Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000875505
Ethics application status
Approved
Date submitted
30/06/2024
Date registered
17/07/2024
Date last updated
17/07/2024
Date data sharing statement initially provided
17/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Self-Instruction and Neurological Music Therapy on Executive Functioning in adult traumatic brain injury
Scientific title
Evaluate the Effectiveness of Self-Instruction and Neurological Music therapy on Executive Functioning in adult traumatic brain injury for patients aged 18 - 70 years old.
Secondary ID [1] 312482 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 334024 0
Condition category
Condition code
Neurological 330694 330694 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined Self-Instruction and Neurological Music Therapy

This study aims to see how group-based interventions utilising neurological music therapy and combined self-instruction with neurological music therapy affect executive functioning in people with moderate to severe traumatic brain injury.

Participants will be placed in small groups of 4 to 6 people. Groups will receive either a Neurological Music Therapy intervention, or an intervention combining Self-Instruction training and Neurological Music Therapy. The interventions will involve two one-hour group sessions each week for 5 weeks, for a total of 10 sessions.

In the neurological music therapy intervention, each session will include an overview of drumming practices around the world, drumming basics, beat selection, and structured practice.

In the combined self-instruction and neurological music therapy intervention, the sessions will include learning about executive functioning and practicing self-talk strategies, such as utilising verbal self-commands to redirect behaviour. Participants will also practice their verbal self commands while playing hand-drums.

The same trained facilitator will deliver each intervention in order to minimise the differences in delivery and mitigate the risk of variability in facilitator skill levels affecting study outcomes.
Attendance will be taken at each session, to monitor intervention adherence.

Once the sessions are finished, participants will do a post-intervention assessment, to see if anything has changed with their executive functioning skills. They will be given feedback and the opportunity to discuss their results with the team.
Intervention code [1] 328755 0
Rehabilitation
Intervention code [2] 329001 0
Treatment: Other
Comparator / control treatment
The effectiveness of the neurological music therapy and combined self-instruction and neurological music therapy interventions will be compared with self-Instruction training alone.

The self-instruction intervention will involve learning about executive functioning, and practicing instruction phrases to improve executive functioning skills in everyday life. The self-instruction training will follow the same format, number of sessions and frequency as the neurological music therapy and combined group interventions.
Control group
Active

Outcomes
Primary outcome [1] 338452 0
Executive Functioning.
Timepoint [1] 338452 0
Baseline and 1-week post intervention
Secondary outcome [1] 435979 0
Depression
Timepoint [1] 435979 0
Baseline and 1-week post assessment
Secondary outcome [2] 435980 0
Quality of Life
Timepoint [2] 435980 0
Baseline and 1-week post intervention
Secondary outcome [3] 435981 0
Executive Functioning
Timepoint [3] 435981 0
Baseline and 1-week post intervention
Secondary outcome [4] 435982 0
Mental Flexibility
Timepoint [4] 435982 0
Baseline and 1-week post intervention
Secondary outcome [5] 437349 0
Anxiety
Timepoint [5] 437349 0
Baseline and 1 week post-intervention
Secondary outcome [6] 437350 0
Stress
Timepoint [6] 437350 0
Baseline and 1 week post-intervention

Eligibility
Key inclusion criteria
1. History of Traumatic brain injury (moderate to severe traumatic brain injury as indicated by PTA > 24 hours and/or GCS <13 following head trauma
2. Age range: 18-70
3. Able to understand and answer questionnaires and engage in cognitive tests
4. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
5. Participants will be in the post-acute phase of recovery (i.e., more than 24 months since the injury
6. Participants will have a person willing to complete informant questionnaires.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Results within normal limits on all BRIEF-A measures;
2. Neurological symptoms that interfere with motor requirements or comprehension of tests, questionnaires or program material (e.g., global dysphasia),
3. Previous neurological or severe psychiatric illness (necessitating hospitalization),
4. Non-fluent in English,
5. Unable to provide informed consent.

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)
At the point of randomisation, the project coordinators will access the secure randomization system, enter the participant's unique identifier, and receive a randomization number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
28/08/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26652 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 26653 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 42692 0
2170 - Liverpool
Recruitment postcode(s) [2] 42693 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 316684 0
University
Name [1] 316684 0
Macquarie University
Country [1] 316684 0
Australia
Funding source category [2] 316904 0
Commercial sector/Industry
Name [2] 316904 0
Advanced Neuropsychological Treatment Services
Country [2] 316904 0
Australia
Primary sponsor type
University
Name
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Address
Country
Australia
Secondary sponsor category [1] 319153 0
None
Name [1] 319153 0
Address [1] 319153 0
Country [1] 319153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315459 0
HREC Humanities and Social Sciences
Ethics committee address [1] 315459 0
https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
Ethics committee country [1] 315459 0
Australia
Date submitted for ethics approval [1] 315459 0
19/02/2024
Approval date [1] 315459 0
16/05/2024
Ethics approval number [1] 315459 0

Summary
Brief summary
This study aims to see how group-based self-instructional training, neurological music therapy, and a combination of both will affect executive functioning in people with moderate to severe traumatic brain injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134770 0
A/Prof Jennifer Batchelor
Address 134770 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 134770 0
Australia
Phone 134770 0
+61 2 9850 8012
Fax 134770 0
Email 134770 0
[email protected]
Contact person for public queries
Name 134771 0
Jennifer Batchelor
Address 134771 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 134771 0
Australia
Phone 134771 0
+61 2 9850 8012
Fax 134771 0
Email 134771 0
[email protected]
Contact person for scientific queries
Name 134772 0
Jamie Berry
Address 134772 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country 134772 0
Australia
Phone 134772 0
+61300 224 331
Fax 134772 0
Email 134772 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


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.