Status:
UNKNOWN
Cerina-A Pilot Randomized Controlled Trial
Lead Sponsor:
Cerina Therapeutics
Collaborating Sponsors:
University of Ulster
European Commission
Conditions:
Treatment Adherence
Generalized Anxiety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this pilot Randomized Controlled Trial is twofold: 1) To learn about the feasibility and usefulness of a mobile application for generalised anxiety symptoms (Cerina); 2) To test the prelim...
Detailed Description
The study is a pilot Randomised Controlled Trial (RCT) with two conditions: Treatment and a waitlist control group. Included eligible participants who have completed the baseline questionnaire will be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06146530
Start Date
April 24 2023
End Date
August 31 2024
Last Update
December 20 2023
Active Locations (1)
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1
Ulster University
Belfast, United Kingdom