Clinical trial NCT06634446: Self-administered COgnitive Personalized Training in Early Psychosis
Official title: Self-administered COgnitive Personalized Training in Early Psychosis: a Randomized Controlled Trial in Adolescents and Young Adults to Assess Efficacy and Efficiency of an EHealth Application Providing Personalized Cognitive Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: First Episode Psychosis (FEP)
Keywords: First Episode Psychosis (FEP),
schizophrenia
Cognitive Personalized training
adolescents and young adults FEP
personalized cognitive training
Chronic psychosis
Biological Testing
Metabolic Alterations
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 240
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities.

Cognitive remediation improves quality of life and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in FEP and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions.

Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training.

Our background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing FEP and that this effect is modulated by individual brain plasticity abilities.


Eligibility criteria: Inclusion Criteria:

* Adolescent and young adults, both genders, aged 16 to 35,
* Seeking help in one of the recruiting centers,
* Newly diagnosed as experiencing an Episode of Psychosis (reaching criteria as described in the Comprehensive Assessment of at Risk Mental States (CAARMS) within the year
* Written informed consent signed (and from one legal guardian for minors).

Exclusion Criteria:

* Severe and unstabilized medical conditions,
* Insufficient level in reading and/or French language,
* Absence of medical insurance,
* Participation in another intervention trial,
* Enforced hospitalization (ASPDT, ASPPI, ASPRE),
* Intellectuel Deficiency (IQ\&lt;70), and / or sensorimotor deficits incompatible with the cognitive training,

Primary outcomes:
measure: Primary assessment criterion
timeFrame: Month 9
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Universitaire Paris - Psychiatrie et Neurosciences, (GHU Paris)
Study officials:
affiliation: GHU PARIS Saint-Anne
name: Marie Odile MO KREBS, PROFESSEUR
role: PRINCIPAL_INVESTIGATOR
References: