ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Psychological Distress

Help-seeking intentions

Perceived burdensomeness

Sense of belonging

Emotion regulation

Suicidal ideation

Mental health literacy

Condition category

Condition code

Mental Health

Suicide

Mental Health

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]

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]

Psychological Distress

Timepoint [1]

Baseline (T1), 2 weeks after baseline (T2), and four weeks after baseline (T3, primary timepoint)

Secondary outcome [1]

Help Seeking Intentions for Suicidal Ideation

Timepoint [1]