[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438987":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":98,"centralContacts":103,"locations":114,"responsibleParty":257,"collaborators":259,"id":282,"slug":283,"hasResults":284,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":284,"sex":290,"minAge":291,"maxAge":292,"enrollmentInfo":293,"targetDuration":138,"studyType":296,"phases":297,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":117,"whyStopped":138,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},{"fullName":5,"class":6},"University of Greifswald","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Behavioral Analysis System of Psychotherapy (CBASP)","EXPERIMENTAL","Cognitive Behavioral Analysis System of Psychotherapy (CBASP) as acute treatment (5 wk. inpatient and 5 wk. either inpatient or dayclinic) followed by continuation treatment (6 wk. outpatient group therapy).",[13,14,15,16,17,18],"Behavioral: inpatient CBASP individual therapy","Behavioral: inpatient CBASP group therapy","Behavioral: inpatient CBASP nurse contact","Behavioral: inpatient CBASP exercise therapy","Behavioral: outpatient CBASP group therapy","Drug: algorithm-based study medication",{"label":20,"type":21,"description":22,"interventionNames":23},"Behavioral Activation (BA)","ACTIVE_COMPARATOR","Behavioral Activation (BA) as acute treatment (5 wk. inpatient and 5 wk. either inpatient or dayclinic) followed by continuation treatment (6 wk. outpatient group therapy).",[24,25,26,27,28,18],"Behavioral: inpatient BA individual therapy","Behavioral: inpatient BA group therapy","Behavioral: inpatient BA nurse contact","Behavioral: inpatient BA exercise therapy","Behavioral: outpatient BA group therapy",[30,37,43,49,55,61,67,73,79,85,91],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","inpatient CBASP individual therapy","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 2 individual CBASP therapy sessions (duration: 50 min per session).",[9],[36],"Cognitive Behavioral Analysis System of Psychotherapy - inpatient individual therapy",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"inpatient CBASP group therapy","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 2 CBASP group therapy sessions (duration: 100 min per session).",[9],[42],"Cognitive Behavioral Analysis System of Psychotherapy - inpatient group therapy",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"inpatient CBASP nurse contact","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 1 CBASP nurse contact (duration: 25 min per session).",[9],[48],"Cognitive Behavioral Analysis System of Psychotherapy - inpatient nurse contact",{"type":31,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"inpatient CBASP exercise therapy","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 1 CBASP exercise therapy (duration: 75 min per session).",[9],[54],"Cognitive Behavioral Analysis System of Psychotherapy - inpatient exercise therapy",{"type":31,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"outpatient CBASP group therapy","During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).",[9],[60],"Cognitive Behavioral Analysis System of Psychotherapy - outpatient group therapy",{"type":31,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"inpatient BA individual therapy","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 2 individual BA therapy sessions (duration: 50 min per session).",[20],[66],"Behavioral Activation - inpatient individual therapy",{"type":31,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"inpatient BA group therapy","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 2 BA group therapy sessions (duration: 100 min per session).",[20],[72],"Behavioral Activation - inpatient group therapy",{"type":31,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"inpatient BA nurse contact","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 1 BA nurse contact (duration: 25 min per session)",[20],[78],"Behavioral Activation - inpatient nurse contact",{"type":31,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"inpatient BA exercise therapy","During the 5-week inpatient phase I and the 5-week inpatient phase II \u002F dayclinic treatment all patients in this arm will receive 1 BA exercise therapy (duration: 75 min per session).",[20],[84],"Behavioral Activation - inpatient exercise therapy",{"type":31,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"outpatient BA group therapy","During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).",[20],[90],"Behavioral Activation - outpatient group therapy",{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"DRUG","algorithm-based study medication","All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse:\n\n* 1st line dose escalation (if appropriate)\n* 2nd line lithium augmentation\n* 3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants\n* 4th line change of antidepressant.",[20,9],[97],"antidepressant medication",[99],{"name":100,"affiliation":101,"role":102},"Eva-Lotta Brakemeier, Prof. Dr.","University Greifswald","PRINCIPAL_INVESTIGATOR",[104,109],{"name":100,"role":105,"phone":106,"phoneExt":107,"email":108},"CONTACT","+49 3834 420","3718","eva-lotta.brakemeier@uni-greifswald.de",{"name":110,"role":105,"phone":111,"phoneExt":112,"email":113},"Johannes Zimmermann, Prof. Dr.","+49 561 804","3833","jz@uni-kassel.de",[115,139,157,167,185,203,221,239],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"Charité, University Medicine Berlin","RECRUITING","Berlin","State of Berlin","10117","Germany","DE",{"type":124,"coordinates":125},"Point",[126,127],13.41053,52.52437,{"lat":127,"lon":126},[130,135],{"name":131,"role":105,"phone":132,"phoneExt":133,"email":134},"Stephan Köhler, Prof. Dr.","49-30-450","617408","stephan.koehler@charite.de",{"name":136,"role":137,"phone":138,"phoneExt":138,"email":138},"Henrik Walter, Prof. Dr.","SUB_INVESTIGATOR",null,{"facility":140,"status":117,"city":141,"state":138,"zip":142,"country":121,"countryCode":122,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Universitätsklinikum Bonn","Bonn","53127",{"type":124,"coordinates":144},[145,146],7.09549,50.73438,{"lat":146,"lon":145},[149,153],{"name":150,"role":105,"phone":151,"phoneExt":138,"email":152},"Alexandra Philipsen, Prof. Dr.","+49-228-287-15723","alexandra.philipsen@ukbonn.de",{"name":154,"role":105,"phone":155,"phoneExt":138,"email":156},"Silke Lux, Prof. Dr.","+49-228-287-16368","silke.lux@ukbonn.de",{"facility":158,"status":159,"city":160,"state":138,"zip":161,"country":121,"countryCode":122,"cosmosGeoPoint":162,"geoPoint":166,"contacts":138},"Medizinische Hochschule Hannover","TERMINATED","Hanover","30625",{"type":124,"coordinates":163},[164,165],9.73322,52.37052,{"lat":165,"lon":164},{"facility":168,"status":117,"city":169,"state":138,"zip":170,"country":121,"countryCode":122,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Universitätsklinikum Jena","Jena","07743",{"type":124,"coordinates":172},[173,174],11.5899,50.92878,{"lat":174,"lon":173},[177,181],{"name":178,"role":105,"phone":179,"phoneExt":138,"email":180},"Nils Opel, Prof. Dr.","+49 - 3641-9-390101","nils.opel@med.uni-jena.de",{"name":182,"role":105,"phone":183,"phoneExt":138,"email":184},"Martin Walter, Prof. Dr.","+49-3641-9390102","martin.walter@med.uni-jena.de",{"facility":186,"status":117,"city":187,"state":138,"zip":188,"country":121,"countryCode":122,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Universität zu Lübeck","Lübeck","23562",{"type":124,"coordinates":190},[191,192],10.68729,53.86893,{"lat":192,"lon":191},[195,199],{"name":196,"role":105,"phone":197,"phoneExt":138,"email":198},"Philipp Klein, PD Dr.","+49-451-500-98871","philipp.klein@uksh.de",{"name":200,"role":105,"phone":201,"phoneExt":138,"email":202},"Bartosz Zurowski, Dr. med.","+49-451-500-98831","bartosz.zurowski@uksh.de",{"facility":204,"status":117,"city":205,"state":138,"zip":206,"country":121,"countryCode":122,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Universitätsklinikum Marburg","Marburg","35039",{"type":124,"coordinates":208},[209,210],8.77069,50.80904,{"lat":210,"lon":209},[213,217],{"name":214,"role":105,"phone":215,"phoneExt":138,"email":216},"Tilo Kircher, Prof. Dr.","+49-6421-58-65200","tilo.kircher@staff.uni-marburg.de",{"name":218,"role":105,"phone":219,"phoneExt":138,"email":220},"Ina Kluge, Dr.","+49-6421-58-6219","ina.kluge@staff.uni-marburg.de",{"facility":222,"status":117,"city":223,"state":138,"zip":224,"country":121,"countryCode":122,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Klinikum der Universität München","München","80336",{"type":124,"coordinates":226},[227,228],13.31243,51.60698,{"lat":228,"lon":227},[231,235],{"name":232,"role":105,"phone":233,"phoneExt":138,"email":234},"Frank Padberg, Prof. Dr.","+49-89 4400-53358","frank.padberg@med.uni-muenchen.de",{"name":236,"role":105,"phone":237,"phoneExt":138,"email":238},"Matthias Reinhard, Dr.","+49-89 4400-55512","matthias.reinhard@med.uni-muenchen.de",{"facility":240,"status":117,"city":241,"state":138,"zip":242,"country":121,"countryCode":122,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Universitätsklinikum Tübingen","Tübingen","72076",{"type":124,"coordinates":244},[245,246],9.05222,48.52266,{"lat":246,"lon":245},[249,253],{"name":250,"role":105,"phone":251,"phoneExt":138,"email":252},"Andreas Fallgatter, Prof. Dr.","+49-7071-29-84858","andreas.fallgatter@med.uni-tuebingen.de",{"name":254,"role":105,"phone":255,"phoneExt":138,"email":256},"Rainald Mössner, Prof. Dr.","+49-7071-29-4141","rainald.moessner@med.uni-tuebingen.de",{"type":258,"investigatorFullName":138,"investigatorTitle":138,"investigatorAffiliation":138,"oldNameTitle":138,"oldOrganization":138},"SPONSOR",[260,262,264,266,268,270,272,274,276,278,280],{"name":261,"class":6},"German Research Foundation",{"name":263,"class":6},"University of Kassel",{"name":265,"class":6},"University Medicine Greifswald",{"name":267,"class":6},"Charite University, Berlin, Germany",{"name":269,"class":6},"Hannover Medical School",{"name":271,"class":6},"University Hospital Lübeck",{"name":273,"class":6},"Philipps University Marburg",{"name":275,"class":6},"Ludwig-Maximilians - University of Munich",{"name":277,"class":6},"University Hospital Tuebingen",{"name":279,"class":6},"University Hospital, Bonn",{"name":281,"class":6},"Jena University Hospital","100438987","a-comparison-of-two-psychotherapy-programs-in-persistently-depressed-treatment-resistant-inpatients-100438987",false,"NCT04996433","A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients","Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Behavioral Activation (BA) in Persistently Depressed Treatment-resistant Inpatients: Efficacy, Moderators, and Mediators of Change","ChangePDD","Inclusion Criteria:\n\n* Primary DSM-5 diagnosis of PDD (300.4, 296.2x, 296.3x)\n* Total Hamilton Depression Rating Scale (HDRS-24) Score ≥ 20\n* Treatment-resistance (TR) (defined by the ATHF-SF or medication intolerance or one psychotherapy at least 25 sessions by a certified therapist in the current episode)\n* Sufficient knowledge of the German language\n* Written informed consent\n\nExclusion Criteria:\n\n* Bipolar I or II disorder\n* Active substance use disorders (abstinence shorter than 6 months)\n* Schizophrenia spectrum and other psychotic disorders\n* Antisocial personality disorder\n* Acute suicidality (HRSD item 3 \\> 2 or agreement with C-SSRS item 4 and\u002For item 5)\n* Previous CBASP or BA treatment within the last year\n* Inability to tolerate CBASP or BA (e.g., organic brain disorders, severe cognitive deficits)\n* Inability to participate in dayclinic or outpatient continuation treatment\n* Participation in another (psycho)therapeutic study of an interventional nature","ALL","18 Years","75 Years",{"count":294,"type":295},396,"ESTIMATED","INTERVENTIONAL",[298],"NA","The purpose of this study is to compare the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) conducted over 16 weeks (acute and continuation treatment) with Behavioral Activation (BA; same dose and duration) in persistently depressed treatment-resistant inpatients regarding efficacy, moderators and mediators of change.",[301,302],"Persistent Depressive Disorder","Treatment-resistant Depression",[304,305,306,307,308,309,310,311],"Psychotherapy","Depression","Inpatient Treatment","Child Maltreatment","Epigenetic","Moderator","Mediator","Efficacy","2026-05-20",{"date":314,"type":315},"2026-05-26","ACTUAL",{"date":317,"type":315},"2021-12-01",{"date":319,"type":295},"2028-04",{"name":5,"class":6},8]