[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555861":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":61,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Goethe University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Process-based Cognitive Behavioral Therapy","EXPERIMENTAL","In PBT (20 sessions), treatment is initiated by a collaborative interpretation of the dynamic network model using smartphone-based Ecological Momentary Assessment collected during the baseline. Based on the outcome of the dynamic network model, interventions are selected on the basis of empirical evidence for mechanisms of change matching to the central node of the individual patient, besides feedback loops and self-loops, as the key process maintaining the maladaptive pattern. Interventions are conceptualized in the evolutionary framework as variation, selection and retention of an adaptive mode of the central node related to the specific context of the problem. The change of this variable is monitored using daily judgements on the basis of EMA. Further treatment planning focuses on additional targets to establish the adaptive modes of the dimensions as defined in the positive network model. Concomitant medication is allowed and will be controlled in statistical analyses.",[13],"Other: Process-based Cognitive Behavioral Therapy (PBT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Cognitive Behavioral Therapy","ACTIVE_COMPARATOR","In r-CBT (20 sessions) a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the effects of the interventions on factors maintaining the disorder, e.g. avoidance and exposure in anxiety disorder or reduced reinforcement of activities and behavioral activation in depression. Interventions are selected on the basis of common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to taylor the techniques to the problem behaviors or dysfunctional thoughts of patients. Treatment process focuses mainly on the implementation of the manualized interventions adapted to the individual patient as recommended in the National guidelines for treatment of depression and anxiety disorders. Concomitant medication is allowed and will be controlled in statistical analyses.",[19],"Other: Cognitive Behavioral Therapy (CBT)",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Process-based Cognitive Behavioral Therapy (PBT)","PBT (20 sessions), intervention planning based on the use of EMA data, feedback of dynamic network analysis and matching of interventions to central nodes of the network.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Cognitive Behavioral Therapy (CBT)","CBT (20 sessions), intervention planning as usual based on manual.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Ulrich Stangier, PhD","CONTACT","049 1707339293","stangier@psych.uni-frankfurt.de",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"JWGUniversity","RECRUITING","Frankfurt am Main","Hesse","60486","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],8.68417,50.11552,{"lat":49,"lon":48},[52,55,58],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":35},"Ulrich Stangier, Prof.","800-555-5555",{"name":56,"role":33,"phone":57,"phoneExt":25,"email":35},"Stangier","0491707339293",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Ulrich Stangier","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Prof. Dr. Ulrich Stangier","Director of the Department of Clinical Psychology and Psychotherapy and Center for Psychotherapy",[65],{"name":66,"class":6},"Philipps University Marburg","100555861","process-based-therapy-for-difficult-to-treat-anxiety-disorders-and-depression-100555861",false,"NCT06517589","Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression","Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression","PBTRAND","Inclusion Criteria:\n\n* A primary DSM-5 diagnosis of depressive or anxiety disorder\n* At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)\n* Age 18-65 years\n* Sufficient knowledge of the German language\n* Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period\n\nExclusion Criteria:\n\n* Increased suicidality\n* Substance abuse or dependency\n* Borderline personality disorder\n* Pervasive developmental disorder\n* Psychotic disorder\n* Eating disorder\n* Bipolar disorder\n* Severe physical illness","ALL","18 Years","65 Years",{"count":79,"type":80},80,"ESTIMATED","INTERVENTIONAL",[83],"NA","The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.",[86,87],"Depression","Anxiety Disorder","2024-07-28",{"date":90,"type":91},"2024-07-30","ACTUAL",{"date":93,"type":91},"2024-01-29",{"date":95,"type":80},"2025-07-30",{"name":5,"class":6},1]