[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519966":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":73,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":36,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":56,"whyStopped":36,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",[8,13,19],{"label":9,"type":6,"description":10,"interventionNames":11},"Treatment as Usual (TAU)","The TAU condition will follow the standard treatment of the EDs Unit of the HSCSP for AN. This treatment consists of visits with a psychiatrist with a frequency decided according to the clinical situation and, in some cases, nursing follow-up and\u002For relapse prevention group that takes place twice per month",[12],"Other: Treatment As Usual",{"label":14,"type":15,"description":16,"interventionNames":17},"TAU + Radically Open Dialectical Behaviour Therapy (RO-DBT)","EXPERIMENTAL","2\\. TAU + skills of the RO-DBT: In this treatment branch, a RO-DBT skills training therapy will be added to TAU. Treatment and therapists: RO DBT skills training consists of a 30-week intervention program in which a set of skills specifically designed to treat overcontrol are taught on an ongoing basis. The duration of each session is 2 hours. Table X provides an overall summary of each skill training session content. Detailed and extensive information about the treatment can be found elsewhere \\[24\\], \\[34\\]. Three clinical psychologists and one psychiatrist will conduct the treatment, all of whom have undergone extensive training in RO DBT. A maximum of two therapists will be in charge of each session, and the same two therapists will go throughout each group intervention. The team will be supervised by an approved RO DBT supervisor to improve therapeutic skills and ensure adherence to the protocol.",[18],"Behavioral: Radically Open Dialectical Behaviour Therapy (RO-DBT)",{"label":20,"type":6,"description":21,"interventionNames":22},"Healty controls","All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.",[23],"Other: No intervention",[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Radically Open Dialectical Behaviour Therapy (RO-DBT)","RO-DBT is a transdiagnostic intervention specifically designed to treat a spectrum of disorders characterized by excessive overcontrol such as resistant depression, avoidant and obsessive-compulsive personality disorders, mood disorders, anorexia nervosa and autism spectrum disorder.",[14],[31],"non",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Treatment As Usual","he TAU condition will follow the standard treatment of the EDs Unit of the HSCSP for AN. This treatment consists of visits with a psychiatrist with a frequency decided according to the clinical situation and, in some cases, nursing follow-up and\u002For relapse prevention group that takes place twice per month",[9],null,{"type":6,"name":38,"description":21,"armGroupLabels":39,"otherNames":36},"No intervention",[20],[41],{"name":42,"affiliation":5,"role":43},"Cristina Carmona","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":36,"email":49},"Cristina Carmona, Doctor","CONTACT","0034650003427","ccarmonaf@santpau.cat",{"name":51,"role":47,"phone":36,"phoneExt":36,"email":52},"Aina Avila","aavila@santpau.cat",[54],{"facility":55,"status":56,"city":57,"state":36,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Hospital de la Santa Creu i Sant Pau","RECRUITING","Barcelona","08041","Spain","ES",{"type":62,"coordinates":63},"Point",[64,65],2.15899,41.38879,{"lat":65,"lon":64},[68,71],{"name":69,"role":47,"phone":70,"phoneExt":36,"email":49},"Cristina Carmona, Phd","+34935537813",{"name":69,"role":47,"phone":72,"phoneExt":36,"email":49},"650003427",{"type":74,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[76],{"name":77,"class":6},"Fundació La Marató de TV3","100519966","radically-open-dialectical-behaviour-therapy-in-patients-with-anorexia-nervosa-100519966",false,"NCT06050421","Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa","Evaluating the Efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in Patients With Anorexia Nervosa: a Randomized Controlled Clinical Trial","RODBT-AN","Inclusion Criteria:\n\n* female patients\n* aged between 18 to 65 years old,\n* having a diagnosis of AN (DSM 5 criteria),\n* having had weigh restoration treatment (normal BMI considered \\>19 kg\u002Fm2)\n* having an overcontrol personality style assessed with the styles of coping Word-Pair Checklist scale (ASC-WP)\n\nExclusion Criteria:\n\n* diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder)\n* diagnosis of borderline personality disorder (BPD) or positive result in McLean Screening Instrument for BPD\n* mental retardation\n* being under standardized psychotherapy at the baseline\n* being illiterate or not able to understand Spanish language,\n* being left-handed\n* being pregnant for MRI requirements.",true,"FEMALE","18 Years","65 Years",{"count":91,"type":92},96,"ESTIMATED","INTERVENTIONAL",[95],"NA","Randomized controlled clinical trial to evaluate the efficacy of \"Radically Open Dialectical Behaviour Therapy\" in patients with eating disorders: a proof-of-concept study.",[98,99,100],"Anorexia Nervosa","Anorexia Nervosa in Remission","Anorexia Nervosa Restricting Type",[102],"anorexia nervosa, RODBT","2023-09-15",{"date":105,"type":106},"2023-09-22","ACTUAL",{"date":108,"type":106},"2023-06-22",{"date":110,"type":92},"2026-06-30",{"name":5,"class":6},1]