Cerina-A Pilot Randomized Controlled Trial

Launched by CERINA THERAPEUTICS · Nov 19, 2023

Keywords

ClinConnect Summary

The Cerina-A Pilot Randomized Controlled Trial is studying the Cerina mobile app to see if it can help reduce symptoms of generalized anxiety disorder (GAD) among students at Ulster University. The trial aims to find out if the app is easy to use and if it is effective compared to a group of students who will wait before using the app. Eligible participants are students aged 18 and older who report mild to moderate anxiety symptoms, as measured by a specific questionnaire. They must also have a smartphone and an internet connection.

Participants in the study will be randomly assigned to one of two groups: one group will use the Cerina app for six weeks, while the other group will wait six weeks before starting the app. Both groups will complete assessments at the beginning, halfway through, and at the end of the study to track any changes in their anxiety symptoms. Additionally, after the study, participants will have the chance to share their thoughts about the app in feedback interviews. This trial is currently recruiting participants, and it’s important to know that anyone with severe anxiety symptoms or recent suicidal thoughts will not be eligible to join.

Gender

ALL

Eligibility 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.