Cerina: cognitive–behavioural therapy-based mobile application for managing GAD symptoms among Ulster University Students in Northern Ireland – a protocol for a pilot feasibility randomised controlled trial

Abstract

Abstract 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 Strengths and Limitations Low-threshold CBT-based mobile application, easily accessible to university student population Partnership between Ulster University, Ulster Student Wellbeing team and a mental health start-up to increase the reach and access the target population and evaluate the intervention. The study is designed as a feasibility trial and is not powered to detect statistically significant effect of the intervention. The study results might not generalise beyond the inclusion and exclusion criteria of the current study. The waitlist control groups are known to overestimate the effects of the intervention compared to treatment as usual

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