Self-administered COgnitive Personalized Training in Early Psychosis (SCOPe)

Centre Hospitalier St Anne

Status: Enrolling

Conditions: First Episode Psychosis (FEP)

Treatments: Device: video games; Device: a mobile application for cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT06634446

D19-P002

2019 A00399 48 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 16 to 35 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Experimental group

Experimental group

Description:

the experimental group will use a mobile application for cognitive training for 3 months.

Treatment:

Device: a mobile application for cognitive training

comparative control group

Active Comparator group

Description:

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

Treatment:

Device: video games