[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469490":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":18,"centralContacts":18,"locations":31,"responsibleParty":64,"collaborators":18,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"GREMO patients","EXPERIMENTAL","1. 5 months of baseline : usual care of in a medico-social service (medical, social, neuropsychological and psychological),\n2. 5 months of dialectical behavior therapy (DBT)\n\n   -DBT skills training group : during 19 weeks\n3. 5 months of follow-up : usual care of + monthly reminders of DBT intervention skills",[13],"Behavioral: Dialectical Behavior Therapy and Radically Open dialectical behavior therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Controls without brain injury","NO_INTERVENTION","People without brain injury used as controls for linguistic markers of emotional expression regulation and free will.",null,{"label":20,"type":16,"description":21,"interventionNames":18},"GREMO patients' family","GREMO patients' relatives, without brain injury, living with the GREMO patient and ready to complete every day and adapted self-observational diary card similar to the one of the GREMO patient",{"label":23,"type":16,"description":24,"interventionNames":18},"Qualitative research ABI patients and families","Patients and relatives followed by the same medico-social service but not meeting GREMO patients eligibility criteria, participating only in the qualitative research on free will and spirituality",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":18},"BEHAVIORAL","Dialectical Behavior Therapy and Radically Open dialectical behavior therapy","Dialectical Behavior Therapy is a third wave cognitive-behavioral therapy. It focuses on emotional dysregulation and interactions between the patient and his family in genesis and maintenance of challenging behaviors. It is used here in an adapted form for cognitive problems.\n\nDelivered in a group format of 19 weeks + individual sessions.",[9],[32],{"facility":33,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)","RECRUITING","Illkirch-Graffenstaden","67402","France","FR",{"type":40,"coordinates":41},"Point",[42,43],7.71523,48.52894,{"lat":43,"lon":42},[46,51,53,56,58,60,62],{"name":47,"role":48,"phone":49,"phoneExt":18,"email":50},"Agata KRASNY-PACINI","CONTACT","+33 3 69 06 30 42","agata.krasny-pacini@ugecam.assurance-maladie.fr",{"name":47,"role":52,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Marie-Eve ISNER-HOROBETI","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":18,"phoneExt":18,"email":18},"Maud ELBEL",{"name":59,"role":55,"phone":18,"phoneExt":18,"email":18},"Guillaume BEHR",{"name":61,"role":55,"phone":18,"phoneExt":18,"email":18},"Mathilde LAUGEL",{"name":63,"role":55,"phone":18,"phoneExt":18,"email":18},"Marie KUPPELIN",{"type":65,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100469490","regulating-emotions-and-behaviors-after-brain-injury-100469490",false,"NCT05393492","Regulating Emotions and Behaviors After Brain Injury","Dialectical Behavior Therapy for Challenging Behaviors and Emotional Distress After Acquired Brain Injury : a Pilot Study","GREMO-LCA","Eligibility Criteria: \\* (Limit: 15,000 characters)\n\nSummary criteria for participant selection.\n\nMain eligibility criteria\n\nGREMO patients :\n\n* Inclusion criteria:\n\n  * Persons with acquired brain injury regardless of the type or location of the injury\n  * Age between 18 and 68\n  * Over 18 months since the acquired brain injury (or 6 month if mild traumatic brain injury)\n  * Challenging behaviors or emotional dysregulation or high level of anxiety \u002F depression or family's complaints about emotional dysregulation\n  * Secondary or exacerbated by an acquired brain injury\n  * Causing important suffering for themselves or their families\n  * Being affiliated to a social security\n  * Fluent in French\n  * Being able to understand goals and risks and to give a dated and signed consent\n* Exclusion criteria:\n\n  * Clinically evident severe lack of insight, lack of abstract reasoning, or severe anosognosia\n  * Patients without any complaints\n  * Severe cognitive impairments, aphasia or intellectual impairments that doesn't allow to understand DBT skills, questionnaires or group intreactions\n  * Non fluent in French\n  * Associated brain degenerative disease\n  * Cancerous brain injury with uncertain progression\n  * Non-stabilized psychotic disorder\n  * Following a third wave cognitive behavioral therapy during the research study (for example : acceptance and commitment therapy)\n\nControls without brain injury\n\n* Inclusion criteria :\n\n  * Being 18 years old or more\n  * Without brain injury\n* Exclusion criteria :\n\n  * Non fluent in French\n  * History of brain injury or brain disease\n  * History of psychiatric disorder\n  * Personality disorder\n  * GREMO patient's family member living together\n  * Psychologist, neuropsychologist or people with an emotional regulation knowledge linked to their profession\n  * Being under guardianship or curatorship\n  * Being pregnant or breastfeeding\n\nGREMO patients' family members\n\n* Inclusion criteria :\n\n  * Being 18 years old or more\n  * GREMO patient's family member\n  * Living with a GREMO patient\n  * Agreeing to rate an emotion-behavior-skills diary cards\n* Exclusion criteria :\n\n  * GREMO patient's refusal for their family member to participate\n  * Non fluent in French\n  * Brain injury or brain disease\n  * Major lack of insight\n  * Being under trusteeship or curatorship\n\nQualitative research ABI patients and families\n\n* Inclusion criteria :\n\n  * Person with ABI attending the same medico-social service as GREMO patients\n  * Ineligible for GREMO patients group (participation refusal, major insight difficulty…)\n  * Agreeing to talk about their free will or spirituality\n* Exclusion criteria :\n\n  * Aphasia or dysarthria not allowing understandable recording\n  * Impossibility to understand oral questions\n  * Non fluent in French",true,"ALL","18 Years",{"count":78,"type":79},77,"ESTIMATED","INTERVENTIONAL",[82],"NA","After acquired brain injury (ABI), persons can experience emotional and behavioral difficulties, that can be painful both for the person and his\u002Fher family. This clinical study aims at measuring the effectiveness of a third wave cognitive behavioral therapy called \"dialectical behavior therapy\" (DBT). DBT aims at teaching persons emotion regulation skills, interpersonal effectiveness skills, mindfulness and distress tolerance skills through group and individual sessions.\n\nThe study's hypothesis is that DBT, in an adapted format for persons with ABI can lead to\n\n* a better quality of life, emotional and behavioral regulation, and self-esteem\n* decrease in problematic behaviors\n* progress in life goals\n* increase post traumatic growth and spirituality\n* better family functioning and lesser burden for care givers\n* experiencing more emotions and more free will\n\n  45 persons with an ABI sustained more than 18 month back, will follow a 3 phases, follow-up with care as usual for 5 months, followed by 5 months of DBT, followed by 5 months of care as usual + DBT monthly sessions.\n\nSelf- and family-questionnaire will explore quality of life, emotional regulation, self-esteem, stress, anxiety, cognitive difficulties, family functioning and coping, post traumatic growth and spirituality and will be compared across the 3 phases. Results will be analyzed at a group level but also at an individual level (each patient separately) to test for decrease in unwanted behaviors and at a dyadic level (the person and his\u002Fher spouse) to test for the mutual effect of regulating emotions. Persons' memories will by analyzed at 3 time points by a linguistic analysis, and experience of free will after ABI will be analyzed by transcribed narratives of participants.",[85,86,87,88,89,90],"Acquired Brain Injury","Stroke\u002F Cerebrovascular Accident (Ischemic or Hemorrhagic)","Brain Tumor (After Recovery)","Encephalitis","Cerebral Anoxia","Meningitis",[92,93,94,95,96,97,98,99,100,101,102,103,104],"brain injury","dialectical behavior therapy","emotions","emotional dysregulation","behavioral disorders","spirituality","challenging behaviors","linguistic markers","emotional distress","family burden","free will","interpretative phenomenological analysis","single-case experimental design","2026-06-05",{"date":107,"type":108},"2026-06-09","ACTUAL",{"date":110,"type":108},"2022-05-19",{"date":112,"type":79},"2028-12",{"name":5,"class":6},1]