Introduction: University students are one of the most vulnerable populations for anxiety disorders worldwide. In Northern Ireland, anxiety disorders appear to be more common among the university student population due to the population demographics across the region. Despite the need, these students show less inclination to access the widely available on-campus well-being services and other external professional services. Digital Cognitive Behaviour Therapy (CBT) aims to bridge this gap between the need for psychological help and access to it. However, challenges such as limited reach, low adoption, implementation barriers and poor long-term maintenance are mainstay issues resulting in reduced uptake of digital CBT. As a result, the potential impact of digital CBT is currently restricted. The proposed intervention Cerina is a scalable CBT-based mobile app with an interactive user interface that can be implemented in University settings if found to be feasible and effective. Methods and analysis: The study is a single-blind pilot feasibility Randomized Controlled Trial (RCT) aiming to test the feasibility and preliminary effects of Cerina in reducing Generalised Anxiety Disorder (GAD) symptoms. Participants are 90 Ulster University students aged 18 and above with self-reported GAD symptoms. They will be allocated to two conditions: Treatment (i.e., access to Cerina for 6 weeks) and a waitlist control group (i.e., optional on-campus wellbeing services for 6 weeks). Participants in the waitlist will access Cerina 6 weeks after their randomization and participants in both conditions will be assessed at baseline, at 3 (mid-assessment), and 6 weeks (post-assessment). The primary outcome is the feasibility of Cerina (i.e. adherence to the intervention, its usability and the potential to deliver a full trial in the future). The secondary outcomes include generalised anxiety, depression, worry and quality of life. Additionally, participants in both conditions will be invited to semi-structured interviews for process evaluation. Ethics and dissemination: Ethical approval for the study has been granted by the Ulster University Research Ethics Committee (ID: FCPSY-22-084). The results of the study will be disseminated through publications in scientific articles and presentations at relevant conferences and/or public events. Trial registration: ClinicalTrials.gov ID NCT06146530

The authors have declared no competing interest.

ClinicalTrials.gov ID NCT06146530

This work was conducted as part of the NWE INTERREG IT4Anxiety project in partnership between Cerina Therapeutics and Ulster University. The project is supported by the European Commission. The sponsor was not involved in writing up the manuscript and/or in the decision to submit it for the publication.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for the study has been granted by the Ulster University Research Ethics Committee (ID: FCPSY-22-084).

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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All data produced in the present study are available upon reasonable request to the authors