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NCT Number: NCT06634446

Self-administered COgnitive Personalized Training in Early Psychosis

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.

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Key information

Conditions

First Episode Psychosis (FEP) Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, France

Location status: Recruiting

Location contact

Khaoussou SYLLA, PhD

CONTACT

[email protected]

0031 45 65 81 66

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

a mobile application for cognitive training

Device

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.

Other names: cognitive training, HappyNeuron Pro, Personalized cognitive training

Video games

Device

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

Primary outcomes

  1. Primary assessment criterion

    Time frame: Month 9

    The main outcome will be the global functioning measured by the Personal and Social Performance (PSP) Scale after 3 months of cognitive training . The PSP is a 100-point single-item rating scale. The ratings are done by a clinician, in 5-10 min, and require minimal training, with excellent inter-rater reliability. The scale considers four main areas:

    • socially useful activities;
    • personal and social relationships;
    • self-care; and 4) disturbing and aggressive behaviours during a determined reference period (hereit will be the last month). It was found to be a quick and valid measure, sensitive to change, of patients; personal and social functioning even in early stage of psychosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda SCORIELS, PhD

CONTACT

[email protected]

+33140789269

Marie Odile KREBS, PROFESSEUR

CONTACT

[email protected]

+331 456 586 46

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study 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

Acronym: SCOPe

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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