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NCT06634446Recruiting

Self-administered COgnitive Personalized Training in Early Psychosis

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

Source: ClinicalTrials.gov · Last updated 10 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
3 Oct 2024
Start date
26 Oct 2021
Primary completion date
30 Dec 2026
Lead sponsor
Centre Hospitalier St Anne
NCT number
NCT06634446

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 26 Oct 2021 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe and unstabilized medical conditions,

Other

  • 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,

Who the study is looking for

  • 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).

Age in the registry: 16 years to 35 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Groupe Hospitalier Universitaire Paris - Psychiatrie et Neurosciences, (GHU Paris)
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.