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Trial registered on ANZCTR
Registration number
ACTRN12619000649112
Ethics application status
Approved
Date submitted
16/04/2019
Date registered
1/05/2019
Date last updated
17/09/2020
Date data sharing statement initially provided
1/05/2019
Date results information initially provided
17/09/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
A wellbeing and performance enhancement program for Professional Dancers
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Scientific title
Mindfulness Acceptance Commitment (MAC) for Performance Enhancement: A randomised controlled trial for Professional Ballet Dancers
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Secondary ID [1]
297990
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None
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Universal Trial Number (UTN)
U1111-1231-8905
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Trial acronym
MAC
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Linked study record
Not applicable
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Health condition
Health condition(s) or problem(s) studied:
Holistic wellbeing
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Condition category
Condition code
Mental Health
310971
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The RCT has been proposed for this study to compare the effect of a 7 week
wellbeing and performance program called ‘Mindfulness Acceptance Commitment (MAC) for
Performance Enhancement’ with a waitlist control group. Specifically, this trial will examine if the MAC program increases subjective and psychological wellbeing in Professional Ballet Dancers at The Australian Ballet. The face to face sessions will be conducted once a week for 30 minutes over a total of 7 weeks. Mode of administration: groups of approximately 10, we anticipate there will be approximately 10 participants in each of the 2 groups.
All participants will complete a baseline quantitative questionnaire after which they will be randomly allocated to either the intervention or waitlist group. The intervention group will be provided with education and mindfulness training, whilst the waitlist control group will receive the education component only. The waitlist control group will be provided with an opportunity to receive the mindfulness component after the study should they be interested. All participants will be quantitatively reassessed at week 8 completing the same initial questionnaire from week 1.
Participants will be asked to refrain from completing other psychological skills training for the duration of the intervention.
Each participant will work with the student researcher with whom they will complete 7 x 30 minute sessions.
The intervention sessions will include education about injury, performance and recovery and incorporate a mixture of theory and practice in mindfulness and acceptance and commitment training.
The waitlist control group, they will be provided with the education component including injury, performance and recovery only.
In week 8, semistructured interviews with participants from both the intervention and the waitlist control group will be conducted to gain further depth and insight into awareness of holistic wellbeing and performance.
* Participants will be provided with a voucher at the completion of week 8, funded by the student researcher, in appreciation of their time and in an attempt to encourage adherence and participation for the duration of the 8 week study period.
*Participants will be asked to not discuss their program procedures with others in order to try to control for contamination effects.
During data collection, all data from participants will be coded as participant numbers. A participant number will be placed on the data and the name of participant cut off the top of any forms. Only the participant number will be included in the data set. A master list will be created that includes names and participant numbers and will remain in a folder on the student researcher's personal, locked computer.
The student researcher holds a teacher training certificate in Mindfulness, has been trained in Acceptance and Commitment Therapy and has an accreditation in the development of wellness programs. The student researcher will also follow the MAC protocol (c.f., Gardner & Moore, 2007) that includes a stepbystep protocol for the performance enhancement program.
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Intervention code [1]
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Behaviour
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Comparator / control treatment
The waitlist control group will receive the education component only. The waitlist control group will be provided with an opportunity to receive the mindfulness component after the
study should they be interested. The waitlist comparison group will be provided with injury, performance and recovery education during the study. At the end of the 8 week study period should they be interested, the waitlist control group participants will be offered the mindfulness training and practice component.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary aim of the study is to identify if there is a relationship between self reported holistic wellbeing and mindfulness practice. This will be assessed by comparing the Mindfulness questionnaire responses from week 1 and week 7. Analysis of the data will be conducted to identify any statistically significant improvements and through discussions in the semi-structured interview week 8.The questionnaires administered at week 1 at 7 have been validated and include: RESTQ-Sport, The Acceptance and Action Questionnaire II (AAQ-II), the Assessing Athletes' mindfulness skills - the Mindfulness Inventory for Sport (MIS) questionnaire and the Sport Performance Questionnaire (SPQ).
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Assessment method [1]
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Timepoint [1]
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8 weeks
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Secondary outcome [1]
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A composite secondary aim of the study is to investigate if the mindfulness intervention leads to reduced injury incidence. Injury incidence will be determined by data-linkage to medical records. The method of assessment is to identify injury incidence throughout the 7 weeks in both groups and run statistical analysis to identify if there is any difference in injury incidence between the two groups.
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Assessment method [1]
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Timepoint [1]
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8 weeks
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Eligibility
Key inclusion criteria
Professional dancers at The Australian Ballet, employed full time and over the age of 18 years will be invited to participate.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Participants will be excluded from the study if they have:
a) participated in a Mindfulness Acceptance–Commitment program previously,
b) if they have participated in a mindfulness program in the last 12 months and
c) if they have previously engaged (in the last 12 months) or currently engage in mindfulness training via a web based application, such as Headspace or the like.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
To measure changes in wellness and injury incidence relative to work related
activity collected via the Athlete Management System, with ballet dancers over a 7 week period, a repeated measures ANOVA design will be used.
SPSS statistical software will be used to analyse the data. The data will be checked for missing or out of range values and that the data is univariately normally distributed. Significant baseline demographic differences (sex, age, nature of impairment) will be determined using the independent t test and Fisher exact probability test, as appropriate. Basic descriptive statistics will be used to report the demographic data of the participants.
Outcomes will be analysed using analysis of covariance on the change scores with the baseline measure of that variable used as the covariate. If the baseline variables are significantly different, they too will be entered as covariates. The mean difference within each group and the mean difference between the groups and the 95% CIs of the mean differences will also be calculated. Effect sizes and 95% CIs will also be calculated
for the change scores. To avoid bias and to maximize the randomization process, intention to treat analysis will be used.
Data from the postintervention semistructured interviews will be compared and analysed against the preintervention goals and interview using a thematic analysis and the software management tool NVivo (version 10).
Comparisons between week 1 and week 7 questionnaire responses will be reviewed via SPSS statistical analysis. Furthermore group comparisons of the intervention and waitlist
control group will be conducted to identify any differences between the two groups.
Semistructured interviews will be transcribed and thematic analysis conducted to identify themes from the experiences of the dancers.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/06/2019
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Actual
3/06/2019
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Date of last participant enrolment
Anticipated
24/06/2019
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Actual
24/06/2019
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Date of last data collection
Anticipated
7/10/2019
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Actual
8/10/2019
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Sample size
Target
20
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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The Autralian Ballet
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Address [1]
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Level 4, 2 Kavanagh Street, Southbank Victoria 3006
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Country [1]
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
Plenty Road, Bundoora, VIC 3086
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
302423
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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La Trobe University Human Ethics Committee
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Ethics committee address [1]
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Plenty Road, Bundoora, VIC 3086
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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08/03/2019
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Approval date [1]
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29/04/2019
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Ethics approval number [1]
303170
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HEC19093
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Summary
Brief summary
There continues to be a culturally embedded perspective that performing artists may need to “suffer for their art” and often wellness and artistry
are treated as if they are unrelated. This randomised controlled trial will compare the effect of a 7week
wellbeing and performance
enhancement program with mindfulness, to a waitlist
control group who receive the education only (without the mindfulness component), for
Professional Ballet Dancers employed at The Australian Ballet. Dancers will be asked to complete electronic questionnaires and semistructured
interviews in addition to completing the wellbeing
program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Carly Harrison
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Address
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La Trobe University
Plenty Road, Bundoora, VIC 3086
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Country
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Australia
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Phone
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+61 401614638
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Carly Harrison
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Address
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La Trobe University
Plenty Road, Bundoora, VIC 3086
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Country
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Australia
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Phone
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+61 401614638
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Mandy Ruddock-Hudson
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Address
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La Trobe University
Plenty Road, Bundoora, VIC 3086
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Country
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Australia
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Phone
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+61 3 9479 3526
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All data will be presented as group averages. No individual data will be used.
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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.
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