{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T11:50:14Z","timestamp":1791805814566,"version":"4.3.4"},"reference-count":53,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T00:00:00Z","timestamp":1791763200000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J Mental Health Nurs"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Family caregivers play a pivotal role in the recovery of people experiencing first\u2010episode psychosis (FEP). However, they may suffer from high levels of psychological distress and lack access to structured support. Although international recommendations highlight the need for psychoeducational interventions for caregivers, their implementation in France remains limited. This study aims to evaluate the impact of a structured, multicomponent support pathway, coordinated by advanced practice nurses (APNs), for family caregivers of people with FEP. This multicentre, stepped\u2010wedge (cluster with sequential permutation) randomized controlled trial involves six centres specializing in FEP in France. The intervention includes an initial consultation conducted by an APN, a single\u2010family psychoeducational programme (BREF) and a multifamily psychoeducational programme (PEPs Aidant). The primary outcome measure is the change in caregiver burden between 0 and 6\u2009months. Secondary outcome measures include caregiver mood, self\u2010efficacy and quality of life, as well as patient engagement and perception of recovery. A qualitative study will explore the processes and experiences related to the implementation of the intervention. The reporting of the study follows the SPIRIT guidelines. The intervention aims to reduce caregiver burden, improving their coping strategies and self\u2010efficacy and strengthening patient engagement. The results should enable the development of evidence\u2010based guidelines for structured caregiver support in FEP services. This project aims to provide families with support and a structured, coordinated care pathway led by advanced nurse practitioners with rigorous comparative evaluation and potential generalization to other FEP services. The present trial has been registered in the\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    database (NCT07041463) since 26 June 2025.\n                  <\/jats:p>","DOI":"10.1111\/inm.70373","type":"journal-article","created":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T11:34:36Z","timestamp":1791804876000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Reducing Caregiver Burden in First\u2010Episode Psychosis: Effects of a Psychoeducational Pathway Led by an Advanced Practice Nurse\u2014A Multicentre Stepped\u2010Wedge Randomized Trial"],"prefix":"10.1111","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7478-0260","authenticated-orcid":false,"given":"Damasceno","family":"Caroline","sequence":"first","affiliation":[{"name":"PEPs and CoVuJeunes Teams, University Psychiatry Department of Lyon M\u00e9tropole Le Vinatier  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9109-5604","authenticated-orcid":false,"given":"Haesebaert","family":"Julie","sequence":"additional","affiliation":[{"name":"Public Health Division, Department of Clinical Research and Epidemiology Hospices Civils de Lyon  Lyon France"},{"name":"Reshape Team (Research on Healthcare Performance, INSERM U1290) University of Lyon 1  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1955-2019","authenticated-orcid":false,"given":"Subtil","family":"Fabien","sequence":"additional","affiliation":[{"name":"HCL Biostatistics Department \u2013 Public Health Division, Health Biostatistics Team \u2013 Laboratory of Biometry and Evolutionary Biology (LBBE) University of Lyon 1  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4603-3575","authenticated-orcid":false,"given":"Rey","family":"Romain","sequence":"additional","affiliation":[{"name":"PSYR2 Team, Lyon Neuroscience Research Center (CRNL) Inserm U1028\/CNRS UMR5292, University of Lyon 1  Lyon France"},{"name":"Lyon Center for Caregivers in Psychiatry (CLAP), University Psychiatry Department of Lyon M\u00e9tropole Le Vinatier  Lyon France"},{"name":"University Psychiatry Department of Lyon Metropole, Le Vinatier  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6813-9012","authenticated-orcid":false,"given":"Haesebaert","family":"Fr\u00e9d\u00e9ric","sequence":"additional","affiliation":[{"name":"PEPs and CoVuJeunes Teams, University Psychiatry Department of Lyon M\u00e9tropole Le Vinatier  Lyon France"},{"name":"PSYR2 Team, Lyon Neuroscience Research Center (CRNL) Inserm U1028\/CNRS UMR5292, University of Lyon 1  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,12]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1080\/01612840.2019.1630532"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2012.05.007"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.4103\/0019\u20105545.102423"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/j.1440\u20101614.2006.01921.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2015.09.008"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.187.48.s116"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2017.05.041"},{"issue":"1","key":"e_1_2_10_9_1","first-page":"57","article-title":"Measuring the Burden for Carers of Dependent Elderly With the Zarit Inventory","volume":"44","author":"Bocquet H.","year":"1996","journal-title":"Revue D'epidemiologie et De Sante Publique"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.3917\/spub.146.0783"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11920\u2010017\u20100756\u2010z"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2016.04.030"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj\u20102024\u2010081477"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.encep.2007.12.009"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2018.0623"},{"key":"e_1_2_10_17_1","volume-title":"In This Together: Family Work in Early Psychosis","author":"Crisp K.","year":"2014"},{"key":"e_1_2_10_18_1","volume-title":"Community Mental Health in Canada: Theory, Policy, and Practice","author":"Davis S.","year":"2013"},{"key":"e_1_2_10_19_1","volume-title":"Troubles psychotiques: Protocoles d'intervention pr\u00e9coce","author":"De Boer E.","year":"2019"},{"key":"e_1_2_10_20_1","unstructured":"Delamaire M. L. andG.Lafortune.2010.\u201cNurses in advanced roles: A Description and Evaluation of Experiences in 12 Developed Countries.\u201dhttps:\/\/www.oecd\u2010ilibrary.org\/social\u2010issues\u2010migration\u2010health\/nurses\u2010in\u2010advanced\u2010roles_5kmbrcfms5g7\u2010en."},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.3917\/spub.033.0313"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD007906.pub2"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102019\u2010032391"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/0004867416641195"},{"key":"e_1_2_10_25_1","volume-title":"Les enjeux li\u00e9s \u00e0 la confidentialit\u00e9 dans la pratique du travail social en milieu d'urgence hospitali\u00e8re","author":"Galvao S.","year":"2012"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2023.03.019"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2025.01.006"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h391"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k1614"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20822"},{"key":"e_1_2_10_31_1","unstructured":"JORF.2019. \u201cD\u00e9cret du 12 ao\u00fbt 2019 modifiant le d\u00e9cret du 18 juillet 2018 relatif au programme de formation menant au dipl\u00f4me d\u2019\u00c9tat en soins infirmiers de pratique avanc\u00e9e.\u201d loi n\u00b0 0187.https:\/\/www.legifrance.gouv.fr."},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2016.16010103"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1177\/070674371506000802"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1111\/eip.12494"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.5172\/jamh.4.3.210"},{"key":"e_1_2_10_36_1","volume-title":"National Association of Clinical Nurse Specialists. Statement on Clinical Nurse Specialist Practice and Education","author":"NACNS","year":"2004"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1186\/1756\u20100500\u20105\u2010399"},{"key":"e_1_2_10_38_1","volume-title":"Nursing's Social Policy Statement","author":"Neuman C. E.","year":"2004"},{"key":"e_1_2_10_39_1","volume-title":"Psychosis and Schizophrenia in Adults: Prevention and Management","author":"NICE","year":"2014"},{"key":"e_1_2_10_40_1","volume-title":"Australian Clinical Guidelines for Early Psychosis","author":"ORYGEN","year":"2016"},{"key":"e_1_2_10_41_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.113.127753"},{"key":"e_1_2_10_42_1","unstructured":"PIPEP.2019.\u201cCadre de r\u00e9f\u00e9rence des Programmes d'interventions pour premiers \u00e9pisodes psychotiques.\u201dhttps:\/\/publications.msss.gouv.qc.ca\/msss\/fichiers\/2018\/18\u2010914\u201012W.pdf."},{"key":"e_1_2_10_43_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2011.03.008"},{"key":"e_1_2_10_44_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2023.1284096"},{"key":"e_1_2_10_45_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40596\u2010022\u201001632\u20101"},{"key":"e_1_2_10_46_1","unstructured":"Saleh D. L.Romo andN.Camart.2016.\u201cValidation of the General Self\u2010Efficacy Scale \u2018GSE\u2019 in French university students. (Validation de l'\u00e9chelle du sentiment d'auto\u2010efficacit\u00e9 \u2018GSE\u2019 chez des \u00e9tudiants universitaires fran\u00e7ais).\u201dhttps:\/\/doi.org\/10.13140\/RG.2.2.21879.62885."},{"key":"e_1_2_10_47_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.NAJ.0000336406.45248.4c"},{"key":"e_1_2_10_48_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.12r08308"},{"key":"e_1_2_10_49_1","doi-asserted-by":"publisher","DOI":"10.1080\/09638230020023570\u20102"},{"key":"e_1_2_10_50_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0033291798006667"},{"key":"e_1_2_10_51_1","doi-asserted-by":"publisher","DOI":"10.1159\/000054800"},{"key":"e_1_2_10_52_1","doi-asserted-by":"publisher","DOI":"10.1176\/ps.2010.61.5.508"},{"key":"e_1_2_10_53_1","volume-title":"Plan d'action global pour la sant\u00e9 mentale 2013\u20132020","author":"WHO","year":"2013"},{"key":"e_1_2_10_54_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2024.1460151"}],"container-title":["International Journal of Mental Health Nursing"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/inm.70373","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/inm.70373","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/inm.70373","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T11:34:40Z","timestamp":1791804880000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/inm.70373"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":53,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1111\/inm.70373"],"URL":"https:\/\/doi.org\/10.1111\/inm.70373","archive":["Portico"],"relation":{},"ISSN":["1445-8330","1447-0349"],"issn-type":[{"value":"1445-8330","type":"print"},{"value":"1447-0349","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10]]},"assertion":[{"value":"2026-04-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70373"}}