PsyCARE Trial - "Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis : A Prospective Randomised Controlled Trial "
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 18
- 主要终点
- Global functioning
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TAU + cognitive training
干预措施: Cognitive training (Behavioral)
TAU + personalized neuroprotective strategies
干预措施: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC (Drug)
TAU + personalized neuroprotective strategies + cognitive training
干预措施: Cognitive training (Behavioral)
TAU + personalized neuroprotective strategies + cognitive training
干预措施: Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC (Drug)
TAU + personalized neuroprotective strategies + cognitive training
干预措施: Treatment as usual (TAU) (Other)
TAU + personalized neuroprotective strategies
干预措施: Treatment as usual (TAU) (Other)
TAU + cognitive training
干预措施: Treatment as usual (TAU) (Other)
Treatment as usual (TAU)
干预措施: Treatment as usual (TAU) (Other)
结局指标
主要结局
Global functioning
时间窗: 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
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
次要结局
- 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)
- Efficiency of composite personalised care on cognitive functions (Selective attention)(3 to 4 Month and 6 to 8 Month after the beginning of intervention)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Embodiment ability in virtual reality environment(at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention)
- Efficiency of composite personalised care on motivation(at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention)
- 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)
- 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)
- Effect of Composite Personalised Care on medication adherence(at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention)
- Acceptability of the program for the e-Health application(3 to 4 months after the beginning of intervention)
- Level and changes of biological markers (lipid membranes)(at baseline and 6 to 8 months after the beginning of intervention)
- Longitudinal epigenetic and seric changes associated with outcome (1)(at baseline and 6 to 8 months after the beginning of intervention)
- Longitudinal epigenetic and seric changes associated with outcome (2)(at baseline and 6 to 8 months after the beginning of intervention)
- Cost-effectiveness of Composite Personalised Care(at the end of the follow-up, up to 4 years)
- Budgetary impact analysis of the generalization of Composite Personalised Care(at the end of the follow-up, up to 4 years)
- Persistence of efficacy on global functioning(at baseline, then 3 to 4 months and 6 to 8 months after the beginning of intervention)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Efficiency of composite personalised care on neurological soft signs (1)(at baseline and 6 to 8 months after the beginning of intervention)
- Level and changes of biological markers (metabolism of monocarbon compounds)(at baseline and 6 to 8 months after the beginning of intervention)
- Efficiency of composite personalised care on cognitive complaints(at baseline, 3 to 4 months and 6 to 8 months after the beginning of intervention)
- Patient's satisfaction with the e-health application(3 to 4 months after the beginning of intervention)
- 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)
- 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)
- 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)
- Persistence of efficacy on global functioning(6 to 8 months after the beginning of intervention)
研究者
Khaoussou SYLLA
Scientific
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience