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Trial registered on ANZCTR
Registration number
ACTRN12624000783527
Ethics application status
Approved
Date submitted
13/06/2024
Date registered
25/06/2024
Date last updated
25/06/2024
Date data sharing statement initially provided
25/06/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Western Australian Medical Schools Mindfulness Project: A Randomised Control Trial
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Scientific title
The Western Australian Medical Schools Mindfulness Project: A Randomised Controlled Trial of the impact of an online mindfulness program on wellbeing and study engagement in medical students.
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Secondary ID [1]
312334
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stress
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Condition category
Condition code
Mental Health
330775
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The online mindfulness training intervention, referred to as the "Mindfulness Training Program" (MTP) was delivered over eight weeks. It included eight mini-lectures (10 minutes duration each) focusing on various applications of mindfulness relevant to medical students (including multi-tasking, stress & performance, distraction & procrastination, mindful communication, regulating your emotions, compassion, self-compassion and e-mindfulness) and eight guided mindfulness meditation sessions (5 minutes duration). One mini-lecture was emailed as an audiovisual recording to participants each week and one mindfulness meditation was sent via SMS as an audio recording daily from Monday to Friday. Participants had ongoing access to all the mini-lectures and mindfulness recordings on completion of the 8-week program and were encouraged to utilize these resources over the following 6-month period. Adherence was monitored by a weekly email survey requesting participants to record frequency, duration and quality of their formal and informal mindfulness practice for the duration of the 8-week program.
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Intervention code [1]
328817
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Treatment: Other
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Intervention code [2]
328873
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Behaviour
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Comparator / control treatment
The control group received the usual medical school curriculum for the duration of the study and were offered the opportunity to participate in the mindfulness program on completion of their participation in the trial as an incentive to participate in the study.
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Control group
Active
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Outcomes
Primary outcome [1]
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% changes in the medical students' trait mindfulness
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Assessment method [1]
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Frieburg Mindfulness Inventory
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Timepoint [1]
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Baseline, at completion of the 8-week program (primary timepoint), 6 months post intervention (post-intervention timepoint)
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Primary outcome [2]
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% changes in the medical students' self-reported perceived stress levels
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Assessment method [2]
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Perceived Stress Scale
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Timepoint [2]
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Baseline, completion of the 8-week intervention (primary timepoint), 6 months post intervention (post-intervention timepoint)
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Primary outcome [3]
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% change in medical students' self-reported self-compassion levels.
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Assessment method [3]
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Self-Compassion Scale
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Timepoint [3]
338537
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Baseline, completion of the 8-week intervention (primary timepoint), 6 months post intervention (post-intervention timepoint)
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Secondary outcome [1]
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% change in medical students' self-reported levels of study engagement
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Assessment method [1]
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Utrecht Study Engagement Scale
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Timepoint [1]
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Baseline, completion of 8-week intervention, 6 months post intervention (post-intervention timepoint)
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Eligibility
Key inclusion criteria
All medical students attending University of Western Australia and University of Notre Dame Medicals schools in Perth, Western Australia, including students at the Rural Clinical School of Western Australia.
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Minimum age
18
Years
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Maximum age
60
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
None
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Study design
Purpose of the study
Treatment
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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)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization codes were generated using SAS PROC PLAN procedure. Randomization was run separately for male and female participants, as a ‘surrogate’ for stratification, due to (a) previous evidence for differential effects of mindfulness and (b) disproportionately more female participants.
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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
Sample size calculations were performed using the PROC POWER procedure in SAS for each of the primary outcome measures, namely the score changes in trait mindfulness, stress, self-compassion, and study engagement, from baseline to program completion. Assuming negligible (i.e., near zero) changes within the Control group, and modest improvements, of approximately 10% of the baseline score, within the Intervention group, a minimum of n=60 and n=40 would be required for the Intervention group and the Control group, respectively. All minimum planned sample sizes were expected to afford a statistical power of at least 0.8 and statistical significance level of 0.05.
Data on outcome measures were first summarised descriptively. The statistical significances of before-after within-group score changes on trait mindfulness, perceived stress, self-compassion and study engagement were assessed using paired t-test. Measures of mindfulness practice for intervention participants were also described using mean and standard deviations. Statistical predictors of significant score changes were assessed using generalized linear modelling (GLM). Candidate statistical predictors considered in the GLM models included the participants’ age, gender, ethnicity, prior exposure to mindfulness, and current practice of mindfulness.
Study data were collected and managed using the REDCap electronic data capture application hosted at University of WA (Harris et al., 2019; Harris et al., 2009). Data were then exported to Excel for cleaning and then SAS (version 9.4) for statistical analyses. Consistent with the randomised controlled design, intention-to-treat (ITT) analysis approach was followed. Statistical significance was set at a=0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
15/02/2018
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Date of last participant enrolment
Anticipated
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Actual
3/03/2020
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Date of last data collection
Anticipated
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Actual
27/11/2020
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Sample size
Target
100
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Accrual to date
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Final
114
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Western Australia
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Rural Clinical School of Western Australia, University of Western Australia
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Address
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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]
318944
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Address [1]
318944
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Country [1]
318944
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Other collaborator category [1]
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University
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Name [1]
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University of Notre Dame University
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Address [1]
283087
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Country [1]
283087
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Australia
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Other collaborator category [2]
283088
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University
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Name [2]
283088
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Monash University
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Address [2]
283088
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Country [2]
283088
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315507
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The University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
315507
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http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
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Ethics committee country [1]
315507
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Australia
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Date submitted for ethics approval [1]
315507
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21/11/2017
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Approval date [1]
315507
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13/12/2017
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Ethics approval number [1]
315507
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RA/4/20/4135
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Summary
Brief summary
This Research Project will involve a randomised control trial of an online mindfulness training program (MTP) designed specifically for medical students studying at UWA and University of Notre Dame, Fremantle, to assess the feasibility and effectiveness of the program with regards to reducing perceived stress and improving mindfulness, self-compassion and study engagement.
The MTP has been developed to include brief, daily mindfulness meditation practices and brief, weekly video teachings on the applications of mindfulness meditation for medical students. The program will be delivered via an online platform. This delivery mode aims to minimise the time required by busy medical students to invest in the program while providing stress management and self-care skills that are traditionally not taught as part of medical school training.
The program will be evaluated using both quantitative, including quantitative surveys before and after the program. We hypothesise that students who participate in the intervention will have improved levels of perceived stress, mindfulness, self-compassion and study engagement compared to controls who do not at the end of the 8-week program compared to baseline, with a number of intervention participants maintaining those improvements at 6-months post-intervention.
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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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Dr Sarah Moore
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Address
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Rural Clinical School of WA, University of Western Australia, 76 Gale St, Busselton WA 6282
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Country
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Australia
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Phone
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+61 897526400
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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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Sarah Moore
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Address
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Rural Clinical School of WA, University of Western Australia, 76 Gale St, Busselton WA 6282
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Country
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Australia
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Phone
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+61 897526400
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Fax
134915
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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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Sarah Moore
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Address
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Rural Clinical School of WA, University of Western Australia, 76 Gale St, Busselton WA 6282
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Country
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Australia
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Phone
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+61 897526400
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Fax
134916
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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)?
Yes
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What data in particular will be shared?
Individual participant data collected during the trial following de-identification
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When will data be available (start and end dates)?
Immediately following publication
No end date determined
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Available to whom?
Researchers who provide a methodologically sound proposal on a case-be-case basis at the discretion of the Primary Sponsor
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Available for what types of analyses?
To achieve the aims in the approved study proposal
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How or where can data be obtained?
Access subject to approvals by Principal Investigator via email
[email protected]
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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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