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PsychosisENTERNCT05127278

E-Detection Tool for Emerging Mental Disorders

An observational study of Psychosis, run by King's College London at 2 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Psychosis
How many people
3,000 participants
Where
2 sitesUnited Kingdom
Study dates
20 Apr 2022to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: General Popualtion

Who may be able to join

  • 12-35 years of age
  • Informed consent
  • Absence of previous psychotic disorders

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paolo Fuasr Poli, MD PhD contact

+442078480900

paolo.fusar-poli@kcl.ac.uk

Peter Uhlhaas, MD PhD contact

peter.Uhlhaas@glasgow.ac.uk

United Kingdom2 sites, 2 recruiting
  • Glasgow University

    Glasgow

    Peter Uhlhaas, Peter.Uhlhaas@glasgow.ac.uk

    Recruiting
  • King's College London

    London, SE5 8AF

    Paolo Fuasr Poli, paolo.fusar-poli@gmail.com

    Recruiting

Other trials in United Kingdom

About this study

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.

Read the detailed description

The current proposal will develop an innovative E-DetectioN Tool for Emerging Mental DisoRders (ENTER). This tool will be implemented on a website and the Investigators will invite participants to the site via email-invitations, flyers as well as through advertisements on social media as in previous work byt he team. ENTER will be tested in young people who are experiencing potentially an emerging psychosis, specifically who may meet At Risk Mental State (ARMS) or First Episode Psychosis criteria. The proposed 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. This will ultimately improve the mental health and the life of many young people.

The refined digital screening will enhance previous approaches by incorporating novel features beyond the standard PQ-16 questionnaire, which encompass three overarching domains:

Firstly the Investigators will assess robust epidemiologically-based environmental risk and protective factors that are predicting the onset of psychotic disorders. Some of these factors have already demonstrated prognostic utility, as highlighted by previous work in this area. The selection of these factors has been informed by robust evidence-based synthesis. Digital assessment of exposure to these factors is collected through a Polyrisk Prognostic Score (PPS). This self-rated questionnaire has previously shown to be feasible and non-distressing for young people, discriminating ARMS individuals from healthy. Since most of these factors have been shown to accumulate in ARMS participants, the Investigators expect that the addition of these environmental risk and protective factors will increase the prognostic accuracy of the tool.

Secondly, the Investigators will measure the frequent subthreshold features which characterise emerging psychotic disorders in terms of bipolar risk. To do so the Investigators will employ self-assessment tools that have recently been validated for young people such as the self-rated Bipolar Prodrome Symptom Scale for patients (BPPS-FP) - a brief self-report measure used to assess symptoms of the prodrome to bipolar disorder in order to screen and identify people for whom further evaluation is indicated.

Thirdly, the Investigators will build on recent evidence indicating that cognitive deficits and speech analysis can be used to better identify emerging psychosis. Impaired performance processing speed is one of the most robust indicators of cognitive impairment in psychosis and predicts transition to psychosis in ARMS populations. The Investigators therefore plan to use the self-rated digit symbol task (DST) to assess speed of processing. Moreover, subtle language abnormalities, such as in semantic features and syntactic complexity, can predict outcomes in ARMS populations. To test this the Investigators plan to acquire speech samples in response to Thematic Apperception Test (TAT) to assess speech anomalies.

ENTER will represent a new integrated, comprehensive, scalable, first-in-class e-detection tool that can be implemented in the community. This is particularly important as only 5% of FEP cases are detected through conventional detection strategies that mostly focus on mental health services. Following the validation of ENTER, the Investigators plan that the resulting tool will be implemented on phones and tablets to allow for testing of emerging psychosis in clinical and non-clinical settings.

Conditions
Psychosis
Keywords
Ultra High Risk for Psychosis, Clinical High Rish for Psychosis, At Risk Mental State
Medical subject headings
Psychotic Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation of online Screener

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start20 Apr 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05127278
Sponsor's protocol ID
885
Other IDs
215793/Z/19/Z
Acronym
ENTER
Status last verified
Nov 2024
First submitted
9 Nov 2021
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Psychosis, run by King's College London at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paolo Fuasr Poli, MD PhD (+442078480900, paolo.fusar-poli@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation of online Screener (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.

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