[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442069":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":66,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Hôpital le Vinatier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","The design is a stepped-wedge cluster randomized controlled trial. The study will be conducted in 9 centers (clusters) and will be conducted in 6 successive phases of 4 months each.\n\nDuring the first period, groups will be in the control period, then sequentially and according to a randomly defined order, at each time, one group will go into the intervention period after a transition period of 4 months allowing the intervention to be deployed (training of three health professionals for each center and then implementation of the BREF program).\n\nThus, each cluster will belong successively to the control group and the intervention group. During the control period, caregivers will be supported according to the usual practices of each center. During the intervention period, the BREF program will be offered to all eligible caregivers.",[13],"Other: control group",{"label":15,"type":16,"description":17,"interventionNames":18},"intervention group","EXPERIMENTAL","Thus, each cluster will belong successively to the control group and the intervention group. During the intervention period, the BREF program will be offered to all eligible caregivers.",[19],"Other: Intervention group",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"control group","The control group consisted of caregivers included during the control period, before the intervention was deployed, i.e., before the BREF program was implemented by the centers.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Intervention group","The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.",[15],[31],{"name":32,"affiliation":33,"role":34},"Romain REY, MD, PhD","CH LE VINATIER","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+33437915495","romain.rey@ch-le-vinatier.fr",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Anne-Lise BOHEC, PhD","Anne-lise.BOHEC@ch-le-vinatier.fr",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hopital Vinatier","RECRUITING","Bron","69678","France","FR",{"type":52,"coordinates":53},"Point",[54,55],4.91303,45.73865,{"lat":55,"lon":54},[58,62],{"name":59,"role":37,"phone":60,"phoneExt":25,"email":61},"ROMAIN REY, PH","+33(0)437915280","Romain.Rey@ch-le-vinatier.fr",{"name":63,"role":37,"phone":64,"phoneExt":25,"email":65},"VERONIQUE VIAL","+33(0)437915531","Veronique.Vial@ch-le-vinatier.fr",{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100442069","efficiency-assessment-of-breform-a-multicentric-stepped-wedge-randomized-control-trial-100442069",false,"NCT05036590","Efficiency Assessment of BREFORM. A Multicentric Stepped-wedge Randomized Control Trial.","Efficiency Assessment of a Mental Health Professionals' Training Course for a Short Psychoeducational Program (BREF) for Families and Caregivers of Patients With Schizophrenia or First Psychotic Episode.","BREFORM","Inclusion Criteria:\n\n* people over 18yo\n* first-degree relatives (parents, siblings, children) or spouse of the patient\n* primary caregiver of a patient with schizophrenic disorders or first psychotic episode (DSM5)\n* consenting to participate to the study\n\nExclusion Criteria:\n\n* mental disorder on Axis I\n* having already benefited from a family intervention such as psychoeducation\n* caring for several people with severe psychiatric disorders\n* receiving income for the caring activities\n* being legally responsible of the patient\n* having difficulty understanding fluent French\n* illiterate","ALL","18 Years",{"count":79,"type":80},206,"ESTIMATED","INTERVENTIONAL",[83],"NA","In psychiatry, caregiver burden is associated with excess physical and psychological morbidity in relatives of patients with schizophrenic disorders Single or multi-family psychoeducation for caregivers of patients with schizophrenic disorders or first episode psychosis has a direct benefit on the health of the caregiver and an indirect benefit on the health of the ill family member. It is associated with a reduction in the rate of relapse and re-hospitalization and with better compliance with treatment. For single-family psychoeducation, the number of caregivers to be treated to avoid re-hospitalization of the sick family member is 3. For caregivers, psychoeducation is accompanied by an improvement in knowledge of the disorders and coping strategies. Therefore, international recommendations recommend that psychoeducation for caregivers be systematic, early, and integrated into routine care.\n\nCurrently, the organization of the French care system does not allow these recommendations to be met. In order to increase the use of psychoeducation in France, early interventions for caregivers must be offered systematically. The effectiveness of early psychoeducation for caregivers needs to be evaluated; only three randomized controlled trials are available in the literature and none have been conducted in France.",[86],"Schizophrenia","2026-06-10",{"date":89,"type":90},"2026-06-12","ACTUAL",{"date":92,"type":90},"2022-04-05",{"date":94,"type":80},"2026-12-31",{"name":5,"class":6},1]