[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647138":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":49,"responsibleParty":69,"collaborators":38,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":38,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":52,"whyStopped":38,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Goethe University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Process Based Psychotherapy (PBT)","EXPERIMENTAL","In PBT, treatment planning is based on a dynamic network analysis of EMA data collected during the baseline phase. Therapists identify the central node, significant edges, self-loops, and feedback loops between the nodes. Using this information, interventions are selected based on empirical evidence for mechanisms of change that correspond to the network characteristics. These interventions are framed within an evolutionary framework as the variation, selection, and retention of an adaptive mode of the central node in relation to the specific context of the problem. The change in this key variable is monitored through daily judgments based on EMA. Treatment also focuses on additional targets to establish adaptive modes of the dimensions as defined in the positive network model. Concomitant medication is allowed and will be controlled by the study design.",[13,14],"Other: Process Based Psychotherapy (PBT)","Drug: Psychiatric medication kept constant over study duration",{"label":16,"type":17,"description":18,"interventionNames":19},"Routine practice (r-PT)","ACTIVE_COMPARATOR","In r-PT, as opposed to PBT, a naturalistic setting is retained for treatment decisions. Treatment planning follows traditional theories about the factors maintaining the disorder and interventions changing them, e.g. avoidance and exposure in anxiety disorders or reduced reinforcement of activities and behavioral activation in depression. Interventions are based on common treatment manuals related to diagnoses, e.g. CBT for depression. Individual data from the behavioral analysis are used to tailor the techniques to the individual problems of the patients. Treatment process is largely structured by personal preferences of the therapist due to experience, knowledge or recommendations of the National guidelines for the mental health problem.Concomitant medication is allowed and will be controlled by the study design.",[20,14],"Other: Routine practice",[22,27,33],{"type":6,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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],[26],"Process-based Therapy with Ecological Momentary Assessment",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Routine practice","Intervention planning as usual.",[16],[32],"Routine psychotherapy",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Psychiatric medication kept constant over study duration","Psychiatric medication is kept constant during the trial. Participants are not required to take medication. If participants enlisting in the trial are on medication however, they will be asked to keep medication constant over the study duration",[9,16],null,[40],{"name":41,"affiliation":42,"role":43},"Ulrich Stangier, PhD","Goethe Universität Frankfurt","PRINCIPAL_INVESTIGATOR",[45],{"name":41,"role":46,"phone":47,"phoneExt":38,"email":48},"CONTACT","049 1707339293","stangier@psych.uni-frankfurt.de",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"JWGUniversity","RECRUITING","Frankfurt am Main","Hesse","60486","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],8.68417,50.11552,{"lat":62,"lon":61},[65,68],{"name":66,"role":46,"phone":67,"phoneExt":38,"email":48},"Ulrich Stangier Research Professor, PhD","+491707339293",{"name":41,"role":43,"phone":38,"phoneExt":38,"email":38},{"type":43,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Prof. Dr. Ulrich Stangier","Research Professor at the Department of Clinical Psychology and Psychotherapy and Center for Psychotherapy","100647138","testing-the-effectiveness-of-process-based-therapy-in-routine-patient-care-and-assessing-its-influence-on-therapist-decision-making-100647138",false,"NCT07704138","Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making","Process Based Therapy Applicability, Effectiveness and Compatibility (PBACE). A Within Therapist Randomized Controlled Trial Testing the Effectiveness of Process Based Therapy in Routine Patient Care and Assessing Its Influence on Therapist Decision Making","PBACE","Inclusion Criteria:\n\n* A primary ICD-11 diagnosis of a depressive or anxiety disorder\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* diagnosis of a cluster A or B (DSM-5) personality disorder\n* pervasive developmental disorder, psychotic disorder, eating disorder, bipolar disorder, or severe physical illness.","ALL","18 Years","65 Years",{"count":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88],"NA","Background: Process Based Therapy (PBT) is a novel approach for a more personalized psychotherapy by integrating patient's ecological momentary assessment (EMA) data into treatment planning and focusing on empirically measured maladaptive processes. Previous pilot studies have examined the efficacy and feasibility of PBT in different settings. However, the effectiveness of this approach as well as the influence of providing EMA data on therapist's decision-making as well as treatment planning is yet unexplored.\n\nObjective: This study aims to evaluate the effectiveness of PBT in a naturalistic setting as well examine the influence of the provision of EMA data on therapists' decision-making.\n\nMethods: Thiry therapists as well as 60 patients will be recruited. Therapists will each treat two patients which are randomly allocated to either an intervention group receiving PBT or an active control group receiving routine psychotherapy. Treatment outcomes will be measured pre and post treatment as well as a 6-month follow-up. Therapists' decision making will be measured before training in PBT as well as during the treatment process using think aloud protocols (TAP) as well as quantitative measurements for decision making styles and self efficacy in decision making.\n\nDiscussion: This study could add insights into the ongoing research about the efficacy and effectiveness of PBT as well as provide insights into therapists' treatment decisions. While PBT holds theoretical promise for a more personalized and effective treatment, empirical data is still needed to assess its theoretical merit, which this study could provide. Expanding on the thus far scarce literature on decision-making in the therapeutic process, valuable information about processes guiding therapists' treatment decisions could be gained.",[91],"Depressive and Anxiety Disorders",[93,94],"Process Based Therapy","effectiveness","2026-07-09",{"date":97,"type":98},"2026-07-15","ACTUAL",{"date":100,"type":85},"2026-06-27",{"date":102,"type":85},"2029-01-01",{"name":5,"class":6},1]