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Trial registered on ANZCTR


Registration number
ACTRN12617000049370p
Ethics application status
Submitted, not yet approved
Date submitted
16/12/2016
Date registered
11/01/2017
Date last updated
11/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Wellbeing and Empathic Skills of Junior Medical Officers with Mindfulness Meditation
Scientific title
Enhancing wellbeing of JMOs with mindfulness meditation pilot programme
Secondary ID [1] 290776 0
Nill known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress levels 301381 0
Anxiety 301382 0
Burnout 301383 0
Improved mood
 301386 0
Empathy 301387 0
Engagement 301388 0
Condition category
Condition code
Mental Health 301127 301127 0 0
Depression
Mental Health 301220 301220 0 0
Anxiety
Mental Health 301221 301221 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: a structured, mindfulness-based practice

The intervention period is six weeks, involving weekly 75-minute face-to-face sessions held in a meeting room at RPAH with a trained instructor (psychologist). The active intervention is based on an established mindfulness program delivered by Openground Mindfulness Training (http://www.openground.com.au). This group program utilizes cognitive strategies and reflective activities aimed to reduce stress, and improve wellbeing and resilience. One instructor will deliver the intervention and has been trained in our risk management protocols as used in our previous study of this intervention at the University. Participants will be encouraged to practice independently in between the sessions, with compliance reinforced at each instructional session with verbal encouragement. There will be no set duration/frequencies for independent practice, any form of independent practice is encouraged. Participants will receive a reminder email on the day of their session and adherence to the intervention will be monitored by registering the attendance at sessions, The intervention will be conducted twice, in consecutive terms. Adherence will be tracked

All potential participants will be informed of the limited numbers of places available in the course (max 20 per course). Whilst places are available in course one they can choose either the first, or the second course. Once places are filled in course one they will be informed and given the option of becoming part of the wait list control.
Intervention code [1] 296687 0
Treatment: Other
Comparator / control treatment
- Wait list controls until the next session starts after 6-8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 300538 0
Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10).
Timepoint [1] 300538 0
Prior to the start of the first session, at the end of the sixth session, and 12 weeks after completion of the sixth session.
Primary outcome [2] 300539 0
Change in wellbeing as measured by the Warwick-Edinburgh Mental Well-being scale (WEMWBS).
Timepoint [2] 300539 0
Prior to the start of the first session, at the end of the sixth session, and 12 weeks after completion of the sixth session.
Primary outcome [3] 300540 0
Change in Burnout score as measured by the Maslach Burnout Inventory Questionnaire.
Timepoint [3] 300540 0
Prior to the start of the first session, at the end of the sixth session, and 12 weeks after completion of the sixth session.
Secondary outcome [1] 330269 0
Change in workplace engagement, measured using the Utrecht Work Engagement Scale
Timepoint [1] 330269 0
Prior to the start of the first session, at the end of the sixth session, and 12 weeks after completion of the sixth session.
Secondary outcome [2] 330270 0
Change in empathy, measured by the Toronto Empathy Questionnaire
Timepoint [2] 330270 0
Prior to the start of the first session, at the end of the sixth session, and 12 weeks after completion of the sixth session.

Eligibility
Key inclusion criteria
JMOs at RPAH or final-year medical students at Sydney Medical School who will commence work as JMOs in 2017 and who are willing to commit and consent to the full six-week, 75-minute group sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
As a naturalistic study there are no specific additional inclusion or exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
This is a pilot study intended to assess potential effects and feasibility. We can accommodate 15-20 participants in each of the two courses, totaling approximately 30-40 participants.

Analysis
The measures will be analysed comparing pre-post changes. If there are sufficient control numbers comparisons will be made between participants and control groups using t-tests or Chi square as appropriate. Between-group comparison of these change scores will be examined using independent t-tests for both groups. Linear regression analyses will be used to control for the effect of the baseline (T1) on the follow-up (T2) scores and calculated change scores for each of the scales. Data will be analysed on an intention to treat (ITT) basis using the Last Observation Carried Forward (LOCF) approach. The same approach will taken to analyse the first vs second groups to check for early adopter effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
Date of last participant enrolment
Anticipated
1/06/2017
Actual
Date of last data collection
Anticipated
1/08/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7166 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 14924 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 295198 0
Government body
Name [1] 295198 0
Health Education and Training Institute NSW (HETI)
Country [1] 295198 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 294028 0
None
Name [1] 294028 0
None
Address [1] 294028 0
None
Country [1] 294028 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296547 0
University of Sydney ethics committee
Ethics committee address [1] 296547 0
Ethics committee country [1] 296547 0
Australia
Date submitted for ethics approval [1] 296547 0
26/09/2016
Approval date [1] 296547 0
Ethics approval number [1] 296547 0

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

Contacts
Principal investigator
Name 71242 0
Prof Nicholas Glozier
Address 71242 0
University of Sydney
Brain and Mind Centre & Discipline of Psychiatry
Level 5, Marie Bashir Centre, Missenden Road, Camperdown. NSW 2050
Country 71242 0
Australia
Phone 71242 0
+61 2 9515 1596
Fax 71242 0
Email 71242 0
nick.glozier@sydney.edu.au
Contact person for public queries
Name 71243 0
Elizabeth Stratton
Address 71243 0
University of Sydney
Brain and Mind Centre
Level 5, Marie Bashir Centre, Missenden Road, Camperdown. NSW 2050
Country 71243 0
Australia
Phone 71243 0
+61 2 9515 1439
Fax 71243 0
Email 71243 0
eodg5192@uni.sydney.edu.au
Contact person for scientific queries
Name 71244 0
Elizabeth Stratton
Address 71244 0
University of Sydney
Brain and Mind Centre
Level 5, Marie Bashir Centre, Missenden Road, Camperdown. NSW 2050
Country 71244 0
Australia
Phone 71244 0
+61 2 9515 1439
Fax 71244 0
Email 71244 0
eodg5192@uni.sydney.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.