Cerina-A Pilot Randomized Controlled Trial

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 preliminary effects of Cerina in reducing generalized anxiety symptoms compared to a waitlist-control group among Ulster University students presenting mild to moderate symptoms of Generalized Anxiety Disorder (GAD) symptoms. The main research questions are:

Is the Cerina app usable and feasible among Ulster University students reporting mild to moderate GAD symptoms? Is there an indication of the effectiveness of the Cerina app in reducing GAD symptoms compared to a wait-list control group among Ulster University students?

* After the baseline assessment, eligible and consenting participants will be randomized to either intervention or to the wait-list control group.
* Those who are allocated to the intervention group will have access to the Cerina app for 6 weeks.
* Those who are in the wait-list control group will wait for 6 weeks until the intervention group finishes the intervention for their access.
* The wait-list control group will have access to the services offered by the Ulster University Student Wellbeing team.
* Participants in both groups will do mid- (at week 3 after their randomization) and post-assessment (At week 6 after their randomization).
* All participants will also be invited to the post-assessment feedback interviews once they complete their post-assessments. The purpose is to have more in-depth information on their views of the Cerina app, the User Interface, the clinical content, the potential facilitators, and barriers to using it in daily life.

Conditions

• Treatment Adherence
• Generalized Anxiety
• Treatment Adherence and Compliance

Interventions

DEVICE

Treatment

The intervention consists of 7 sessions of CBT for the treatment of GAD. Each session contains a range of information and tasks/exercises to help the user understand the condition of GAD, the treatment approach, and how it will be applicable to them. The intervention is based on an evidence-based treatment protocol; hence the sessions will flow from one to the other and the user will complete the sessions in a progressive direction. However, they can repeat a session before going on to the next session. Once all sessions have been completed, the user can go back over any of the sessions. There are anxiety management exercises, which the user can go to whenever they wish. There are also a therapy reflection journal and self-care resources including further anxiety management techniques, resources, and podcasts that the user will have access to whenever they want.

Sponsors & Collaborators

• University of Ulster

  collaborator OTHER

• European Commission

  collaborator OTHER

• Cerina Therapeutics

  lead INDUSTRY

Principal Investigators

• Gerard Leavey, Prof. dr · Ulster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-24

Primary Completion

2024-04-30

Completion

2024-08-31

Countries

• United Kingdom

Study Locations