Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000584437
Ethics application status
Approved
Date submitted
20/05/2025
Date registered
4/06/2025
Date last updated
4/06/2025
Date data sharing statement initially provided
4/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Bud App: A Randomised Controlled Trial Targeting Modifiable Risk and Protective Factors for Suicide Among International Students
Scientific title
The Bud App: A Protocol for a Randomized Controlled Trial with an Internal Pilot Phase Targeting Modifiable Risk and Protective Factors for Suicide Among International Students
Secondary ID [1] 314069 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 336816 0
Help-seeking intentions 336817 0
Perceived burdensomeness 336818 0
Sense of belonging 336819 0
Emotion regulation 336820 0
Suicidal ideation 336822 0
Mental health literacy 337654 0
Condition category
Condition code
Mental Health 333314 333314 0 0
Suicide
Mental Health 333315 333315 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1 (INTERVENTION GROUP): BUD APP

Bud is a digital intervention delivered via a mobile application. It was co-designed with international students to address their mental health and wellbeing needs in tertiary education settings. The app targets modifiable risk factors (e.g., stress, isolation) and protective factors (e.g., social support, help-seeking) associated with suicide among international students. Key components include mood tracking, evidence-informed tools, lived experience stories, a brief gatekeeper training course, and gamification elements.

Core components of the app include:

• Mood Monitoring: Users can complete daily mood check-ins, which are used to support emotional awareness and tailor content recommendations to users' reported emotional states and current challenges.

• Therapeutic Tools: The app includes a library of interactive, evidence-informed exercises based on cognitive behavioural therapy (CBT), dialectical behaviour therapy (DBT), and acceptance and commitment therapy (ACT). These exercises vary in duration and are designed to support users in developing skills relevant to emotional wellbeing. Examples include:
- Reframing (reconsidering interpretations of challenging situations)
- Distress tolerance (e.g., temperature-based techniques to manage emotional intensity)
- Gratitude reflection (e.g., guided lists of positive experiences)
- Emotion regulation (e.g., guided breathing exercises)
- Problem-solving (e.g., structured step-by-step decision-making)

• Gatekeeper Training Module: A brief, self-paced suicide prevention course developed specifically for this study. The course consists of four modules, each approximately five minutes long. Content is primarily text-based and includes interactive question sequences designed to resemble text message conversations. In these sequences, users select from predefined responses and receive automated feedback to reinforce learning. The course aims to increase awareness of suicide warning signs and provide guidance on how to respond and support others. It was developed in alignment with best-practice recommendations for culturally responsive gatekeeper training, including adaptations used in non-Western settings.

• Lived Experience Stories: Video and text-based narratives from international students who describe their experiences with distress and accessing support. These stories aim to reflect diverse experiences and promote reliability.

• Gamification: A points-based system rewards user engagement, contributing to the growth of a virtual “Bud” character to promote ongoing use.

Delivery and Support:

The Bud app is self-guided and available on Android and iOS platforms. Participants can use the app flexibly at any time and location during the 4-week trial period. There is no prescribed dosage, but participants are encouraged to complete daily mood check-ins and engage with therapeutic content as needed. Optional push notifications are used to prompt regular engagement.

Participants receive an onboarding pack at enrolment that includes a written user guide and a short instructional video. Technical assistance is available via email or phone, provided by the research team.

App Features Not Included:

The app does not include any chat or messaging functionality. Participants are not able to communicate with other users or with mental health professionals via the app. However, the app includes an emergency contact page that provides information for accessing support, including contact details for emergency services, Lifeline, and the International Student Hotline.

Adherence Monitoring:

In-app analytics will track participant engagement, including log-in frequency, time spent in the app, number and type of activities completed, and responses to prompts asking whether activities were perceived as helpful or unhelpful.

INTERNAL PILOT PHASE

An internal pilot phase will be embedded in the first six months of recruitment to assess the feasibility of trial procedures, including recruitment, retention, and engagement. This pilot is not limited to a fixed number of participants. All participants recruited during this phase will be randomised into either the intervention or control group and included in the main trial analysis, provided no substantial protocol changes are required. No interim outcome data will be reviewed during this phase to preserve trial integrity.

Feasibility will be assessed using a Red-Amber-Green (RAG) framework, with the following thresholds and actions:

Recruitment:
• Green: Equal to or more than 50% of the target sample recruited within 6 months – No action required
• Amber: 30–50% of target sample recruited within 6 months – Explore expanded recruitment channels, revised outreach materials, and/or strengthened partnerships
• Red: Less than 30% recruited within 6 months – Review trial viability with sponsor and HREC; consider pause or termination

Retention (survey completion):
• Green: Equal to or more than 60% of participants complete follow-up surveys – No action required
• Amber: 40–60% complete follow-up surveys – Use additional automated reminders, explore additional incentives, assess survey burden.
• Red: Less than 40% of participants complete follow-up surveys – Investigate barriers to retention, assess feasibility of continuing, consider additional supports or modified data collection.

Engagement (intervention use):
• Green: Equal to or more than 50% of intervention participants use the app at least three times – No action required
• Amber: 30–50% use the app at least three times – Explore opportunities for additional push notifications, adjusted onboarding, enhanced motivational elements, or enhanced UX elements.
• Red: Less than 30% of participants use the app at least once – Conduct urgent review of app usability and content; consult with developers; assess feasibility of updates within study timeframe.
Intervention code [1] 330645 0
Prevention
Comparator / control treatment
ARM 2 (CONTROL GROUP): MENTAL HEALTH FACTSHEETS

Participants randomised to the control group will receive access to four psychoeducational factsheets that provide general mental health information tailored for international students. These factsheets are designed to reflect the type of resources commonly available on university and tertiary education websites. The aim is to present brief, accessible information that promotes mental health awareness and encourages help-seeking.

Factsheet topics include:

1. Staying well through self-care
2. Staying connected and making friends
3. Signs to reach out for mental health support
4. Seeking professional mental health support

Each factsheet is designed to take approximately five minutes to read and was developed by a registered psychologist with experience producing mental health materials for culturally diverse populations.

Participants will receive a secure REDCap weblink to access the factsheets after completing the baseline (T1) survey and being randomised to the control condition. They will be encouraged to read at least one factsheet per week over the four-week intervention period (between T1 and T3), but may access all materials at any time during the trial. Engagement will be encouraged through weekly reminders via email and text message.

Adherence Monitoring:

Engagement with the factsheets will be monitored via REDCap. Metrics will include the number of factsheets accessed, time spent on each factsheet, the number of times each factsheet is accessed, and self-report checks asking participants whether they have read each factsheet. These data will be used to assess engagement and adherence in the control condition, consistent with the adherence monitoring approach used in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 340890 0
Psychological Distress
Timepoint [1] 340890 0
Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3, primary timepoint)
Secondary outcome [1] 445358 0
Help Seeking Intentions for Suicidal Ideation
Timepoint [1] 445358 0
Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3)
Secondary outcome [2] 445359 0
Perceived burdensomeness
Timepoint [2] 445359 0
Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3)
Secondary outcome [3] 445360 0
Sense of belonging
Timepoint [3] 445360 0
Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3)
Secondary outcome [4] 445361 0
Emotion regulation
Timepoint [4] 445361 0
Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3)
Secondary outcome [5] 445362 0
Suicidal ideation
Timepoint [5] 445362 0
Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3)
Secondary outcome [6] 445363 0
Mental Health Literacy
Timepoint [6] 445363 0
Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3)
Secondary outcome [7] 445364 0
Acceptability - Intervention Group
Timepoint [7] 445364 0
Four weeks after baseline (T3)
Secondary outcome [8] 445365 0
Acceptability
Timepoint [8] 445365 0
Four weeks after baseline (T3)
Secondary outcome [9] 447900 0
Engagement - Intervention Group
Timepoint [9] 447900 0
During intervention period starting immediately after T1 (baseline) and up to T3 (4 weeks post intervention)
Secondary outcome [10] 448195 0
Iatrogenic effects
Timepoint [10] 448195 0
Four weeks after baseline (T3)
Secondary outcome [11] 448196 0
Engagement - Control Group
Timepoint [11] 448196 0
During intervention period starting immediately after T1 (baseline) and up to T3 (4 weeks post intervention)
Secondary outcome [12] 448463 0
Feasibility – Recruitment
Timepoint [12] 448463 0
First 6 months of the trial (internal pilot phase only)
Secondary outcome [13] 448464 0
Feasibility – Retention
Timepoint [13] 448464 0
First 6 months of the trial (internal pilot phase only)
Secondary outcome [14] 448465 0
Feasibility – Engagement (App use)
Timepoint [14] 448465 0
First 6 months of the trial (internal pilot phase only)

Eligibility
Key inclusion criteria
To participate, participants must be:
• Enrolled as an international student studying onshore at an education institution in Australia
• Aged 18+
• Be able to read and speak in English
• Access to a smartphone running Android or IOS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be generated using a computer-generated algorithm within REDCap by a researcher independent of the main study team. Participants will be randomised automatically upon completion of the baseline survey, and allocation will remain concealed from the research team until the point of assignment to prevent bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a stratified block randomisation approach to ensure a balanced allocation between the intervention and control groups while accounting for baseline suicidal ideation (SI) levels.

Given that some participants may report no suicidal ideation at baseline, stratification will occur across three predefined SI levels to ensure equal distribution across conditions:

- No or Mild SI (YSIS-3 = 0–3)
- Moderate SI (YSIS-3 = 4–6)
- Severe SI (YSIS-3 = 7+)

Within each stratum, participants will be randomised in a 1:1 ratio to either the intervention group (Bud App) or the control group (psychoeducational fact sheets) using block randomisation with a block size of 6. This ensures that at every stage of recruitment, the number of participants in each group remains balanced, preventing significant imbalances in baseline SI or other risk factors. The use of random permuted blocks within each stratum further prevents predictability in allocation.
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
Quantitative data analysis will be conducted following the completion of T3 data collection using R statistical software. Descriptive statistics, including frequencies, percentages, means, and standard deviations, will summarise demographic characteristics, feasibility (recruitment rates, attrition, assessment completion), app engagement metrics, and acceptability ratings.

Changes in the primary and secondary outcomes will be evaluated using generalised linear mixed models (GLMMs), including random intercepts for participants, random slopes for time, and fixed effects for group, time, and their interaction. For zero-inflated outcomes such as suicidal ideation (e.g., a large number of individuals reporting no ideation), model diagnostics will be used to assess the appropriateness of the GLMM approach, with consideration of alternative specifications (e.g., two-part models such as the zero-inflated Poisson model) if indicated. Measures of acceptability and iatrogenic effects will be assessed with descriptive statistics. Pearson correlations will explore associations between app engagement and mental health outcomes.

Exploratory analyses will investigate potential moderators (e.g., demographics, emotion regulation) of the primary and secondary outcomes. Sensitivity analyses will be conducted to assess whether outcome patterns differ as a function of intervention engagement or baseline stratification levels of suicidal ideation.

All quantitative analyses will follow intention-to-treat principles. Missing data in outcome measures will be handled using maximum likelihood estimation within the generalised linear mixed models (GLMMs), which provide unbiased estimates under the assumption that data are missing at random (MAR) - i.e., the probability of missingness depends on observed but not unobserved data. This approach is consistent with the planned analytic strategy and enables the use of all available data without imputation. Model diagnostics will be used to examine the plausibility of the MAR assumption. If substantial missingness or deviations from MAR are identified, sensitivity analyses (e.g., multiple imputation or pattern-mixture models) may be conducted to evaluate the robustness of findings.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/06/2025
Actual
Date of last participant enrolment
Anticipated
27/03/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
302
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318576 0
University
Name [1] 318576 0
Univeristy of Melbourne Early Career Researcher Grant
Country [1] 318576 0
Australia
Funding source category [2] 318578 0
Charities/Societies/Foundations
Name [2] 318578 0
Suicide Prevention Australia Innovation Grant
Country [2] 318578 0
Australia
Funding source category [3] 318579 0
Government body
Name [3] 318579 0
Study Melbourne Inclusion Program Grant
Country [3] 318579 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
Country
Australia
Secondary sponsor category [1] 320974 0
University
Name [1] 320974 0
University of Melbourne
Address [1] 320974 0
Country [1] 320974 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317175 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 317175 0
Ethics committee country [1] 317175 0
Australia
Date submitted for ethics approval [1] 317175 0
18/03/2025
Approval date [1] 317175 0
28/04/2025
Ethics approval number [1] 317175 0
2025-32102-65516-3

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

Contacts
Principal investigator
Name 140250 0
Dr Samuel McKay
Address 140250 0
Orygen, 35 Poplar Road, Parkville, Victoria, 3052
Country 140250 0
Australia
Phone 140250 0
+61 427 668 632
Fax 140250 0
Email 140250 0
[email protected]
Contact person for public queries
Name 140251 0
Samuel McKay
Address 140251 0
Orygen, 35 Poplar Road, Parkville, Victoria, 3052
Country 140251 0
Australia
Phone 140251 0
+61 427 668 632
Fax 140251 0
Email 140251 0
[email protected]
Contact person for scientific queries
Name 140252 0
Samuel McKay
Address 140252 0
Orygen, 35 Poplar Road, Parkville, Victoria, 3052
Country 140252 0
Australia
Phone 140252 0
+61 427 668 632
Fax 140252 0
Email 140252 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.