NCT06634446 Self-administered COgnitive Personalized Training in Early Psychosis
| NCT ID | NCT06634446 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | First Episode Psychosis (FEP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2021-10-26 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2021-10-26 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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\<70), and / or sensorimotor deficits incompatible with the cognitive training,
Contact & Investigator
Marie Odile MO KREBS, PROFESSEUR
PRINCIPAL INVESTIGATOR
GHU PARIS Saint-Anne
Frequently Asked Questions
Who can join the NCT06634446 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying First Episode Psychosis (FEP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06634446 currently recruiting?
Yes, NCT06634446 is actively recruiting participants. Contact the research team at MO.KREBS@ghu-paris.fr for enrollment information.
Where is the NCT06634446 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06634446 clinical trial?
NCT06634446 is sponsored by Centre Hospitalier St Anne. The principal investigator is Marie Odile MO KREBS, PROFESSEUR at GHU PARIS Saint-Anne. The trial plans to enroll 240 participants.