Self-administered COgnitive Personalized Training in Early Psychosis

NCT06634446 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-10-10

No results posted yet for this study

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.

Conditions

  • First Episode Psychosis (FEP)

Interventions

DEVICE

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. 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.

DEVICE

video games

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

Sponsors & Collaborators

  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Marie Odile MO KREBS, PROFESSEUR · GHU PARIS Saint-Anne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634446 on ClinicalTrials.gov