Self-administered COgnitive Personalized Training in Early Psychosis
NCT ID: NCT06634446
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2021-10-26
2027-12-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group
the experimental group will use a mobile application for cognitive training for 3 months.
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.
comparative control group
Patients in the control group will use video games with no prominent cognitive involvement
video games
Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement
Interventions
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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.
video games
Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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,
16 Years
35 Years
ALL
Yes
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Principal Investigators
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Marie Odile MO KREBS, PROFESSEUR
Role: PRINCIPAL_INVESTIGATOR
GHU PARIS Saint-Anne
Locations
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Groupe Hospitalier Universitaire Paris - Psychiatrie et Neurosciences, (GHU Paris)
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019 A00399 48
Identifier Type: REGISTRY
Identifier Source: secondary_id
D19-P002
Identifier Type: -
Identifier Source: org_study_id
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