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Trial registered on ANZCTR


Registration number
ACTRN12621001126808
Ethics application status
Approved
Date submitted
20/07/2021
Date registered
23/08/2021
Date last updated
23/08/2022
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
MindYourHead web-app: a randomized controlled trial of the effect of online personalised mental wellbeing feedback on help-seeking among Chinese international students
Scientific title
MindYourHead web-app: a randomized controlled trial on the effectiveness of online personalised mental wellbeing feedback on improving help-seeking among Chinese international students
Secondary ID [1] 304830 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
wellbeing
 322915 0
Condition category
Condition code
Public Health 320491 320491 0 0
Health promotion/education
Mental Health 320668 320668 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms:
1. Intervention arm: enhanced MindYourHead web-app
2. Attention-control arm: standard MindYourHead web-app

Both arms are delivered entirely online. The trial is held at the study website. Participants are able to access the intervention as many times as they wish over the study period (6 weeks).

Intervention arm:
Participants complete validated mental health screening questionnaires and receive personalised symptom feedback, tailored psychoeducation on symptoms and treatments, and tailored links to external resources and local mental health services. This information is presented in written text.
The screening questionnaires is provided across 7 categories of mental health, including: distress, sleep, stress, alcohol consumption, smoking, procrastination, and social support. Participants can decide which of the categories they wish to explore on the app. They have the autonomy to elect to complete as many or as few of the categories as they wish.
Each level of feedback for each category is tailored to the participant's score for the relevant scale for that category (e.g. K-10). Participant’s scores will fall into one of two or three levels (e.g. high distress, moderate distress or low distress). Participants will receive personalised feedback immediately after completing the questionnaires based on their score level, along with three levels of information, “what does this mean?”, “what can I do?”, and “where can I find help?”. The feedback includes information about symptoms, frequency in the student population, the potential of reducing symptoms, and increasing wellbeing using psychological treatments and strategies. Participants are provided with up to four tailored links to external resources and supports.

Adherence: The app automatically records number of logins, surveys completed, pages viewed, and external link clicks.
Intervention code [1] 321210 0
Behaviour
Intervention code [2] 321211 0
Lifestyle
Comparator / control treatment
The attention control arm receive the 'standard MindYourHead app'. They are given access to a visually similar website with the same 7 categories of mental health including: distress, sleep, stress, alcohol consumption, smoking, procrastination, and social support. Participants can decide which of the categories they wish to explore on the app. They have the autonomy to elect to complete as many or as few of the categories as they wish. Participants are provided with up to four links to relevant external resources or supports under each category.
Control group
Active

Outcomes
Primary outcome [1] 328315 0
Change in Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF) scores
Timepoint [1] 328315 0
Baseline
7 days after commencement of intervention (primary endpoint)
6 weeks after commencement of intervention
Primary outcome [2] 328316 0
Change in intention to seek help on the General Help Seeking Questionnaire (GHSQ)
Timepoint [2] 328316 0
Baseline
7 days after commencement of intervention (primary endpoint)
6 weeks after commencement of intervention
Secondary outcome [1] 398573 0
Actual Help Seeking Questionnaire (AHSQ)
Timepoint [1] 398573 0
Baseline
7 days after commencement of intervention (primary endpoint)
6 weeks after commencement of intervention
Secondary outcome [2] 398574 0
Items on mental health literacy on where to seek information from the Mental Health Literacy Scale
Timepoint [2] 398574 0
Baseline
7 days after commencement of intervention (primary endpoint)
6 weeks after commencement of intervention
Secondary outcome [3] 398575 0
WHO-5 Wellbeing Index (WHO-5)
Timepoint [3] 398575 0
Baseline
7 days after commencement of intervention (primary endpoint)
6 weeks after commencement of intervention
Secondary outcome [4] 398576 0
Self-stigma of Seeking Help Scale (SSOSH)
Timepoint [4] 398576 0
Baseline
7 days after commencement of intervention (primary endpoint)
6 weeks after commencement of intervention

Eligibility
Key inclusion criteria
International student from Chinese-speaking background, currently enrolled at an Australian university, have a valid university student email, willingness to give informed consent, and have reliable internet access.
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no a priori exclusion criteria.

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)
Automatic computerised randomisation is triggered within the study website when eligible participants completed the baseline assessment. The allocation is set at a 1:1 ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A previous study of an online intervention designed to improve help-seeking in English-speaking university students found a between group difference of 3.46 points on the same primary measure of this study, the ATTSPH-SF, with a baseline mean of 35 points and variance of 6.1 points, which equates to Cohen’s d= 0.58 (Taylor-Rodgers & Batterham, 2014). From our pilot data, Chinese international students had lower levels of help-seeking intentions (M=16.83, SD=3.59), and as a result we would expect a smaller between group difference. In our study sample, we would expect to see a 20% less efficacy of the online intervention in improving Chinese international student help-seeking attitudes, which would equate to 1.436 points difference, with a mean of 16.83 and variance of 3.59 (Cohen’s d=0.4).

Power analysis for the RCT was performed by simulation using the R package. The effect of group on the change score was the outcome of interest, using the pre-test scores as a covariate, and was simulated at 1000 times per group. A sample size of 85 per arm is needed to detect a difference of 1.436 points on the ATTSPH-SF (equivalent to Cohen’s d=0.4), with a variance of 3.59, at a significance level of 5% with a power of 80%. Allowing for 40% attrition, as is standard in online intervention studies, 284 participants need to be recruited.

A series of between-subjects analysis of covariance (ANCOVA) will be used to compare the MYH app and the control on outcome measures (help-seeking attitudes, intentions, actual help-seeking, mental health literacy, self-stigma, wellbeing) at post-intervention and follow-up using with baseline scores and previous help-seeking as covariates. The independent variables were group and wave (baseline vs post-intervention and baseline vs. follow up). The interaction of group x wave tests whether the intervention was effective in modifying the outcomes of interest.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/09/2021
Actual
4/11/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
24/02/2023
Actual
Sample size
Target
284
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23992 0
China
State/province [1] 23992 0
Country [2] 23993 0
Taiwan, Province Of China
State/province [2] 23993 0
Country [3] 23994 0
Hong Kong
State/province [3] 23994 0
Country [4] 23995 0
Macao
State/province [4] 23995 0

Funding & Sponsors
Funding source category [1] 309203 0
Government body
Name [1] 309203 0
National Foundation of Australia-China Relations
Country [1] 309203 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown
2006 NSW
Country
Australia
Secondary sponsor category [1] 310166 0
None
Name [1] 310166 0
Address [1] 310166 0
Country [1] 310166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309056 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 309056 0
Ethics committee country [1] 309056 0
Australia
Date submitted for ethics approval [1] 309056 0
19/07/2021
Approval date [1] 309056 0
21/09/2021
Ethics approval number [1] 309056 0

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

Contacts
Principal investigator
Name 112814 0
Dr Isabella Choi
Address 112814 0
Level 5, Professor Marie Bashir Building
Missenden Road
University of Sydney
Camperdown
NSW 2050
Country 112814 0
Australia
Phone 112814 0
+61286277240
Fax 112814 0
Email 112814 0
isabella.choi@sydney.edu.au
Contact person for public queries
Name 112815 0
Isabella Choi
Address 112815 0
Level 5, Professor Marie Bashir Building
Missenden Road
University of Sydney
Camperdown
NSW 2050
Country 112815 0
Australia
Phone 112815 0
+61286277240
Fax 112815 0
Email 112815 0
isabella.choi@sydney.edu.au
Contact person for scientific queries
Name 112816 0
Isabella Choi
Address 112816 0
Level 5, Professor Marie Bashir Building
Missenden Road
Camperdown
NSW 2050
Country 112816 0
Australia
Phone 112816 0
+61286277240
Fax 112816 0
Email 112816 0
isabella.choi@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not sought participant consent for sharing data for other purposes.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12616Study protocol  isabella.choi@sydney.edu.au Upon request via email.
12617Ethical approval  isabella.choi@sydney.edu.au Uploaded 382439-(Uploaded-22-08-2022-15-58-42)-Study-related document.pdf



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.