Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Dec 30, 2024
Date Accepted: Aug 4, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Cerina- Cognitive Behavioural Therapy based mobile application for managing GAD symptoms among university students: results from a pilot feasibility randomised controlled trial
ABSTRACT
Background:
Generalised Anxiety Disorder (GAD) is common among university students due to academic pressure and financial uncertainty among other challenges. Despite the need, the receipt of available psychological services is often low.
Objective:
The present study investigates the feasibility of a digital unguided Cognitive Behavioural Therapy (CBT)-based mobile application-Cerina, and it examines the likely effects of this intervention in reducing GAD symptoms compared to the wait-list control group.
Methods:
Eligible students (N=158) with mild to moderate GAD symptoms were self-assessed through online questionnaires and were randomly allocated to the intervention group (N=79) or to the wait-list control group (N=79) following their informed consent. The intervention group had direct access to Cerina and followed CBT-based interactive sessions for 6 weeks. The wait-list control group participants had access to optional on-campus wellbeing services and they were given access to Cerina 6 weeks after their randomisation. Participants in both conditions completed baseline, mid-assessment and post-test online questionnaires on usability, generalised anxiety, depression, worry and functional impairment. Additionally, upon completing the intervention, participants in both conditions were invited to an online interview to understand the implementation of the intervention in more depth.
Results:
On average (N=10/79, 13%) intervention group participants dropped out and (N=36/69, 61 %) completed the core clinical content (2 sessions) and (N=7/69, 12%) completed desired number of sessions (6 and/or 7 sessions). The completers analyses revealed significant group differences in generalised anxiety (p=.03) (d=-0.7) and worry symptoms (p=.02 ) (d=-0.8) as well as functional impairment (p=.04) (d=-0.6) in favour of the intervention group at post-test with medium to large effect sizes. There was also potential impact of the intervention on depression symptoms among completers with medium effect sizes (p=.12) (d=-0.5). The intention-to-treat analyses confirmed significant group differences in generalised anxiety symptoms (p=.03) (d=-0.4), and there were marginally non-significant group differences in worry symptoms (p=.05) (d=-0.3) in favour of the intervention group at post-test with medium effect sizes.
Conclusions:
The Cerina app showed promising results in reducing GAD symptoms among students. The usability issues highlight the importance of refining the intervention iteratively with feedback and testing the long-term effects of engagement features in mitigating such issues. Clinical Trial: https://clinicaltrials.gov/study/NCT06146530
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