E-Detection Tool for Emerging Mental Disorders

Psychosis Clinical Trial

— ENTER  

Official title:

E-Detection Tool for Emerging Mental Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127278
• Other study ID #: 885
• Secondary ID: 215793/Z/19/Z
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: King's College London
• Contact: Paolo Fuasr Poli, MD PhD
• Phone: +442078480900
• Email: paolo.fusar-poli[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Locations

Country	Name	City	State
United Kingdom	Glasgow University	Glasgow
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of online Screener	Validate self report online screener for psychosis by verification with gold standard	2 years