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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 our research team and it is expected to provide novel avenues to enable the identification of young people with emerging psychosis.


Clinical Trial 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 we will invite participants to the site via email-invitations, flyers as well as through advertisements on social media as in our previous work (McDonald, Christoforidou et al., 2019). Specifically, ENTER will be tested in young people who are experiencing potentially an emerging psychosis, specifically who may meet ARMS or FEP-criteria. The proposed digital approach leverages previous expertise by our 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 our previous approach by incorporating novel features beyond the standard PQ-16 questionnaire, which encompass three overarching domains: Firstly we 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 our previous work in this area (Fusar-Poli, Rutigliano et al., 2017, Fusar-Poli, Werbeloff et al., 2018). The selection of these factors has been informed by robust evidence-based synthesis (Radua, Ramella-Cravaro et al., 2018). 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 controls (Oliver, Spada et al., 2020). Since most of these factors have been shown to accumulate in ARMS participants (Fusar-Poli, Tantardini et al., 2017), we expect that the addition of these environmental risk and protective factors will increase the prognostic accuracy of our tool. Secondly, we will measure the frequent subthreshold features which characterise emerging psychotic disorders in terms of bipolar risk To do so we 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) (Van Meter, Guinart et al., 2019), 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, we will build on recent evidence indicating that cognitive deficits (Seidman, Shapiro et al., 2016) and speech analysis (Bedi, Carrillo et al., 2015; Corcoran, Carrillo et al., 2018) can be used to better identify emerging psychosis. Impaired performance processing speed is one of the most robust indicators of cognitive impairment in psychosis (Dickinson, Ramsey et al., 2007) and predicts transition to psychosis in ARMS populations (Seidman, Shapiro et al., 2016). We therefore plan to use the self-rated digit symbol task (DST) to assess speed of processing (Dickinson, Ramsey et al., 2007). Moreover, subtle language abnormalities, such as in semantic features and syntactic complexity, can predict outcomes in ARMS populations (Bedi, Carrillo et al., 2015). To test this we plan to acquire speech samples in response to Thematic Apperception Test (TAT) to assess speech anomalies (Corcoran, Carrillo et al., 2018). 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 (Fusar-Poli, Rutigliano et al., 2017). Following the validation of ENTER, we 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05127278
Study type Observational
Source King's College London
Contact Paolo Fuasr Poli, MD PhD
Phone +442078480900
Email [email protected]
Status Not yet recruiting
Phase
Start date December 2021
Completion date December 2025

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