RecruitingNot ApplicableNCT06634446

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


Sponsor

Centre Hospitalier St Anne

Enrollment

240 participants

Start Date

Oct 26, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 16 YearsMax Age: 35 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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,

Interventions

DEVICEa 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. Functionality: The program offers 22 cognitive exercises targeting seven key functions outlined in the MATRICS framework: Processing Speed, Selective Attention, Reasoning and Working Memory, Verbal Memory, Visual Memory, and Auditory Memory. Exercises are customizable to meet individual patient needs, facilitating personalized cognitive training. User Experience: Each session comprises brief, self-administered exercises, with the order and difficulty adjusted by clinicians.

DEVICEvideo games

Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement


Locations(1)

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

Paris, France

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NCT06634446


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