NCT06146530

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

November 19, 2023

Last Update Submit

December 13, 2023

Conditions

Treatment AdherenceGeneralized AnxietyTreatment Adherence and Compliance

Keywords

e-health, mhealth, Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (1)

  • The Generalised Anxiety Disorder Scale-7 (GAD-7)

    GAD-7 is a 7-item self-report scale that identifies and measures the severity of GAD. Scores range from 0 to 21, with a cut-off score of 5 distinguishing between clinical and non-clinical populations. The scale has good psychometric properties

    baseline, week 3 and week 6

Secondary Outcomes (4)

  • The Penn State Worry Questionnaire (PSWQ-PW)

    baseline, week 3 and week 6

  • The Patient Health Questionnaire (PHQ-9)

    baseline, week 3 and week 6

  • The Work and Social Adjustment Scale (WSAS)

    baseline, week 3 and week 6

  • Usability

    week 3 and week 6

Study Arms (2)

Treatment

EXPERIMENTAL

Participants in the treatment arm will have access to Cerina for 6 weeks. The intervention (Cerina) consists of 7 sessions of Cognitive Behavioural Threapy (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 apply to them.

Device: Treatment

Wait-list

ACTIVE COMPARATOR

Participants in the waiting-list control condition will have access to the campus-based well-being services offered by the Student Wellbeing team.

Device: Treatment

Interventions

TreatmentDEVICE

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.

Also known as: Cerina
TreatmentWait-list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having mild to severe self-reported anxiety symptoms. Those who score between 5 and 19 on the GAD7 questionnaire will be accepted as eligible, ,
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulster University

Belfast, United Kingdom

RECRUITING

Related Publications (2)

  • Eylem-van Bergeijk O, Robinson T, Manktelow M, Olympios M, Poulter S, Mane P, Panagioti M, Condell J, Leavey G. Cerina-Cognitive Behavioral Therapy-Based Mobile App for Managing Generalized Anxiety Disorder Symptoms Among University Students: Results From a Pilot Feasibility Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Oct 9;13:e70691. doi: 10.2196/70691.

    PMID: 41066166DERIVED

  • Eylem-van Bergeijk O, Poulter S, Ashcroft K, Robinson T, Mane P, Islam M, Condell J, Leavey G. Cerina: cognitive-behavioural therapy-based mobile application for managing GAD symptoms among Ulster University Students in Northern Ireland - a protocol for a pilot feasibility randomised controlled trial. BMJ Open. 2024 Jul 1;14(6):e083554. doi: 10.1136/bmjopen-2023-083554.

    PMID: 38950994DERIVED

Related Links

MeSH Terms

Conditions

Treatment Adherence and ComplianceGeneralized Anxiety Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorAnxiety DisordersMental Disorders

Study Officials

  • Gerard Leavey, Prof. dr

    Ulster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozlem Eylem-van Bergeijk, Dr

CONTACT

+31646136756oe.van.bergeijk@cerina.co

Siobhan Poulter, Dr

CONTACT

S.Poulter@ulster.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The randomization scheme will be derived using random allocation software by the Cerina technical lead who is not involved in the study. Randomization will take place in blocks of 6, and will take place in a 1:1 ratio. All participants will be informed about the condition they are assigned to. Please see below for the study design.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study is a single-blind pilot RCT with two conditions: Treatment (i.e., access to Cerina for 6 weeks) and a waitlist control group (i.e., optional campus-based wellbeing services for 6 weeks)
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doctoral Research Associate

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 24, 2023

Study Start

April 24, 2023

Primary Completion

April 30, 2024

Study Completion

August 31, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Anonymized data including self-reported questionnaires completed by the participants at week 3 and week 6 could be shared with other researchers who inquire the research team about an IPD meta-analysis. If this is the case, in line with the Ulster University GDPR, only anonymized data will be shared in a format which is compatible with R and/or excel for the data analysis.

Shared Documents
ANALYTIC CODE
Time Frame
The data will be available upon completion of the study (by the end of August 2024) for 10 years.
Access Criteria
The anonymized data will only be available for IPD meta-analyses

Locations

GB(1)