Efficiency of a composite personalised care on functional outcome in early psychosis: A Prospective Randomised Controlled Trial

Phase 4

Not yet recruiting

Conditions: Ultra High Risk of psychosis and first episode psychosis

Interventions: Other: Treatment as usual (TAU)
Behavioral: Cognitive training

Registration Number: 2025-520573-39-00

Lead Sponsor: Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

Brief Summary: To assess the efficacy of a composite personalised care (CPC) based on biological tests and clinical profile including (A) adaptation of add-on medications; (B) cognitive reinforcement using digital applications; or (A+B) their combination in patients with early psychosis, from baseline to 3 months, as compared as Treatment as usual (TAU) on global functioning measured by the Personal and Social Performance (PSP) Scale.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

Adolescent and young adults, both sexes, aged 15 to 30 years,
Persons characterised according to the CAARMS criteria 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 (AME is not considered as a regular health insurance)

Exclusion Criteria

Severe and unstabilised medical conditions

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

Insufficient level in reading and/or French language,

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

Enforced hospitalization (ASPDT, ASPPI, ASPRE)

Intellectual Deficiency (i.e. IQ<70), and / or sensorimotor deficits incompatible with a 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 criterium)

Receiving therapeutic levels of antipsychotics for more than 12 months

Current medication with benzodiazepine >30 mg per day equivalent diazepam

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Treatment as usual (TAU)	Treatment as usual (TAU)	-
TAU + cognitive training	Cognitive training	-
TAU + cognitive training	Treatment as usual (TAU)	-
TAU + personalized neuroprotective strategies	Treatment as usual (TAU)	-
TAU + personalized neuroprotective strategies + cognitive training	Cognitive training	-
TAU + personalized neuroprotective strategies + cognitive training	Treatment as usual (TAU)	-

Primary Outcome Measures

Name	Time	Method
Global functioning will be assessed using the Personal and Social Performance Scale (PSP), determined reference period 3 to 4 months after the begning		Global functioning will be assessed using the Personal and Social Performance Scale (PSP), determined reference period 3 to 4 months after the begning

Secondary Outcome Measures

Name	Time	Method
Efficiency of composite personalised care on cognitive functions (Social cognition)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	Consensus autour de la COgnition Sociale (CLACOS) (PerSo)
Efficiency of composite personalised care on cognitive functions (Selective attention)	3 to 4 Month and 6 to 8 Month after the beginning of intervention	D2-R test
Efficiency of composite personalised care on cognitive functions (Verbal long-term memory)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	Hopskins Verbal Learning Test (HVLT) delayed recall
Efficiency of composite personalised care on cognitive functions (Visuospatial learning and memory)	3 to 4 Month and 6 to 8 Month after the beginning of intervention	Brief Visuospatial Memory test
Efficiency of composite personalised care on cognitive functions (Planning abilities)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	Shopping test (Martin 1972)
Efficiency of composite personalised care on cognitive functions (Speed processing)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	Wechsler Adult Intelligence Scale (WAIS) (code)
Efficiency of composite personalised care on cognitive functions (Inhibition control)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	Stroop (Incompatibility)
Efficiency of composite personalised care on cognitive functions (Visuospatial long-term memory)	3 to 4 Month and 6 to 8 Month after the beginning of intervention	Brief Visuospatial Memory test (BVMT) delayed recall
Efficiency of composite personalised care on cognitive functions (Working Memory)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	Wechsler Adult Intelligence Scale (WAIS) (Digit span)
Efficiency of composite personalised care on motivation	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)
Embodiment ability in virtual reality environment	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
Effect of Composite Personalised Care on Health-related quality-of-life (1)	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
Effect of Composite Personalised Care on Health-related quality-of-life (2)	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.
Effect of Composite Personalised Care on medication adherence	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
Acceptability of the program for the e-Health application	3 to 4 months after the beginning of intervention	amount of time spent on the application
Level and changes of biological markers (lipid membranes)	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)
Longitudinal epigenetic and seric changes associated with outcome (1)	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.
Longitudinal epigenetic and seric changes associated with outcome (2)	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.
Cost-effectiveness of Composite Personalised Care	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.
Budgetary impact analysis of the generalization of Composite Personalised Care	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.
Persistence of efficacy on global functioning	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.
Efficiency of Composite Personalised Care (CPC) on clinical outcome (5)	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
Efficiency of Composite Personalised Care (CPC) on clinical outcome (6)	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).
Efficiency of composite personalised care on cognitive functions (Verbal learning and memory)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	Hopkins Verbal Learning Test
Efficiency of Composite Personalised Care (CPC) on clinical outcome (1)	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)
Efficiency of Composite Personalised Care (CPC) on clinical outcome (3)	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.
Efficiency of Composite Personalised Care (CPC) on clinical outcome (7)	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).
Efficiency of Composite Personalised Care (CPC) on clinical outcome (2)	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.
Efficiency of composite personalised care on cognitive functions (Flexibility)	at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention	TMT A/B (Reitan, 1959)
Efficiency of Composite Personalised Care (CPC) on clinical outcome (4)	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.
Efficiency of Composite Personalised Care on linguistic and discourse markers	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.
Efficiency of composite personalised care on neurological soft signs (2)	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).
Efficiency of composite personalised care on neurological soft signs (1)	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).
Level and changes of biological markers (metabolism of monocarbon compounds)	at baseline and 6 to 8 months after the beginning of intervention	dosage of folates, B12 vitamin, homocysteine
Efficiency of composite personalised care on cognitive complaints	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.
Patient's satisfaction with the e-health application	3 to 4 months after the beginning of intervention	satisfaction score measured by the User Version of the Mobile Application Rating Scale (uMARS)

Trial Locations

Locations (13): Centre Hospotalier Guillaume Regnier
🇫🇷
Rennes, France
University Hospital Of Clermont-Ferrand
🇫🇷
Clermont Ferrand Cedex 1, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷
Grenoble Cedex 9, France
Centre Psychotherapique De Nancy
🇫🇷
Laxou, France
Centre Hospitalier Universitaire De Lille
🇫🇷
Lille, France
Groupe Hospitalier Nord Essonne
🇫🇷
Orsay, France
Centre Hospitalier Henri Laborit
🇫🇷
Poitiers Cedex, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷
Toulouse, France
Centre Hospitalier Universitaire De Montpellier
🇫🇷
Montpellier Cedex 5, France
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
🇫🇷
Paris, France
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Centre Hospotalier Guillaume Regnier
🇫🇷Rennes, France
DRAPIER Dominique 0299333937
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0299333937
d.drapier@ch-guillaumeregnier.fr