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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
Type of registration
Prospectively registered

Titles & IDs
Public title
A wellbeing and performance enhancement program for Professional Dancers
Scientific title
Mindfulness Acceptance Commitment (MAC) for Performance Enhancement: A randomised controlled trial for Professional Ballet Dancers
Secondary ID [1] 297990 0
None
Universal Trial Number (UTN)
U1111-1231-8905
Trial acronym
MAC
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Holistic wellbeing 312411 0
Condition category
Condition code
Mental Health 310971 310971 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314214 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 319774 0
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).
Timepoint [1] 319774 0
8 weeks
Secondary outcome [1] 369495 0
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.
Timepoint [1] 369495 0
8 weeks

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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2019
Actual
3/06/2019
Date of last participant enrolment
Anticipated
24/06/2019
Actual
24/06/2019
Date of last data collection
Anticipated
7/10/2019
Actual
8/10/2019
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302514 0
Commercial sector/Industry
Name [1] 302514 0
The Autralian Ballet
Country [1] 302514 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road, Bundoora, VIC 3086
Country
Australia
Secondary sponsor category [1] 302423 0
None
Name [1] 302423 0
Address [1] 302423 0
Country [1] 302423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303170 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 303170 0
Ethics committee country [1] 303170 0
Australia
Date submitted for ethics approval [1] 303170 0
08/03/2019
Approval date [1] 303170 0
29/04/2019
Ethics approval number [1] 303170 0
HEC19093

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

Contacts
Principal investigator
Name 92726 0
Ms Carly Harrison
Address 92726 0
La Trobe University
Plenty Road, Bundoora, VIC 3086
Country 92726 0
Australia
Phone 92726 0
+61 401614638
Fax 92726 0
Email 92726 0
C.Harrison@latrobe.edu.au
Contact person for public queries
Name 92727 0
Carly Harrison
Address 92727 0
La Trobe University
Plenty Road, Bundoora, VIC 3086
Country 92727 0
Australia
Phone 92727 0
+61 401614638
Fax 92727 0
Email 92727 0
C.Harrison@latrobe.edu.au
Contact person for scientific queries
Name 92728 0
Mandy Ruddock-Hudson
Address 92728 0
La Trobe University
Plenty Road, Bundoora, VIC 3086
Country 92728 0
Australia
Phone 92728 0
+61 3 9479 3526
Fax 92728 0
Email 92728 0
m.ruddock@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be presented as group averages. No individual data will be used.


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.