Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001181998
Ethics application status
Approved
Date submitted
9/10/2020
Date registered
9/11/2020
Date last updated
28/06/2021
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of alternative terminology for depression on help-seeking intention in adults living in Australia
Scientific title
Impact of alternative terminology for depression on help-seeking intention in adults living in Australia
Secondary ID [1] 302462 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 319291 0
Burnout 319292 0
Condition category
Condition code
Public Health 317261 317261 0 0
Other public health
Mental Health 317262 317262 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The scenario intervention consists of half an A4 page of text (approx 250 words), which takes no longer than 1 minute to read. It will be administered as an online survey (created by a research assistant) via the Qualtrics survey platform.

Participants will be asked to imagine that over the past few months they have not been feeling themselves, so they go to their general practitioner (GP) and explain how they have been feeling. Each scenario depicts an appointment with the participants’ GP. The symptoms described are the same in all conditions, except for a slight difference between men and women.

LABEL CONDITION:
Participants will be randomised to one of four groups. The first group is the control which is detailed below. In the second group, the doctor provides the label of ‘depression’ to explain their symptoms. The third group will receive the label of ‘burnout’ for their reported symptoms and the final group will receive the label ‘functional impairment syndrome’.

RECOMMENDATION CONDITION:
Participants will also be randomised to receive either a recommendation to see a “clinical psychologist” or a “mind coach”.

Adherence to the intervention will be monitored by accessing Qualtrics analytics (i.e. randomisation count, time taken to complete survey).
Intervention code [1] 318754 0
Behaviour
Comparator / control treatment
The first group will receive the same hypothetical vignette in which the doctor provides no label for their reported symptoms.

This control group will also be randomised to receive either a recommendation to see a clinical psychological or a mind coach.
Control group
Active

Outcomes
Primary outcome [1] 325319 0
Help-seeking intention
5-point scale (1= ‘Very unlikely’ to 5 = ‘Very likely’)
If you were in this scenario, how likely would you be to seek help from a clinical psychologist/mind coach?
Timepoint [1] 325319 0
Immediately after intervention
Secondary outcome [1] 387482 0
Intention to speak to boss
5-point scale (1 = ‘Very unlikely’ to 5 = ‘Very likely’)
If you were in this scenario, how likely would you be to speak to your boss about what the doctor has told you?
Timepoint [1] 387482 0
Immediately after intervention
Secondary outcome [2] 387483 0
Self-stigma (shame)
5-point scale (1 = ‘strongly disagree’ to 5 = ‘strongly agree’)
How would you think of or feel about yourself if you were in this situation?
• I would feel ashamed
• I would feel embarrassed
• I would feel inferior to other people
• I would feel disappointed in myself
Timepoint [2] 387483 0
Immediately after intervention
Secondary outcome [3] 387484 0
Self-stigma (self-blame)
5-point scale (1 = ‘strongly disagree’ to 5 = ‘strongly agree’)
How would you think of or feel about yourself if you were in this situation?

• I would think I should be able to cope with things
• I would think I should be able to ‘pull myself together’
• I would think I should be stronger
• I would think I only had myself to blame
Timepoint [3] 387484 0
Immediately after intervention
Secondary outcome [4] 387485 0
Self-stigma (Help-seeking inhibition)
5-point scale (1 = ‘strongly disagree’ to 5 = ‘strongly agree’)
How would you think of or feel about yourself if you were in this situation?

• I would feel embarrassed about seeking professional help
• I would feel embarrassed if others knew I was seeking professional help
• I would see myself as weak if I took medication
• I wouldn’t want people to know that I wasn’t coping
Timepoint [4] 387485 0
Immediately after intervention
Secondary outcome [5] 387486 0
Self-stigma (Social inadequacy)
5-point scale (1 = ‘strongly disagree’ to 5 = ‘strongly agree’)
How would you think of or feel about yourself if you were in this situation?

• I would feel I couldn’t contribute much socially
• I would feel inadequate around other people
• I would feel like I was good company *
• I would feel like a burden to other people
*Reverse scored
Timepoint [5] 387486 0
Immediately after intervention
Secondary outcome [6] 387487 0
Worry
7-point scale (1 = ‘not at all’ to 7 = ‘extremely worried’)
How worried would you be about your situation/depression/burnout/functional impairment syndrome?
Timepoint [6] 387487 0
Immediately after intervention
Secondary outcome [7] 388673 0
Perceived severity
7-point scale (1 = ‘strongly disagree’ to 7 = ‘strongly agree’)
I feel that being in this situation/having depression/having burnout/having functional impairment syndrome would be serious.
Timepoint [7] 388673 0
Immediately after intervention
Secondary outcome [8] 388674 0
Brief Illness Perception Questionnaire (IPQ; cognitive representation) - Consequences
0-10 response scale (higher scores = more threatening view of the illness)

How much would your situation/depression/burnout/functional impairment syndrome affect your life?
Timepoint [8] 388674 0
Immediately after intervention
Secondary outcome [9] 388675 0
Brief IPQ (cognitive representation) - Timeline
0-10 response scale (higher scores = more threatening view of the illness)

How long do you think your situation/depression/burnout/functional impairment syndrome would continue?
Timepoint [9] 388675 0
Immediately after intervention
Secondary outcome [10] 388676 0
Brief IPQ (cognitive representation) - Personal control
0-10 response scale (higher scores = more threatening view of the illness)

How much control do you feel you would have over your situation/depression/burnout/functional impairment syndrome?
Timepoint [10] 388676 0
Immediately after intervention
Secondary outcome [11] 388677 0
Brief IPQ (cognitive representation) - Treatment control
0-10 response scale (higher scores = more threatening view of the illness)

How much do you think treatment could help your situation/depression/burnout/functional impairment syndrome?
Timepoint [11] 388677 0
Immediately after intervention
Secondary outcome [12] 388678 0
Personal Depression Stigma Scale
Five-point scale (0 = ‘strongly disagree’ to 4 = ‘strongly agree’)
Score range: 0 to 36

• People in this situation/with depression/with burnout/with functional impairment syndrome could snap out of it if they wanted.
• Having this experience/depression/burnout/functional impairment syndrome is a sign of personal weakness.
• This experience/Depression/Burnout/Functional impairment syndrome is not a real medical illness.
• People in this situation/with depression/with burnout/with functional impairment syndrome are dangerous.
• It is best to avoid people in this situation/with depression/with burnout/with functional impairment syndrome, so you don’t start feeling like this yourself.
• People in this situation/with depression/with burnout/with functional impairment syndrome are unpredictable.
• If I had this experience/depression/burnout/functional impairment syndrome I would not tell anyone.
• I would not employ someone if I knew they had been in this situation/diagnosed with depression/diagnosed with burnout/diagnosed with functional impairment syndrome.
• I would not vote for a politician if I knew they had been in this situation/diagnosed with depression/diagnosed with burnout/diagnosed with functional impairment syndrome.
Timepoint [12] 388678 0
Immediately after intervention

Eligibility
Key inclusion criteria
Aged 18-70 years
Adequate understanding of English
Currently living in Australia
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer: Qualtrics survey software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics survey software utilizes the Mersenne Twister pseudorandom number generator to randomise participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will test for overall differences between randomised conditions using multinomial regression models for ordinal outcomes, and linear regression models for continuous variables. All statistical models will include label condition (no label, depression, burnout, functional impairment syndrome) and recommendation condition (clinical psychologist, wellness trainer) as categorical covariates, as well as their interaction, whilst controlling for gender (to account for the minor differences in the scenarios presented to male and female participants). Planned simple contrasts will also be conducted to test where any differences may lie between the different label condition groups. Analyses of pilot data will be used to estimate the magnitude of differences in outcomes between conditions and inform the required sample size required for the full study; the same statistical methods will be applied to the full study data (whilst employing a Bonferroni-adjusted significance threshold of p=0.008 for multiple pairwise comparisons).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2020
Actual
4/12/2020
Date of last participant enrolment
Anticipated
Actual
14/01/2021
Date of last data collection
Anticipated
Actual
14/01/2021
Sample size
Target
640
Accrual to date
Final
967
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306888 0
Government body
Name [1] 306888 0
National Health and Medical Research Council Program
Country [1] 306888 0
Australia
Primary sponsor type
University
Name
School of Public Health, University of Sydney
Address
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 307447 0
None
Name [1] 307447 0
Address [1] 307447 0
Country [1] 307447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307045 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 307045 0
Ethics committee country [1] 307045 0
Australia
Date submitted for ethics approval [1] 307045 0
10/03/2020
Approval date [1] 307045 0
30/03/2020
Ethics approval number [1] 307045 0
2020/058

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

Contacts
Principal investigator
Name 105834 0
Prof Kirsten McCaffery
Address 105834 0
Room 128B, Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 105834 0
Australia
Phone 105834 0
+61 2 9351 7220
Fax 105834 0
Email 105834 0
[email protected]
Contact person for public queries
Name 105835 0
Jenna Smith
Address 105835 0
Room 128C, Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 105835 0
Australia
Phone 105835 0
+61 2 8627 0095
Fax 105835 0
Email 105835 0
[email protected]
Contact person for scientific queries
Name 105836 0
Jenna Smith
Address 105836 0
Room 128C, Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 105836 0
Australia
Phone 105836 0
+61 2 8627 0095
Fax 105836 0
Email 105836 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?
All individual participant data collected during the trial can be made available in de-identified csv or excel datasets, along with the data dictionary.
When will data be available (start and end dates)?
Data will be made available once the manuscript outlining results from the study has been published for up to 5 years after publication.
Available to whom?
Data will be made available upon request to anyone wishing to access it who provides a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Replication and meta-analysis.
How or where can data be obtained?
Data will be made available upon direct contact with the principal investigator. Contact details of the principal investigator are: [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.