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E-Detection Tool for Emerging Mental Disorders

Sponsor: King's College London

NCT ID: NCT05127278

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
12 Years to 35 Years
Who
All
Number of participants
3,000
Started
2022-04-20
Last checked
2024-11

Plain English Summary

What is this study?

  • • Testing a new treatment for psychosis
  • • Clinical study - 3,000 participants
  • • Psychosis is a severe mental disorder that involves abnormal experiences and altered behaviour

Who can take part?

  • • Ages 12 Years to 35 Years
  • • Diagnosed with psychosis

Where?

  • • Glasgow - Glasgow University
  • • London - King's College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Psychosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years - 35 Years
  • Who can join: All genders

What the study is looking for

  • ✓12-35 years of age
  • ✓agreement to take part
  • ✓Absence of previous psychotic disorders

Who cannot take part

  • ✗\<12 or \>35 years of age
  • ✗An existing psychotic disorder
See the full criteria
Inclusion Criteria: * 12-35 years of age * Informed consent * Absence of previous psychotic disorders Exclusion Criteria: * \<12 or \>35 years of age * An existing psychotic disorder

Where Is This Study? (2 UK sites)

Glasgow University

Glasgow, United Kingdom

Recruiting
Site contact (verified)

King's College London

London SE5 8AF, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Paolo Fuasr Poli, MD PhD

Sponsor contact

CONTACT

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

Peter Uhlhaas, MD PhD

Sponsor contact

CONTACT

peter.Uhlhaas@glasgow.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-11