Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis

ConditionPsychosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-30
SponsorCentre Hospitalier St Anne

About this trial

Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery.

Pioneering epigenetic analyses indicate that psychosis onset involves oxidative stress and inflammation suggesting that neuroprotective strategies could limit or even prevent the onset of or the transition into a chronic disorder. Several biological factors associated with the emergence of psychosis can all be rectified by using safe and easily accepted supplements including alterations folate deficiency/hyperhomocysteinemia; redox imbalance and deficit in polyunsaturated fatty acids (PUFA). The prevalence of these anomalies (20-30%) justifies a systematic detection and could guide personalised add-on strategy.

Cognitive remediation improves quality of life (QoL) 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 patients at ultra-high risk (UHR) for psychosis and patient with a first episode of psychosis (FEP) and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatising tools, such as applications with cognitive strategies, motivational tools and functioning guidance personalised according to the need of each individual. Patients can have access to it, wherever they live.

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.

The study hypothesis is that promoting neuroplasticity by cognitive training and personalised virtual psychoeducation guidance could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients UHR or FEP and that this effect is modulated by individual brain plasticity abilities. The overall objective of PsyCARE\_trial is to improve early intervention in psychosis by providing a composite personalised care (CPC) that will enable personalised cognitive training and psychoeducation guidance, adapted to individuals' needs, cognitive abilities and biological background.

Eligibility criteria

Qualifiers

Adolescent and young adults, both sexes, aged 15 to 30 years,

Persons characterised according to the CAARMS criteria [8] as UHR or FEP in the first year after having received diagnosis and care, if any

Informed and written signed consent,

Participant with regular health insurance

Disqualifiers

Severe and unstabilised medical conditions,

Insufficient level in reading and/or French language,

Current participation in another intervention trial or in a full cognitive remediation programme,

Enforced hospitalization ,

Trial design

Treatments tested in this trial

  • Cognitive training
  • Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC
  • Treatment as usual (TAU)

Treatment groups

500 Participants
are divided into 4 treatment groups

Sponsors and collaborators