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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Page 1 of 1 (1 locations)

1

Ulster University

Belfast, United Kingdom