NCT05127278

Brief Summary

Psychosis is a severe mental disorder that involves abnormal experiences and altered behaviour. Although the onset of psychosis occurs in young people, most cases will only be identified later in the course of illness. The delayed detection is the main cause of significant negative long-term outcomes. The current proposal will develop an innovative E-mental health detection tool to effectively improve the identification of young people with emerging psychosis. This tool will be implemented on digital platforms including websites, tablets and mobile phones. Young people will be asked to complete an online questionnaire and two short online-exercises and will then be invited for face-to-face assessments to further confirm whether they are experiencing an emerging psychosis. This digital approach leverages previous expertise by the research team and it is expected to provide novel avenues to enable the identification of young people with emerging psychosis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

3.6 years

First QC Date

November 9, 2021

Last Update Submit

November 26, 2024

Conditions

Psychosis

Keywords

Ultra High Risk for PsychosisClinical High Rish for PsychosisAt Risk Mental State

Outcome Measures

Primary Outcomes (1)

  • Validation of online Screener

    Validate self report online screener for psychosis by verification with gold standard

    2 years

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

General Popualtion

You may qualify if:

  • years of age
  • Informed consent
  • Absence of previous psychotic disorders

You may not qualify if:

  • \<12 or \>35 years of age
  • An existing psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Glasgow University

Glasgow, United Kingdom

RECRUITING

King's College London

London, SE5 8AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Paolo Fuasr Poli, MD PhD

CONTACT

+442078480900paolo.fusar-poli@kcl.ac.uk

Peter Uhlhaas, MD PhD

CONTACT

peter.Uhlhaas@glasgow.ac.uk

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

April 20, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)