Cerina - Risk Management Process

Accessing Cerina

Cerina strives to ensure a seamless and user-friendly registration process to minimize barriers for individuals seeking mental health support. Our registration process is designed to be straightforward and intuitive, reducing potential anxiety associated with seeking help for mental health issues. Upon accessing the app, users are provided with a clear explanation of our safety protocol, and their consent is required before proceeding further. 

What are the potentials risks?

As part of our commitment to being user safety, Cerina incorporates a robust risk assessment process to identify and mitigate potential risks. Users are guided through a screening process upon initial engagement with the app, which includes assessing mood and anxiety levels using standardized self-report measures such as the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaires. If a user's scores 10 or higher on PHQ-9, or 15 or higher on GAD-7, they are alerted that the app may not be suitable for their current needs and are encouraged to seek support from a mental health professional.

In instances where users report suicidal ideation during the screening process, Cerina signposts users to crisis support and resources provided within the app. Users are also encouraged to seek professional assistance tailored to their individual needs.

How the risk will be managed and by whom? 

The safety protocol is managed by the Cerina Executive Team, with the chief psychologist (Dr Momotaj Islam) taking the lead as the Clinical Safety Officer.  

Our safety protocol is evidence based and has been established (i.e. it has been tested in clinical trials) by the research and clinical teams in collaboration with our regulatory advisors. This is also in line with the evidence indicating the safety of the CBT based digital interventions for anxiety disorders.  

It is expected that the user may observe increased levels of anxiety whilst practicing some techniques requiring exposure and/or challenging their unhelpful thoughts suggested in the app. This is the case in both face-to-face therapy as it is in digital space. This is part of the therapy process, and the increased levels of anxiety symptoms often diminish over time once users get used to practicing those techniques in daily life.

If the user experiences difficulties with a particular therapeutic technique on the app and/or a technical problem, and would like to talk about it over the phone, they are advised to contact the Cerina support team on [email protected].

If the user experiences a distressing situation unrelated with Cerina they are advised to talk to their GP or other healthcare professional as appropriate.

Clinical Safety Governance Structure

Cerina's commitment to clinical safety is upheld by a dedicated Clinical Safety Governance Committee, led by our Chief Psychologist, Dr. Momotaj Islam, who serves as the Clinical Safety Officer. The committee comprises multidisciplinary experts from clinical, technical, and regulatory backgrounds, ensuring a comprehensive approach to safety management. Key members include Dr. Özlem Eylem-van Bergeijk, serving as the Research Lead, Priyadharshini Rajaram, our Technical Product Manager, and Vanisha Mistry-Ngumbau, our Regulatory Consultant. Regular meetings are convened to review safety protocols, assess emerging risks, and evaluate the effectiveness of mitigation strategies. This governance structure fosters collaboration and accountability, ensuring that clinical safety remains a top priority throughout Cerina's development and operation lifecycle.

Clinical Risk Management Techniques

  1. Hazard Identification:

  2. Risk Analysis and Evaluation:

  3. Risk Control:

  4. Documentation and Monitoring:

  5. Feedback Loop:

Safety Protocols and User Support

In addition to our proactive risk management efforts, Cerina offers robust user support mechanisms to address safety concerns and technical issues effectively. Users experiencing difficulties with specific therapeutic techniques or technical challenges are encouraged to contact our dedicated Cerina support team at [email protected] for prompt assistance. Furthermore, users encountering distressing situations unrelated to Cerina are advised to seek support from their general practitioner or other appropriate healthcare professionals, reinforcing our commitment to holistic user care and safety.