Trial Review

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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
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.
Secondary ID [1] 312334 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 334103 0
Condition category
Condition code
Mental Health 330775 330775 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328817 0
Treatment: Other
Intervention code [2] 328873 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 338535 0
% changes in the medical students' trait mindfulness
Timepoint [1] 338535 0
Baseline, at completion of the 8-week program (primary timepoint), 6 months post intervention (post-intervention timepoint)
Primary outcome [2] 338536 0
% changes in the medical students' self-reported perceived stress levels
Timepoint [2] 338536 0
Baseline, completion of the 8-week intervention (primary timepoint), 6 months post intervention (post-intervention timepoint)
Primary outcome [3] 338537 0
% change in medical students' self-reported self-compassion levels.
Timepoint [3] 338537 0
Baseline, completion of the 8-week intervention (primary timepoint), 6 months post intervention (post-intervention timepoint)
Secondary outcome [1] 436339 0
% change in medical students' self-reported levels of study engagement
Timepoint [1] 436339 0
Baseline, completion of 8-week intervention, 6 months post intervention (post-intervention timepoint)

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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 computer
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.
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
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2018
Date of last participant enrolment
Anticipated
Actual
3/03/2020
Date of last data collection
Anticipated
Actual
27/11/2020
Sample size
Target
100
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316733 0
University
Name [1] 316733 0
University of Western Australia
Country [1] 316733 0
Australia
Primary sponsor type
University
Name
Rural Clinical School of Western Australia, University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 318944 0
None
Name [1] 318944 0
Address [1] 318944 0
Country [1] 318944 0
Other collaborator category [1] 283087 0
University
Name [1] 283087 0
University of Notre Dame University
Address [1] 283087 0
Country [1] 283087 0
Australia
Other collaborator category [2] 283088 0
University
Name [2] 283088 0
Monash University
Address [2] 283088 0
Country [2] 283088 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315507 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 315507 0
Ethics committee country [1] 315507 0
Australia
Date submitted for ethics approval [1] 315507 0
21/11/2017
Approval date [1] 315507 0
13/12/2017
Ethics approval number [1] 315507 0
RA/4/20/4135

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

Contacts
Principal investigator
Name 134914 0
Dr Sarah Moore
Address 134914 0
Rural Clinical School of WA, University of Western Australia, 76 Gale St, Busselton WA 6282
Country 134914 0
Australia
Phone 134914 0
+61 897526400
Fax 134914 0
Email 134914 0
sarah.j.moore@rcswa.edu.au
Contact person for public queries
Name 134915 0
Sarah Moore
Address 134915 0
Rural Clinical School of WA, University of Western Australia, 76 Gale St, Busselton WA 6282
Country 134915 0
Australia
Phone 134915 0
+61 897526400
Fax 134915 0
Email 134915 0
sarah.j.moore@rcswa.edu.au
Contact person for scientific queries
Name 134916 0
Sarah Moore
Address 134916 0
Rural Clinical School of WA, University of Western Australia, 76 Gale St, Busselton WA 6282
Country 134916 0
Australia
Phone 134916 0
+61 897526400
Fax 134916 0
Email 134916 0
sarah.j.moore@rcswa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial following de-identification
When will data be available (start and end dates)?
Immediately following publication
No end date determined
Available to whom?
Researchers who provide a methodologically sound proposal on a case-be-case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
To achieve the aims in the approved study proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator via email sarah.j.moore@rcswa.edu.au


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.