Guidelines for user participation: adapting digital mental health across borders

Abstract

Increased user participation in developing and adapting digital mental health solutions helps to tackle barriers and enhance facilitators for uptake of and engagement with digital mental health solutions.

These guideline aims to aid this process of involving and empowering the intended users and provide a practical step-by-step guide to better understand and include them in a meaningful way. To do so, we will elaborate on the importance and concept of this participation. Then, we will present Design Thinking as a process framework, referring to methods you can use for user participation throughout the process.

To provide depth, the guidelines incorporate insights from transnational adaptations of two digital mental health solutions: the Stress Autism Mate (SAM) app and the SAFE app. These real-world examples highlight the challenges and successes encountered when scaling solutions across cultural contexts. Finally, we summarise our recommendations in concrete topics you should be aware of when working with user participation for digital mental health innovation in an international context.

Full text

2025
Guidelines for user participation:
adapting digital mental health across borders

Foreword
In the last decade, mental health has finally gained the attention it deserves.
Still, even with this progress, barriers like stigma and long waiting lists prevent
many from receiving the care they need. In a world where mental health struggles
affect so many, it’s heartbreaking to see that some are still left waiting.
Technology offers a new way forward — a potential bridge over these gaps.
But technology alone is not the solution.
We’ve learned that the key to success lies in involving the people who will use these
solutions: the different stakeholders and intended users.
Their voices, experiences, and needs must be heard and respected in every step of
the way. By actively participating, the intended users can help shape the technology
that truly works for them, ensuring it meets their unique needs and challenges.
With this level of engagement, we build better digital mental health tools that align
with social, cultural and economic factors that may influence successful adoption
and create a sense of shared ownership and trust.
The guidelines set up during the SUPER project serves as a foundation for this
participation. The steps presented are not meant to restrict but to guide. They provide
a framework for respectful interaction and participation, ensuring every user feels
safe and supported. When we follow them, we create a space where creativity and
innovation can flourish.
These guidelines not only describe the ‘how’ of involving the intended users but also
focus on ensuring these technologies work across borders by highlighting the
importance of assessing different stakeholders’ needs to ensure regionally and
contextually appropriate solutions.
By adapting digital mental health to different cultural contexts, such as the Dutch
Stress Autism Mate (SAM) and SAFE application, we can extend these benefits to
a broader community. Together, through active participation and collaboration, we
can help reshape mental health care for a brighter future.
Signed,
Yvette
Guidelines for user participation: adapting digital mental health across borders
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Guidelines for user participation: adapting digital mental health across borders
The SUPER project (www.interregnorthsea.eu/super)
The SUPER project aims to ensure better digital tools for mental health care
across Europe and a higher uptake of existing solutions.
To accomplish this, our guidelines for user participation in digital mental health,
targeted at digital mental health developers and mental health organisations,
have been developed to aid the involvement of the intended users in the
development, implementation, and adaption of digital tools.
The guidelines have been tested within the SUPER project by adapting two
existing digital solutions to new markets (SAM and SAFE) and
subsequently refined within the project.
The project is co-founded by Interreg North Sea.
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Guidelines for user participation: adapting digital mental health across borders
The Stress Autism Mate app
The Stress Autism Mate (SAM) app was developed by GGZ Centraal in
cooperation with the intended users, people with autism.
SAM is a personalized application that supports the self-management
of the client with an autism spectrum disorder in dealing with the daily
stress experienced.
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Acknowledgements
Guidelines for user participation: adapting digital mental health across borders
The SAFE app
The SAFE app has been developed in the Region of Zealand, Denmark.
The app offers self-harm information and prevention guidance and has
been co-created with input from patients, relatives, healthcare
providers, and developers; it is designed to meet users’ needs.
The following guidelines have been developed by the SUPER project team and optimised by relevant and
insightful input and feedback from members of the SUPER project expert pool of over 60 individuals from
across Europe.
Therefore, we want to thank them and express our gratitude for their time and efforts in enhancing these
guidelines. In particular, we would like to thank Arina Van Domselaar (GGz Centraal), Christina Qvist (Region
of Southern Denmark), Hanneke Kip (University of Twente), Hannes Jarke (EuroHealthNet), Hobbe Jan
Hiemstra (ARQ), Joris Swaak (Panton), Katalin Vikuk (HekaVR), Kevin Jacobs (VindiQu), Kitty Ludovica
Hiert (Super Family), Matt Birch (Queen’s University Belfast), Nele De Witte (Thomas More), Vitalii Klymchuk
(University of Luxembourg), and Roel Smolders (MEDVIA).
We would also like to thank Lene Lauge Berring (Region Zealand) for allowing us to use and adapt the SAFE
app for our pilot test.
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Foreword 1
Acknowledgements 4
Table of content 5
Introduction 6
What is user participation? 7
Why does user participation matter? 8
Applying Design Thinking to user participation in digital mental health 9
Why Design Thinking? 9
Steps of Design Thinking 10
Empathise 11
Define 15
Ideate 19
Prototype 23
Test 27
Key considerations for upscaling a digital mental health solution 31
Annex of methods 35
References 43
Guidelines for user participation: adapting digital mental health across borders
Table of contents
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Introduction
Increased user participation in developing and adapting digital mental health solutions
helps to tackle barriers and enhance facilitators for uptake of and engagement with
digital mental health solutions [1].
These guidelines aims to aid this process of involving and empowering the intended users
and provide a practical step-by-step guide to better understand and include them in a
meaningful way. To do so, we will elaborate on the importance and concept of this
participation. Then, we will present Design Thinking as a process framework, referring to
methods you can use for user participation throughout the process.
To provide depth, the guidelines incorporate insights from transnational adaptations of
two digital mental health solutions: the Stress Autism Mate (SAM) app and the SAFE app.
These real-world examples highlight the challenges and successes encountered when
scaling solutions across cultural contexts. Finally, we summarise our recommendations
in concrete topics you should be aware of when working with user participation for digital
mental health innovation in an international context.
Regular guidelines addressing user participation might not
sufficiently focus on these aspects.
Although best-practice recommendations on involving indi-
viduals with mental health conditions in the development of
digital mental health solutions are available (e.g. [2]), these
initiatives often lack a transnational perspective.
Specific guidelines for digital mental health innovations (rather
than technological innovations in general) can be justified by this
sector’s unique challenges. Mental health is complex and involves
sensitive topics such as stigma, cultural views on mental illness,
and variations in mental health literacy. In addition, the intended
users are often vulnerable populations.
Guidelines for user participation: adapting digital mental health across borders
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What is user participation?
User participation refers to the involvement of different people or groups in
one or more stages of developing and implementing digital mental health
services. These users can be a variety of stakeholders, such as patients and
their relatives, mental health organisations, clinicians or developers.
There are several ways to involve different users, and we focus on three main
approaches: user-centred design, participatory design (or co-design), and
user innovation [3,4]. These approaches differ based on how much control and
influence users have over the design and development process.
• User-centred design is an interdisciplinary approach where users are involved to
help designers better understand their needs and how they interact with the
digital solution.
The process often includes gathering user input and improving the solution
through repeated testing and evaluation with users [5].
• Participatory design/Co-design: In this approach, users work more closely with
the designers and developers, participating from the initial idea stage to final
decision-making.
Users have more say in the process than in user-centred design [6].
• User innovation refers to the process during which users themselves, either
individuals or organisations, take the lead in creating new products or services.
Instead of relying solely on designers or developers, users identify their needs
and develop solutions that address them directly [7].
This is also the approach applied within the
SUPER project, as we worked with two
existing solutions, which limited the
room for extensive changes and further
development due to technical and
financial restraints.
User-centred design is the most often used method for involving users. The most com-
mon methods for user participation include focus groups, surveys, interviews,
and various forms of user testing [8].
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Guidelines for user participation: adapting digital mental health across borders

Why does user participation matter?
Involving the intended users (and other stakeholders) in developing digital mental health
solutions ensures that the solution meets their needs and expectations.
User participation helps to empower your intended users, enhance cultural sensitivity,
enrich ideas, increase acceptance of and engagement with these solutions, and even
create a sense of community [1]. Moreover, users have a unique understanding of their
needs and challenges. Accordingly, they can offer fresh ideas or suggestions you might
not have thought otherwise.
By involving the intended users early on and throughout the process, you can
gain valuable feedback and a deeper understanding of their everyday
problems and the features and solutions they find most beneficial.
Furthermore, user participation can empower potentially vulnerable, stigmatised or
hard-to-reach target groups. This is especially important in digital mental health, where
stigma can be a significant barrier to seeking help. By deeply understanding users’
concerns and perspectives, we can design more inclusive, effective, and supportive
solutions that promote well-being and reduce stigma.
From a practical perspective, user participation also helps to spot potential issues before
the solution is finalised, allowing you to make the necessary improvements or
adaptations to ensure a better relevance and experience for the intended users.
Ultimately, this could lead to a better implementation of your solution within a new
context or market by addressing barriers and fostering facilitators early on in the
innovation process.
When expanding a digital solution to a new country or context, user participation is
essential to ensure you understand the intended users so you can adapt and test your
solution within different markets and cultural contexts.
This also helps ensure the solution is relevant and effective in the specific context or
market. While research is unclear on specific outcomes concerning uptake and efficacy,
findings support the importance of user participation in tackling barriers and enhancing
facilitators to uptake and engagement [1].
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Applying Design Thinking to
user participation in digital mental health
Why Design Thinking?
Design Thinking is a helpful mindset and method for developing and adapting
digital solutions, especially when it comes to involving intended users and
stakeholders. It helps to involve them early on, ensuring the solution meets
their needs and challenges, which can be especially relevant when adapting
your solution for new languages and cultures. Early involvement of users also
helps to quickly test assumptions and challenges to avoid lengthy and,
at times, indifferent development processes.
In this section, we will explain how design thinking works, show you ways to
involve users in the process, suggest methods you can use, and convey what
we learned by adapting two existing digital mental health solutions to new
settings.
Keep in mind that the methods we highlight in bold are just suggestions –
design thinking is not a one-size-fits-all approach.
You will have to adapt it to what works best for your project.
Empathise Define Ideate Prototype Test
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Guidelines for user participation: adapting digital mental health across borders

Steps of Design Thinking
Design thinking involves several steps that can guide your user participation process.
Here is a quick overview:
1. Empathise: Get to know your users by understanding their
experiences, challenges, and needs.
2. Define: Based on the insights gathered, define the challenges
or needs that your digital solution should address.
3. Ideate: Brainstorm and generate creative solutions to your
defined challenges or needs.
4. Prototype: Create simple versions of your solution and share
them with users for feedback.
5. Test: Have users interact with your refined prototype and
gather their feedback to refine your solution further.
By following these iterative and often overlapping steps and being open to going back and
forth between the phases, you can create digital mental health solutions that are
effective, meaningful, culturally relevant, and user-centred.
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Empathise
What?
The empathise phase focuses on understanding users’ needs
and challenges by observing, listening, and asking questions.
This phase is crucial as it provides valuable insights into users’
experiences, enabling the creation of solutions that genuinely
address their challenges and needs.
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Guidelines for user participation: adapting digital mental health across borders

How?
Guidelines for user participation: adapting digital mental health across borders
Key activities in the empathise phase involve identifying the intended users and
other stakeholders, their challenges and needs, and existing mental health
solutions. This helps to determine the actual need for your solution and
challenge your own assumptions.
Desk research can be beneficial to initially gain a good understanding of the
intended users’ needs and the current solutions and landscape. Interviews can be
an excellent method to gain a deeper insight into the users’ needs.
You can start by interviewing clinicians who work closely with the intended users,
as we did in our adaption of SAM and SAFE.
Their input offers essential knowledge about existing solutions and the
intended users’ daily lives, challenges, and needs.
During a group interview or focus group, testing can help empathise with how users
interact with your solution and understand users’ needs. For example, an A/B test
can be used in a later iteration to compare different versions of content, which can
help you understand your users and how language affects their comprehension.
Additionally, the testing phase can reveal how well the design and functionalities
meet users’ needs and further deepen your understanding of the intended users
through multiple iterations of the design thinking steps.
It is also essential during this phase to investigate the necessary monetary
investments and the legal and regulatory requirements, such as data
protection and medical device regulations, to ensure local compliance.
Furthermore, it can be relevant to assess condition-specific accessibility needs for
your intended users.
In addition, it is necessary to gain a deep understanding of the digital mental health
solution if the solution is unfamiliar to you, e.g. by thoroughly testing the solution
yourself and conducting interviews with relevant stakeholders.
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What we learned from this phase
This phase established a clear need for the SAM and SAFE apps in the
respective countries. Through desk research and interviews with
clinicians, we learned that the intended users experienced challenges with
both stress management (SAM) and self-harm (SAFE).
Furthermore, we established that existing solutions were
lacking and did not meet the needs of the intended users.
To involve the intended users of the SAFE app, GGZ Centraal could rely on
their existing network of clinicians and patients. However, it became clear
that the Dutch clinicians needed to use the SAFE app first to recruit
intended users effectively.
For the SAM app, recruitment posed more challenges since we had not
worked with individuals with autism before. Therefore, reaching out to
relevant partners, e.g., patient networks, municipalities, and healthcare
organisations, required more time.
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Guidelines for user participation: adapting digital mental health across borders

Checklist
 Deskresearchaboutdigitalmentalhealthsolutionsinyourspecificcontext.
 Ifthesolutionisnewtoyou,getagoodunderstandingofitanditsfunctionalities.
 Interviewintendedusers/stakeholdersdependingonyourbackground
(i.e.,clients/patients,mentalhealthprofessionals,developers,directorsoforganisations,etc.)
 Identifylegalandregulatoryrequirements(e.g.GDPR,MDR)
Allocate plenty of time to fully understand your
intended users.
Interview relevant clinicians and intended users
to achieve this.
Use your network or partner up with local
organisations to recruit users.
DO
DON’T
Take recruitment for granted.
Especially when you are dealing with
intended users of a digital mental health
solution, which can be a vulnerable group.
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Guidelines for user participation: adapting digital mental health across borders

Define
What?
The define phase involves analysing the findings gathered
during the empathise phase, clearly identifying and defining
the scope of your solution along with intended users and their
needs, goals, and challenges. This helps to build the foundation
and direction for your continued work, ensuring that your
solution is aligned with the intended users’ needs.
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How?
Personas can be a good starting point for summarising the findings from the
empathise phase, defining the intended users and their needs, goals, challenges
and potential cultural differences. This was also the approach for adapting the SAM
app, where we created a persona, formalising and articulating our understanding
of the intended users in Denmark.
When defining and formalising your understanding of the intended users, mapping
out the user journey and potential workflow for clinicians can also be beneficial.
Visualising the users’ experience as they interact with the product. It highlights
pain points, opportunities, and possible improvement areas, helping better
understand the user’s perspective. During our project, this journey was mapped
for SAM and SAFE with clinicians’ help to better understand how the apps could be
incorporated into existing workflows and patient courses.
Once you have defined the users and their needs, inviting them into the
defining step can be beneficial and empower users by giving them a
voice in the design process, especially in participatory design.
Defining the legal and regulatory requirements in a potential new market and the
functional and technical requirements for adapting the solution to a new language
and market is crucial. This includes figuring out whether the underlying technical
infrastructure of the digital solution is already prepared for multiple languages.
Alternatively, it might be easier to clone the solution and build it up for the new
market. The expected monetary investment and business model for technically
developing or adapting the solution can also be defined during this phase.
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What we learned from this phase
This phase established a deeper understanding of the intended users in
Denmark and the Netherlands and the cultural differences between the
two countries.
For example, we learned that access to mental health
services in the Netherlands differs from that in Denmark.
We also learned that Dutch users did not resonate with the term
“self-harmer” used throughout the SAFE app. We defined the term as
not only uncommon but also stigmatising. Accordingly, this was adjusted
to “people who self-harm” in the Dutch adaptation.
Similarly, we defined that Danish users preferred a more informal tone.
We also defined the technical requirements where the two apps differed
significantly. The underlying technical infrastructure for the SAM app
was already prepared for multiple languages, making it easier to adapt.
In contrast, the SAFE app had to be cloned and set up in Dutch.
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Define:
 Targetgroup(s)
 Theirneedsandchallenges
 Culturaldifferencesorotherdifferencesbetweencountries
 Successcriteria
 Userjourneyandworkflowforclinicians
 Legalandregulatoryrequirementsthedigitalmentalhealthsolutionmustadhereto
 Functionalandtechnicalrequirementswithdevelopers
Take time to analyse and summarise your data.
Consider creating multiple personas,
considering different perspectives.
DO
DON’T
Assume you already know the users
or their needs and challenges –
avoid jumping to conclusions.
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Ideate
What?
The ideate phase involves exploring a wide range of
possibilities. This exploration is essential before narrowing
down to the most promising solutions that meet the intended
users’ defined needs, challenges, and potential cultural
differences. This allows you to remain explorative and offers a
fresh perspective, setting the stage for creative
problem-solving.
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How?
When it comes to ideation, it’s often a team effort.
Whether a classic brainstorm or a mind map, these methods provide an excellent
starting point for exploring ideas and meeting the defined needs, challenges, and
cultural differences. They help structure your collective ideas to
meet the users’ needs.
Inviting the intended users into the brainstorming can also be a game-changer to
get diverse perspectives and ideas on their desired solution features while
empowering your users, especially in participatory design.
Another method you can use is How Might We.
This involves rephrasing users’ challenges into open questions to help your creative
thinking and idea generation.
During our pilot test, we brainstormed how the content and information in the SAM
and SAFE app could be adapted to meet the defined needs and cultural differences.
During this process, relevant clinicians were also involved, giving their perspectives
on the required changes.
In the ideate phase, meeting with developers to discuss technical possibilities can
also be beneficial, whether adapting an existing solution or developing a new one.
Moreover, it helps to prepare an action plan detailing how your solution can be
adapted to and tested with the intended user in the new market.
Even when adapting existing solutions, the ideate phase plays a minor
but crucial role. While the overall concept of the digital solution is al-
ready established, this process can help to look at the solution from
new perspectives.
It can also provide opportunities for incremental improvements and new features
within the limits of the existing solution and potential financial restraints.
During our pilot testing, we started to collect, prepare, and translate the required
content for the two apps to Dutch and Danish. While doing so, we also created
different versions of the app content (e.g. informal and formal tone) that
could be used in our prototypes.
Guidelines for user participation: adapting digital mental health across borders
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What we learned from this phase
The translation process posed challenges for both apps. The SAFE app relied
on AI-generated translations proofed by clinicians, which was time-intensive.
The SAM app used professional translators, but their limited familiarity with
mental healthcare contexts created issues.
Key lessons included preparing content thoroughly, involving
professionals in the translation, and ensuring proofing by skilled
clinicians.
The process underscored the need for clear procedures and agreements on
who does what and when.
Technically, the SAM app supported multilingual features, allowing users
to select their preferred language, which made a Danish adaptation more
straightforward.
In contrast, the SAFE app was designed for Danish users, requiring the app to
be cloned and its content extracted for translation, ultimately complicating the
process.
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Checklist
 Brainstormorholdaworkshop(withstakeholders)todiscusshowthedigital 
 mentalhealthsolutioncanmeettheabovementioneddefinitions.
 Prepareaplanandtimelinewithdevelopersfortheadaptionsordevelopment
 ofthedigitalsolution.
 Collectandtranslatetherequiredcontentforthesolution.
Be open-minded to potential ideas and solutions.
Build on each other’s ideas.
Set clear procedures and agree on responsibilities
during the translation process.
DO
DON’T
Take the translation process lightly –
allow plenty of time to prepare
the material and proofreading it.
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Prototype
What?
The prototype phase transforms ideas into tangible models to be
tested and iterated upon. This phase is vital as it enables you to
explore and refine potential solutions through direct user
interaction and multiple iterations. By building prototypes, you can
quickly identify what works and what does not, gathering insights
on how users engage with the solution and where improvements
can be made.
Guidelines for user participation: adapting digital mental health across borders
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How?
Key activities in this phase include creating solution prototypes that can be tested
and refined through several iterations. Low-fidelity prototypes are quick, simple,
low-cost representations like sketches or paper mock-ups. In contrast, high-fidelity
prototypes are more detailed and interactive, resembling the final product.
By creating high-fidelity prototypes, you can get valuable input from your intended
users to refine your product and spot potential issues before commencing your final
development. By conducting interviews with clinicians, we gathered insights specific
to their perspectives on the prototype’s design and features.
During interviews, an A/B test can also be used to test different
prototype versions. For example, we prepared a low-fidelity prototype
with two versions of the same content from the SAM app written in
informal and formal language to test with clinicians.
Adding to that, we used high-fidelity prototypes set up in Figma, allowing focused
feedback from clinicians to refine both apps. After these adjustments, the
adapted content was transformed into a fully functioning prototype for
testing with the intended users.
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What we learned from this phase
The combination of low- and high-fidelity prototypes worked very well for both
apps. Paper prototypes required minimal resources and still allowed clinicians
to provide quick feedback and make corrections. Similarly, in our A/B test,
clinicians offered valuable insights into the preferences of the intended users.
This led to adjustments to our prototypes before testing them with
the intended users. For example, we changed the tips in the SAM
app, making them more actionable and concrete.
When we presented the high-fidelity prototypes, it enabled the intended users to
clearly see what they could expect from SAM and SAFE. It also allowed them to
be very specific about what they like or dislike when they review a more tangible
product. We also experienced that prototyping required several iterations
before a solution could be presented to the intended users.
However, it was well spent, saving time in the long run.
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Checklist
 Preparematerialsfortesting,e.g.mock-ups,Figmawireframes,
 textsnippets,paperprototypesetc.
 Conductafunctionalitytestofyourprototype.
 Collectfeedbackonlow-fidelityprototypestoimplementin
 high-fidelityprototypes.
Consider a simple prototype; a phrase of a
text written in different tones or a paper
mock-up of your digital solution.
DO
DON’T
Wait until you have a fully functioning
or perfect prototype to
start your tests.
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Test
What?
The test phase focuses on evaluating and refining ideas or
prototypes by seeking direct feedback from users. This phase
involves presenting solutions to the intended users, observing
their interactions, and gathering insights to identify strengths
and areas for improvement. Testing ensures your solution
aligns with users’ needs and enhances its impact and usability.
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How?
Key activities include testing the prototypes through several iterations and
applying different methods. Early iterations with A/B tests or low-fidelity prototypes
can provide valuable insights into the preferences of the intended users.
Later iterations can focus more on high-fidelity prototypes using usability testing
and gathering feedback through interviews, surveys, and observations, evaluating
how users interact with your solution.
During our test of the SAM app, we initially used A/B tests with clinicians to test two
versions of central content from the app. Consequently, we created and adapted our
high-fidelity prototype for usability testing and evaluating how the intended users
interacted with the app. Usability testing can involve different methods.
For example, we combined user interviews, observations, and think-aloud tests,
where users completed specific tasks while sharing their thoughts. This helped us
understand how they engaged with the prototypes.
For optimal testing, incorporate iterative testing cycles, where insights
from one test allow for refinements for the next, gradually aligning the
design closer to user expectations and requirements.
Create a comfortable setting where users can interact with the solution as they
would in real life, allowing them to choose the location — whether at their home
or another place that feels safe and natural to them. Think-aloud tests encourage
users to verbalise their thoughts as they navigate your prototype.
This can reveal hidden challenges or unmet needs. By documenting findings
systematically, testing becomes a valuable tool for validating assumptions and
ensuring your solution is relevant and meets the intended user’s needs.
This hands-on testing allows users to experience the solution’s functionality
realistically, revealing valuable insights into usability and effectiveness. Observing
user interactions with the prototype provided essential data for further refinements
and ensured alignment with user needs. Take into account that this phase, while
critical for refining the solution, also requires time and resources.
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What we learned from this phase
User testing recruitment strategies offer distinct pros and cons.
For the SAM app, outreach through social media, patient organisations, and
municipalities enabled direct access to the intended users for in-person feed-
back, yielding rich insights.
In contrast, SAFE app recruitment had to focus on clinicians, patients, and
relatives. While recruiting clinicians was straightforward, involving patients
and relatives through clinicians led to indirect access and feedback via sur-
veys.
This hindered immediate feedback from patients and relatives, resulting in
less rich insights.
In conclusion, direct outreach requires significant effort to engage
stakeholders, but it offers valuable returns by fostering deeper
insights.
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Checklist
 Createaninterviewguideforusabilitytesting,includinganactionplan,tasks,
 questions,andA/Bscenarios.
 Testtheidentifiedneedsandchallengesthroughmethodssuchasin-personor
 onlineinterviewsorsurveys.
 Conduct3-5usabilitytestsinpersonwithintendedusers
 (usingthethink-aloudmethod).
 Reviewresults–doesyourprototypemeettheintendeduser’sneeds?
 Refineyourdigitalsolution’stranslatedcontentandfeaturesbasedon
 insightsfromprototypetests.
Prioritize direct engagement with all target groups of
intended users, if possible.
Explore high-effort methods as they may also have
the highest returns (e.g. think aloud).
Ensure regulatory and ethical compliance concerning
tests in clinical populations.
DO
DON’T
Settle for one iteration
of testing.
Guidelines for user participation: adapting digital mental health across borders
Page 30

Key considerations for
upscaling a digital mental health solution
in a transnational context
When expanding a digital mental health solution to another country, there are several
critical factors to keep in mind to ensure the solution is culturally relevant,
accessible, and effective.
Below are our primary considerations when relying on design thinking for your
adaption, testing and upscaling to a new market.
Conduct comprehensive market research
Collaborate with local experts
Start by gaining an understanding of the target country’s mental health landscape, cultural
norms, values, attitudes, and readiness toward digital mental health solutions. Understand which
solutions and services exist, where the gaps are, and how your solution can fill those gaps.
This research is essential for understanding the market and the users within, as well as
identifying potential local experts and partners who can aid the adaption and
implementation of your solution.
Setting up (formal) collaborations with
local mental health organisations,
professionals, and community
leaders can be essential when
expanding to a new country.
Their insights can help navigate nu-
ances in language and culture, regu-
latory requirements, and accessibility
challenges. Leveraging organisations’
broad reach allows for refined
market research, solution adaptation,
and effective implementation.
Collaborating with a local entity is
especially valuable for understanding
the local landscape and facilitating
access to intended users for
interviews or usability testing.
Guidelines for user participation: adapting digital mental health across borders
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Apply design thinking as an iterative process
Consider cultural, socioeconomic, policy
and other differences
Allocate sufficient time for translation and local
adaptation
Applying design thinking for user participation is a cycle of continuous testing,
feedback, and refinement, sometimes requiring going back and forth through the
phases. Each iteration provides valuable insights that can help tailor and refine your
solution to better fit the needs of the intended users. Accordingly, you should revisit
and revise earlier stages as new information emerges.
This flexibility is essential to develop an effective, user-centred solution that
genuinely addresses the needs and challenges of the intended users.
Cultural differences and similarities can appear in various ways, such as healthcare
systems, language, race, religion, and customs. For language, translate your
materials using professional translators or native speakers. Involve intended users
to ensure clarity and relatability. Be mindful of visuals and examples to be inclusive
and diverse. Additionally, mental health perceptions and stigmas can vary, so
collaborate with local experts to align your solution with the cultural context
and sensitivities of the target context.
Translating and adapting the content to the local context should not be
underestimated. Therefore, allocating sufficient time for this at the onset and
throughout the process is critical. Frequent optimisations might be required as
you move through the different steps of design thinking.
This process also benefits from involving various stakeholders, particularly
intended users, to check whether regional features and contextual nuances are
correctly addressed.
Guideline for user participation in digital mental health: a transnational perspective
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Guidelines for user participation: adapting digital mental health across borders

Clarify your expectations to the intended users
Prioritise safety and flexibility
Set clear expectations by detailing what you are asking users to do, why, and how
long it will take. Ensure the invitation to participate is easy to understand,
informative, and inviting.
Share enough details for users to understand the purpose and their role clearly. In
your dialogue, clearly state the added value of their input and the boundaries of their
decision-making power and influence on the final solution.
This approach ensures that users are well-informed, engaged, and aware of how
their contributions will impact the development process. It can also be good to show
appreciation for their participation and engagement by offering small tokens of
appreciation after tests, interviews or other activities.
When working with vulnerable groups, following ethical guidelines and creating a
respectful and safe environment for user participation is essential.
Consult with clinicians or relatives beforehand to better understand and engage the
intended users so you abide by their terms.
When interacting with the intended users, it is crucial to be flexible and pay attention
to how comfortable they are within the process. If specific tasks push them out of
their comfort zones, be flexible and adjust to their needs.
Also, be mindful of your own or other’s misconceptions or biased ideas about mental
health.
Guidelines for user participation: adapting digital mental health across borders
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Ensure regulatory compliance
Ensure sustainable financing
Familiarise yourself with the regulatory environment for digital mental health in-
terventions in the target country to have a realistic view of the potential (additional)
costs. Considering this factor in your development or upscaling process should
ensure compliance with local laws and regulations.
Depending on the nature of your digital mental health interventions, you must also
address privacy and data protection concerns according to local standards, e.g., the
European General Data Protection Regulation (GDPR), Medical Device Regulation
(MDR), or, in some cases, the EU AI Act. Ensure you meet local regulations for
accessibility by adhering to standards such as the Web Content Accessibility Guide-
line (WCAG).
Depending on the digital solution, you may need to integrate it with local healthcare
systems, such as electronic health records (EHRs) or existing mental health services.
It is crucial to have sufficient funding or a solid business plan from the beginning of the design
thinking process and consider financial sustainability throughout all phases.
Even the best-designed product may fail without proper financial backing, as no resources will
be available for maintenance, further development, or long-term sustainability.
Planning for funding ensures that the product can evolve and remain viable, ultimately achieving
lasting success.
Guidelines for user participation: adapting digital mental health across borders
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Annex of methods
This annex serves as a “methods library” with successful
methods we have worked with during or
before the SUPER project.
The different methods are briefly presented, along with a link to
further resources and guidance.
We have shared details on the methods used
(e.g., interview questions, personas, prototypes)
and the accompanying data and results via the Open Science Framework
(https://osf.io/wpax5/).
More detailed findings will also be published in a scientific paper.
Guidelines for user participation: adapting digital mental health across borders
Page 35

Focus groups
Focus groups are a valuable qualitative method where a group of intended
users or relevant stakeholders come together to discuss and provide feedback
on a concept, prototype or product. These discussions are typically moderated
to ensure that a range of perspectives and insights are captured.
The main goal is to gather detailed, in-depth information that can
inform decision-making processes and product development and,
most importantly, significantly improve user experience.
For more information, extensive guidance exists for planning and
facilitating focus groups, e.g., from the Interaction Design Foundation
(https://www.interaction-design.org/literature/article/how-to-conduct-focus-groups).
Guidelines for user participation: adapting digital mental health across borders
Interviews
A one-on-one method where you can delve into the intended user’s
experiences, needs, and challenges, gathering rich, in-depth insights.
This approach allows for detailed understanding and
will enable you to ask follow-up questions and dive into
relevant topics uncovered during the interview.
For more information, extensive guidance exists for carrying out interviews,
e.g., from the Universal Design Guide
(https://universaldesignguide.com/method/user-interviews/).
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Surveys
Surveys are a quantitative research method involving structured
questionnaires sent to a large group of intended users or relevant
stakeholders. This approach is efficient for gathering information on topics
like user preferences, behaviours, and opinions.
Surveys help identify trends and patterns within a
target population by reaching numerous individuals
quickly and efficiently.
The collected data can then be analysed to make informed decisions
regarding your solution. This method ensures a broad understanding of
the target audience’s needs and preferences.
For more information, extensive guidance exists for sending out surveys,
e.g., from the Nielsen Norman Group
(https://www.nngroup.com/articles/surveys-design-cycle).
Guidelines for user participation: adapting digital mental health across borders
Brainstorm
Brainstorming is a dynamic and collaborative activity that fosters creativity
and innovation. During a session, participants freely share diverse ideas
and solutions without criticism, encouraging various perspectives.
This open environment helps to break down mental
barriers, spark new thoughts, and explore
unconventional approaches to a problem.
The goal is to generate numerous ideas, which can later be reviewed,
refined, and potentially developed into relevant solutions.
For more information, extensive guidance exists for brainstorming, e.g.,
from IDEO
(https://www.ideou.com/pages/brainstorming).
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Guidelines for user participation: adapting digital mental health across borders
Guideline for user participation in digital mental health: a transnational perspective
Mind map
A visual technique to organise ideas, concepts, or problems by
connecting associated thoughts and information.
This method promotes brainstorming and
highlights connections between your ideas and
related topics and notes, enabling clearer
thinking and problem-solving.
Its intuitive structure enhances creativity, making it a powerful
tool for understanding complex issues.
For more information, extensive guidance exists along with digital
tools for creating a mind map, e.g., from Canva
(https://www.canva.com/graphs/mind-maps/).
User journeys / Journey mapping
User journeys are visualisations that show the steps your intended us-
ers take to reach a goal when using a product or service. They help you to
understand what your intended user goes through, including their feelings,
needs, and any difficulties they encounter.
By breaking down the process into clear stages, user
journeys highlight where things might go wrong or
where improvements can be made.
This makes it easier to create better user experiences by addressing pain
points and making the path to the goal as smooth as possible.
For more information, extensive guidance exists for creating user journeys,
e.g., from Yale University
(https://usability.yale.edu/understanding-your-user/user-journey-maps).
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Personas
Creating a persona involves creating a fictional yet realistic character
based on research and user data to represent your intended users.
This helps ensure a clear understanding of user needs, guiding your
development process.
You need qualitative and quantitative data to identify
user patterns and characteristics.
Once data is collected, you create a detailed persona describing their
goals, challenges, and needs.
For more information, extensive guidance exists for creating a persona,
e.g., from the Nielsen Norman Group
(https://www.nngroup.com/articles/personas-study-guide/).
How might we
“How might we” helps frame challenges or insights as open-ended
questions, encouraging innovative solutions. This approach transforms
constraints into opportunities, fostering creativity and teamwork.
By asking, “How might we,” you shift your mindset
from limitations to possibilities, inviting a broader
range of ideas and collaborative problem-solving.
For more information, extensive guidance exists for asking “How might
we” questions, e.g., from Design Kit
(https://www.designkit.org/methods/how-might-we.html).
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Guidelines for user participation: adapting digital mental health across borders

A/B test
A/B testing involves creating and testing two versions of the same content
or solution for your intended users to determine which version performs
better. This method helps optimise design decisions by comparing user
interactions and outcomes.
You can identify the most compelling features and
make data-driven improvements by analysing
the results.
For more information, extensive guidance exists for A/B testing, e.g., from
the Nielsen Norman Group
(https://www.nngroup.com/articles/ab-testing/).
Observations
Observing your intended users when interacting with a product or
prototype in a natural environment provides valuable insights into
their behaviour and preferences.
This can help you identify potential pain points, unknown
workarounds, or usability issues.
By observing how they use the solution, you can gather real-time
feedback and understand their pain points and preferences.
This process is crucial for understanding your intended users and
uncovering potential obstacles or frustrations they may encounter.
For more information, extensive guidance exists for observations,
e.g., from Medium
(https://medium.com/@ashraful.ruet15/observation-in-the-design-think-
ing-process-44f065616f70).
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Guidelines for user participation: adapting digital mental health across borders

Desk research
Desk research involves reviewing existing data, studies, reports, or articles to
gain insights into trends or issues. This method doesn’t require direct interac-
tion with the intended users, allowing researchers to analyse and understand
the broader context based on previously gathered information.
It’s a cost-effective and time-efficient way to collect
valuable data, identify patterns, and make informed
decisions before directly involving your
intended users or relevant stakeholders.
For more information, extensive guidance exists for conducting desk research,
e.g., from the Nielsen Norman Group
(https://www.nngroup.com/articles/secondary-research-in-ux).
Usability tests
Usability tests are conducted with your intended users to assess the ease of
use and overall user experience of a finished solution or prototype. The intend-
ed users interact with the product/prototype while you observe and collect
feedback on their experience.
The goal is to identify usability issues and get insights
into the intended users’ behaviour when interacting with
your solution.
This helps to ensure that it meets the needs and expectations of your intended
users while allowing you to refine and improve your solution further.
For more information, extensive guidance exists for usability testing, e.g., from
Yale University
(https://usability.yale.edu/usability-testing/usability-testing).
Page 41
Guidelines for user participation: adapting digital mental health across borders

Page 42
Low-fidelity prototyping
Low-fidelity prototyping involves creating simple, often paper-based models
to test ideas and concepts before investing in high-fidelity prototypes. These
simple prototypes help convey and test a concept to users or stakeholders
to gather feedback and identify potential issues early.
This cost-effective method allows for rapid iterations,
experimentation, and innovation.
Accordingly, when resources are invested in detailed prototypes, the designs
can be more well-informed and directed towards feasible solutions.
For more information, extensive guidance exists for creating high-fidelity
prototypes, e.g., from the Interaction Design Foundation
(https://www.interaction-design.org/literature/article/prototyping-learn-eight-com-
mon-methods-and-best-practices).
High-fidelity prototyping
Using a design tool like Figma allows you to create detailed and interactive
digital high-fidelity prototypes that can be tested, shared, and iterated upon,
mimicking the final product.
Doing so lets you get valuable insights and inputs from
your intended users, allowing you to identify potential
issues and room for improvement.
Accordingly, you can adjust and refine your solution before spending time
and resources to develop your actual solution.
For more information, extensive guidance exists for creating a high-fidelity
prototype, e.g., from Figma
(https://www.figma.com/resource-library/high-fidelity-prototyping/).
Guidelines for user participation: adapting digital mental health across borders

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Guidelines for user participation: adapting digital mental health across borders
Page 43

GGz Centraal (NL), Centre for Digital Psychiatry (DK) and Thomas More
University of Applied Sciences (BE) collaborated on this project.
GGz Centraal and the Centre for Digital Psychiatry already involve users
in developing their applications. At the same time, Thomas More
University of Applied Sciences has conducted multiple
practice-oriented research projects involving stakeholders
in developing and implementing digital mental health solutions.
GGz
Centraal
(NL)
GGz Centraal, the fourth largest psy-
chiatric hospital in the Netherlands,
offers specialized mental health treat-
ment through diagnostics, counselling,
and more.
They provide care for individuals with
mental health issues and provides
user-centered solutions and support.
As part of this, they have co-designed
the Stress Autism Mate app with cli-
ents (SAM).
The Centre for
Digital
Psychiatry (DK)
The Centre for Digital Psychiatry,
Region of Southern Denmark, is a
frontrunner in using digital solutions
to promote mental health and
psychiatric treatment.
The Centre successfully matches the
needs of psychiatry with technology
that enhances the accessibility, the
quality and flexibility for patients and
their relatives.
Citation suggestion:
Lange Nielsen, S., Korthé Carlsen, C., Roke, Y., Schaap, J., Van Daele, T., & Bernaerts, S. (2025).
Guidelines for user participation: adapting digital mental health across borders. Interreg North Sea SUPER.
Retrieved from https://www.interregnorthsea.eu/super/guidelines
Thomas More
University of Applied
Sciences (BE)
Psychology and technology at
Thomas More University of Applied
Sciences conducts applied,
practice-oriented research in the
broad field of digital mental health.
There is a strong focus on the
interaction between both domains
and the synergy they create,
particularly within mental healthcare
and human-technology interaction.
Guidelines for user participation: adapting digital mental health across borders
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