Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001623482
Ethics application status
Approved
Date submitted
22/11/2016
Date registered
24/11/2016
Date last updated
14/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does song writing enhance wellbeing of people with acquired brain injury or spinal cord injury?: A pilot and feasibility study
Scientific title
The effect of a songwriting protocol on self-concept and wellbeing of people with acquired brain injury or spinal cord injury: A pilot and feasibility study
Secondary ID [1] 290533 0
ARC-DP150100201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 300955 0
Spinal Cord Injury 300956 0
Condition category
Condition code
Neurological 300758 300758 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 sessions of therapeutic songwriting provided to an adult with either spinal cord injury or acquired brain injury by a registered music therapist. The protocol is designed to target the self-concept whereby the therapist engages the participant in the creation of three songs guided by covering the six domains of the self-concept - the social self, the personal self, the family self, the physical self, the moral self, the academic self. The participant writes the first song about the past self (4 x 1 hour sessions twice per week), the second song about the present self (4 x 1 hour sessions twice per week), and a song about the imagined future self (4 x 1 hour sessions twice per week). sessions will be individual, provided in a face to face context, bedside or in a private room within the hospital or participants' homes. A log of session attendance will be used to monitor adherence. The music therapist with at least 5 years experience will utilise an iPad with garageband software to facilitate the creation and recording of lyrics and music.
Intervention code [1] 296387 0
Rehabilitation
Intervention code [2] 296388 0
Lifestyle
Intervention code [3] 296477 0
Treatment: Other
Comparator / control treatment
Standard Care: Participants in this group will receive their usual therapy
Control group
Active

Outcomes
Primary outcome [1] 300174 0
Self-concept: Head Injury Semantic Differential Scale
Timepoint [1] 300174 0
Baseline, mid-intervention (immediately following the 6th session), post-intervention, 6-month follow-up
Secondary outcome [1] 329245 0
Emotion regulation: Emotion Regulation Questionnaire
Timepoint [1] 329245 0
Baseline, mid-intervention (immediately following the 6th session), post-intervention, 6-month follow-up
Secondary outcome [2] 329246 0
Anxiety: GAD-7
Timepoint [2] 329246 0
Baseline, mid-intervention (immediately following the 6th session), post-intervention, 6-month follow-up
Secondary outcome [3] 329247 0
Satisfaction with life: Satisfaction with Life Scale
Timepoint [3] 329247 0
Baseline, mid-intervention (immediately following the 6th session), post-intervention, 6-month follow-up
Secondary outcome [4] 329248 0
Positive and negative affect: Positive and Negative Affect Scale-2
Timepoint [4] 329248 0
Baseline, mid-intervention (immediately following the 6th session), post-intervention, 6-month follow-up
Secondary outcome [5] 329249 0
Flourishing: Flourishing Scale
Timepoint [5] 329249 0
Baseline, mid-intervention (immediately following the 6th session), post-intervention, 6-month follow-up
Secondary outcome [6] 329250 0
Self-esteem: Rosenberg Self-Esteem Scale
Timepoint [6] 329250 0
Baseline, mid-intervention (immediately following the 6th session), post-intervention, 6-month follow-up
Secondary outcome [7] 329251 0
Flow: Short Flow Scale
Timepoint [7] 329251 0
immediately post song 1, song 2, and song 3
Secondary outcome [8] 329252 0
Meaningfulness of songwriting sessions: Songwriting Process and Product Questionnaire
Timepoint [8] 329252 0
immediately post song 1, song 2, and song 3
Secondary outcome [9] 350656 0
Depression - Patient Health Questionnaire - 9
Timepoint [9] 350656 0
Baseline, mid-intervention (immediately following 6th session), post intervention, 6-month follow up

Eligibility
Key inclusion criteria
1. Current inpatients at the Royal Talbot Rehabilitation Centre from ABI, Spinal or Neurology units, Kingston Monash Health, Epworth Richmond, or Caulfield Hospital
2. Former patients at the Royal Talbot Rehabilitation Centre from ABI, Spinal or Neurology units, Kingston Monash Health, Epworth, or Caulfield Hospital
3. A diagnosis of spinal cord injury or acquired brain injury. In this study, acquired brain injury refers to brain injury caused by events after birth and encompasses traumatic brain injury, stroke, brain tumors, substance abuse etc.
4. 0-24 months post discharge from inpatient rehabilitation units.
5. Living within a 25 kilometre radius of one of the 4 sites.
6. Able to communicate (in English)
7. Willing and able to participate in songwriting sessions (2 times weekly for 6-8 weeks) or to be a control participant
8. Confirmation from rehabilitation consultant or other team member of cognitive ability to complete assessment measures and emotional stability to examine self-concept
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe cognitive impairment or memory problems
2. Severe language problems or hearing impairment
3. Patients currently in Post Traumatic Amnesia

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)
seal opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE ESTIMATION & JUSTIFICATION
32 ABI and 32 SCI participants would be a feasible number to recruit over the study period and sufficient to determine the effect size of the intervention and the factors of efficacy.

STATISTICAL METHODS TO BE UNDERTAKEN
The data will be summarized as mean (standard deviation) and analyzed using paired sample t-tests using a significance level of 0.05. Effect size calculations will also be conducted, in addition to the probability analyses, to determine the size of any clinically significant changes in wellbeing. We will also search for correlations between the wellbeing measures (including experience sampling) and flow and meaningfulness of the songwriting process and song product.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
31/05/2017
Actual
30/06/2017
Date of last data collection
Anticipated
1/03/2018
Actual
Sample size
Target
64
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294960 0
Government body
Name [1] 294960 0
Australia Research Council
Country [1] 294960 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne Conservatorium of Music
The University of Melbourne
Royal Parade, Parkville
VIC 3010
Country
Australia
Secondary sponsor category [1] 293781 0
None
Name [1] 293781 0
Address [1] 293781 0
Country [1] 293781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296387 0
Austin Health HREC
Ethics committee address [1] 296387 0
Ethics committee country [1] 296387 0
Australia
Date submitted for ethics approval [1] 296387 0
24/08/2014
Approval date [1] 296387 0
24/10/2014
Ethics approval number [1] 296387 0
HREC14Austin422
Ethics committee name [2] 296390 0
Alfred Health HREC
Ethics committee address [2] 296390 0
Ethics committee country [2] 296390 0
Australia
Date submitted for ethics approval [2] 296390 0
12/11/2015
Approval date [2] 296390 0
14/12/2015
Ethics approval number [2] 296390 0
544-15

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

Contacts
Principal investigator
Name 70438 0
Prof Felicity A Baker
Address 70438 0
Department of Music Therapy
Melbourne Conservatorium of Music
The University of Melbourne
Building 862, Level 2
234 St Kilda Road VIC 3006
Country 70438 0
Australia
Phone 70438 0
+61 402172795
Fax 70438 0
Email 70438 0
[email protected]
Contact person for public queries
Name 70439 0
Young-Eun Claire Lee
Address 70439 0
Department of Music Therapy
Melbourne Conservatorium of Music
The University of Melbourne
Building 862, Level 2
234 St Kilda Road VIC 3006
Country 70439 0
Australia
Phone 70439 0
+61 3 8344 3003
Fax 70439 0
Email 70439 0
[email protected]
Contact person for scientific queries
Name 70440 0
Young-Eun Claire Lee
Address 70440 0
Department of Music Therapy
Melbourne Conservatorium of Music
The University of Melbourne
Building 862, Level 2
234 St Kilda Road VIC 3006
Country 70440 0
Australia
Phone 70440 0
+61 413596587
Fax 70440 0
Email 70440 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
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