilda Road
Southbank, Victoria 3006 Australia
Country 83919 0
Australia
Phone 83919 0
+61 3 8344 4449
Fax 83919 0
Email 83919 0
phoebe.stretton@unimelb.edu.au
Contact person for scientific queries
Name 83920 0
Imogen Clark
Address 83920 0
Room 228, Building 862, 234 St Kilda Road
Southbank, Victoria 3006 Australia
Country 83920 0
Australia
Phone 83920 0
+61 3 8344 4449
Fax 83920 0
Email 83920 0
imogen.clark@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not provided consent for retention and sharing of data.


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.