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Unified Protocol for Emotional Disorders: HiTOP-PRO Trial
Sponsor: National Institute of Mental Health, Czech Republic
Summary
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/personality 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.
Official title: Investigating the Impact of the Unified Protocol on HiTOP Dimensions and Temperamental Traits in Patients With Emotional Disorders
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-10-08
Completion Date
2028-07-31
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
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.
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/psychoanalytic/integrative). Treatment is delivered over approximately the same observation window (\~14 weeks).
Locations (1)
National Institute of Mental healh
Prague, Czechia