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Self-administered COgnitive Personalized Training in Early Psychosis

Not Applicable
Recruiting
Conditions
First Episode Psychosis (FEP)
Interventions
Device: a mobile application for cognitive training
Device: video games
Registration Number
NCT06634446
Lead Sponsor
Centre Hospitalier St Anne
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
240
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,

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupa mobile application for cognitive trainingthe experimental group will use a mobile application for cognitive training for 3 months.
comparative control groupvideo gamesPatients in the control group will use video games with no prominent cognitive involvement
Primary Outcome Measures
NameTimeMethod
Primary assessment criterionMonth 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:

1. socially useful activities;

2. personal and social relationships;

3. 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

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Paris, France

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