Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001745831
Ethics application status
Approved
Date submitted
29/11/2021
Date registered
21/12/2021
Date last updated
22/11/2022
Date data sharing statement initially provided
21/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Online music therapy for people with dementia and their families.
Scientific title
The effects of online music therapy on mental health and quality of life of people with dementia and their family care partners.
Secondary ID [1] 305916 0
None.
Universal Trial Number (UTN)
U1111-1272-0714
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 324495 0
Depression 324496 0
Condition category
Condition code
Neurological 321978 321978 0 0
Dementias
Mental Health 321979 321979 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial investigates the effects and experience of an online therapeutic songwriting intervention for people with dementia and their family care partners. The online therapeutic songwriting process involves the 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).

The 10-week online music therapy songwriting intervention proposed for this project will occur in 2 phases. In phase 1, each dyad will meet with a RMT for 4 online weekly 1-hour music therapy songwriting sessions. These initial sessions will aim to establish rapport, gain an understanding of the dyad’s personal and music history, observe how they interact via an online platform, support them to overcome any technical difficulties, and familiarise them with the songwriting process. These more individualised sessions will help dyads to gain confidence with music therapy songwriting methods before moving to the online group context. In phase 2, groups of 3-4 dyads will be formed. Groups will be homogeneous where possible, with dyads who are in the same relationship types (for example, spousal/partner or other family). Each group will receive 6 weekly 1-hour online group music therapy songwriting sessions.


The therapeutic songwriting intervention will be informed by a person-centred, experience-based model. In keeping with this model, 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. The music therapist will monitor for adherence by checking participant attendance at each scheduled session.
Intervention code [1] 322311 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329728 0
Quality of life as assessed by the Quality of Life-AD (QoL-AD) for people with dementia
Timepoint [1] 329728 0

At baseline, week 5 (after 4 weekly songwriting sessions), and week 11 (7-days post-intervention)
Primary outcome [2] 329731 0
Quality of life as assessed by the Assessment of Quality of Life (AQoL-8D) for family caregivers
Timepoint [2] 329731 0
At baseline, week 5 (after 4 weekly songwriting sessions), and week 11 (7-days post-intervention)
Secondary outcome [1] 403593 0
Presence of symptoms of depression as assessed by the Cornell Scale for Depression in Dementia (CSDD) for people living with dementia
Timepoint [1] 403593 0
At baseline, week 5 (after 4 weekly songwriting sessions), and week 11 (7-days post-intervention)
Secondary outcome [2] 403595 0
Presence of symptoms of depression as assessed by the Patient Health Questionnaire (PHQ-9) for family caregivers.
Timepoint [2] 403595 0
At baseline, week 5 (after 4 weekly songwriting sessions), and week 11 (7-days post-intervention)
Secondary outcome [3] 404169 0
30 to 60 minute audio-recorded online qualitative interviews will be conducted with dyads (participants with dementia and family care partners) to evaluate intervention experiences and acceptability. Interviews will ask participants to reflect on their music therapy songwriting session experiences. They will also be asked about practical aspects of the program including participation enablers and barriers associated with session facilitation, online delivery, and assessments
Timepoint [3] 404169 0
Post intervention (week 11)
Secondary outcome [4] 404170 0
Session attendance records will be collected to measure feasibility, adherence and acceptability of the online songwriting intervention. Attendance of 80% or greater will indicate sufficient attendance.
Timepoint [4] 404170 0
Throughout the intervention period.

Eligibility
Key inclusion criteria
Inclusion criteria: there will be no restrictions based on dementia diagnosis or severity of symptoms, relationship type, or living arrangements. Eligible dyads will: be aged 18 years or older, have access to video conferencing technology, have functional hearing with or without aids, and have English communication skills (current or previous if nonverbal). Participants with dementia may be living in the family home with their family care partner, or separately either because they live in a care home or separate residence. Family care partners, may be a spouse/partner, adult child, other relative, or friend of the person with dementia.
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; and 2) have non-functional hearing. 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.

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?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This project examines the feasibility and acceptability of a 10-week online music therapy songwriting program or people with dementia and their family care partners. We aim to recruit 10 dyads) to examine the sensitivity of outcomes measures and to explore how people with dementia and their family care partners experience an online music therapy program. The project is not aiming to measure for statistical significance.

Participant demographics, background details and session attendance will be recorded descriptively, and if appropriate, means and standard deviations will be calculated. Pre, mid and post outcome measure data will be analysed using repeated measures analysis of variance and paired sample t-tests with a significance level of 0.05. Given this feasibility project aims to examine the sensitivity of outcome measures to change, pre to post effect sizes will be calculated using Cohen’s d and interpreted as small (d = 0.2), medium (d = 0.5), or large (d = 0.8) (Cohen, 1988). Qualitative data will be analysed using reflexive thematic analysis to interpret participant experiences recognising our own experiences, preconceptions and assumptions as researchers and clinicians (Braun & Clarke, 2020).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
7/03/2022
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
15/05/2023
Actual
Sample size
Target
20
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 36108 0
3006 - Southbank

Funding & Sponsors
Funding source category [1] 310265 0
University
Name [1] 310265 0
University of Melbourne
Country [1] 310265 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] 311365 0
None
Name [1] 311365 0
Address [1] 311365 0
Country [1] 311365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309937 0
Humanities, Arts and Social Sciences Ethics Committee, University of Melbourne
Ethics committee address [1] 309937 0
Ethics committee country [1] 309937 0
Australia
Date submitted for ethics approval [1] 309937 0
29/11/2021
Approval date [1] 309937 0
27/01/2022
Ethics approval number [1] 309937 0
23220

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

Contacts
Principal investigator
Name 115906 0
Dr Imogen Clark
Address 115906 0
Faculty of Fine Arts and Music, University of Melbourne, 234 St Kilda Road, Southbank, Victoria 3006, Australia.
Country 115906 0
Australia
Phone 115906 0
+61 3 83444449
Fax 115906 0
Email 115906 0
[email protected]
Contact person for public queries
Name 115907 0
Imogen Clark
Address 115907 0
Faculty of Fine Arts and Music, University of Melbourne, 234 St Kilda Road, Southbank, Victoria 3006, Australia.
Country 115907 0
Australia
Phone 115907 0
+61 3 83444449
Fax 115907 0
Email 115907 0
[email protected]
Contact person for scientific queries
Name 115908 0
Imogen Clark
Address 115908 0
Faculty of Fine Arts and Music, University of Melbourne, 234 St Kilda Road, Southbank, Victoria 3006, Australia.
Country 115908 0
Australia
Phone 115908 0
+61 3 83444449
Fax 115908 0
Email 115908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Owing to the small sample size, we are not seeking ethical approval to publish IPD.


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.