Mobile app for managing generalized anxiety symptoms in students
Cerina- Cognitive Behavioural Therapy Based Mobile Application for Managing GAD Symptoms: A Pilot Randomized Controlled Trial
This study is testing whether a mobile app can help students at Ulster University manage their anxiety better than just waiting for treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cerina Therapeutics Industry-sponsored |
| Locations | 1 site (Belfast) |
| Trial ID | NCT06146530 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the feasibility and effectiveness of the Cerina mobile application in reducing generalized anxiety symptoms among Ulster University students with mild to moderate anxiety. Participants will be randomly assigned to either use the Cerina app for six weeks or be placed in a wait-list control group. Throughout the study, participants will complete online self-report measures of anxiety and undergo semi-structured interviews to assess their experiences with the app. The study seeks to gather insights on usability and preliminary effects of the intervention compared to routine care.
Who should consider this trial
Good fit: Ideal candidates for this study are Ulster University students aged 18 and older who report mild to moderate anxiety symptoms.
Not a fit: Patients with severe anxiety symptoms or those experiencing suicidal thoughts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an innovative digital tool for students to manage and reduce their anxiety symptoms effectively.
How similar studies have performed: Other studies have shown promise in using mobile applications for mental health management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having mild to severe self-reported anxiety symptoms. Those who score between 5 and 19 on the GAD7 questionnaire will be accepted as eligible, , * 18 years of age and older * Enrolled as a student at Ulster University (i.e. having a student id number) * Fluency in English * Provision of an informed consent * Having a smartphone (i.e. Android device or iPhone). * Having an internet connection Exclusion Criteria: * Having minimal anxiety symptoms as defined by a score of 5 and below on the GAD7 questionnaire * Scoring 19 and above on the GAD7 questionnaire * Having self-reported suicidal thoughts based on their scores on the Patient Health Questionnaire-9 (PHQ9). * Having recently (within the last 6 weeks) started taking psychotropic medication. * Not consenting that their contact details (name, surname, email address) will be shared with the Student Wellbeing team (see the safety section) * Receiving psychological treatment is not part of the exclusion criteria.
Where this trial is running
Belfast
- Ulster University — Belfast, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gerard Leavey, Prof. dr — Ulster University
- Study coordinator: Ozlem Eylem-van Bergeijk, Dr
- Email: oe.van.bergeijk@cerina.co
- Phone: +31646136756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.