Nctid:
NCT06616337
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D010554", "term"=>"Personality Disorders"}, {"id"=>"D001883", "term"=>"Borderline Personality Disorder"}], "ancestors"=>[{"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M15376", "name"=>"Schizophrenia", "relevance"=>"LOW"}, {"id"=>"M4996", "name"=>"Bipolar Disorder", "relevance"=>"LOW"}, {"id"=>"M4594", "name"=>"Attention Deficit Disorder with Hyperactivity", "relevance"=>"LOW"}, {"id"=>"M9999", "name"=>"Hyperkinesis", "relevance"=>"LOW"}, {"id"=>"M13462", "name"=>"Personality Disorders", "asFound"=>"Personality Disorder", "relevance"=>"HIGH"}, {"id"=>"M5161", "name"=>"Borderline Personality Disorder", "asFound"=>"Borderline Personality Disorder", "relevance"=>"HIGH"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-21", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2025-01-21", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-26", "studyFirstSubmitDate"=>"2024-05-21", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Evaluate the change of symptoms of emotional dysregulation", "timeFrame"=>"Up to 1 year", "description"=>"* The assessment is based on the DERS scale. Participants are asked to indicate how often the items apply to themselves, with responses ranging from 1 to 5,\n* The score between :\n\n * 1 means almost never (0 to 10%),\n * 2 means sometimes (11 to 35%),\n * 3 means about half the time (36 to 65%),\n * 4 means most of the time (66 to 90%),\n * 5 means almost always (91 to 100%)."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Emotional Dysregulation", "Schizophrenia", "Bipolar disorder", "Borderline personality disorder", "Attention deficit hyperactivity disorder (ADHD)"], "conditions"=>["Emotional Dysregulation"]}, "descriptionModule"=>{"briefSummary"=>"Emotional dysregulation (ED) is a common syndrome in psychiatric disorders. It is characterized by intense emotions, easily triggered, and with significant psychological impact: explosions of anger, irritability, impulsivity, emotional lability, etc. It is systematic in borderline personality disorder, and observed in a majority of patients with bipolar disorder. (even in the interictal period), adult ADHD, or addictions. ED is a cause of psychological distress, suicidal behavior or non-suicidal self-injury, and impaired quality of life. Pharmacological treatments only very partially improve these symptoms. Psychotherapies aimed at reducing ED are poorly developed in France. Dialectical behavioral therapy is a therapy that has shown its effectiveness in ED of BPD.\n\nThis is why the psychiatry and addiction center of the University Hospitals of Strasbourg has set up groups using this psychotherapeutic approach based on this technique for almost 3 years. This technique being very little practiced in France, and even less studied, we want to see if it is adapted to a French population not accustomed to this type of practice."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Major subject (≥18 years old) having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol during the period from January 1, 2018 to December 31, 2023.", "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Major subject (≥18 years old)\n* Having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol from January 1, 2018 to December 31, 2023,\n* Subject not opposing the reuse of their data for scientific research purposes.\n\nExclusion Criteria:\n\n* Subject having expressed their opposition to the reuse of their personal data for scientific research purposes."}, "identificationModule"=>{"nctId"=>"NCT06616337", "acronym"=>"Dys-Emotion", "briefTitle"=>"Patients Suffering From Emotional Dysregulation", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Strasbourg, France"}, "officialTitle"=>"Retrospective Study of the Acceptability and Effectiveness of a Dialectical Behavioral Therapy Group in Patients Suffering From Emotional Dysregulation (Borderline Personality Disorder, Bipolar Disorder and Adult ADHD)", "orgStudyIdInfo"=>{"id"=>"9137"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"67091", "city"=>"Strasbourg", "status"=>"RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Sébastien WEIBEL, MD", "role"=>"CONTACT", "email"=>"sebastien.weibel@chru-strasbourg.fr", "phone"=>"33 3 88 11 51 57"}, {"name"=>"Sébastien WEIBEL, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Amaury DURPOIX, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Service de Psychiatrie 2 - CHU de Strasbourg - France", "geoPoint"=>{"lat"=>48.58392, "lon"=>7.74553}}], "centralContacts"=>[{"name"=>"Sébastien WEIBEL, MD", "role"=>"CONTACT", "email"=>"sebastien.weibel@chru-strasbourg.fr", "phone"=>"33 3 88 11 51 57"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Strasbourg, France", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
