Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000326796p
Ethics application status
Submitted, not yet approved
Date submitted
13/02/2022
Date registered
22/02/2022
Date last updated
22/02/2022
Date data sharing statement initially provided
22/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating a combined approach of songwriting, psychology and social media on the mental health of care-partners and people living with younger-onset dementia
Scientific title
Music And Psychology & Social connections (MAPS): A randomised controlled trial investigating the effect of combined music therapy/therapeutic songwriting, cognitive behavioural therapy and social media on depressive, anxiety and stress in care-partners and people with younger-onset dementia.
Secondary ID [1] 306397 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 325228 0
anxiety 325229 0
stress 325230 0
coping skills 325231 0
neuropsychiatric symptoms 325232 0
dementia
 325284 0
Condition category
Condition code
Neurological 322629 322629 0 0
Dementias
Mental Health 322630 322630 0 0
Anxiety
Mental Health 322685 322685 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MAPS intervention: 8 x group online sessions of 90 minutes (with a break), co-facilitated by a music therapist and psychologist, supplemented by a closed Facebook group (social media) for care-partners and people living with younger-onset dementia.
Dyads (i.e care-partners and people with younger-onset dementia) will attend Session 1 and 8 together for joint-sessions
Sessions 2 - 7: Care-partners and people with younger-onset dementia will attend in separate group sessions.
These sessions will occur weekly. The major themes that will be covered over the sessions include: the changes that occur with being a care-partner or being diagnosed with dementia; focusing on the positives and staying well; promoting normalcy; collaborative and open communication; social support; and lifestyle changes and self-care.
There will be optional "homework". This is anticipated to take about 30 minutes of sharing content to the closed Facebook group. This might include sharing songs or resources. The closed Facebook group will be moderated/monitored by the research team.
The other "homework" will involve practicing the relaxation strategies which will be discussed during the online group sessions - this might take 5-10 minutes at night.
Participants will be provided with workbooks which will be referred to and used during the online sessions and will be given these prior to the beginning of the intervention.
The intervention will occur online, via the videoconferencing platform Zoom - the participants will likely be in their own homes, but can also be located in another venue if they prefer as long as they can access the internet and Zoom.
The facilitators (music therapist and psychologist - qualified with a higher degree, at least 24 months research/clinical experience working with care-partners and people with dementia) will have a manual to work with.
The facilitators will have fortnightly supervision with their respective senior researchers.
Fidelity assessments - A standard fidelity checklist will be developed and session 2 or 3 will be recorded (cameras off/faces blurred) so that other members of the research team can rate fidelity.

Allocation of participants to MAPS intervention vs waitlist control - Dyads who pass screening will be randomly generated a number 0 or 1 and if they receive a "1", they will be allocated to the intervention first.
Intervention code [1] 322840 0
Treatment: Other
Intervention code [2] 322841 0
Behaviour
Comparator / control treatment
Wait list control - these dyads will be offered the MAPS intervention after the 2 month intervention period (following the completion of previous 8 week intervention).
Control group
Active

Outcomes
Primary outcome [1] 330442 0
Change in mental health, using the Depression, Anxiety and Stress Score (DASS21, Lovibond & Lovibond 1995) - CARE-PARTNER
Timepoint [1] 330442 0
Post-MAPS intervention (8 week intervention) - post-intervention measure will be taken at week 9
Primary outcome [2] 330443 0
Change to more adaptive coping skills on the BriefCOPE (Carver 1997)
Timepoint [2] 330443 0
Post-MAPS intervention (8 weeks) - at week 9
Primary outcome [3] 330444 0
Changed social connectedness on the Hawthorne Friendship Scale (Hawthorne, 2006)
Timepoint [3] 330444 0
Post-MAPS intervention (8 weeks) - at 9 weeks
Secondary outcome [1] 406234 0
Change in the Neuropsychiatric Inventory Questionnaire, NPI-Q (Kaufer et al 2000)
Timepoint [1] 406234 0
Post-MAPS intervention (8 week) - at 9 weeks.
Secondary outcome [2] 406235 0
Change in caregiving efficacy, using the Revised Scale for Caregiving Efficacy (Steffen et al. 2002)
Timepoint [2] 406235 0
Post-MAPS intervention (8 week intervention) - at 9 weeks.
Secondary outcome [3] 406390 0
PRIMARY OUTCOME FOR PEOPLE WITH DEMENTIA - change in depression using the Cornell Scale for Depression in Dementia (Alexopoulous et al. 1988)
Timepoint [3] 406390 0
Post-MAPS intervention (8 week intervention) - at 9 weeks.

Eligibility
Key inclusion criteria
PERSON WITH YOUNGER-ONSET DEMENTIA - all genders included.
Living at home. Symptom onset less than 65 years old (i.e can be older than 65 years old upon entry into the study). Mini mental state examination score between 22-28 years old. Sufficient english language, hearing and vision sufficient to tolerate 2 x 45 minute sessions. Access to the internet and labtop/tablet device.

CARE-PARTNERS - spouses and living with the people with younger-onset dementia. Sufficient english language, hearing and vision sufficient to tolerate 2 x 45 minute sessions. Access to the internet and laptop/tablet device
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia onset more than 65 years old. Not living at home in the community. Severe dementia as measured by a mini mental state examination score < 22.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using a computer/phone will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence randomisation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Dyads who are eligible for the trial will be allocated a random number generation of either 0 or 1. If they receive a "1", they will be allocated to the MAPS intervention. Those who receive a "0" will be a wait list control and offered the MAPS intervention in the next 2 months, following the cessation of the previous round of MAPS intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our primary outcome measure is an improvement in the DASS (pre- and post-), with a 4-point reduction (SD of differences = 8). Using ß=80% (power) and a=0.05 and medium effect size=0.5 (p<0.05), we will require a sample size of n=54 dyads. Accounting for 10% attrition, we aim to recruit for 60 dyads. For demographic analysis we will use frequencies and descriptive statistics. Categorical tests such as c2 will be used to compare groups on factors such as dementia types and sex. Paired t-tests will be used to compare pre- and post- primary and secondary outcomes and we will also calculate effect sizes to determine the size of the changes in DASS and other measures. Statistical Program for Social Sciences (SPSS) version 27 will be used for quantitative analyses. Qualitative analysis of focus group interviews will use Interpretative Phenomenological Analysis to synthesise their experiences, benefits, and limitations of participating in the project.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21704 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 21705 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 36756 0
3050 - Parkville
Recruitment outside Australia
Country [1] 24572 0
New Zealand
State/province [1] 24572 0

Funding & Sponsors
Funding source category [1] 310752 0
University
Name [1] 310752 0
University of Melbourne
Country [1] 310752 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of Psychiatry
300 Grattan Street,
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 311979 0
None
Name [1] 311979 0
Address [1] 311979 0
Country [1] 311979 0
Other collaborator category [1] 282155 0
Hospital
Name [1] 282155 0
Royal Melbourne Hospital
Address [1] 282155 0
300 Grattan Street
Parkville VIC 3050
Country [1] 282155 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310329 0
University of Melbourne
Ethics committee address [1] 310329 0
Ethics committee country [1] 310329 0
Australia
Date submitted for ethics approval [1] 310329 0
06/01/2022
Approval date [1] 310329 0
Ethics approval number [1] 310329 0

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

Contacts
Principal investigator
Name 117262 0
A/Prof Samantha Loi
Address 117262 0
Neuropsychiatry
University of Melbourne and Royal Melbourne Hospital
John Cade level 2
300 Grattan Street
Parkville VIC 3050
Country 117262 0
Australia
Phone 117262 0
+61393428750
Fax 117262 0
+6139342 8483
Email 117262 0
[email protected]
Contact person for public queries
Name 117263 0
Samantha Loi
Address 117263 0
Neuropsychiatry
University of Melbourne and Royal Melbourne Hospital
John Cade level 2
300 Grattan Street
Parkville VIC 3050
Country 117263 0
Australia
Phone 117263 0
+613 93428750
Fax 117263 0
+6139342 8483
Email 117263 0
[email protected]
Contact person for scientific queries
Name 117264 0
Samantha Loi
Address 117264 0
Neuropsychiatry
University of Melbourne and Royal Melbourne Hospital
John Cade level 2
300 Grattan Street
Parkville VIC 3050
Country 117264 0
Australia
Phone 117264 0
+61393428750
Fax 117264 0
+6139342 8483
Email 117264 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
As per ethical submission, no participant data will be shared.
Only data for publication will be shared through reasonable request.


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.