Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000740897p
Ethics application status
Submitted, not yet approved
Date submitted
17/04/2021
Date registered
11/06/2021
Date last updated
11/06/2021
Date data sharing statement initially provided
11/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Reflective Groups for Junior Doctors on the Incidence of Burnout
Scientific title
The Effect of Reflective Groups for Junior Doctors on the Incidence of Burnout
Secondary ID [1] 303988 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burnout 321600 0
Condition category
Condition code
Mental Health 319340 319340 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 319654 319654 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40 weekly group sessions of 1.25 hours delivered over 12 months.

Delivered by a group therapist, with a relevant qualification, and either more that 5 years of group therapy experience, of supervised by an experienced group therapist.

Delivered either in person or via teleconference, in hospital.

Intervention incorporates psychological preparedness and exposure therapy to share and reflect on work-related stress and interpersonal issues.

Aims to support improved function and reduce burnout in junior doctors.

Intervention will be adapted to maintain emotional arousal to a moderate level, and to encourage communication between all participants, such that the therapist will intervene if there is a lack of communication, or if strong positive or negative emotions emerge.

Adherence to the intervention will be monitored by the therapist producing a written record of attendance and a summary of the process and content of each session immediately after each session.
Intervention code [1] 320292 0
Treatment: Other
Intervention code [2] 320293 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327206 0
Maaslach Burnout Inventory
Timepoint [1] 327206 0
12 months (end of treatment)
Secondary outcome [1] 394209 0
Standardised telephone or in-person interview and study-specific questionnaire rating the experience.
Timepoint [1] 394209 0
12 months (end of treatment)

Eligibility
Key inclusion criteria
Medical practitioner
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active substance misuse, active psychosis or other major mental illness

Study design
Purpose of the study
Prevention
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
T-tests comparing outcomes at end of treatment to outcomes at baseline

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19140 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 19141 0
Westmead Hospital - Westmead
Recruitment hospital [3] 19142 0
Bloomfield Hospital - Orange
Recruitment postcode(s) [1] 33699 0
2065 - St Leonards
Recruitment postcode(s) [2] 33700 0
2145 - Westmead
Recruitment postcode(s) [3] 33701 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 308370 0
Hospital
Name [1] 308370 0
Royal North Shore Hospital
Country [1] 308370 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Road, St Leonards, NSW 2065, Australia
Country
Australia
Secondary sponsor category [1] 309187 0
Hospital
Name [1] 309187 0
Orange Health Service
Address [1] 309187 0
1530 Forest Road, Orange NSW 2800
Country [1] 309187 0
Australia
Secondary sponsor category [2] 309473 0
Hospital
Name [2] 309473 0
Westmead Hospital
Address [2] 309473 0
Hawkesbury Road, Westmead, NSW 2145
Country [2] 309473 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308336 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 308336 0
Ethics committee country [1] 308336 0
Australia
Date submitted for ethics approval [1] 308336 0
07/06/2021
Approval date [1] 308336 0
Ethics approval number [1] 308336 0

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

Contacts
Principal investigator
Name 110350 0
Dr Myles Gutkin
Address 110350 0
Department of Consultation-Liaison Psychiatry,
Level 3 ASB, Royal North Shore Hospital
St Leonards, NSW 2065
Country 110350 0
Australia
Phone 110350 0
+61 2 94631507
Fax 110350 0
Email 110350 0
[email protected]
Contact person for public queries
Name 110351 0
Myles Gutkin
Address 110351 0
Department of Consultation-Liaison Psychiatry,
Level 3 ASB, Royal North Shore Hospital
St Leonards, NSW 2065
Country 110351 0
Australia
Phone 110351 0
+61 2 94631507
Fax 110351 0
Email 110351 0
[email protected]
Contact person for scientific queries
Name 110352 0
Myles Gutkin
Address 110352 0
Department of Consultation-Liaison Psychiatry,
Level 3 ASB, Royal North Shore Hospital
St Leonards, NSW 2065
Country 110352 0
Australia
Phone 110352 0
+61 2 94631507
Fax 110352 0
Email 110352 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
Not a pathological sample


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.