[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635771":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":35,"locations":41,"responsibleParty":63,"collaborators":24,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"National Institute of Mental Health, Czech Republic","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Unified Protocol (UP)","EXPERIMENTAL","A manualised transdiagnostic cognitive-behavioural therapy for emotional disorders, delivered individually in 14-16 sessions (approximately 60 minutes each) over approximately 14 weeks, following the UP therapist guide\u002Fmanual.",[13],"Behavioral: Unified Protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as Usual (TAU)","ACTIVE_COMPARATOR","Participants receive treatment as usual (TAU) in routine outpatient care at NÚDZ. TAU consists of standard psychotherapy delivered according to clinical indication and service availability; the modality may vary (e.g., psychodynamic\u002Fpsychoanalytic\u002Fintegrative). Treatment is provided during the approximately 14-week study observation period.",[19],"Behavioral: Treatment as usual (TAU)",{"label":21,"type":22,"description":23,"interventionNames":24},"Waiting List (WL)","NO_INTERVENTION","Participants are assigned to a waitlist condition and receive no active study psychotherapy during the approximately 14-week observation period. They complete the same assessment schedule as other arms (baseline and post-assessment). After completion of study assessments, participants are offered treatment.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","Unified Protocol","Manualised transdiagnostic cognitive-behavioural psychotherapy delivered individually according to the Unified Protocol therapist manual. Treatment consists of approximately 14-16 sessions (about 60 minutes each) delivered over \\~14 weeks in routine outpatient conditions.",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Treatment as usual (TAU)","Routine outpatient psychotherapy provided as part of standard clinical care at NÚDZ. The psychotherapy modality may vary according to clinical indication and usual practice (e.g., psychodynamic\u002Fpsychoanalytic\u002Fintegrative). Treatment is delivered over approximately the same observation window (\\~14 weeks).",[15],[36],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Eva Dreyfus, MSc.","CONTACT","+420283088282","eva.dreyfus@nudz.cz",[42],{"facility":43,"status":44,"city":45,"state":24,"zip":46,"country":47,"countryCode":24,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"National Institute of Mental healh","RECRUITING","Prague","170 00","Czechia",{"type":49,"coordinates":50},"Point",[51,52],14.42076,50.08804,{"lat":52,"lon":51},[55,58,61],{"name":56,"role":38,"phone":57,"phoneExt":24,"email":40},"Eva Dreyfus, Master of Science","+420 283088282",{"name":59,"role":38,"phone":57,"phoneExt":24,"email":60},"Maria Dodaj, Psychology Intern","maria.dodaj@nudz.cz",{"name":56,"role":62,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"type":64,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100635771","unified-protocol-for-emotional-disorders-hitop-pro-trial-100635771",false,"NCT07557017","Unified Protocol for Emotional Disorders: HiTOP-PRO Trial","Investigating the Impact of the Unified Protocol on HiTOP Dimensions and Temperamental Traits in Patients With Emotional Disorders","UP-HITOP","Inclusion Criteria: Adults aged 18-65 years.\n\nSeeking outpatient treatment at NÚDZ for emotional disorder symptoms.\n\nMeets diagnostic eligibility on ADIS-5 for at least one of the following (ICD-10 categories consistent with the protocol): F32, F33, F34, F40, F41, F42, F43, F45, F60, F61.\n\nAble to understand and complete study questionnaires and procedures (Czech language).\n\nWilling and able to participate in psychotherapy and complete assessments at baseline and post-treatment (14 weeks).\n\nIf taking psychotropic medication: dose stable for ≥6 weeks prior to enrolment and expected to remain stable during the acute study period where clinically feasible.\n\nProvides written informed consent.\n\nExclusion Criteria: Current or lifetime psychotic disorder or current manic\u002Fhypomanic episode.\n\nHigh acute suicide risk requiring a higher level of care (e.g., imminent risk, recent serious attempt) or current severe self-harm risk incompatible with outpatient psychotherapy study procedures.\n\nPrimary substance use disorder requiring specialised treatment or acute intoxication\u002Fwithdrawal.\n\nSevere cognitive impairment or neurodevelopmental\u002Fneurological condition that prevents valid consent or completion of study procedures.\n\nConcurrent psychological treatment that would conflict with study participation (e.g., starting a new structured psychotherapy during the 14-week study period), unless it constitutes the assigned TAU.\n\nImmediate need for intensive treatment (e.g., inpatient admission) at the time of screening.\n\nInability to commit to the study schedule or complete required assessments.","ALL","18 Years",{"count":76,"type":77},90,"ESTIMATED","INTERVENTIONAL",[80],"NA","This randomised, parallel-group clinical trial evaluates the effects of the Unified Protocol (UP), a transdiagnostic cognitive-behavioural psychotherapy, on dimensional symptom outcomes aligned with the Hierarchical Taxonomy of Psychopathology (HiTOP) and on related temperamental\u002Fpersonality traits in adults with emotional disorders. Participants are randomly assigned (1:1:1) to UP, treatment as usual (TAU), or a waitlist (WL). Outcomes are assessed at baseline and after approximately 14 weeks. A planned follow-up assessment approximately 3 months after treatment completion is collected in the UP arm only.",[83],"Emotional Disorder",[85,86,87,88,89,90,91],"emotional disorders","unified protocol","HiTOP","Hierarchical Taxonomy Of Psychopathology","transdiagnostic therapy","personality traits","temperamental traits","2026-04-22",{"date":94,"type":95},"2026-04-29","ACTUAL",{"date":97,"type":95},"2025-10-08",{"date":99,"type":77},"2028-07-31",{"name":5,"class":6},1]