[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596131":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":28,"locations":39,"responsibleParty":121,"collaborators":23,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":132,"minAge":133,"maxAge":23,"enrollmentInfo":134,"targetDuration":23,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":146,"overallStatus":62,"whyStopped":23,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Hôpital le Vinatier","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychoeducation program coordinated by an APRN","EXPERIMENTAL","The intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach.\n\n* Individual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices:\n* BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care.\n* PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center.",[13,14],"Other: Psychoeducation program coordinated by an APRN","Other: Usual Care",{"label":16,"type":6,"description":17,"interventionNames":18},"USUAL intervention","The intervention includes an APRN reception, listening and orientation consultation, harmonized during a preparatory meeting prior to setting up the study. At the very least, this should include empathetic listening to the young person's problems, a tour of the unit, an explanation of the young person's background and an explanation of the approach.\n\nIn the control phase, the caregiver will benefit from the interventions and referrals provided for caregivers \"as usual\" at each center.",[14],[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"Individual and group psycho-education programs. Each investigating center will be trained in the same tools, in order to harmonize practices:\n\n* BREF: This is a 3-session psycho-educational program in which each family is received individually by a pair of caregivers who are not involved in the patient's care.\n* PEPs Caregiver: This is a group psycho-education program in 5 2-hour sessions developed in the coordinating center.",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Usual Care","The caregiver will benefit from the interventions and referrals provided for caregivers \"as usual\" at each center.",[9,16],[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Caroline DAMASCENO, Nurse","CONTACT","07 85 58 68 10","+33","caroline.damasceno@ch-le-vinatier.fr",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Lydie SARTELET","0437915531","lydie.sartelet@ch-le-vinatier.fr",[40,60,74,90,105],{"facility":41,"status":42,"city":43,"state":23,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"CHRU de Brest - Hôpital de BOHARS,","NOT_YET_RECRUITING","Bohars","29820","France","FR",{"type":48,"coordinates":49},"Point",[50,51],-4.51424,48.42917,{"lat":51,"lon":50},[54,58],{"name":55,"role":31,"phone":56,"phoneExt":33,"email":57},"Lucie DUSSAUZE, Nurse","0607060398","lucie.dussauze@chu-brest.fr",{"name":55,"role":59,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":62,"city":63,"state":23,"zip":64,"country":45,"countryCode":46,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"CH le Vinatier","RECRUITING","Bron","69678",{"type":48,"coordinates":66},[67,68],4.91303,45.73865,{"lat":68,"lon":67},[71,73],{"name":72,"role":31,"phone":32,"phoneExt":33,"email":34},"Caroline DAMASCENO",{"name":72,"role":59,"phone":23,"phoneExt":23,"email":23},{"facility":75,"status":42,"city":76,"state":23,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Groupe Hospitalier Marius Lacroix","La Rochelle","17000",{"type":48,"coordinates":79},[80,81],-1.15222,46.16308,{"lat":81,"lon":80},[84,88],{"name":85,"role":31,"phone":86,"phoneExt":33,"email":87},"Hugues MONJARET, Nurse","07 89 29 08 75","Hugues.monjaret@ght-atlantique17.fr",{"name":89,"role":59,"phone":23,"phoneExt":23,"email":23},"Hugues MONJARET",{"facility":91,"status":42,"city":92,"state":23,"zip":93,"country":45,"countryCode":46,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Hôpital La Colombière","Montpellier","34295",{"type":48,"coordinates":95},[96,97],3.87635,43.61093,{"lat":97,"lon":96},[100,104],{"name":101,"role":31,"phone":102,"phoneExt":33,"email":103},"Nathalie FOURNIER, Nurse","0616740672","ice-uja@chu-montpellier.fr",{"name":101,"role":59,"phone":23,"phoneExt":23,"email":23},{"facility":106,"status":42,"city":107,"state":23,"zip":108,"country":45,"countryCode":46,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHU de Nîmes","Nîmes","30029",{"type":48,"coordinates":110},[111,112],4.35788,43.83665,{"lat":112,"lon":111},[115,119],{"name":116,"role":31,"phone":117,"phoneExt":33,"email":118},"NAdia LIPPLER, Nurse","0466686868","nadia.LIPPLER@chu-nimes.fr",{"name":120,"role":59,"phone":23,"phoneExt":23,"email":23},"Nadia LIPPLER, Nurse",{"type":122,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","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":135,"type":136},180,"ESTIMATED","INTERVENTIONAL",[139],"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.",[142,143,144,145],"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",[142,147,148],"Caregiver burden","Advanced Practice Nurse","2026-06-05",{"date":151,"type":152},"2026-06-09","ACTUAL",{"date":149,"type":152},{"date":155,"type":136},"2030-11-04",{"name":5,"class":6},5]