Developing innovative digital tools to support mental health is exciting and offers great potential—but it comes with its own set of challenges. The MENTBEST project recently hosted a workshop to capture key learnings from setting up a multi-country clinical trial for the MENTINA app. Here’s what we discovered.

Evaluating a digital mental health intervention across Europe

The MENTINA app has been designed for self-monitoring of mental health and self-management of depressive symptoms. To evaluate its effectiveness, the MENTBEST project is running randomised clinical trials across Spain, Germany, and Denmark.

However, obtaining ethical and regulatory approval for such a digital medical device proved complex, particularly because the digital health regulatory landscape in Europe is still evolving. The workshop aimed to capture what worked, what didn’t, and what can guide future projects. It brought together consortium partners and the project’s external ethics advisor, Prof. Dr Nathalie Smuha.

Key Learnings

From ethics and regulatory approvals:

• Multi-country trials add complexity: processes, costs, and requirements vary significantly between Denmark, Germany, and Spain.
• Detailed mapping of processes and resources is critical to accurate budget design for multi-country trials.
• Sequential approvals (starting in one country and applying lessons learned to others) help streamline the process.
• Integrating AI was not feasible in the MENTINA trial, as algorithms were not allowed to be trained on collected data during the study. The trained algorithm would have to be trialled separately to avoid introducing changes during the study.
• Rapid technological change can outpace lengthy approval and clinical development cycles, bearing the risk that the end product will be outdated by the time it enters the market.

From participant feedback:

• Clear, simple explanations of how personal data is used are essential; videos or animations can help.
• Engaging participants in creating information sheets improves comprehension.
• A unified EU-wide approach to digital consent (e-consent) would benefit future research.

From the Ethics Advisor:

• While the AI Act excludes “science and research” from its scope, research aimed at developing commercialisable digital medical tools should still follow stringent ethical and regulatory procedures to enable future commercialisation.
• Understanding the scope and decision-making power of relevant authorities enables researchers to navigate approvals effectively.

Moving Forward: Implications for Digital Mental Health Research

Despite the challenges, the enthusiasm of participants and the innovative potential of MENTINA confirm that this work is valuable and needed. The workshop highlighted key actions for the future:

1. Design research protocols with country-specific regulatory requirements in mind to avoid repeated amendments.
2. Plan resources realistically, including time, budget, and training for staff involved in ethical and regulatory submissions.
3. Embed ethical and regulatory considerations early in the development of digital tools to ensure a feasible path to commercialisation.
4. Leverage lessons learned from multi-country trials to improve efficiency, clarity, and participant experience in future studies.

By applying these lessons, digital tools developed through research have a stronger chance of reaching the people who need them most.

Looking Ahead: Shaping the Future of Digital Mental Health

The MENTBEST workshop demonstrated that ethical and regulatory processes, while challenging, provide essential learning for the development of AI-based digital medical tools. Multi-country collaboration, careful planning, and participant-centred design are crucial to navigating these processes successfully.

As the AI regulatory landscape evolves, projects like MENTBEST offer valuable insights for researchers and developers in mental health technology, ensuring that innovation does not come at the cost of participant safety. Stay tuned to the MENTBEST website for more updates on the MENTINA trial and how we are continuing to innovate in digital mental health solutions for vulnerable populations.

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Author: Dr. Katharina Schnitzspahn from the European Alliance Against Depression (EAAD)