[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"first-episode-psychosis-fep\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:first-episode-psychosis-fep":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,70,103,144,173,198,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100596131","psychoeducation-program-for-family-caregivers-coordinated-by-an-aprn-100596131",false,"NCT07041463","Psychoeducation Program for Family Caregivers Coordinated by an APRN","Impact of a New Psychoeducation Program Coordinated by an Advanced Practce Nurse on the Burden of Family Caregivers of Patients With a First Pyschotic Episode.","APIPEP","Inclusion Criteria:\n\n* Caregiver relative of a patient under the care of the FEP team and meeting the criteria of international recommendations of FEP diagnosis made by the specialized team of less than 6 months, between 18 and 35 years of age.\n* Caregiver having received information about the study and having giveń consent.\n* Caregiver covered by a health insurance plan\n\nExclusion Criteria:\n\n* Caregiver under curatorship, guardianship, safeguard of justice, family habilitation or future protection mandate\n* Caregiver participating in another study that may interact with this one\n* Caregiver not fluent in French (comprehension\u002Freading)\n* Caregiver who has already received psycho-education on FEP\n* Patient's opposition to caregiver's participation in research",true,"ALL","18 Years",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"NA","The aim of this study is to assess the impact of implementing a specific family program coordinated by APRNs, covering the 5 levels of the family care pyramid through a consultation, an individual psychoeducation program and a group psychoeducation program, on improving caregiver burden and thus contributing to the recovery of users suffering from FEP.\n\nDetailed Description: Psychotic disorders are among the most disabling chronic pathologies in psychiatry. These disorders modify the individual's perceptions, thoughts, moods, behaviours and day-to-day functioning (Implementing interventions as early as possible in the first psychotic episode (FEP) would be likely to decrease the severity and consequences of the illness and improve prospects for recovery. Evidence supports the establishment of multidisciplinary teams to detect early and treat early those experiencing FEP and those at increased risk of psychosis. Recommended interventions include cognitive-behavioral therapies, family interventions, employment and educational support, and above all, at the heart of the system, case management. These specialized teams need to be multidisciplinary, bringing together psychiatrists, psychologists and social workers in addition to case managers. More recently in France, Advanced practice nurse (APRN) have joined these teams. But getting young people to accept both disorders and care is a difficult necessity, and remains a major challenge. Poor compliance with treatment is said to be one of the primary causes of relapse after FEP. Factors that increase the risk of relapse include initially more severe symptoms, persistent substance abuse, poor adherence to treatment and inadequate support from family and friends. Nowadays, support from a close caregiver for a person living with a psychic disorder is recognized as a very favorable factor for long-term prognosis. But the occurrence of a FEP often has the effect of a tidal wave for loved ones, who present high levels of psychological distress and feelings of burden. Unfortunately, it is still difficult for families to gain access to family caregiver support services, which are still insufficiently available and often unknown to them. A number of barriers stand in the way of systematically proposing family interventions, such as health professionals' lack of awareness of the effectiveness of interventions aimed at family carers, their difficulty in establishing a double therapeutic alliance with the young person and his or her family, or the misperception that family interventions are in contradiction with professional secrecy.\n\nThe pyramid of family care in early intervention presents the family support that should be available to families of young people with FEP. The levels of intervention are designed to meet the support needs of family caregivers and can be used flexibly depending on specific needs or the phase of the psychotic episode. Also, APRNs could contribute to the success of these caregiver support programs thanks to their skills in prevention, assessment and coordination of complex pathways. This study therefore aims to determine the extent to which a specific program coordinated by APRNs can influence the burden of a family caregiver of a young person suffering from FEP.",[28,29,30,31],"First Episode Psychosis (FEP)","Caregiver Burden","Nurse Practitioners","IMPACT OF A NEW PSYCHOEDUCATION PROGRAM COORDINATED BY AN ADVANCED PRACTICE NURSE ON THE BURDEN OF FAMILY CAREGIVERS OF PATIENTS WITH A FIRST PSYCHOTIC EPISODE",[28,33,34],"Caregiver burden","Advanced Practice Nurse","RECRUITING","2026-06-05",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":36,"type":39},{"date":42,"type":22},"2030-11-04",{"name":44,"class":45},"Hôpital le Vinatier","OTHER",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100641033","digital-heart-rate-variability-biofeedback-intervention-for-first-episode-psychosis-100641033","NCT07628699","Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis","Digital Heart Rate Variability Biofeedback Intervention for First Episode Psychosis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with first-episode-psychosis who have been in treatment for less than 5 years\n* Inclusive of affective and non-affective psychosis\n* Aged 18-55\n* A diagnosis of schizophrenia-spectrum disorders or affective psychosis including schizoaffective disorder, bipolar affective disorders and depression with psychosis based on DSM V diagnostic criteria\n* Able to provide written informed consent.\n* Patients should be stable but with symptoms present\n* Score a minimum of 7 on the Calgary Depression Scale.\n\nExclusion Criteria:\n\n* Any organic neurological or cardiac conditions\n* Prescription of cardiovascular medication\n* Active severe suicidal ideation\n* Diabetes as this can affect HRV\n* Current substance abuse\n* An ECG will be performed on each participant prior to joining the study to exclude undiagnosed cardiac conditions","55 Years",{"count":56,"type":22},80,[25],"The objective of the current study is to assess the impact of a five-week digital heart rate variability biofeedback (HRV-B) intervention or music listening on the well-being of first episode psychosis patients. Heart rate variability (HRV) is a measure of how an individual's heart rate can adapt to a changing environment and mental and physiological challenges. It has been well established that HRV can be regulated through actions such as slow breathing and meditation. HRV Biofeedback (HRV-B) involves breathing at a specific frequency, usually around 6 breaths per minute, which has been shown to maximize HRV. Research has shown that HRV-B interventions improved mental health symptoms in various populations including individuals at clinical high risk for psychosis.",[28],"NOT_YET_RECRUITING","2026-06-02",{"date":36,"type":39},{"date":64,"type":22},"2026-06-01",{"date":66,"type":22},"2026-08",{"name":68,"class":45},"The University of Hong Kong",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":69},"100608043","early-psychosis-investigating-cognition-100608043","NCT07196423","Early Psychosis: Investigating Cognition","Glutamate Changes as a New Neurocognitive Marker in Psychosis","EPIC","Inclusion Criteria for FEP Group (studies 1a and 1b):\n\nEligibility criteria for first episode psychosis group are as follows:\n\n1. Aged 18-55 years.\n2. Ability to understand and willing to give written informed consent.\n3. Fluent in English to be able to understand all cognitive task instructions and questionnaires.\n4. Current psychotic disorder of less than 5yrs total duration. Defined as meeting DSM-5 criteria consistent with a diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, or severe depression with psychosis.\n5. At least 8 weeks of stable treatment.\n6. Ability to travel to the University of Nottingham for in-person testing.\n\nExclusion Criteria for FEP Group (Studies 1a and 1b):\n\n1. Clinically significant neurological or comorbid psychiatric disorder in the opinion of the investigator.\n2. History of clinically significant head injury\n3. Current harmful use of, or dependence on, psychoactive substances (excluding nicotine) in the opinion of the investigator\n4. Current use of any medication which may interfere with the study in the opinion of the investigator, i.e. any medication that might affect the neurochemicals of interest\n5. Contraindications for MR scanning as assessed by SPMIC screening form and trained scanner operator (e.g. claustrophobia, pregnancy, metal implants, etc.)\n6. Contraindications for transcranial direct current stimulation as assessed by standard screening form (e.g. cardiac pacemaker or other implanted devices, seizures, epilepsy, open head wound, etc.)\n7. Having taken part within the previous month as a participant in a clinical trial that involved taking a drug or having an invasive procedure.\n\nInclusion Criteria for Healthy Matched Controls (Studies 1a and 1b):\n\nMatched healthy control participants will be recruited from a local database of volunteers, from posters and online advertisements.\n\nInclusion criteria (matched controls):\n\n1. Aged 18 - 55 years.\n2. Ability to understand and willing to give written informed consent.\n3. English as first language or fluent in English.\n4. Ability to travel to the University of Nottingham for in-person testing.\n\nExclusion criteria for Health Matched Controls (Studies 1a and 1b):\n\n1. Personal or family history of psychosis.\n2. Clinically significant neurological or psychiatric disorder.\n3. History of clinically significant head injury.\n4. Current harmful use of, or dependence on, psychoactive substances (excluding nicotine and caffeine) in the opinion of the investigator.\n5. Current use of any medication, which may interfere with the study in the opinion of the investigator i.e. any medication that might affect the neurochemicals of interest.\n6. Contraindications for MR scanning as assessed by SPMIC screening form and trained scanner operator (e.g. claustrophobia, pregnancy etc).\n7. Contraindications for transcranial direct current stimulation as assessed by standard screening form (e.g. cardiac pacemaker or other implanted devices, seizures, epilepsy, open head wound, etc.)\n8. Having taken part within the previous month as a participant in a clinical trial that involved taking a drug, being paid an inconvenience allowance, or having an invasive procedure (e.g. venepuncture \\>50ml, endoscopy).\n\nInclusion Criteria for participants with lived experiences of psychosis (Study 2):\n\n1. Aged 18+ years.\n2. Ability to understand and willing to give written informed consent.\n3. Fluent in English to be able to understand and answer all questions.\n4. History of psychotic disorder defined as DSM-5 criteria for diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, or severe depression with psychosis. No limit of time since first episode.\n5. At least 8 weeks of stable treatment.\n6. Ability to travel to the University of Nottingham for in-person testing.\n\nExclusion Criteria for participants with lived experiences of psychosis (Study 2):\n\n1. Clinically significant neurological or comorbid psychiatric disorder.\n2. Current harmful use of, or dependence on, psychoactive substances (excluding nicotine) in the opinion of the investigator.\n3. Having taken part within the previous month as a participant in a clinical trial that involved taking a drug or having an invasive procedure.\n4. Lived experience where psychosis symptoms have not been directly experienced by the individual (e.g., support or carer role to someone else).",{"count":79,"type":22},106,[25],"The project aims to explore changes in brain chemistry in individuals who have recently experienced psychosis. Recent research suggests that chemicals in the brain, specifically one called glutamate, may behave differently in people who have experienced psychosis compared to those who have not. It is also known that some individuals with psychosis can find tasks involving memory and attention more challenging. This study aims at understanding how brain chemistry is linked to memory and attention, and if this is different between people who have and have not experienced psychosis.\n\nThe study will also investigate how a commonly used brain stimulation technique might help people with psychosis and other conditions by altering brain chemistry for a very short period. Non-invasive brain stimulation using very weak electrical stimulation has been used to help improve symptoms in individuals with psychosis and many other conditions, and has been shown to alter brain chemistry for a few hours after stimulation. However, it does not work for everyone. It will be investigated if levels of glutamate can predict whether brain stimulation will help an individual or not. In other words, the study investigates if glutamate can be used as a marker for tailoring treatments.\n\nThis project also aims to collect personal experiences or challenges that individuals with psychosis face. This information will be gathered through interviews. This will help to understand what specific difficulties individuals have, such as with certain aspects of memory and attention. The interview will also gather opinions and concerns about brain imaging and brain stimulation and current understandings of chemicals in the brain. For example, the study will explore why individuals may not want to take part in brain imaging or brain stimulation.",[28,83],"Psychosis",[85,86,87,88,89,90,91,92,93],"psychosis","cognition","glutamate","transcranial direct current stimulation","fMRS","first episode psychosis","GABA","working memory","magnetic resonance spectroscopy","2026-04-28",{"date":96,"type":39},"2026-05-04",{"date":98,"type":39},"2026-02-09",{"date":100,"type":22},"2027-08",{"name":102,"class":45},"University of Nottingham",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":69},"100611794","testing-the-efficacy-of-the-cannabis-clinic-for-patients-with-psychosis-ccp-intervention-for-cannabis-use-reductioncessation-in-patients-with-first-episode-psychosis-fep-100611794","NCT07245212","Testing the Efficacy of the Cannabis Clinic for Patients With Psychosis (CCP) Intervention for Cannabis Use Reduction\u002FCessation in Patients With First Episode Psychosis (FEP)","Testing the Efficacy of the Cannabis Clinic for Patients With Psychosis (CCP) Intervention for Cannabis Use Reduction\u002FCessation in Patients With First Episode Psychosis","CCP RCT","Inclusion Criteria:\n\n* First episode psychosis Community Mental Health teams receiving care under of SLaM Early Intervention for Psychosis Adult Mental Health Teams\n* CUDIT≥9 (Dependent on Cannabis)\n* age=18 to 65 years old ( age range of adult psychiatric services)\n* Capacity to give informed consent, as assessed by clinical teams\n\nExclusion Criteria:\n\n* Lack capacity to consent\n* High levels of suicidal ideation, judged by clinical team\n\n  -≥2 days\u002Fweek frequency use of any other illicit drug\n* Participation in any other current intervention trial\n* In active crises and\u002For expressing suicidal ideations","65 Years",{"count":56,"type":22},[25],"People suffering from psychosis who use cannabis experience more relapses, long and compulsory admissions, with huge costs to the individual, families and health services. The Cannabis Clinic for Psychosis (CCP) was developed to respond to this clinical need. A published review of the CCP's intervention showed its safety and efficacy in supporting people suffering from psychosis with reducing their cannabis use. Nevertheless, for the CCP model of care to be applied widely and benefit a larger clinical population, its intervention needs to be tested in a Randomised Control Trial (RCT). The proposed CCP RCT is a waiting list randomised controlled trial that aims to evaluate the clinical efficacy of the existing CCP intervention. Participants will be adults currently under the care of South London and Maudsley (SLaM) Early Intervention Teams for first onset psychosis, who are dependent on cannabis and who express an intention to reduce or stop their use. The RCT primary outcome will measure changes in all participants' cannabis use. Participants will be randomised to either the intervention group or the waiting list control group receiving Treatment As Usual (TAU). The CCP intervention comprises 12 weekly (+\u002F- 4 weeks) one-to-one sessions, with optional participation in a weekly online peer group. Sessions are delivered by trained clinicians and include evidence-based psychosocial techniques, including Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), SMART goal settings and support for co-occurring tobacco use. The treatment is non-pharmacological and administered via participant-led approach that accommodates online or face-to-face sessions to meet the patient preference. Qualitative data from the recent CCP proof of concept paper indicate that the flexibility in allowing patients choice on the session's modality (online\u002Fface to face, hybrid) increased and maintained engagement.\n\nThe study is fully funded by the Maudsley Charity and due to last 30 months from the start of recruitment.",[83,116,28],"Cannabis Use Disorder",[116,83,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"First Episode Psychosis","Cannabis Cessation","Cannabis","Reduction","Cessation","Psychosocial Intervention","Psychosocial","Intervention","Cognitive Behavioural Therapy","Motivational Interviewing","Randomised Controlled Trial","Early Intervention in Psychosis","Cannabis Clinic for Psychosis","psychoeducation","peer support","flexibility","personalised","2025-11-20",{"date":137,"type":39},"2025-11-24",{"date":139,"type":22},"2025-12-01",{"date":141,"type":22},"2028-11-30",{"name":143,"class":45},"King's College London",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":69},"100612374","dopamine-and-insulin-in-psychosis-100612374","NCT07252752","Dopamine and Insulin in Psychosis","Dopamine and Insulin in Psychosis: Imaging the Effects of Intranasal Insulin on Dopamine Transmission","DIPS","Inclusion Criteria:\n\nAll participants\n\n* age 18-40\n* Body mass index (BMI) range 18-25\n* good general health according to physical examination and medical history\n* absence of relevant abnormalities in laboratory screening, electrocardiogram (ECG) or vital signs\n* no regular use of drugs of abuse or alcohol based on history and urine drug screen\n\nPatients only\n\n* diagnosis of schizophrenia or schizophreniform disorder according to DSM-5\n* ability to give informed consent\n* minimum Positive and Negative Syndrome Scale (PANSS) score of 55 with \\>3 on at least two or \\>4 on one PANSS psychosis item\n\nExclusion Criteria:\n\nAll participants\n\n* severe or unstable medical or neurological illness or clinically significant abnormality on screening laboratory studies or ECG\n* established diagnosis of type 1 or type 2 diabetes\n* current substance use disorder or regular recreational drug abuse (except nicotine and caffeine)\n* pregnancy or breastfeeding\n* history of head trauma resulting in loss of consciousness of \\>1min or requiring medical attention\n* presence of MRI exclusion criteria\n* if participation in this study would exceed annual radiation dose limits (30mSv)\n* clinically established diagnosis of intellectual disability\n\nHealthy volunteers only\n\n* Psychiatric disorder according to Mini-International Neuropsychiatric Interview (M.I.N.I.)\n* Schizophrenia or bipolar disorder in first degree family members\n\nPatients only\n\n● Previous oral antipsychotic treatment for more than 2 weeks or previous treatment with antipsychotic depot preparation","40 Years",{"count":154,"type":22},46,[25],"Patients with schizophrenia have a high risk of developing metabolic disorders and current evidence points to an overlap in mechanisms underlying psychiatric symptoms and metabolic disturbances. The main goal of this study is to investigate effects of brain insulin on dopamine signaling and energy metabolism in patients with schizophrenia experiencing their first psychotic episode (FEP). To this end, patients with schizophrenia and healthy volunteers will undergo two \\[11C\\]-(+)-PHNO positron emission (PET) scans to measure the changes in dopamine receptor availability after nasally applied insulin, as well as single proton magnetic resonance spectroscopy (1H-MRS) to assess the impact of intranasal insulin on levels of glucose and glutamate in the hippocampus.",[28],[159,160,161,162,163],"positron emission tomography (PET)","dopamine","schizophrenia","intranasal insulin","magnetic resonance spectroscopy (MRS)","2025-11-18",{"date":166,"type":39},"2025-11-28",{"date":168,"type":22},"2026-01-01",{"date":170,"type":22},"2029-01-01",{"name":172,"class":45},"Medical University of Vienna",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100608898","physical-exercise-in-patients-with-first-psychotic-episode-100608898","NCT07207538","Physical Exercise in Patients With First Psychotic Episode","Impact of Physical Exercise on Telomere Length and Other Markers of Premature Ageing in First-episode Psychosis.","Inclusion Criteria:\n\n* be at least 18 years of age\n* Having experienced a first psychotic episode in the last 3 years\n\nExclusion Criteria:\n\n* are unable to read and understand the patient information sheet and sign the informed consent form.",{"count":181,"type":22},40,[25],"Justification: Patients with first-episode psychosis are at increased risk of premature ageing and early mortality, associated with telomere shortening and increased inflammatory markers. Physical exercise has shown protective effects in the general population, but there are no intervention studies in this population.\n\nObjective: To evaluate the effect of a strength training programme on telomere length and other markers of cellular ageing in people with a first episode of psychosis.\n\nMaterial and methods: Quasi-experimental study with patients aged 18-35 years included in the PRINT programme (Salamanca). Standard treatment will be compared with standard treatment plus a 12-week strength training programme. Telomere length (qPCR), inflammatory and senescence markers (proteomics), body composition, frailty and quality of life will be analysed.\n\nApplicability: The results could support the inclusion of physical exercise programmes as a complementary intervention in early psychosis care, promoting overall health, quality of life and reducing the gap in life expectancy compared to the general population.",[185,186,28],"Telomere Length","Exercise",[186,188,189],"Telomere length","Aging","2025-10-01",{"date":192,"type":39},"2025-10-06",{"date":168,"type":22},{"date":195,"type":22},"2026-12-31",{"name":197,"class":45},"University of Salamanca",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":69},"100566112","nursing-intervention-in-weight-and-metabolic-syndrome-management-in-first-episode-psychosis-metakop-100566112","NCT06650943","Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)","Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)","MetaKOP","Inclusion Criteria:\n\n1. Patients admitted to the Early Intervention Program (EIP).\n2. First-episode psychosis (FEP) within the last 5 years.\n3. Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10.\n\nExclusion Criteria:\n\n1. Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures.\n2. Comorbid diagnosis of neurological pathology.\n3. Language or comprehension impairments preventing accurate data collection.\n4. Use of hypoglycemic medication before or during the study.\n5. Refusal to participate",{"count":207,"type":22},88,[25],"The goal of this clinical trial is to evaluate if a nursing intervention based on the carbohydrate-insulin model can effectively reduce weight and manage the risk of metabolic syndrome (MetS) in individuals with first-episode psychosis. The main questions it aims to answer are:\n\nWill the intervention lead to a clinically significant weight loss (≥5%)? Can the intervention improve metabolic parameters, psychopathological state, physical activity level, and quality of life? Researchers will compare participants receiving the specialized nursing consultations to those receiving routine care to see if the former group experiences greater improvements in weight loss and metabolic risk reduction.\n\nParticipants will:\n\nAttend a series of 8 nursing consultations focused on dietary habits based on the carbohydrate-insulin model and physical activity.\n\nComplete assessments at the start, 6 months, and 12 months, including weight, metabolic parameters, and psychological evaluations.",[28,211],"Metabolic Syndrome X",[213,85,214,215,216],"FEP","metabolic syndrome","nursing","mental health nurse","2024-10-20",{"date":219,"type":39},"2024-10-22",{"date":221,"type":39},"2023-10-25",{"date":223,"type":22},"2026-06-30",{"name":225,"class":45},"Hospital de Basurto",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":17,"sex":18,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":69},"100564843","self-administered-cognitive-personalized-training-in-early-psychosis-100564843","NCT06634446","Self-administered COgnitive Personalized Training in Early Psychosis","Self-administered COgnitive Personalized Training in Early Psychosis: a Randomized Controlled Trial in Adolescents and Young Adults to Assess Efficacy and Efficiency of an EHealth Application Providing Personalized Cognitive Training","SCOPe","Inclusion Criteria:\n\n* Adolescent and young adults, both genders, aged 16 to 35,\n* Seeking help in one of the recruiting centers,\n* Newly diagnosed as experiencing an Episode of Psychosis (reaching criteria as described in the Comprehensive Assessment of at Risk Mental States (CAARMS) within the year\n* Written informed consent signed (and from one legal guardian for minors).\n\nExclusion Criteria:\n\n* Severe and unstabilized medical conditions,\n* Insufficient level in reading and\u002For French language,\n* Absence of medical insurance,\n* Participation in another intervention trial,\n* Enforced hospitalization (ASPDT, ASPPI, ASPRE),\n* Intellectuel Deficiency (IQ\\<70), and \u002F or sensorimotor deficits incompatible with the cognitive training,","16 Years","35 Years",{"count":237,"type":22},240,[25],"The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities.\n\nCognitive remediation improves quality of life 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 FEP and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions.\n\nEarly 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.\n\nOur background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing FEP and that this effect is modulated by individual brain plasticity abilities.",[28],[242,161,243,244,245,246,247,248],"First Episode Psychosis (FEP),","Cognitive Personalized training","adolescents and young adults FEP","personalized cognitive training","Chronic psychosis","Biological Testing","Metabolic Alterations","2024-10-08",{"date":251,"type":39},"2024-10-10",{"date":253,"type":39},"2021-10-26",{"date":255,"type":22},"2027-12-30",{"name":257,"class":45},"Centre Hospitalier St Anne"]