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

First Episode Psychosis (FEP)

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

Plain Language Summary

Simplified for easier understanding

This study is testing a self-administered digital cognitive training program for young people who are experiencing their first episode of psychosis (a break from reality often involving hallucinations, delusions, or disorganized thinking). The goal is to help improve thinking and concentration skills — which are commonly affected — through a personalized app-based approach. **You may be eligible if...** - You are between 16 and 35 years old - You are seeking mental health support at one of the participating clinics - You have been newly diagnosed as experiencing a first episode of psychosis within the past year (meeting specific clinical criteria) - You or a legal guardian can give written informed consent **You may NOT be eligible if...** - You have severe or unstabilized medical conditions - You do not read or understand French sufficiently - You do not have national health insurance - You are currently hospitalized under a court-mandated order - You have an intellectual disability (IQ below 70) or sensory/motor problems that prevent using the cognitive training - You are participating in another intervention trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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