{"doc_desc":{"title":"\u00abThe assessment of EMDR* to treat post-traumatic-stress-disorder \u00bb Involvement of corticotropic and sympathetic axes.","idno":"FRESH-PEF8571-en","producers":[{"name":"ISABELLE CHAUDIEU","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8571-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8571"},{"agency":"FReSH","code":"FRESH-PEF8571"}]},"title":"\u00abThe assessment of EMDR* to treat post-traumatic-stress-disorder \u00bb Involvement of corticotropic and sympathetic axes.","alternate_title":"EVEREST"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Isabelle;CHAUDIEU","PILabo":"INSERM \/ Inserm U1061","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-0587-4842","role":"pi id"},{"title":"IdRef","uri":"03361086X","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.chaudieu@inserm.fr","isContact":"Yes"}],"oth_id":[{"name":"ABC of psychotraumas, Biological","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"","extlink":[],"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","email":"isabelle.chaudieu@inserm.fr","type":"contact","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":"Prospective study"},{"keyword":"psychiatry"},{"keyword":"naturalistic study"},{"keyword":"EMDR psychotherapy assessment"},{"keyword":"biological markers"},{"keyword":"corticotropic and sympathetic axes"},{"keyword":"salivary cortisol"},{"keyword":"metabolic marker"},{"keyword":"heart rate"},{"keyword":"cutaneous conductance"},{"keyword":"randomized study"},{"keyword":"multicenter study"},{"keyword":"psychiatric comorbidities."},{"keyword":"Post traumatic stress disorder"},{"keyword":"PTSD"},{"keyword":"clinical research"},{"keyword":"allostatic load"}],"topics":[{"topic":"Endocrinology","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":"Psychiatry","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":"The main objective is to compare the effectiveness of EMDR psychotherapy and a supportive psychotherapy in chronic post-traumatic stress disorder patients, through a pragmatic-trial based on a daily practice of a psychiatry sector. Secondary objectives are 1)To study the link between diurnal salivary cortisol secretion and post traumatic symptoms 11)Over all the participants in the survey both at the inclusion and the 3 months visits 12)Over all the EMDR group participants, one year after the beginning of the cares. 2)To study the link between salivary cortisol levels during the EMDR sessions and post traumatic symptoms at 3 months (group 1) 3)To study the link between neurovegetative excitation regulation during the EMDR sessions and post traumatic symptoms at 3 months (group 1) 4)To assess the EMDR psychotherapy effect on a midterm, one year after the first EMDR session.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Women and men aged 18-75 years  - Chronical PTSD patients (for more than 3 months,  diagnosed by the CAPS scale\\\/DSM IV criteria - Patients who are not following a psychotherapy focused on PTSD - Patients that never have followedr a CBT (Cognitive behavioral therapy) or a EMDR psychotherapy focused on the traumatic memory - Patients without psychotropic treatment or who have a stabilized treatment for at least 3 months.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"['DSM IV']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"- 80"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"07-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"09-10-2017","isContributorPI":"No","contributorName":"ISABELLE CHAUDIEU","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Private non-profit"],"otherSponsorType":["","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"- self and administrated-reported scales, clinical administration and biological samples ; manual data entry (from paper documents)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"- 2 centers : CMP (Medical and psychological center) of Narbonne and Lezignan-Corbi\u00e8res"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"- Blood samples at visit 1 ; Total cholesterol, HDL, LDL, triglyceride, HbA1C - Salivary cortisol samples ; visit 1, psychotherapy sessions, visit 2 and 3 - Heart rate and cutaneous conductance ; visit 1, psychotherapies sessions, visit 2 and 3 - Morphometric measurements at visit 1 ; blood pression, weight and size, the waist to hip ratio","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}