Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000033145
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
11/01/2019
Date last updated
28/06/2021
Date data sharing statement initially provided
11/01/2019
Date results information initially provided
28/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Balint Groups in Junior Doctors
Scientific title
Effectiveness of Balint Groups in Junior Doctors in preventing Professional Burnout
Secondary ID [1] 296987 0
Nil
Universal Trial Number (UTN)
U1111-1226-3579
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Professional Burnout 310949 0
Stress 310991 0
Condition category
Condition code
Mental Health 309615 309615 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 309644 309644 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten sessions of a monthly psychological intervention/support group - Balint Group, provided by experienced Balint facilitators, all of whom are psychiatric doctors. There will be 10 sessions of 90 minutes each, one each month, with the aim for groups of 10 participants. Attendance will be monitored through the facilitators keeping a roll.
The description below is copied from http://www.balintaustralianewzealand.org/what-happens-in-a-balint-group/ :

"A Balint group is an experiential, small group educational activity in which health care professionals discuss cases from their practices with a focus on the clinician-patient relationship or health professional – client relationship.Most Balint groups have a set membership of 8-12 participants who meet monthly for 1-2 hours.
Group participants sit in a circle, with a trained leader or two co-leaders. Clinicians present cases from their own practices. Group members listen to the presenter’s story, then discuss the case, with a focus on the clinician-patient relationship. Each presentation and discussion usually takes about 45 minutes, and groups often meet for 90 minutes.
The presenter tells the group about the case in an informal way, quite briefly, and without notes – because sometimes the way the story is told, including what is left out, can provide valuable clues to the nature of the presenter’s interaction with the patient. The presenter tries to convey the essence of how they experience the interaction with the patient and the atmosphere in the consulting room, to describe anything they are finding difficult and to include their own feelings and reactions.

The presenter is free to choose any patient to present. Often the patient presented will have have elicited strong feelings in the presenter, such as distress, frustration, surprise, difficulty, puzzlement or uncertainty.

In the group discussion, the group aims to explore the interaction between clinician and patient and to empathize with both of them. The group is encouraged to speculate, without any pressure to be “right”. The aim is to understand the situation in a deeper way, not to judge, advise, or offer solutions. It is important for the presenter to be protected from interrogation or criticism and to have time to listen and reflect on the group’s contributions. The atmosphere is mutually respectful and non-threatening. There is time to “sit” with uncertainty and complexity without the pressure to know the answer.
Intervention code [1] 313259 0
Prevention
Intervention code [2] 313286 0
Behaviour
Comparator / control treatment
Control group will be on a waiting list and will have Balint groups offered once the trial has concluded (12 months for each cohort). They will receive the normal employee support and pastoral care (supervision by a Director of Prevocational Training and individual term supervisors, access to the Employee Assistance Program provided by the organisation) afforded to junior doctors in the hospital system.
Control group
Active

Outcomes
Primary outcome [1] 318578 0
Scores on the Maslach Burnout Inventory
Timepoint [1] 318578 0
Measurements taken at 6 and 12 months post-commencement. Primary timepoint is measured at 12 months post-commencement of the intervention and will roughly coincide with the final Balint session.
Secondary outcome [1] 365406 0
Scores on Jefferson Scale of Empathy
Timepoint [1] 365406 0
Measurements taken at 6 and 12 months post-commencement. Primary timepoint is measured at 12 months post-commencement of the intervention and will roughly coincide with the final Balint session.

Eligibility
Key inclusion criteria
Interns (recent graduates of medical school) beginning their first year of post-graduation work as doctors.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil, aside from declining consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
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
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID, as above
Date of first participant enrolment
Anticipated
25/01/2019
Actual
25/01/2019
Date of last participant enrolment
Anticipated
29/01/2021
Actual
25/01/2019
Date of last data collection
Anticipated
28/01/2022
Actual
20/12/2019
Sample size
Target
60
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12829 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 12830 0
Shellharbour Hospital - Mount Warrigal
Recruitment postcode(s) [1] 25298 0
2500 - Wollongong
Recruitment postcode(s) [2] 25299 0
2528 - Mount Warrigal

Funding & Sponsors
Funding source category [1] 301560 0
Government body
Name [1] 301560 0
NSW Ministry of Health
Country [1] 301560 0
Australia
Primary sponsor type
Government body
Name
NSW Ministry of Health
Address
73 Miller St
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 301257 0
Government body
Name [1] 301257 0
Illawarra Shoalhaven Local Health District
Address [1] 301257 0
Wollongong Hospital
Crown St, Wollongong NSW 2500
Country [1] 301257 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302291 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 302291 0
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Australia
Ethics committee country [1] 302291 0
Australia
Date submitted for ethics approval [1] 302291 0
17/01/2019
Approval date [1] 302291 0
17/01/2019
Ethics approval number [1] 302291 0

Summary
Brief summary
Balint groups are a type of facilitated support group that has evidence for improving medical student empathy for patients and each other, and subsequently preventing burnout. The project would be aimed at establishing an initial Balint Group with local psychiatrists who are trained in this area, while simultaneously training co-facilitators who can continue the groups on a wider scale. The study is aimed at determining whether Balint Groups can help junior doctors maintain empathy and prevent burnout.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89718 0
Dr Matthew Macfarlane
Address 89718 0
Consultation-Liaison Psychiatry Service
Level 3, Block D
Wollongong Hospital
Crown St, Wollongong, NSW 2500
Country 89718 0
Australia
Phone 89718 0
+61 2 42534315
Fax 89718 0
Email 89718 0
[email protected]
Contact person for public queries
Name 89719 0
Dr Matthew Macfarlane
Address 89719 0
Consultation-Liaison Psychiatry Service
Level 3, Block D
Wollongong Hospital
Crown St, Wollongong, NSW 2500
Country 89719 0
Australia
Phone 89719 0
+61 2 42534315
Fax 89719 0
Email 89719 0
[email protected]
Contact person for scientific queries
Name 89720 0
Dr Matthew Macfarlane
Address 89720 0
Consultation-Liaison Psychiatry Service
Level 3, Block D
Wollongong Hospital
Crown St, Wollongong, NSW 2500
Country 89720 0
Australia
Phone 89720 0
+61 2 42534315
Fax 89720 0
Email 89720 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
954Study protocol    376665-(Uploaded-08-01-2019-09-50-57)-Study-related document.docx



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.