Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001104640
Ethics application status
Approved
Date submitted
20/09/2023
Date registered
20/10/2023
Date last updated
27/06/2024
Date data sharing statement initially provided
20/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of mindfulness meditation and clinical hypnosis for addressing burnout and optimising wellbeing in competitive athletes: A replicated single-case experimental design
Scientific title
Investigating the effectiveness of brief mindfulness meditation and clinical hypnosis training for symptoms of burnout in uninjured competitive athletes: A replicated single-case experimental design
Secondary ID [1] 310492 0
Nil
Universal Trial Number (UTN)
U1111-1297-2682
Trial acronym
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Burnout 331279 0
Stress 331280 0
Condition category
Condition code
Mental Health 328038 328038 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two brief interventions (described below) being compared comprise five training sessions of 20 minutes in length, delivered across five consecutive days. Athletes are randomised to condition and will only receive one of the two trainings. The training sessions will be delivered as audio recordings via Qualtrics so that athletes can listen to the recordings (via headphones) in a location of their choice. Participants will also have access to the recordings during the post-training maintenance period. The length of the baseline period and maintenance period will be randomly assigned as either 5-days, 10-days, or 15-days in length such that the total duration of participation for all participants totals 25 days. The treatment period immediately follows the last day of baseline monitoring, and the maintenance period immediately follows the last day of treatment. Adherence will be tracked by the researchers via a function on Qualtrics. Both interventions will be recorded by A/Prof Melissa Day, a endorsed Clinical and Health Psychologist, with the same recording listened to by participants in each condition on each day of treatment and following treatment.

Condition 1, Mindfulness Meditation (MM): The MM recording will be adapted from Day (2017). It will first instruct the listener to anchor attention on the breath while being mindfully aware of any physical sensations that arise throughout the body. The listener is then encouraged to explore sensations with non-judgmental attentiveness, without attempts to change the sensation in any way. This will implicitly provide training in mindful acceptance. Finally, the listener is instructed to simply label any thinking that arises as “thinking”, before returning to the object of the meditation.

Condition 2, Clinical Hypnosis (HYP): The HYP recording will be adapted from Jensen (2011). It will take the listener through a standardised self-hypnosis practice that includes an induction, followed by tailored suggestions. Specifically, the HYP session aims to take the listener through four basic ideas: 1) an induction to get the individual into a state of readiness to accept new ideas; 2) instructions to go to a favourite place to deepen the induction and provide a context for feeling heat while being relaxed; 3) linking suggestions for reducing automatic behavioural inhibition system and behavioural activation system (BIS-BAS) activation in response to stressors and enhancing awareness of when to activate each system; 4) suggestions that target enhancing self-confidence and reducing competitive anxiety and 5) alerting.
Intervention code [1] 326877 0
Behaviour
Comparator / control treatment
The study design is a replicated single-cased experimental design. Thus, each participant will serve as their own in-person control as they will undertake a randomised baseline self-monitoring phase, followed by introduction of the intervention phase (MM or HYP), with a subsequent randomised maintenance period following the intervention phase. The trajectories of outcome and mechanism change will also be visually inspected across MM vs HYP.
Control group
Active

Outcomes
Primary outcome [1] 335910 0
Burnout
Timepoint [1] 335910 0
Athlete Burnout Questionnaire (ABQ): Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [1] 426105 0
Stress
Timepoint [1] 426105 0
Depression Anxiety Stress Scales – 9 item Short Form – Stress Subscale (DASS-S-3): Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [2] 426106 0
Fear
Timepoint [2] 426106 0
Positive and Negative Affect Schedule Expanded form (PANAS-X) - 6-item Fear Subscale: Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [3] 426107 0
Fatigue
Timepoint [3] 426107 0
100-point Numerical Rating Scale of Fatigue: Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [4] 426109 0
Serenity
Timepoint [4] 426109 0
Positive and Negative Affect Schedule Expanded form (PANAS-X) - Serenity Subscale: Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [5] 426914 0
Heart Rate Variability (HRV) chest strap monitor
Timepoint [5] 426914 0
Heart rate variability will be assessed during experimental pain stimulation using a thermal pain paradigm at four sampling points 1) at the commencement of the baseline data collection period; 2) at the start of the intervention period; 3) at the end of the intervention period; and 4) at the end of the maintenance period.
Secondary outcome [6] 426915 0
Peak Pain Intensity
Timepoint [6] 426915 0
Numerical Rating Scale (NRS) - Peak Pain Intensity: Peak pain intensity reported during experimental pain stimulation using a thermal pain paradigm at four sampling points 1) at the commencement of the baseline data collection period; 2) at the start of the intervention period; 3) at the end of the intervention period; and 4) at the end of the maintenance period.
Secondary outcome [7] 426916 0
Peak Pain Unpleasantness
Timepoint [7] 426916 0
Numerical Rating Scale (NRS) - Peak Pain Unpleasantness: Peak pain unpleasantness reported during experimental pain stimulation using a thermal pain paradigm at four sampling points 1) at the commencement of the baseline data collection period; 2) at the start of the intervention period; 3) at the end of the intervention period; and 4) at the end of the maintenance period.
Secondary outcome [8] 426917 0
Self-Confidence
Timepoint [8] 426917 0
Competitive State Anxiety Scale (CSAI-2R) – Self-Confidence Subscale: A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [9] 426918 0
Sports Competition Rumination
Timepoint [9] 426918 0
Sports Competition Rumination Scale (SCRS): A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [10] 426919 0
Anxiety
Timepoint [10] 426919 0
Competitive State Anxiety Scale (CSAI-2R) – Cognitive Anxiety Subscale: A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [11] 426920 0
Decentering
Timepoint [11] 426920 0
Metacognitive Processes of Decentring Scale - State Scale: A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)

Eligibility
Key inclusion criteria
a) be a competitive athlete (i.e., compete at a level beyond recreational or casual participation. This includes athletes who participate in regional, national, or international competitions, and those who are members of competitive teams or clubs),

b) have participated in a competition in the past six months and are currently training for a future or ongoing competition),

c) currently experiencing burnout, as indicated by a score of 79 or higher on the 18-item Shirom-Melamed Burnout Measure

d) be 18 or over,

e) read, speak, and understand the English language,

f) have access to the internet on a computer or smartphone,

g) have access to a set of earphones,

h) be willing to be randomly assigned to both conditions and listen to five 20-minute treatment sessions,

i) be willing to participate in a daily survey for 25 consecutive days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) having a current or previous injury within the last 6 months that lasted for 8 days or longer and that prevented you from participating in your sport during that time;
b) report <2 on a numerical rating scale for pain intensity in response to experimental "heat" pain stimuli;
c) having used alcohol and/or pain medication in the 24 hours before the thermal pain stimulus;
d) current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
e) psychiatric hospitalisation within the past 6 months;
f) psychiatric or behavioural conditions in which symptoms were unstable or severe within the past 6 months;
g) problems with allergic skin reactions or excessive bruising;
h) previous participation in a thermal pain stimulus experiment;
i) current or past participation in a research study with treatment components that may overlap those in the current study.

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)
Central randomisation, by software generated randomisation plan
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
Replicated single-case experimental design.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
23/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 41393 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 314870 0
University
Name [1] 314870 0
The University of Queensland
Country [1] 314870 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
330 McElwain Building, The University of Queensland, St Lucia, 4072, QLD
Country
Australia
Secondary sponsor category [1] 316866 0
None
Name [1] 316866 0
Address [1] 316866 0
Country [1] 316866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313710 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 313710 0
Ethics committee country [1] 313710 0
Australia
Date submitted for ethics approval [1] 313710 0
27/03/2023
Approval date [1] 313710 0
03/07/2023
Ethics approval number [1] 313710 0
2023/HE00036

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

Contacts
Principal investigator
Name 129094 0
A/Prof Melissa Day
Address 129094 0
330 McElwain Building, The University of Queensland, Brisbane, 4072, QLD
Country 129094 0
Australia
Phone 129094 0
+61733656421
Fax 129094 0
Email 129094 0
[email protected]
Contact person for public queries
Name 129095 0
Nicole Rickerby
Address 129095 0
330 McElwain Building, The University of Queensland, Brisbane, 4072, QLD
Country 129095 0
Australia
Phone 129095 0
+61733656421
Fax 129095 0
Email 129095 0
[email protected]
Contact person for scientific queries
Name 129096 0
Nicole Rickerby
Address 129096 0
330 McElwain Building, The University of Queensland, Brisbane, 4072, QLD
Country 129096 0
Australia
Phone 129096 0
+61733656421
Fax 129096 0
Email 129096 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.