Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000672550
Ethics application status
Approved
Date submitted
13/05/2024
Date registered
27/05/2024
Date last updated
27/05/2024
Date data sharing statement initially provided
27/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of a Digital Coach for Self Esteem.
Scientific title
Feasibility of a Digital Coach for Self Esteem in Healthy Adults Not Currently Experiencing Mental Health Problems
Secondary ID [1] 312106 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low self-esteem 333742 0
Condition category
Condition code
Mental Health 330428 330428 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following completion of the baseline measures, participants will engage with a conversational agent (CA) called HAFSE (Helper Agent for Self Esteem). 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 15 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 but we will not know if participants follow the advice. 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.
Intervention code [1] 328548 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338182 0
Change in Self Esteem
Timepoint [1] 338182 0
Baseline and after 15 minute psycho-education with HAFSE
Primary outcome [2] 338285 0
Change in Self Esteem
Timepoint [2] 338285 0
Baseline and after 15 minute psycho-education with HAFSE
Secondary outcome [1] 434845 0
Change in self-efficacy
Timepoint [1] 434845 0
Baseline and after 15 minute psycho-education with HAFSE
Secondary outcome [2] 434846 0
Extent of a human-agent working alliance
Timepoint [2] 434846 0
After 15 minute psycho-education interaction with HAFSE

Eligibility
Key inclusion criteria
The consent form also requires that participants are:
-Not currently receiving any professional psychotherapy (from a psychologist, counsellor, psychiatrist etc).
-Not currently experiencing severe levels of anxiety, depression, stress or other mental health problems
- Currently a student
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
DASS-8 (Depression Anxiety and Stress Scale) will be used as inclusion criteria for the participants to enter into the study. Participants with severe score in any dimension will not be given access.

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/05/2024
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
400
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316464 0
University
Name [1] 316464 0
Macquarie University
Country [1] 316464 0
Australia
Funding source category [2] 316466 0
Government body
Name [2] 316466 0
Higher Education Commission Pakistan
Country [2] 316466 0
Pakistan
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 318638 0
Government body
Name [1] 318638 0
Higher Education Commission Pakistan
Address [1] 318638 0
Country [1] 318638 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315254 0
Macquarie University HREC Humanities & Social Sciences Committee
Ethics committee address [1] 315254 0
Ethics committee country [1] 315254 0
Australia
Date submitted for ethics approval [1] 315254 0
08/04/2024
Approval date [1] 315254 0
07/05/2024
Ethics approval number [1] 315254 0
520241697056726

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

Contacts
Principal investigator
Name 134142 0
Prof Deborah Richards
Address 134142 0
4 Research Park Drive, Macquarie University, NSW, 2109
Country 134142 0
Australia
Phone 134142 0
+61 02 98509567
Fax 134142 0
Email 134142 0
[email protected]
Contact person for public queries
Name 134143 0
Deborah Richards
Address 134143 0
4 Research Park Drive, Macquarie University, NSW, 2109
Country 134143 0
Australia
Phone 134143 0
+61 02 98509567
Fax 134143 0
Email 134143 0
[email protected]
Contact person for scientific queries
Name 134144 0
Deborah Richards
Address 134144 0
4 Research Park Drive, Macquarie University, NSW, 2109
Country 134144 0
Australia
Phone 134144 0
+61 02 98509567
Fax 134144 0
Email 134144 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.