Self-administered COgnitive Personalized Training in Early Psychosis

Официальное название

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

Обзор

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.

Вмешательства

• Устройство a mobile application for cognitive training
  Personalized cognitive training (PCT) HappyNeuronwill be delivered via a tablet or mobile application for 24 hours within 12 weeks, with a weekly supervision-call to reinforce their motivation. HappyNeuron Pro is a digital therapy tool designed for clinicians to provide engaging cognitive therapy via a web-based platform. It is compatible with PC, Mac, iPad, and Android devices and is available in multiple languages. The tool features exercises from established cognitive remediation programs.
• Устройство video games
  Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement

Первичные конечные точки

• Primary assessment criterion [Срок оценки: Month 9]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Groupe Hospitalier Universitaire Paris - Psychiatrie et Neurosciences, (GHU Paris) — Paris

Идентификаторы

NCT: NCT06634446 · D19-P002 · 2019 A00399 48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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