Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001078549
Ethics application status
Approved
Date submitted
2/10/2015
Date registered
13/10/2015
Date last updated
7/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Mindfulness Acceptance Commitment (MAC) for Performance Enhancement’ with a Motivational Interviewing Framework: A RCT for Para Athletes, their Well-being and Performance
Scientific title
A RCT for Para athletes using a ‘Mindfulness Acceptance Commitment (MAC) for Performance Enhancement’ with a Motivational Interviewing Framework with wait-list control. Assessing their Subjective, Psychological and Social Well-being, and Performance.
Secondary ID [1] 287591 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being 296385 0
Performance 296386 0
Condition category
Condition code
Mental Health 296658 296658 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial will compare the effect of an 8-week well-being and performance enhancement program with a wait-list control group for Australian Para athletes with a physical impairments who are competing at a national level or above and aged 18 years and over. Athletes will be asked to complete pre and post intervention electronic questionnaires and semi-structured interviews in addition to completing the well-being program. The program will incorporate 8 x 1hr weekly face-to-face sessions with an investigator who holds a teacher-training certificate in Mindfulness, has been trained in Acceptance and Commitment Therapy and Motivational Interviewing, and has delivered Personal Excellence services to national and international athletes for over four years within a state institute of sport.

The intervention will apply a Motivational Interviewing framework, a client-centred approach where the student investigator can use a number of strategies depending on the progress of the conversation with the athlete. Although the conversations with each athlete may be different, the underlying consistency with motivational interviewing will be maintained. Motivational interviewing is a collaborative conversation style for strengthening a person’s own motivation and commitment to change. There are four key aspects underlying spirit of motivational interviewing, these are partnership, acceptance, compassion, and evocation. The key motivational interviewing strategies when addressing ambivalence about change are engaging, focusing, evoking, and planning. Motivational interviewing strategies will be incorporated during the assessment interview, and throughout the MAC program, to encourage change behaviour, and explore and resolve ambivalence about behaviour change, and discrepancies between belief and behaviour. Motivational interviewing employs the use of open questions, affirmations, reflections and summaries during the four key processes mentioned above. As such, motivational interviewing will be used to provide participants with the choice to change, and the choice of what psycho-education tools provided within the MAC program to implement within their athletic careers.

The MAC program is an integration and adaptation of Acceptance and Commitment therapy and Mindfulness Based Stress Reduction for use with an athletic population. It promotes competitive (in the moment) self-regulation necessary for optimal competitive performance as well as the valued goal commitment necessary for quality practice, intense training, and long-term development of athletic skill. The MAC program also targets decision-making, problem-solving, and behavioural processes and flexibility.

The MAC program incorporates an assessment interview and seven modules -

1. Assessment interview
2. Preparing the Client with Psychoeducation
3. Introducing Mindfulness and Cognitive Defusion
4. Introducing Values and Values-Driven Behaviour
5. Introducing Acceptance
6. Enhancing Commitment
7. Skill Consolidation and Poise—Combining Mindfulness, Acceptance, and Commitment
8. Maintaining and Enhancing Mindfulness, Acceptance, and Commitment.

Adherence to each of the 8 sessions will be monitored by the investigator, who will be meeting the participants face-to-face each week. If a participant cannot attend a session, the session will be rescheduled.
Intervention code [1] 292989 0
Treatment: Other
Comparator / control treatment
Wait-list control group; these participants will receive the intervention 8 weeks after baseline measurement.
Control group
Active

Outcomes
Primary outcome [1] 296268 0
One primary outcome to be measured is perceived subjective well-being using the Scale of Positive and Negative Emotions (Diener et al., 2010) and The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985).
Timepoint [1] 296268 0
At baseline (0 weeks) and directly after the intervention period (week 8).
Primary outcome [2] 296307 0
A primary outcome to be measured is perceived psychological well-being using Ryff’s Psychological Well-Being Scale (Ryff, 1989), and The Connor-Davidson Resilience Scale (CD-RISC 10; Campbell-Sills & Steins, 2007).
Timepoint [2] 296307 0
At baseline (0 weeks) and directly after the intervention period (week 8).
Secondary outcome [1] 318016 0
We will ask participants a small number of questions as part of the baseline assessment in order to assess social well-being within a sport context. For example, we would ask questions such as:
1: Can you please tell me what social acceptance/actualization/contribution/coherence mean to you within your sport?
2: How do you feel you are travelling in each of these areas?

Whereas the question at the conclusion of the RCT (directly after the intevention period; week 8) we would ask a small number of questions asking them to reflect on their well-being such as:

1: At the beginning of the program, you discussed how you perceived social well-being and the components of social acceptance/actualization/contribution/coherence and integration. Have any of these areas stayed the same, or changed for you, over the course of the well-being program?

Timepoint [1] 318016 0
Assessment will be at baseline (0 weeks) and directly after the intervention period (week eight)
Secondary outcome [2] 318134 0
A secondary outcome to be measured is physical well-being. Measures include The Athlete Burnout Measure (ABM; Raedeke & Smith, 2001) and The Pain Catastrophizing Scale.
Timepoint [2] 318134 0
Assessment will be at baseline (0 weeks) and directly after the intervention period (week eight)
Secondary outcome [3] 318135 0
A secondary outcome to be measured is performance, measured through the Sport Performance Questionnaire (SPQ; Wolanin, 2005).
Timepoint [3] 318135 0
Assessment will be at baseline (0 weeks) and directly after the intervention period (week eight)
Secondary outcome [4] 318136 0
A secondary outcomes to be measured is mindfulness measured through The Cognitive and Affective Mindfulness Scale—Revised (CAMS-R; Feldman, Hayes, Kumar, Greeson & Laurenceau, 2007).
Timepoint [4] 318136 0
Assessment will be at baseline (0 weeks) and directly after the intervention period (week eight)
Secondary outcome [5] 318137 0
A secondary outcomes to be measured is experiential avoidance measured through the Acceptance and Action Questionnaire II (AAQ-II; Bond et al., 2011).
Timepoint [5] 318137 0
Assessment will be at baseline (0 weeks) and directly after the intervention period (week eight)

Eligibility
Key inclusion criteria
Participants will be Para athletes aged over 18 years and over who are competing at a national level or above in a Paralympic sport who have a physical impairment and live in Melbourne that can attend eight weekly individual sessions. Participants will also be required to be able to read and speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Athletes will be excluded from the program if they are under 18, have a sensory or intellectual impairment, are competing in a state level or below, cannot speak or read English, or have been diagnosed with a mental illness. Athletes will be screened during a pre-intervention information session to ensure they meet the inclusion criteria and do not meet the exclusion criteria.

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)
Central randomisation by computer by independent researcher.
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
The aim of this pilot study is to recruit 20 Para sport athletes (10 in the intervention group and 10 in the wait-list control group). As the study is a pilot study, participant numbers have been based off the number of Para sport athletes located in Melbourne competing at a National level and above as well as previous Mindfulness and Acceptance Commitment Therapy programs.

Data Analysis: 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 post-intervention semi-structured interviews will be compared and analysed against the pre-intervention goals and interview using a thematic analysis and the software management tool NVivo (version 10).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/10/2015
Actual
22/10/2015
Date of last participant enrolment
Anticipated
30/11/2015
Actual
1/04/2016
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292153 0
University
Name [1] 292153 0
La Trobe University
Country [1] 292153 0
Australia
Primary sponsor type
University
Name
La Trobe Univesity
Address
La Trobe University
Corner of Plenty Road and Kingsbury Drive
Bundoora, VIC 3086
Country
Australia
Secondary sponsor category [1] 290860 0
None
Name [1] 290860 0
NA
Address [1] 290860 0
NA
Country [1] 290860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293629 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 293629 0
Ethics committee country [1] 293629 0
Australia
Date submitted for ethics approval [1] 293629 0
26/08/2015
Approval date [1] 293629 0
23/09/2015
Ethics approval number [1] 293629 0
15-074

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

Contacts
Principal investigator
Name 60566 0
Dr Paul O'Halloran
Address 60566 0
La Trobe University
Corner of Plenty Road and Kingsbury Drive
Bundoora, VIC 3086
Country 60566 0
Australia
Phone 60566 0
61394795607
Fax 60566 0
Email 60566 0
[email protected]
Contact person for public queries
Name 60567 0
Hannah Macdoguall
Address 60567 0
La Trobe University
Corner of Plenty Road and Kingsbury Drive
Bundoora, VIC 3086
Country 60567 0
Australia
Phone 60567 0
61394792066
Fax 60567 0
Email 60567 0
[email protected]
Contact person for scientific queries
Name 60568 0
Hannah Macdougall
Address 60568 0
La Trobe University
Corner of Plenty Road and Kingsbury Drive
Bundoora, VIC 3086
Country 60568 0
Australia
Phone 60568 0
61394792066
Fax 60568 0
Email 60568 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

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