[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438987":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":98,"centralContacts":103,"locations":114,"responsibleParty":256,"collaborators":258,"id":281,"slug":137,"hasResults":282,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":282,"sex":288,"minAge":289,"maxAge":290,"enrollmentInfo":291,"targetDuration":137,"studyType":294,"phases":295,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":117,"whyStopped":137,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},{"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",[115,138,156,166,184,202,220,238],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"Charité, University Medicine Berlin","RECRUITING","Berlin","State of Berlin","10117","Germany",{"type":123,"coordinates":124},"Point",[125,126],13.41053,52.52437,{"lat":126,"lon":125},[129,134],{"name":130,"role":105,"phone":131,"phoneExt":132,"email":133},"Stephan Köhler, Prof. Dr.","49-30-450","617408","stephan.koehler@charite.de",{"name":135,"role":136,"phone":137,"phoneExt":137,"email":137},"Henrik Walter, Prof. Dr.","SUB_INVESTIGATOR",null,{"facility":139,"status":117,"city":140,"state":137,"zip":141,"country":121,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Universitätsklinikum Bonn","Bonn","53127",{"type":123,"coordinates":143},[144,145],7.09549,50.73438,{"lat":145,"lon":144},[148,152],{"name":149,"role":105,"phone":150,"phoneExt":137,"email":151},"Alexandra Philipsen, Prof. Dr.","+49-228-287-15723","alexandra.philipsen@ukbonn.de",{"name":153,"role":105,"phone":154,"phoneExt":137,"email":155},"Silke Lux, Prof. Dr.","+49-228-287-16368","silke.lux@ukbonn.de",{"facility":157,"status":158,"city":159,"state":137,"zip":160,"country":121,"cosmosGeoPoint":161,"geoPoint":165,"contacts":137},"Medizinische Hochschule Hannover","TERMINATED","Hanover","30625",{"type":123,"coordinates":162},[163,164],9.73322,52.37052,{"lat":164,"lon":163},{"facility":167,"status":117,"city":168,"state":137,"zip":169,"country":121,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Universitätsklinikum Jena","Jena","07743",{"type":123,"coordinates":171},[172,173],11.5899,50.92878,{"lat":173,"lon":172},[176,180],{"name":177,"role":105,"phone":178,"phoneExt":137,"email":179},"Nils Opel, Prof. Dr.","+49 - 3641-9-390101","nils.opel@med.uni-jena.de",{"name":181,"role":105,"phone":182,"phoneExt":137,"email":183},"Martin Walter, Prof. Dr.","+49-3641-9390102","martin.walter@med.uni-jena.de",{"facility":185,"status":117,"city":186,"state":137,"zip":187,"country":121,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Universität zu Lübeck","Lübeck","23562",{"type":123,"coordinates":189},[190,191],10.68729,53.86893,{"lat":191,"lon":190},[194,198],{"name":195,"role":105,"phone":196,"phoneExt":137,"email":197},"Philipp Klein, PD Dr.","+49-451-500-98871","philipp.klein@uksh.de",{"name":199,"role":105,"phone":200,"phoneExt":137,"email":201},"Bartosz Zurowski, Dr. med.","+49-451-500-98831","bartosz.zurowski@uksh.de",{"facility":203,"status":117,"city":204,"state":137,"zip":205,"country":121,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Universitätsklinikum Marburg","Marburg","35039",{"type":123,"coordinates":207},[208,209],8.77069,50.80904,{"lat":209,"lon":208},[212,216],{"name":213,"role":105,"phone":214,"phoneExt":137,"email":215},"Tilo Kircher, Prof. Dr.","+49-6421-58-65200","tilo.kircher@staff.uni-marburg.de",{"name":217,"role":105,"phone":218,"phoneExt":137,"email":219},"Ina Kluge, Dr.","+49-6421-58-6219","ina.kluge@staff.uni-marburg.de",{"facility":221,"status":117,"city":222,"state":137,"zip":223,"country":121,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Klinikum der Universität München","München","80336",{"type":123,"coordinates":225},[226,227],13.31243,51.60698,{"lat":227,"lon":226},[230,234],{"name":231,"role":105,"phone":232,"phoneExt":137,"email":233},"Frank Padberg, Prof. Dr.","+49-89 4400-53358","frank.padberg@med.uni-muenchen.de",{"name":235,"role":105,"phone":236,"phoneExt":137,"email":237},"Matthias Reinhard, Dr.","+49-89 4400-55512","matthias.reinhard@med.uni-muenchen.de",{"facility":239,"status":117,"city":240,"state":137,"zip":241,"country":121,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Universitätsklinikum Tübingen","Tübingen","72076",{"type":123,"coordinates":243},[244,245],9.05222,48.52266,{"lat":245,"lon":244},[248,252],{"name":249,"role":105,"phone":250,"phoneExt":137,"email":251},"Andreas Fallgatter, Prof. Dr.","+49-7071-29-84858","andreas.fallgatter@med.uni-tuebingen.de",{"name":253,"role":105,"phone":254,"phoneExt":137,"email":255},"Rainald Mössner, Prof. Dr.","+49-7071-29-4141","rainald.moessner@med.uni-tuebingen.de",{"type":257,"investigatorFullName":137,"investigatorTitle":137,"investigatorAffiliation":137,"oldNameTitle":137,"oldOrganization":137},"SPONSOR",[259,261,263,265,267,269,271,273,275,277,279],{"name":260,"class":6},"German Research Foundation",{"name":262,"class":6},"University of Kassel",{"name":264,"class":6},"University Medicine Greifswald",{"name":266,"class":6},"Charite University, Berlin, Germany",{"name":268,"class":6},"Hannover Medical School",{"name":270,"class":6},"University Hospital Lübeck",{"name":272,"class":6},"Philipps University Marburg",{"name":274,"class":6},"Ludwig-Maximilians - University of Munich",{"name":276,"class":6},"University Hospital Tuebingen",{"name":278,"class":6},"University Hospital, Bonn",{"name":280,"class":6},"Jena University Hospital","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":292,"type":293},396,"ESTIMATED","INTERVENTIONAL",[296],"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.",[299,300],"Persistent Depressive Disorder","Treatment-resistant Depression",[302,303,304,305,306,307,308,309],"Psychotherapy","Depression","Inpatient Treatment","Child Maltreatment","Epigenetic","Moderator","Mediator","Efficacy","2026-05-20",{"date":312,"type":313},"2026-05-26","ACTUAL",{"date":315,"type":313},"2021-12-01",{"date":317,"type":293},"2028-04",{"name":5,"class":6},8]