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NCT Number: NCT05796401

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

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.

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Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 ,
  • Intellectual Deficiency (i.e. Intelligence Quotient<70), and / or sensorimotor deficits incompatible with the cognitive reinforcement,
  • Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 12 months established in the inclusion criteria),
  • Current severe depression (in case of doubt, MADRS > 34),
  • Receiving therapeutic levels of antipsychotics for more than 12 months,
  • Current medication with benzodiazepine >30 mg per day equivalent diazepam
  • Current daily use of substance of abuse other than nicotine and alcohol and higher than an average equivalent of 5 cannabis cigarettes AND/OR severe substance use disorder (DSMV criteria/dependence DSMIV criteria) other than nicotine during the last 6 months or for more than 5 years.
  • Pregnant women, parturients, and lactating women,
  • Individuals deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L3212-1 and 3213-1 (Public Health Code),
  • Individuals of legal age who are the subject of a legal protection measure or unable to express their consent

Treatment and study plan

Cognitive training

Behavioral

Cognitive 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

Drug

Personalised 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

Treatment 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)

Primary outcomes

  1. Global functioning

    Time frame: 3 to 4 months after the beginning of intervention

    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

Secondary outcomes

  1. Persistence of efficacy on global functioning

    Time frame: 6 to 8 months after the beginning of intervention

    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

  2. Persistence of efficacy on global functioning

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    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.

  3. Efficiency of Composite Personalised Care (CPC) on clinical outcome (1)

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    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)

  4. Efficiency of Composite Personalised Care (CPC) on clinical outcome (2)

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    • SOFAS (Social and Occupational Functioning Assessment Scale or EFSP. SOFAS specifically estimates social functioning on a scale between 0 and 100.
  5. Efficiency of Composite Personalised Care (CPC) on clinical outcome (3)

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    • MADRS (Montgomery-Asberg depression scale). MADRS is a 10 -item scale that evaluates different aspects of depressive symptomatology. It provides a good estimation of the severity of depression and is sensitive to change.
  6. Efficiency of Composite Personalised Care (CPC) on clinical outcome (4)

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    • Brief Psychiatric Rating Scale (BPRS). BPRS is a scale that evaluates general psychiatric symptomatology.
  7. Efficiency of Composite Personalised Care (CPC) on clinical outcome (5)

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    PANSS (Positive and Negative Syndrome Scale) PANSS is a 30-item scale widely used in schizophrenia research to assess positive and negative psychotic dimensions as well as general symptomatology

  8. Efficiency of Composite Personalised Care (CPC) on clinical outcome (6)

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    Clinical Global Impression (CGI) scale. CGI estimates the current severity, of illness on a 7-point scale, as well as evolution and therapeutic index in reference to the clinicians past experiences of similar patients (3 items).

  9. Efficiency of Composite Personalised Care (CPC) on clinical outcome (7)

    Time frame: at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention

    Clinical Global Impression (CGI) scale. CGI estimates the current severity, of illness on a 7-point scale, as well as evolution and therapeutic index in reference to the clinicians past experiences of similar patients (3 items).

  10. Efficiency of Composite Personalised Care on linguistic and discourse markers

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    The recording of the interview will allow to extract reliable linguistic metrics that will be processed semi-automatically.

  11. Efficiency of composite personalised care on neurological soft signs (1)

    Time frame: at baseline and 6 to 8 months after the beginning of intervention

    Neurological Soft Signs rating scale (NSS) assesses five factors: motor coordination, motor integration, sensory integration, quality of lateralization and involuntary movements or posture; as well as extrapyramidal symptoms (Simpson Angus Scale) and lateralization (Edinburgh questionnaire).

  12. Efficiency of composite personalised care on neurological soft signs (2)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Electronic Neurological Soft Signs (eNNS) This device incorporates a new, tablet-based and clinically suitable app (behavioral tasks), including tasks designed to probe balance of excitation/inhibition (multi-finger tapping task), body scheme tasks where finger posture recognition is measured and visuomotor sequence learning under variable cognitive load (using visual attentional distractors).

  13. Efficiency of composite personalised care on cognitive complaints

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS) is a 21-item Likert-type scale that allows a quantitative approach of cognitive complaint.

  14. Efficiency of composite personalised care on cognitive functions (Verbal learning and memory)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Hopkins Verbal Learning Test

  15. Efficiency of composite personalised care on cognitive functions (Flexibility)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    TMT A/B (Reitan, 1959)

  16. Efficiency of composite personalised care on cognitive functions (Social cognition)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Consensus autour de la COgnition Sociale (CLACOS) (PerSo)

  17. Efficiency of composite personalised care on cognitive functions (Selective attention)

    Time frame: 3 to 4 Month and 6 to 8 Month after the beginning of intervention

    D2-R test

  18. Efficiency of composite personalised care on cognitive functions (Verbal long-term memory)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Hopskins Verbal Learning Test (HVLT) delayed recall

  19. Efficiency of composite personalised care on cognitive functions (Visuospatial learning and memory)

    Time frame: 3 to 4 Month and 6 to 8 Month after the beginning of intervention

    Brief Visuospatial Memory test

  20. Efficiency of composite personalised care on cognitive functions (Planning abilities)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Shopping test (Martin 1972)

  21. Efficiency of composite personalised care on cognitive functions (Speed processing)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Wechsler Adult Intelligence Scale (WAIS) (code)

  22. Efficiency of composite personalised care on cognitive functions (Inhibition control)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Stroop (Incompatibility)

  23. Efficiency of composite personalised care on cognitive functions (Visuospatial long-term memory)

    Time frame: 3 to 4 Month and 6 to 8 Month after the beginning of intervention

    Brief Visuospatial Memory test (BVMT) delayed recall

  24. Efficiency of composite personalised care on cognitive functions (Working Memory)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Wechsler Adult Intelligence Scale (WAIS) (Digit span)

  25. Efficiency of composite personalised care on motivation

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Behavioral inhibition system (BIS) and behavioral activation system (BAS)

  26. Embodiment ability in virtual reality environment

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Embodiment ability in virtual reality environment will be assessed using a simulation of two districts of a lively city via the Vive Pro virtual reality kit

  27. Effect of Composite Personalised Care on Health-related quality-of-life (1)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Short Form -12 items quality of life questionnaire (SF-12) SF-12 is a multipurpose self-report measure of both physical and mental health status

  28. Effect of Composite Personalised Care on Health-related quality-of-life (2)

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L)

    EQ-5D-5L investigates 5 dimensions: mobility, self care, usual activities, pain/discomfort, anxiety/depression. These 5 dimensions are rated on 5 levels ranging from no problems to extreme problems.

  29. Effect of Composite Personalised Care on medication adherence

    Time frame: at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention

    Medication adherence (MARS) is a short assessement (5 items) of the adherence to medication

  30. Acceptability of the program for the e-Health application

    Time frame: 3 to 4 months after the beginning of intervention

    amount of time spent on the application

  31. Patient's satisfaction with the e-health application

    Time frame: 3 to 4 months after the beginning of intervention

    satisfaction score measured by the User Version of the Mobile Application Rating Scale (uMARS)

  32. Level and changes of biological markers (metabolism of monocarbon compounds)

    Time frame: at baseline and 6 to 8 months after the beginning of intervention

    dosage of folates, B12 vitamin, homocysteine

  33. Level and changes of biological markers (lipid membranes)

    Time frame: at baseline and 6 to 8 months after the beginning of intervention

    lipid composition of the red blood cells membrane, including the major lipid classes, such as phosphatidylcholine (PC), phosphatidylserine (PS), sphingomyelin (SM), phosphatidylethanolamine (PE), PE plasmalogen and their molecular species)

  34. Longitudinal epigenetic and seric changes associated with outcome (1)

    Time frame: at baseline and 6 to 8 months after the beginning of intervention

    Levels of RNA (messenger RNA, microRNA, long non-coding RNA) will be assessed using next generation sequencing methods.

  35. Longitudinal epigenetic and seric changes associated with outcome (2)

    Time frame: at baseline and 6 to 8 months after the beginning of intervention

    Levels of RNA (messenger RNA, microRNA, long non-coding RNA) will be assessed using next generation sequencing methods.

  36. Cost-effectiveness of Composite Personalised Care

    Time frame: at the end of the follow-up, up to 4 years

    Incremental cost-effectiveness ratios (ICER) will assess the efficiency of CPC vs. TAU (overall and by component). They will be expressed in cost per quality-adjusted life-years (QALY) gained and in cost per PSP point gained.

  37. Budgetary impact analysis of the generalization of Composite Personalised Care

    Time frame: at the end of the follow-up, up to 4 years

    Total costs and health benefits associated with generalizing CPC will be assessed and compared to TAU over a 5-year period.

Study contacts

Contact information is provided by the study sponsor or research team.

Khaoussou SYLLA

CONTACT

[email protected]

+331.45.65.73.35

Marie-Odile KREBS

CONTACT

[email protected]

+33 1 45 65 74 97

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "

Acronym: PSYCARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Apr 3, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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