Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001248752
Ethics application status
Approved
Date submitted
9/09/2022
Date registered
16/09/2022
Date last updated
31/10/2022
Date data sharing statement initially provided
16/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Fiona Stanley Junior Doctors Online Mindfulness Project
Scientific title
The Fiona Stanley Junior Doctors Online Mindfulness Project: a randomised control trial of the impact of an online mindfulness program on stress levels in junior medical officers.
Secondary ID [1] 307947 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 327601 0
Condition category
Condition code
Mental Health 324689 324689 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention materials:
The online mindfulness training intervention, referred to as the “Mindfulness Training Program (MTP)”, is a novel 8-week online program developed by the coordinating principal investigator, program facilitator (PF) and PhD candidate, Dr Sarah Moore, with input from two mindfulness experts, Dr Craig Hassed and Dr Richard Chambers from Monash University. The MTP intervention includes:
o a weekly email each Monday containing a link to a 10-minute video mini-lecture. Each mini-lecture will focus on a different application of mindfulness, including mindful communication, multi-tasking vs unitasking & effective task switching, stress and performance, distraction and procrastination, regulating emotions, mindful relationships, mindfulness and self-compassion, and using mindfulness clinically.
o a SMS sent to participants' mobile phone 5 days per week for 8 weeks with a link to a guided 5-minute mindfulness meditation practice via a central SMS delivery service that confirms messages are delivered to participants. The focus of the practice will change each week, and include themes such as body scan, mindful breathing, mindful listening, working mindfully with emotions, mountain meditation and compassion meditation.
o the opportunity to correspond with the program facilitator (PF) throughout the program via email, telephone or videoconference to ask questions and discuss any difficulties they may be experiencing.
The PF is a GP and medical educator with 9 years of training in mindfulness.
The intervention will be delivered once for the intervention group, then repeated for the control group participants on completion of all study data collection.
Intervention adherence will be monitored via a survey sent each week for 8-weeks to participants measuring the quantity and quality of their daily mindfulness practice and uptake of the teaching video.
Participants are encouraged to practice mindfulness for 5 minutes per day, Monday to Friday.
Intervention code [1] 324404 0
Treatment: Other
Comparator / control treatment
Control treatment is the normal hospital Junior Medical Officer (JMO) medical education curriculum, which includes a mentoring program for junior doctors to support their wellbeing. The mentoring program involves one on one mentoring with a more senior medical officer, face to face at the discretion of the mentor-mentee partnership.

Control participants will be offered the opportunity to participate in the program on completion of all project data collection, ie 3.5 months following commencement of the study.
Control group
Active

Outcomes
Primary outcome [1] 332506 0
% changes in the junior doctors’ self-reported levels of perceived stress.

Instruments will be the Perceived Stress Scale
Timepoint [1] 332506 0
Timepoints include baseline, up to 7 days prior to commencement of intervention, at completion of 8-week intervention and 4 weeks following the completion of the intervention.
Primary outcome [2] 332532 0
% changes in the junior doctors’ self-reported levels of self-compassion.

Instruments will be the Self-Compassion Scale.
Timepoint [2] 332532 0
Timepoints include baseline, up to 7 days prior to commencement of intervention, at completion of 8-week intervention and 4 weeks following the completion of the intervention.
Primary outcome [3] 332533 0
% changes in the junior doctors’ self-reported levels of mindfulness scores.

Instruments will be the Frieberg Mindfulness Inventory.
Timepoint [3] 332533 0
Timepoints include baseline, up to 7 days prior to commencement of intervention, at completion of 8-week intervention and 4 weeks following the completion of the intervention.
Secondary outcome [1] 413770 0
Quantity and quality of mindfulness practice measured with Mindfulness Adherence Scale (MAQ)
Timepoint [1] 413770 0
At the end of week 1, 2, 3, 4, 5, 6, 7 and 8 during the intervention period.
Secondary outcome [2] 413771 0
Qualitative interviews with participants from the intervention and control groups to explore their experience of the program.

Interview methods will semi-structured via videoconference. Interviews will be either one-on-one or in small groups of 2-3 participants with a member of the research team.

Data collected will related to participants experience of the mindfulness program, perceived benefits and barriers to participation.
Timepoint [2] 413771 0
Between 1-4 weeks after completion of the intervention program.
Secondary outcome [3] 413833 0
% changes in the junior doctors’ self-reported levels work engagement scores.

Instruments will be the Utrecht Works Engagement scale.
Timepoint [3] 413833 0
Timepoints include baseline, up to 7 days prior to commencement of intervention, at completion of 8-week intervention and 4 weeks following the completion of the intervention.
Secondary outcome [4] 413882 0
% change in the junior doctor's self-reported work-related stress scores.

The instrument used will be the Specialist Doctors Stress Inventory,
Timepoint [4] 413882 0
Timepoints include baseline, up to 7 days prior to commencement of intervention, at completion of 8-week intervention and 4 weeks following the completion of the intervention.

Eligibility
Key inclusion criteria
All interns and junior doctors working at Fiona Stanley and Fremantle Hospitals, Perth, WA.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical students, registrars and consultants at Fiona Stanley and Fremantle Hospitals; junior doctors from other health services.

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
There will be 120 interns at Fiona Stanley Hospital in 2022. The junior medical officer numbers are likely to be around 280. A planned sample size of minimum n=30 in each group (Intervention vs Control) is expected to be adequate to afford a high level of statistical power (around 0.9) to detect a difference in the levels of improvement, for Intervention participants vs Control participants, on the outcome measures (PSS, SDSI, SCS, FMI, and UWES), at an adjusted statistical significance level a=0.01. The hypothesized improvement is estimated to be modest for Intervention participants (i.e., of a magnitude around 9%-15% of the participants’ baseline measure), compared to minimal (around 1%-5%) for Control participants.

Depending on the distribution of the outcome data, different statistical methods will be used for analysis. For example, if the score distribution is approximately normal, the MIXED procedure (for multilevel analysis) will be used. Otherwise, if the score data are not normally distributed, General Estimating Equations (GEE) will be used. Both of these approaches include key potential confounding factors such as age, gender, ethnicity, prior experience with mindfulness meditation, current practice in mindfulness, and time points (12 weeks post intervention vs 8 weeks post intervention vs baseline) as co-variates, as well as the possibly unbalanced repeated nature of the data, due to dropouts and missing data.

Thematic analysis of the qualitative data will be conducted using general inductive approach (Thomas, 2006) by the PhD candidate and an experienced qualitative researcher using NVivo software. Each transcript will be read by the PhD candidate and experienced qualitative researcher independently in order to develop a coding framework using thematic analysis. The two researchers will then compare their findings and further refine the framework. Another two investigators will apply this thematic framework on an independent analysis of a subset of qualitative interviews to ensure consistency. The outcome of the qualitative part of the study will be to identify junior doctors’ perceived stressors, self-care strategies, perceived barriers to and benefits from participating in the online mindfulness training program. Further, the results will be utilised to identify system approaches and make recommendations on modifications that will reduce barriers to accessing the online mindfulness training program if the primary outcome shows benefit.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/01/2022
Date of last participant enrolment
Anticipated
14/03/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
60
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23142 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 23143 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 38501 0
6150 - Murdoch
Recruitment postcode(s) [2] 38502 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 312214 0
University
Name [1] 312214 0
University of Western Australia
Country [1] 312214 0
Australia
Funding source category [2] 312220 0
Hospital
Name [2] 312220 0
Fiona Stanley Hospital
Country [2] 312220 0
Australia
Primary sponsor type
University
Name
Rural Clinical School of WA
Address
Rural Clinical School of WA
76 Gale Street
Busselton WA 6280
Country
Australia
Secondary sponsor category [1] 313751 0
None
Name [1] 313751 0
Address [1] 313751 0
Country [1] 313751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311595 0
South Metropolitan Health Service HREC
Ethics committee address [1] 311595 0
Ethics committee country [1] 311595 0
Australia
Date submitted for ethics approval [1] 311595 0
01/11/2021
Approval date [1] 311595 0
19/11/2021
Ethics approval number [1] 311595 0
RGS0000005076
Ethics committee name [2] 311599 0
University of WA HREC
Ethics committee address [2] 311599 0
Ethics committee country [2] 311599 0
Australia
Date submitted for ethics approval [2] 311599 0
22/11/2021
Approval date [2] 311599 0
30/11/2021
Ethics approval number [2] 311599 0
2021/ET001068

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

Contacts
Principal investigator
Name 121654 0
Dr Sarah Moore
Address 121654 0
Rural Clinical School of WA
76 Gale St
Busselton WA 6282
Country 121654 0
Australia
Phone 121654 0
+61 897526400
Fax 121654 0
+61897526444
Email 121654 0
[email protected]
Contact person for public queries
Name 121655 0
Sarah Moore
Address 121655 0
Rural Clinical School of WA
76 Gale St
Busselton WA 6282
Country 121655 0
Australia
Phone 121655 0
+61 897526400
Fax 121655 0
+61897526444
Email 121655 0
[email protected]
Contact person for scientific queries
Name 121656 0
Sarah Moore
Address 121656 0
Rural Clinical School of WA
76 Gale St
Busselton WA 6282
Country 121656 0
Australia
Phone 121656 0
+61 897526400
Fax 121656 0
+61897526444
Email 121656 0
[email protected]

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 [email protected]


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.