Self-administered COgnitive Personalized Training in Early Psychosis

ConditionFirst Episode Psychosis (FEP)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16-35

SponsorCentre Hospitalier St Anne

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

Severe and unstabilized medical conditions,

Insufficient level in reading and/or French language,

Absence of medical insurance,

Participation in another intervention trial,

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: Experimental groupExperimental treatment 1 intervention

Group B: comparative control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Primary assessment criterion

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.

Time frame

Month 9

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier St Anne

Lead sponsor

Source ClinicalTrials.gov

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