{"doc_desc":{"title":"Etude longitudinale sur l'\u00ab EValuation de l\u2019EMDR pour le tRaitement de l\u2019Etat de Stress post-Traumatique \u00bb: implication des axes corticotrope et sympathique","idno":"FRESH-PEF8571-fr","producers":[{"name":"ISABELLE CHAUDIEU","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8571-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8571"},{"agency":"FReSH","code":"FRESH-PEF8571"}]},"title":"Etude longitudinale sur l'\u00ab EValuation de l\u2019EMDR pour le tRaitement de l\u2019Etat de Stress post-Traumatique \u00bb: implication des axes corticotrope et sympathique","alternate_title":"EVEREST"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"name":"Isabelle;CHAUDIEU","firstname":"Isabelle","lastname":"CHAUDIEU","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"isabelle.chaudieu@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM \/ Inserm U1061","isContact":true}],"oth_id":[{"name":"ABC des psychotraumas, Approches Biologiques et Cliniques.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00mthsf17","role":"sponsor id"},{"title":"SIREN","uri":"263400160","role":"sponsor id"}],"role":"sponsor"},{"name":"","role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Isabelle;CHAUDIEU","lastname":"CHAUDIEU","firstname":"Isabelle","type":"contact","email":"isabelle.chaudieu@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Etude prospective"},{"keyword":"Recherche clinique"},{"keyword":"psychiatrie"},{"keyword":"\u00e9tude naturalistique"},{"keyword":"\u00e9valuation th\u00e9rapie EMDR"},{"keyword":"psychoth\u00e9rapie"},{"keyword":"axes corticotrope et sympathique"},{"keyword":"cortisol salivaire"},{"keyword":"fr\u00e9quence cardiaque et conductance cutan\u00e9e"},{"keyword":"\u00e9tude multicentrique"},{"keyword":"comorbidit\u00e9 psychiatrique"},{"keyword":"Etat de stress post-traumatique"},{"keyword":"PTSD"},{"keyword":"marqueurs biologiques"},{"keyword":"charge allostatique"},{"keyword":"essai randomis\u00e9"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]}],"purpose":"L\u2019objectif principal est de comparer l\u2019efficacit\u00e9 de la psychoth\u00e9rapie EMDR et de la th\u00e9rapie de soutien chez des patients atteints d\u2019ESPT chronique dans le cadre d\u2019un essai pragmatique calqu\u00e9 sur la pratique quotidienne d\u2019un secteur de psychiatrie adulte, Les objectifs secondaires sont : \u2022 d\u2019\u00e9tudier la relation entre la s\u00e9cr\u00e9tion de cortisol salivaire diurne et l\u2019expression de sympt\u00f4mes post-traumatiques i) chez tous les sujets inclus dans l\u2019\u00e9tude, \u00e0 l'inclusion et 3 mois apr\u00e8s leur prise en charge th\u00e9rapeutique ainsi que ii) chez les sujets du groupe EMDR, 1 an apr\u00e8s leur prise en charge. \u2022 d\u2019\u00e9tudier la relation entre le taux de cortisol salivaire s\u00e9cr\u00e9t\u00e9 durant les s\u00e9ances d\u2019EMDR et l\u2019expression des sympt\u00f4mes post-traumatiques \u00e0 3 mois (groupe 1), \u2022 d\u2019\u00e9tudier la relation entre la diminution de l\u2019excitation neurov\u00e9g\u00e9tative au cours des s\u00e9ances d\u2019EMDR et l\u2019expression de sympt\u00f4mes post-traumatiques \u00e0 3 mois (groupe 1). \u2022 D'\u00e9valuer l'effet de la th\u00e9rapie EMDR \u00e0 moyen terme, 1 an apr\u00e8s la premi\u00e8re s\u00e9ance d'EMDR.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2014-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Occitanie']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2022Femmes ou hommes de 18 \u00e0 75 ans, \u2022Patients pr\u00e9sentant un ESPT chronique (dur\u00e9e sup\u00e9rieure \u00e0 3 mois) diagnostiqu\u00e9 avec le CAPS (instrument diagnostic, crit\u00e8res DSM-IV) \u2022Patients n\u2019\u00e9tant pas d\u00e9j\u00e0 pris en charge en psychoth\u00e9rapie sp\u00e9cifiquement pour le traitement de l\u2019ESPT. \u2022Patient qui n\u2019a jamais b\u00e9n\u00e9fici\u00e9 d\u2019une th\u00e9rapie comportementale ou EMDR en relation avec la m\u00e9moire traumatique identifi\u00e9e, \u2022Patients ne prenant pas de psychotropes ou dont le traitement est stabilis\u00e9 depuis plus de 3 mois\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['DSM IV']","committee":"","governance":""}],"other_quality_statement":"['Bonnes Pratiques Cliniques :- Utilisation de proc\u00e9dures et modes op\u00e9ratoires,- Monitoring des dossiers tous les 6 mois,- Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment et apr\u00e8s la saisie des donn\u00e9es informatiques ;- Gestion des donn\u00e9es manquantes : Retour au dossier source ;- Relance des sujets pour r\u00e9aliser les visites de suivi ;']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de 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