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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Cognitive training
BehavioralCognitive reinforcement using digital applications (PSYCARE application) during 12 weeks +/- virtual reality based cognitive remediation application : 24 sessions over 12 weeks (only for patients who have a higher cognitive deficits (TMTB score \>110s))
Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC
DrugPersonalised neuroprotective medication adapted to the individual's biological profile : * Vitamin B12 : 500 micrograms per day * Folinic acid : 50 mg per day * Omega 3 : 1380 mg EicosaPentaenoic Acid (EPA) + 1140 mg DocosaHexaenoic Acid (DHA) per day * N-acetyl-cysteine (NAC) : 2400 mg per day duration of supplementation(s) : 12 weeks
Treatment as usual (TAU)
Other interventionTreatment as usual (TAU), including a standardised psycho-education program with a group cognitive behavioural therapy (e.g. I\_Care - You Care) and, in FEP only, second generation antipsychotic from a restricted list (following the recommendations www.orygen.org.au)
Treatment groups
500 Participants
are divided into 4 treatment groupsGroup A: Treatment as usual (TAU)Active comparator 1 intervention
Group B: TAU + cognitive trainingExperimental treatment 2 interventions
Group C: TAU + personalized neuroprotective strategiesExperimental treatment 2 interventions
Group D: TAU + personalized neuroprotective strategies + cognitive trainingExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Global functioning
Global functioning will be assessed using the Personal and Social Performance Scale (PSP), a well-validated tool for the measurement of social functioning previously used in early psychosis. PSP is a 100-point single-item rating scale (minimum value 1; maximum value: 100). The scale evaluates 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
Time frame
3 to 4 months after the beginning of interventionSecondary outcomes
1
Persistence of efficacy on global functioning
Score on the Personal and Social Performance Scale (PSP) PSP is a 100-point single-item rating scale (minimum value 1; maximum value: 100). The scale evaluates 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
Time frame
6 to 8 months after the beginning of intervention2
Persistence of efficacy on global functioning
Scores at Global Functioning Scale-Social and Role \[120\], measured at V2 and V3. This scale provides a 1 to 10 score separately for social role and for functioning.
Time frame
at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention3
Efficiency of Composite Personalised Care (CPC) on clinical outcome (1)
Comprehensive Assessment of At Risk Mental State (CAARMS) CAARMS evaluates seven dimensions of symptomatology. It provides operational criteria to categorise subjects as 'at-risk' or as psychotic (psychosis threshold) on the basis of the first subscale (10 min), 'positive symptoms' encompassing four sub-scales (Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities, Disorganised Speech)
Time frame
at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention4
Efficiency of Composite Personalised Care (CPC) on clinical outcome (2)
\- SOFAS (Social and Occupational Functioning Assessment Scale or EFSP. SOFAS specifically estimates social functioning on a scale between 0 and 100.
Time frame
at baseline, then 3 to 4 months and 6 to 8 months after the beginning of interventionSponsors and contacts
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Source ClinicalTrials.gov