Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000295448
Ethics application status
Approved
Date submitted
5/04/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in Self-esteem in University Students via a Digital Coach
Scientific title
Changes in Self-esteem in University Students via a Digital Coach
Secondary ID [1] 314102 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low self-steem 336881 0
Condition category
Condition code
Mental Health 333358 333358 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following completion of the baseline (T1) measures, participants will engage with a conversational agent (CA) called HAFSE (Helper Agent for Self Esteem). HAFSE is logic based conversational agent. Engagement will involve the agent introducing themselves and then asking participants questions which encourage self-reflection and intention. HAFSE will interact with participants by speaking (digital voice) and text (her conversation will also appear as text). During the conversation, participants will be able to select answers from a pre-defined set of options which will allow them to direct the conversation. The expected interaction time is about 20 minutes.

There will be only one brief online interaction.
There are three conversations discussing:
1. How to change 3 common negative thinking styles (1, all-or-nothing thinking, 2 Magnifying or exaggerating negative experiences, 3. Minimising positives);
2. The value of keeping a Positive Self Diary.
3. Positive self-affirmations.

Participants will access the conversational agent via a website link accessible within the online survey.
We will capture responses during the conversation and will ask if they found the strategies helpful at the end of the session (T2), at 1-week follow-up (T3) and at 1-month follow-up (T4). In the study, all participants will do conversation 1, but they will get to choose between doing conversation 2 and 3. We will ask them if they would like to access later the conversation they did not choose.

Engagement and interaction with HAFSE will be assessed via asking participants questions at the end of the interaction as to how helpful and useful they found their interaction with HAFSE. A unique code identifier (anonymized) will also be generated with accessing the HAFSE program, which will enable the researchers to also monitor how long in minutes and seconds each participant spent interacting with the HAFSE program.
Intervention code [1] 330676 0
Lifestyle
Intervention code [2] 330788 0
Behaviour
Comparator / control treatment
This is an uncontrolled study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340934 0
Change in Self Esteem
Timepoint [1] 340934 0
Baseline and after 20 minute psycho-education with HAFSE (2, primary timepoint), 1-week (T3,) and 1-month (T4) follow-up.
Primary outcome [2] 340936 0
Change in Self-esteem
Timepoint [2] 340936 0
Baseline and after 20 minute psycho-education with HAFSE (2, primary timepoint), 1-week (T3) and 1-month (T4) follow-up.
Secondary outcome [1] 445740 0
Change in Self-Efficacy
Timepoint [1] 445740 0
Baseline (T1) - then again at 1-week (T3) and 1-month (T4) follow-ups.
Secondary outcome [2] 445741 0
Change in affective states
Timepoint [2] 445741 0
Baseline (T1) - and then again post-program completion (T2), 1-week (T3) and 1-month (T4) follow-ups.
Secondary outcome [3] 445742 0
Changes in self-compassion
Timepoint [3] 445742 0
Baseline (T1) - and then again post-program completion (T2), 1-week (T3) and 1-month (T4) follow-ups.
Secondary outcome [4] 445743 0
Shifts in cognitive appraisal strategies
Timepoint [4] 445743 0
Baseline (T1) - and then again at 1-week (T3) and 1-month (T4) follow-ups.
Secondary outcome [5] 445744 0
Changes in self-efficacy for learning and performance
Timepoint [5] 445744 0
Baseline (T1) - and then again at 1-week (T3) and 1-month (T4) follow-ups.
Secondary outcome [6] 445745 0
Changes in achievement related emotions.
Timepoint [6] 445745 0
Baseline (T1) - and then again at 1-week (T3) and 1-month (T4) follow-ups.
Secondary outcome [7] 445746 0
Extent of a human-agent (avatar) working alliance
Timepoint [7] 445746 0
Immediately following the 20-minute psycho-educational interaction with HAFSE

Eligibility
Key inclusion criteria
To be eligible to take part in this study participants must meet the following criteria:
1) Currently enrolled in a course at university (Sydney based institution).
2) Not currently receiving any professional psychotherapy (from a psychologist, counsellor, psychiatrist etc.).
3) Not currently experiencing severe levels of anxiety, depression, stress or other mental health problems. The DASS-8 (Depression Anxiety and Stress Scale) will be used to screen participants into the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants scoring in the severe range on the DASS-8 (Depression Anxiety and Stress Scale) will be excluded from the study. The DASS-8 will be used as an initial screening measure.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2025
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
20/01/2026
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318609 0
University
Name [1] 318609 0
Macquarie University
Country [1] 318609 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 321013 0
None
Name [1] 321013 0
Address [1] 321013 0
Country [1] 321013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317213 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317213 0
Ethics committee country [1] 317213 0
Australia
Date submitted for ethics approval [1] 317213 0
25/02/2025
Approval date [1] 317213 0
04/03/2025
Ethics approval number [1] 317213 0
520251884361642

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

Contacts
Principal investigator
Name 140362 0
Prof Maria Kangas
Address 140362 0
Australian Hearing Hub (AHH) L2.684, Macquarie University, NSW 2109
Country 140362 0
Australia
Phone 140362 0
+61 298508599
Fax 140362 0
Email 140362 0
[email protected]
Contact person for public queries
Name 140363 0
Maria Kangas
Address 140363 0
Australian Hearing Hub (AHH) L2.684, Macquarie University, NSW 2109
Country 140363 0
Australia
Phone 140363 0
+61 298508599
Fax 140363 0
Email 140363 0
[email protected]
Contact person for scientific queries
Name 140364 0
Maria Kangas
Address 140364 0
Australian Hearing Hub (AHH) L2.684, Macquarie University, NSW 2109
Country 140364 0
Australia
Phone 140364 0
+61 298508599
Fax 140364 0
Email 140364 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.