[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576349":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Kaiserslautern-Landau","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"First standardized, second personalized CBT","EXPERIMENTAL","In this study arm, patients will first receive standardized and then personalized CBT. In the standardized CBT phase, a standardized CBT protocol will take place. In the personalized intervention phase, person-specific networks are estimated. A network-based algorithm indicates the treatment target. Participants will receive one out of ten CBT modules addressing their treatment target. A hybrid therapy option, i.e., partially online, will be available. The decision lies with the respective therapists and will be documented as a variable.",[13,14],"Behavioral: personalized Cognitive Behavior Therapy including third-wave","Behavioral: standardized Cognitive Behavior Therapy including third-wave",{"label":16,"type":10,"description":17,"interventionNames":18},"First personalized, second standardized CBT","In this study arm, patients will first receive standardized and then personalized CBT. In the personalized intervention phase, person-specific networks are estimated. A network-based algorithm indicates the treatment target. Participants will receive one out of ten CBT modules addressing their treatment target. In the standardized CBT phase, a manualized, standardized CBT will take place. A hybrid therapy option, i.e., partially online, will be available. The decision lies with the respective therapists and will be documented as a variable.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","personalized Cognitive Behavior Therapy including third-wave","In the personalized CBT, patients first complete 21 days of EMA with six assessment points daily to assess relevant processes of CPP models. Person-specific networks are estimated based on the EMA data. A network-based algorithm indicates the treatment target. The individual CBT modules are selected for the participants from a matching matrix that contains experts' module recommendations for specific treatment targets. After that, participants will receive one out of ten CBT modules addressing their treatment target. All treatment modules are based on evaluated treatment manuals and contain methods from Cognitive Behavior Therapy, Acceptance and Commitment Therapy or Mindful Selfcompassion.",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"standardized Cognitive Behavior Therapy including third-wave","The standardized CBT intervention is manual-based and contains five sessions of cognitive behavioral therapy. Based on the evaluated manual from EFFECT Back, a short version with 5 modules is used: attention control, relaxation techniques, behavioral activation, cognitive strategies, and consolidation.",[16,9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Felicitas Kininger, M.Sc.","CONTACT","+49 6431 280-356-53","f.kininger@rptu.de",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},"Saskia Scholten, PhD","Saskia.scholten@rptu.de",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RPTU Kaiserslautern-Landau, Klinische Psychologie und Psychotherapie des Erwachsenenalters","RECRUITING","Landau","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],8.11692,49.19844,{"lat":50,"lon":49},[53,54],{"name":32,"role":33,"phone":25,"phoneExt":25,"email":35},{"name":37,"role":33,"phone":25,"phoneExt":25,"email":55},"saskia.scholten@rptu.de",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Prof. Dr. Julia Glombiewski","Clinical professor, Head of department clinical psychology and psychotherapy for adults","100576349","network-based-vs-standardized-cognitive-behavioral-therapy-in-chronic-primary-pain-100576349",false,"NCT06784141","Network-Based vs. Standardized Cognitive Behavioral Therapy in Chronic Primary Pain","Network-Based vs. Standardized Cognitive Behavioral Therapy in Chronic Primary Pain: A Single-Case Experimental Design With Randomized Baselines","Inclusion Criteria:\n\n* main diagnosis of chronic pain (i.e. pain persists for at least 6 months and is the most prominent\u002Fmost burdensome symptom)\n* subjective impairment\u002Fdisability (yes-no)\n* access to a smartphone compatible with the app mPath\n\nExclusion Criteria:\n\n* acute hazard due to suicidality, substance abuse, and\u002For psychosis\n* only migraine\u002Fheadache or migraine\u002Fheadache are the focus of pain\n* analphabetism\n* insufficient German knowledge\n* current psychotherapy\n* current participation in another intervention study\n* physical inability to take part in therapy and study sessions","ALL","18 Years",{"count":70,"type":71},75,"ESTIMATED","INTERVENTIONAL",[74],"NA","Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for chronic primary pain (CPP), but overall effect sizes are small to moderate. Process orientation, personalization, and data-driven clinical decision-making may be able to address the heterogeneity among people with CPP and are thus promising ways to increase the effectiveness of CBT for CPP. In a previous study, the feasibility of personalized CBT for CPP using network analysis was investigated. Based on this work, the present study aims to compare this personalized CBT with a standardized CBT as treatment-as-usual condition.\n\nIn a balanced repeated measures design, a personalized CBT intervention is compared with a standardized CBT intervention. Participants are patients with CPP in German outpatient clinics. Primary and secondary outcome measures (disability, treatment expectations, pain intensity, working alliance, and side effects) will be collected after each study period. In addition, a SCED with randomized baselines will be embedded in the study, in which changes in processes relevant to chronic pain will be evaluated.",[77],"Chronic Primary Pain",[79,80,81,82,83],"Chronic Pain","Single Case Experimental Design","Ecological Momentary Assessment","Network Analysis","Cognitive Behavior Therapy","2025-04-30",{"date":86,"type":87},"2025-05-01","ACTUAL",{"date":89,"type":71},"2025-04",{"date":91,"type":71},"2027-04",{"name":58,"class":6},1]