Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000124538
Ethics application status
Approved
Date submitted
16/11/2023
Date registered
12/02/2024
Date last updated
12/02/2024
Date data sharing statement initially provided
12/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a custom-built digital program blended with specialist telehealth treatment on burnout in Australian doctors
Scientific title
Evaluating the effectiveness of a custom-built digital program blended with specialist telehealth treatment on burnout in Australian doctors – a three-arm randomised-controlled trial
Secondary ID [1] 310858 0
None
Universal Trial Number (UTN)
Trial acronym
NBT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burnout 331901 0
Condition category
Condition code
Mental Health 328632 328632 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Navigating Burnout is a digital cognitive-behavioural therapy (CBT) program covering seven topics: (1) understanding burnout; (2) increasing social connections; (3) managing unrealistic expectations; (4) setting limits; (5) valued living; (6) self-care; and (7) a module for managers detailing evidence-based strategies for improving workplace mental health. Each topic contains lived experience videos, behavioural strategies, and CBT worksheets.

Usage of, and adherence to, Navigating Burnout will be monitored through website analytics. Links to Navigating Burnout provided to intervention participants will contain their unique participant identification number. Website analytic tools will then be used to export all website analytics (e.g. time of access, pages visited) containing these unique participant identifiers and the Navigating Burnout web pages visited. These sessions will then be linked to individual participants’ data in order to examine adherence to, and usage of Navigating Burnout (i.e. whether participants accessed Navigating Burnout, which Navigating Burnout pages were visited by participants, whether participants returned to view materials multiple times, etc).

Blended care: In the blended care arm, a clinical psychologist will work through the Navigating Burnout content with participants over 10 weeks in five fortnightly 1-hour clinical psychologist sessions. Sessions will be delivered one-on-one via telehealth. Participants will also be emailed a link to Navigating Burnout at onset, and be directed to specific components of the program (in line with their sessions) to engage with between consultations over the 10 weeks, in order to support awareness and management of burnout.

In addition to the above usage of website analytics to monitor usage of Navigating Burnout, participants' adherence to telehealth sessions in the blended care arm will be monitored through session attendance records completed by the clinical psychologist.

Self-guided: In the self-guided arm, participants will be emailed a link to Navigating Burnout to engage with over 10 weeks. While participants will have access to the entirety of Navigating Burnout from onset, to support completion of the program participants will be emailed structured reminders fortnightly to work through the course and providing them with a link to Navigating Burnout. No specific minimum duration of time engaging with Navigating Burnout will be suggested each week, simply that participants complete the program in its entirety over the course of the 10 weeks (estimated 2-3 hours).
Intervention code [1] 327281 0
Treatment: Other
Comparator / control treatment
In the control condition, participants will receive an active attention control comprising fortnightly emails containing links to generic digital self-care psychoeducation materials. The digital self-care psychoeducation has been based on the self-care component of Navigating Burnout but is not tailored to the healthcare context, and is designed to align with the fortnightly structure of reminders in the self-guided arm (i.e., emails will provide participants with information and activities to work through in a cadence comparable to the self-guided arm (e.g. Week 1 – Self-Care; Week 2 – Diet, etc)).

Adherence to the active attention control will be monitored through website analytics. Links to the active attention control provided to participants will contain their unique participant identification number. Website analytic tools will then be used to export all website analytics (e.g. time of access, pages visited) containing unique participant identifiers and the active attention control web pages visited. These sessions will then be linked to individual participants’ data in order to examine adherence to the active attention control (i.e. whether participants accessed each week's materials, whether participants returned to view materials multiple times, etc).
Control group
Active

Outcomes
Primary outcome [1] 336432 0
Burnout
Timepoint [1] 336432 0
Baseline, immediate post-treatment, 3 months post-treatment (primary timepoint)
Secondary outcome [1] 428355 0
Depression
Timepoint [1] 428355 0
Baseline, immediate post-treatment, 3 months post-treatment
Secondary outcome [2] 428356 0
Anxiety
Timepoint [2] 428356 0
Baseline, immediate post-treatment, 3 months post-treatment
Secondary outcome [3] 428357 0
Psychosocial functioning
Timepoint [3] 428357 0
Baseline, immediate post-treatment, 3 months post-treatment
Secondary outcome [4] 428358 0
Workforce participation
Timepoint [4] 428358 0
Baseline, immediate post-treatment, 3 months post-treatment
Secondary outcome [5] 428359 0
Workforce attrition
Timepoint [5] 428359 0
Baseline, immediate post-treatment, 3 months post-treatment
Secondary outcome [6] 428360 0
Service acceptability
Timepoint [6] 428360 0
Baseline, immediate post-treatment

Eligibility
Key inclusion criteria
• are a registered doctor currently practising in Australia;
• can read and speak English fluently;
• are experiencing self-reported burnout;
• can access the internet in a private location on a device suitable for viewing websites and attending telehealth consultations;
• can attend telehealth consultations during business hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• are currently engaged with psychological therapy such as cognitive-behavioural therapy;
• have a current diagnosis of severe mental illness that requires more specialist support (e.g., bipolar disorder, schizophrenia, etc.);
• report symptom scores in the Severe or Extremely Severe ranges for anxiety or depression during screening (DASS-21);
• report suicidal ideation or problematic alcohol or drug use during screening (rating of Often or Almost Always on screening items addressing these criteria)

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)
A randomisation list in a Microsoft Excel file will be prepared in advance by a member of the research team independent from recruitment and screening. When a participant is ready to be receive allocation, the list holder will be contacted by the researcher responsible for screening and recruitment, and the allocation provided to participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list in a Microsoft Excel file will be prepared in advance by a member of the research team independent from recruitment and screening using a random number generator (www.sealedenvelope.com/simple-randomiser/v1/lists) using block sizes of 6, 9, and 12.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study analyses will follow an intention-to-treat analysis plan using multiple imputation to account for missing data. To understand baseline variation and ensure experimental rigor, baseline scores on all psychosocial and occupational outcomes will be checked for between arm consistency using one-way analysis of variances (ANOVAs).

The primary outcome will be changes in OLBI scores (burnout) between arms at three months post-intervention. Between group variations (i.e., reductions in burnout between arms) will be examined using a 3 (blended, self-guided, active attention control) x 2 (baseline, 3 months post-treatment) mixed model ANCOVA controlling for gender, age, profession, and regionality and explored with pairwise comparisons. Identically formatted mixed model ANCOVAs will be used to analyse the secondary aims and outcomes of between arm and baseline to post-treatment and 3-month post-treatment differences in DASS (anxiety and depression), WSAS (psychosocial functioning), WHO-HPQ (workplace participation), and TIS-6 (attrition intention). The secondary aim and outcomes of comparing service acceptability between arms will be analysed using one-way ANOVAs.

To examine the cost-effectiveness of blended (therapist-guided) Navigating Burnout, direct costs of the blended care arm will be quantified alongside indirect costs such as lost productivity of recipients due to use of the intervention (i.e. time taken out of work where sessions are attended during work hours). Due to a lack of standardised and established estimates of the economic cost of burnout using commonly used measures, the benefits of blended Navigating Burnout will be compared against the value of improvements in occupational outcomes (WHO-HPQ; TIS-6). Comparisons of these costs and benefits between treatment arms will provide an estimate of the net benefit and cost-effectiveness of blended Navigating Burnout. Sensitivity analyses will be performed on assumptions in the model, such as cost estimates of lost productivity due to treatment and the relationship between turnover intention and actual turnover.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/02/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
207
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315712 0
Charities/Societies/Foundations
Name [1] 315712 0
Avant Foundation, Level 6, Tower 3, 201 Sussex Street, Sydney, New South Wales 2000
Country [1] 315712 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney High St Kensington NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 317133 0
None
Name [1] 317133 0
Address [1] 317133 0
Country [1] 317133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314052 0
The University of New South Wales Research Ethics Committee B
Ethics committee address [1] 314052 0
Ethics committee country [1] 314052 0
Australia
Date submitted for ethics approval [1] 314052 0
22/11/2023
Approval date [1] 314052 0
18/12/2023
Ethics approval number [1] 314052 0
iRECS4616

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

Contacts
Principal investigator
Name 130246 0
Dr Peter Baldwin
Address 130246 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 130246 0
Australia
Phone 130246 0
+61 02 9065 9169
Fax 130246 0
Email 130246 0
[email protected]
Contact person for public queries
Name 130247 0
Peter Baldwin
Address 130247 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 130247 0
Australia
Phone 130247 0
+61 02 9065 9169
Fax 130247 0
Email 130247 0
[email protected]
Contact person for scientific queries
Name 130248 0
Peter Baldwin
Address 130248 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 130248 0
Australia
Phone 130248 0
+61 02 9065 9169
Fax 130248 0
Email 130248 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?

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.